Policy Statement

All research involving the use of human subjects under the auspices of Misericordia University conducted by Misericordia University's faculty, staff or students and/or sponsored by the university, must be reviewed and approved prior to the start of the research. Once initiated, the research must be conducted in full compliance with IRB policies and procedures.

Who Should Read This Policy

All research involving human subjects must be reviewed and approved by the IRB prior to the start of the research. This policy applies to:

1.   Misericordia University faculty, administration, staff, and students 

2.   Studies sponsored by the University 

3.   Agents of Misericordia University in connection with his or her institutional responsibilities or using any institutional property or facility 

4.   Studies conducted by non-Misericordia University investigators when Misericordia University faculty, administration, staff, or students are involved 

The Policy

Background

The Public Health Services Act (Title IV, Part G, Section 491a) required the Department of Health and Human Services (DHHS) to issue regulations for the protection of human subjects of research and to implement a program of instruction and guidance in ethical issues associated with such research. The regulations are codified as Title 45 Part 46 of the Code of Federal Regulations (45 CFR 46), issued on June 18, 1991 and revised and published on January 19, 2017. In accordance with Misericordia University's IRB Policies and Procedures and the Federalwide Assurance for the Protection of Human Subjects (#00008971), Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP) (OHRP registered IRB Organization Number IORG0004091), all research conducted by or under the auspices of Misericordia University must be performed in accordance with 45 CFR 46 Parts A, B, C, and D, and conform to federal, state, and local laws.

Authority

In connection with research conducted or proposed to be conducted on human subjects, the IRB performs critical oversight functions to ensure applicable scientific, ethical, and regulatory standards are met. The IRB reviews and monitors research sponsored by the University and/or conducted by:

1.   Misericordia University faculty, administration, staff, and students 

2.   Studies sponsored by the University 

3.   Agents of Misericordia University in connection with their institutional responsibilities or using any institutional property or facility 

4.   Non-Misericordia University investigators when Misericordia University faculty, administration, staff, or students are involved 

The Institutional Official (IO) grants the IRB the responsibility and authority to:

1.   Review, approve, modify, or disapprove new and continuing research projects involving human participants 

2.   Monitor and review, approve, modify, or disapprove approved projects including regularly scheduled continuing review at least every twelve months 

3.   Verify compliance with approved research protocols 

4.   Review, approve, modify, or disapprove all planned changes to protocols prior to implementation 

5.   Review all adverse events occurring in approved projects or in other projects related in context to the approved projects 

6.   Restrict approved research activities to protect participants when necessary 

7.   Suspend/terminate previously approved protocols for non-compliance with established policies 

8.   Observe, or have a third party observe, the consent process 

9.   Observe, or have a third party observe, the conduct of research 

The IRB administrator has the responsibility of communicating to the University administration the outcomes of the reviews conducted by the IRB. As such, the IO and his or her designee will be given access to the online IRB submission system to view meeting minutes and decisions. The University administration has the right to disapprove a protocol approved by the IRB; however, it does not have the right to approve a protocol not approved by the IRB.

The IRB is responsible for establishing and administering University policies and procedures related to the implementation of or compliance with federal, state, and local regulations that govern the protection of individuals participating in human subjects research. The establishment of Misericordia University's IRB and its policies and procedures are derived primarily from 45 CFR 46. The policies and procedures are intended to provide a resource for the preparation and submission of research protocols for IRB reviews. A copy of 45 CFR 46 and the Belmont Report are provided to IRB members to guide them in their decision making relative to each research protocol. The Belmont Report (Click Here to View) and 45 CFR 46 (Click Here to View) are available for anyone wishing access to them at the websites provided.

Ethical Principles, Issues, and Guidance for the Use of Human Subjects in Research

The regulations in 45 CFR 46 are based on the Belmont Report (Click Here to View) which was developed in the 1970's by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report presented three basic ethical principles. The principles of respect for persons, beneficence, and justice remain as essential requirements for the ethical conduct of research involving human subjects. Respect for persons recognizes personal dignity and autonomy of individuals and protection of those that have diminished autonomy. Beneficence includes an obligation to protect individuals from harm by minimizing risks of harm and maximizing benefits. Justice requires that the burdens and benefits of research be distributed fairly.

The IRB considers the subsequent areas of the policy in determining the nature of risks and the extent to which the benefits of the study justify exposing the subjects to risk.

Participation by human subjects must be voluntary, i.e., must occur as a result of free choice, without compulsion or obligation, based upon disclosure of relevant information in a clear, concise and understandable way. The researcher must take care to avoid coercing participation by subjects.

Subjects can be offered some form of incentive or reward for their participation.  Inducements are allowable as long as they are minimal and are not more attractive to some subjects than to others. The primary ethical issue involves the extent to which an inducement might be sufficiently large enough to cloud a person's judgment about whether or not participation in the study is in his/her best interest. In cases where students may earn extra credit from professors, other options to earn extra credit besides research participation must be available. Alternatives to participating in research should be comparable in time and effort to participation in the research study.

Researchers who are professors must not do recruiting of research subjects in their classes. They may have one of their colleagues or research assistants do the recruitment. Precautions must be taken to safeguard against students' perceptions that they are expected to participate in studies conducted by their professors in order to remain in good standing. (See section "Research with Misericordia University Students.")

A second issue involves the extent to which individuals can reasonably choose not to participate, especially in a case where they are approached as a large group such as in a class. This is particularly problematic when the research involves a sensitive issue. For example, if the study focuses on AIDS and a person chooses not to participate, it could be interpreted that the person has AIDS. In such cases, the researcher/recruiter must demonstrate that he/she has recognized this risk and taken appropriate action to protect those who may be at risk. For example, the researcher provides a means of recruitment that does not openly implicate those who choose not to participate.

Advertisements, fliers, or brochures prepared to recruit and inform potential subjects about a research study are considered part of the informed consent process and, as such, also require review and approval by the IRB.

Flyers, posters, and brochures placed in public areas or disseminated through digital means may be used to solicit research participation.  IRB approval is needed for the use of such advertisements and additional approvals from the various sites where they will be posted may also be requested.  All types of advertisement must include information that is presented in such a way that subjects can make an informed decision about whether to participate.  The following information is required on all advertisements: mention that the research study is affiliated with Misericordia University, a clear description of the purpose of the study, time commitment, location of the research study, inclusion/exclusion criteria, benefits/risks, and contact information for the researcher.  Language or visual emphasis on language that may be coercive should be avoided, such as bolding the word "free" in regard to treatment services. If subjects will be recruited by email, by telephone, or in person, a script must be included in the application that details the language to be used. For recruitment procedures using social media, see "Internet-Based Research" within this policy. For recruitment of patients or private health information, see "HIPAA" within this policy.  For recruitment of students, see "Research with Misericordia University Students" within this policy.

The Nuremberg Code and Declaration of Helsinki specifically emphasize that a study is designed so that risks to subjects are minimized and potential benefits justify potential risks giving the IRB an obligation to review study design and scientific quality (Bankurt & Amdur, 2006).  Virtually all research involves some risk, even though it may be minimal (e.g. embarrassment over performance on a task). According to the Belmont Report, "For the investigator, it is a means to examine whether the proposed research is properly designed. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified."  A risk may be of a physical, social, economic, and/or psychological nature. The IRB will consider the extent to which the researcher has attempted to identify the potential risks to the subject and the extent to which those risks have been minimized without interfering with the integrity of the research purpose. In cases where there is a possibility of more than minimal risk to subjects, approval will depend on the following: (1) the benefits of the research; (2) the expertise and prior experience of the researcher(s) in conducting this type of research; (3) the level of inducement to participate; (4) the extent to which the subject is fully informed of the possible risks, and (5) the compensatory treatment or follow-up designed to alleviate any negative consequences from participation. A research procedure may not be used if it is likely to cause serious or lasting harm to subjects (e.g. health problem).

The research should be designed to treat all individuals fairly. The selection of subjects must be based upon fair procedures and not overburden, overuse, or unfairly favor or discriminate against any group.

In all research involving human subjects, it is important to assure the subjects of the confidentiality of their responses. This is especially important in cases where the study involves asking personal questions about the subjects or obtaining other information that might put the subject at risk, if the information was made public. Total anonymity (e.g. where the subject's name or face is never associated with his/her response) is preferable, especially in the case of extremely sensitive or personal information. This generally means that the subject must be able to provide information in complete privacy and to submit the information in such a way that it is mixed in with other subjects' data before it is retrieved by the researcher. Where it is necessary to have the subjects' names or identification numbers associated with their responses (e.g. in order to collate several sets of responses by the same subject), the subjects need to know who will see their data and specifically how this information will be kept confidential.

If anonymity or confidentially cannot be maintained, the subjects have the right to know how the information will be used, with whom it will be shared, and the right to elect not to participate given the inability to maintain anonymity or confidentiality.

In some types of research it may be necessary to withhold some pertinent information from subjects when disclosure of such information would likely impair the validity of the study. In all such cases, subjects should be told that they are invited to participate in research where some features will not be revealed until the research is concluded. Complete nondisclosure of information about the study or its purpose is only justified when the research solely involves observation of a person's behavior in locations where the person might reasonably expect that his/her behavior may be observed by others. In research that involves incomplete disclosure, the following conditions must be met: (1) the research involves no more than minimal risk to the subjects; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) the research could not practically be carried out without the waiver or alteration; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation. If asked directly by research subjects about some part of the study that in not being fully disclosed, researchers must answer the question truthfully even if disclosure has the potential to impact study outcomes.

In most cases, it is desirable for subjects to be debriefed after their participation in the study (e.g. given information about the study and given a chance to ask questions). There are three cases in which debriefing are required: 1) when the research involves incomplete disclosure; 2) when subjects may be left with misleading or potentially harmful perception or inaccurate information; and, 3) when compensatory treatment or follow-up is needed. Debriefing should not be treated as a substitute for informed consent prior to or during the subject's participation in the research. The debriefing should include the following:

a.   Study title 

b.   Researcher's contact information 

c.   Gratitude for participation 

d.   Explanation of what was being studied 

e.   Explanation of deception/how participants were deceived 

f.    Explanation of why deception was necessary 

g.   Explanation of how the results will be evaluated/used 

h.   An opportunity for the participant to withdraw participation and some or all data from the study 

i.    If applicable, an explanation of results thus far 

j.    An offer to provide the participant with the study results 

k.   A list of resources if he/she become distressed 

In some cases, debriefing may not be possible immediately after the study due to a concern about other potential subjects finding out about a deceptive aspect of the study that would preclude further data collection. In these cases, debriefing statements or descriptions must be provided to subjects at a later date through an appropriate means. In rare instances, debriefing may itself pose a social or psychological risk to a subject. In such cases, it may be in the best interest of the subject to forego the debriefing procedure. However, this situation must be presented to the IRB. The IRB will take into consideration the particular elements in the situation and will determine the risk of debriefing the subjects. In most cases this can be avoided by disclosing to the subjects prior to their participation that some harmful information may be uncovered in the course of the study. This falls under the obligation to disclose any risks that are more than minimal.

Language adapted from the University of Massachusetts IRB Website

In cases where some physical or psychological harm might result from the subjects' participation, plans for compensatory treatment or follow-up counseling should be provided.

Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative. The MU IRB will require an informed consent/assent, regardless of level of review, unless the criteria for waiver or alteration outlined below are met as determined by the IRB. An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate in a way that minimizes the possibility of coercion or undue influence. The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative. The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate. No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Required Elements of Consent

Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the consent must be organized and presented in a way that facilitates comprehension.

In seeking informed consent, the following information shall be provided to each subject or legally authorized representative:

a.   A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; 

b.   A description of any reasonably foreseeable risks or discomforts to the subject; 

c.   A description of any benefits to the subject or to others that may reasonably be expected from the research; 

d.   A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; 

e.   A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; 

f.    For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; 

g.   An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; 

h.   A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. 

i.    One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: 

1.   A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or 

2.   A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
 

Additional Elements of Informed Consent

When appropriate, one or more of the following elements of information shall also be provided to each subject or legally authorized representative:

a.   A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; 

b.   Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent; 

c.   Any additional costs to the subject that may result from participation in the research; 

d.   The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; 

e.   A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and 

f.    The approximate number of subjects involved in the study. 

g.   A statement that the subject's biospecimens (even if the identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit. 

h.   A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions. 

i.    For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e. sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequencer of that specimen). 

j.    The amount and schedule of all payments to the participant. 

The informed consent requirements in this policy are not intended to preempt any applicable Federal, state, or local laws (including tribal laws passed by the official governing body of American Indian or Alaska Native tribe) that require additional information to be disclosed in order for the informed consent to be legally effective. Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe).

Waiver of Informed Consent 

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

a.   The research involves no more than minimal risk to the subjects; 

b.   The research could not practicably be carried out without the waiver or alteration; and 

c.   Research involving identifiable private information identifiable biospecimens could not be practically carried out using non-identifiable information or biospecimens; 

d.   The waiver or alteration will not adversely affect the rights and welfare of the subjects; 

e.   Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent for research involving public benefit and service programs conducted by or subject to the approval of state or local officials provided the IRB finds and documents that:

a.   The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and 

b.   The research could not practicably be carried out without the waiver or alteration 

An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:

a.   The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or 

b.   The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens 

Documentation of Informed Consent

Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or subject's legally authorized representative. A written copy shall be given to the person signing the form. The consent form may be either of the following:

a.   A written consent document that embodies the elements of informed consent described above. This form may be read to the subject or the subject's guardian, but in any event, the investigator shall give either the subject or the legally authorized representative adequate opportunity to read it before it is signed; or 

b.   A short form written consent document stating that the elements of informed consent as stated above have been presented orally to the subject or the subject's guardian. 

A short form written informed consent form stating that the elements of informed consent required by 46.116 have been presented orally to the subject or the subject's legally authorized representative, and that the key information required by 46.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject's legally authorized representative, in addition to a copy of the short form.

46.117(a) now specifically allows electronic signatures and specifies that a written copy must be given to the person signing the consent form. In addition, 46.117(b)(1) specifically allows, but does not require, consent forms to be read to the subject. A digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified (21 CFR 11.3(b)(5)).

An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds any of the following:

a.   That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; 

b.   That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or 

c.   If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. 

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Federal and state law stipulates that a person must be 18 years or older to enter into a contract. Subjects under the age of 18 years may participate in research only with the signature of their parent or legal guardian. A guardian according to Pennsylvania State Law is "a person lawfully invested with the power, and charged with the duty, of taking care of and managing the property and rights of another person, who, for some peculiarity of status, or defect of age, understanding or self-control, is considered incapable of administering his or her own affairs" (26 Pennsylvania Law Encyclopedia, 2d, Guardian and Ward 1, p. 120). This also applies to the completion of anonymous questionnaires. Children should have information about their participation in a research study explained to them in language that is understandable, and, if possible, children should sign consent forms - this is called assent. Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Like the informed consent process, the assent process is intended to be an ongoing, interactive conversation between the research team and the child or young adult. The process is not about getting the young person "to sign on the dotted line"; rather, it is about making sure they understand the research and what it means to participate. By engaging young people in understanding the research project, researchers and children become partners in the research process. Children are likely to feel more in control and more involved in the research as a result. When the IRB determines assent is required, it must also determine whether and how assent must be documented.

Fundamentally, before the assent process can begin, parents or guardians must give permission for their children to participate and it shall be documented in accordance with and to the extent required by 46.117. Then, the child or teenager may be provided with a form that explains, in concrete and age-appropriate terms, the purpose of the research, what they will be asked to do, and what procedures they will undergo. For older adolescents (ages 16 or older), this might look very much like the adult informed consent document. For younger children, the terms and explanations will be greatly simplified into words they can understand. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under 46.404 or 46.405. Where research is covered by 46.406 and 46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. In addition to the provisions for waiver contained in 46.116 of Subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, and the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

Assent from children must be obtained and documented when they are capable of providing it. In determining whether children are capable of providing assent, consider the age, maturity, and psychological state of the child/children involved. This determination can be made for all children to be involved in the research under a particular protocol, or for each child, as appropriate.

a.   The requirement for obtaining the assent of children involved in the research may be waived if: 

1.   The capability of some or all of the children is so limited that they cannot reasonably be consulted; 

2.   The intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research; or 

3.   Under circumstances in which consent may be waived in accord with 46.116 of Subpart A. 

The Health Insurance Portability and Accountability Act (HIPAA), the Federal Privacy Rule, requires that "covered entities" engaged in research maintain the privacy of the protected health information (PHI) that is created, accessed, or shared in the course of research activity. A covered entity is a health care provider, payor, or clearinghouse that conducts certain types of electronic billing.  Misericordia University is classified under HIPAA as hybrid entity, meaning that it has divisions which fall under HIPAA regulations and those which do not. Human subjects research is not considered health care and is therefore not a covered entity.

Protected health Information (PHI) as defined by the "Privacy Rule" from the Department of Health and Human Services protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral.

"Individually identifiable health information" is information, including demographic data, that relates to: the individual's past, present, or future physical or mental health or condition, the provision of health care to the individual, or the past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual.

Individually identifiable health information includes many common identifiers (e.g., name, address, birth date, Social Security Number). The Privacy Rule excludes from protected health information employment records that a covered entity maintains in its capacity as an employer and education and certain other records subject to, or defined in, the Family Educational Rights and Privacy Act, 20 U.S.C. §1232g.

A request for the use and disclosure of PHI requires permission from each subject, called an Authorization to Use and Disclose Protected Health Information. "Use" of PHI is the sharing of PHI within the institution (i.e., from clinician to investigator). "Disclosure" of PHI is the sharing of PHI outside of the institution (i.e., from investigator to a participant's physician).

Click here for a summary of the Privacy rule.

The Misericordia University Privacy Officer is responsible for HIPAA compliance at the University. While the MU IRB is not responsible for HIPAA compliance at the covered entities on campus, the IRB will review each protocol on a case-by-case basis to ensure that when the HIPAA regulations apply, they are complied with. Each investigator is responsible for complying with the HIPAA regulations from the institution(s) from which they wish to obtain PHI or where they will be conducting their research.

HIPAA Authorization if a study involves Protected Health Information (PHI) 

In the course of conducting research, investigators may obtain, create, use, and/or disclose individually identifiable health information. Under the Privacy Rule, covered entities are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule. If a study will involve access to or use of PHI, then this must be disclosed in the application.

Although similar to informed consent, the HIPAA Authorization focuses on privacy risks and the use or disclosure of PHI. The HIPAA Authorization is attached to the end of the informed consent form. In the HIPAA Authorization, researchers must state how, why, and to whom the PHI will be used and/or disclosed for research purposes. An Authorization may not require an expiration date; consult state and/or local law. However, a research participant has the right to revoke (in writing) his/her Authorization at any time. A template may be found on the IRB website. The participant or the participant's legally authorized representative must be given a signed copy of the Authorization and researchers must keep a signed copy of participants' Authorization for six years.

Waivers or Alteration of HIPAA Authorization 

The following criteria must be satisfied for the IRB to approve a waiver or alteration of authorization under the Privacy Rule:

a.   The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:  

i.    an adequate plan to protect the identifiers from improper use and disclosure; 

ii.   an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and 

iii. adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart; 

b.   Waiver will not adversely affect the privacy rights and the welfare of the individuals; 

c.   The research could not practicably be conducted without the waiver or alteration; and 

d.   The research could not practicably be conducted without access to and use of the PHI. 

Alteration of Authorization

The requirement to obtain Authorization for use of PHI may also be "altered" for a specific study. An alteration allows a change in certain Authorization requirements, while still requiring authorization for the use of PHI. Examples include making an exception to the required language in an authorization or to the requirement to obtain a signed Authorization. To be granted, an alteration must meet the same criteria above as a waiver or partial waiver.

Informed consent shall comply with all requirements of the Health Insurance Portability and Accountability Act (HIPPA), PL104-191 (Click Here to View)  and the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule) 45 CFR 160 and 164 (Click Here to View).

Click here for HIPAA and research information.

Language adapted from Montclair University IRB Policies and Procedures with permission.

Regarding research with students at Misericordia University, anytime the Family Educational Rights and Privacy Act (FERPA) regulations are applicable, the IRB cannot make a determination about whether or not the research is acceptable in terms of FERPA regulations and Misericordia University policy as that is outside of the scope and purview of the IRB. The Office of the Registrar is responsible for the proper execution of the FERPA rules. Therefore, the Office of the Registrar will conduct ancillary review any time an IRB application involves and/or potentially involves FERPA protected data. The IRB office will send the application packet to the Office of the Registrar for review. The Office of the Registrar will communicate any concerns, needed clarifications or corrections, to the IRB. The IRB will then review the application and provide feedback to the researchers). Once any/all issues have been resolved concerning FERPA, the Office of the Registrar will issue either an approval or disapproval and send it to the IRB office. The IRB office will not issue a final determination concerning approval, until all issues raised by the Office of the Registrar have been addressed and/or a final determination has been issued by the Office of the Registrar.

Per 45 CFR 46.111 (b), when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically disadvantaged persons, additional safeguards must be included in the study to protect the rights and welfare of these subjects including the justification for the use of a vulnerable population. Some groups of individuals by virtue of their situation have been identified by DHHS as vulnerable populations.

1.   Research Involving Pregnant Women or Fetuses 
 
Misericordia University's IRB subscribes to the federal policy on research with pregnant women or fetuses. The federal policy relating to this information can be found here and be used for guidance on working with this population. 

2.   Research Involving Neonates 
 
Misericordia University's IRB subscribes to the federal policy on research with neonates. The federal policy relating to this information can be found  here and be used for guidance on working with this population. 

3.   Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 
 
Misericordia University's IRB subscribes to the federal policy on research with prisoners. The federal policy relating to this information can be found here and be used for guidance on working with this population. 

4.   Additional Protections for Children 
 
The IRB will approve research which demonstrates that there is no greater than minimal risk to children and only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.
 
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects will be considered if the IRB finds that an intervention or procedure holds out the prospect of direct benefit for the individual subject, or that a monitoring procedure is likely to contribute to the subject's well-being. This will be considered only if the following conditions are met: 

1.   The risk is justified by the anticipated benefit to the subjects; 

2.   The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and 

3.   Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians. For information on the requirements for assent, please see section titled "Child Assent." 

Internal institutional research is the gathering of data from employees and students which will be used solely for internal program improvement, informational or required data-collection purposes. For example: course evaluations; surveys to improve institutional services or processes; data collection to establish opinions, experiences or preferences of the University community or information used to characterize the institution.

IRB approval is not required for institutional research except when one of the two conditions exists:

a.   the information deals with sensitive subject matter and disclosure of the responses outside of the research could place the subject at criminal or civil liability or be damaging to the subject's reputation, employability or financial standing; or 

b.   it is anticipated that the data generated will be used for research per the federal definition, the results of which will be disseminated outside of the university. 

Students are held to the same standard for research protocol submission as members of the University faculty and staff. Faculty/staff members are responsible for screening student research projects. They also are responsible for assisting students in the development of the application. Faculty/staff members hold the responsibility for assuring that student submissions meet the standards set by the IRB. Proposals that do not respond to all areas of the application or are poorly written will be returned to the faculty/staff member. The faculty/staff member holds the responsibility for assuring that student proposals are of high quality therefore the faculty/staff member is responsible for working with the student to assure a high quality submission. Additionally, the advising faculty or staff member assumes the responsibility for the ethical conduct of the research. It is important that research subjects have access to the investigators of a study for several years after a study has completed. After a student graduates, it could be a difficult process for a research subject to locate the student who acted as a Primary Investigator, so it is imperative that the faculty/staff member contact information be listed on the study documents and the faculty/staff member serve as one of the contacts on the IRB application. If faculty/staff will be on sabbatical or absent for a period of time, it is his/her responsibility to ensure oversight of the active protocol, whether it be through the addition of another approved researcher on the protocol or maintaining oversight throughout his/her absence.

Students should be aware of actual, potential, or the appearance of a conflict of commitment that can arise when they are asked to participate as a researcher in one or more research activities. This type of conflict can occur when competing, yet important activities (academics versus participation in research), are difficult to balance with the efforts required for a student's educational experience. Conflicts of commitment to research can create a competing influence that biases a student's dedication to his or her academic work or research activities. Students should acknowledge and report any conflicts of commitment they experience to the Vice-President of Academic Affairs.

This policy is designed to discuss requirements and safeguards for using MU students as research participants.  MU IRB considers students as a vulnerable population as researchers' use of students as research participants make them subjects to coercion or undue influence. Students depend upon instructors for grades, letters of recommendation, educational opportunities inside and outside of the classroom, etc. and may feel their lack of participation could negatively affect their educational opportunities. Students' decisions about research participation may not affect grades, potential letters of recommendation, or other opportunities or decisions made by instructor-investigators.  Also, students should not be recruited simply because they comprise a convenient sample for faculty research. Researchers must provide clear explanation for why their students are the most appropriate participants for the study. The IRB will review use of students for research activities to ensure that:

·    risks such as legal risks and psychological stress are minimized; 

·    participation is voluntary and free of undue influence; 

·    informed consent requirements are met; and, 

·    measures to maintain the privacy and confidentiality of information from or about students are appropriate. 

a.   Recruitment - Recruitment of students as research participants must be designed to minimize the possibility of coercion.  Researchers may not directly recruit participants in their classes. Recruitment should be conducted using broad strategies, such as the use of general announcements, postings, other methods that require students who wish to participate to contact the researchers, or the PI should consider that the recruitment be carried out by a colleague or someone who has no means to influence grades. However, a co-researcher or other investigator should accept these responses to ensure that the instructor-investigator is blinded to participants' identities.   The following statement, or something similar, must be included in the recruitment and consent processes: "Your decision to participate or not to participate in this study will have no bearing on your grades or class standing."
For participants identified through university student activities, programs, and/or services, the researcher(s) must obtain written permission from the appropriate administrators or faculty members prior to recruitment. 

b.   Voluntariness - Participation in research must be voluntary. Extra credit or reasonable rewards may be offered for students' participation.  If extra credit is offered, instructor-investigators must provide students with other opportunities for non-research extra credit, which involve comparable time and effort, to ensure undue influence is minimized. Any credit awarded should be in addition to the total number of possible points to be earned in the course, rather than included in the total number of points to be earned. Students must not be penalized for refusing to participate in research or withdrawing from the research. 
Additionally, video and/or audio recording of class activities for use in research (whether or not students participate in any other research-related activities) must happen only with the informed consent of the students. For group activities, the PI should consider only using data if the non-consenting students' data can be effectively excluded. 

c.   Research During Normal Class Time - Some research activities can overlap with normal coursework.  It is the researcher's responsibility to ensure that students can distinguish voluntary research activities from required course activities.  If research activities will occur during normal class time, instructor-investigators must explain how participation in the research is a learning experience for the students and how the research is relevant to the course goals and outcomes. 

d.   Confidentiality - Instructor-investigator must be blinded to the research participants' identities and, where possible, participants should be blinded to the identities of other participants.  When seeking sensitive information, the PI should take every precaution to ensure prevention of a breach of confidentiality. When possible, the PI should consider collecting this anonymously. 

e.   Privacy - The extent to which personal information and/or research data may be accessible to faculty, students, or others not directly involved in the research must be considered and disclosed to potential participants in the informed consent document.  Specifically, if the research involves accessing individually-identifiable information such as grades or any other educational record, signed consent is required. 

When access to student or education records is needed for research activities, please see Section titled "FERPA."

The MU IRB considers all audiovisual data to be identifiable. Because audio, video, or digital recordings include images or voices of research participants, they pose a greater concern to the IRB than do data that do not have readily available identifying information. Therefore, to best protect research participants, the IRB requires that researchers destroy any such recordings in their possession within a definitive timeframe (e.g., five years following the making of the recordings, five years after data are collected).

Although recordings are not specifically addressed in 45 CFR 46, the consent process is clearly defined and holding recordings indefinitely and/or for an unspecified purpose challenges the spirit of informed consent and has the potential to increase risk to participants (e.g., breach of confidentiality, damage to reputation, legal ramifications). To be in line with informed consent and to minimize risk, participants must be informed (in the informed consent form) about the destruction timeframe, as well as informed about who will have access to the recordings and where they will be stored. Please note, exceptional circumstances will be considered on a case-by-case basis to determine whether these guidelines should or should not apply. Also, blanket or general consent forms, such as but not limited to those related to the collection of data in clinical or educational settings, do not allow for the use of these data for research purposes.

Archiving Recordings for Future Research

Because the IRB recognizes the potential value in archiving recordings for future research, if an investigator wishes to archive recordings, the IRB requires the following information to consider the request:

i.    Included in the application must be sound justification for archiving recordings indefinitely. 

ii.  The informed consent form must include the following: 

·     A statement indicating where and how recordings will be stored, secured 

·     A statement indicating who will have access to recordings 

·     Space for participants to indicate whether they 

·     want recordings to be destroyed by the timeframe specified, or 

·     permit the recordings to be archived for future research within a given research area (e.g., language development, spatial perception, conversational attributes). 

Please Note: The application may need to be reviewed by the full board, allowing the IRB to decide collectively whether or not archiving the recordings increases risk to participants. Approved IRB protocols maintaining identifiable data must be kept open until these data have been destroyed for monitoring purposes, even if the recruitment and data collection period has ended.

Using Archived Recordings for Secondary Data Analysis

Any proposed use of already-archived recordings (i.e., secondary data analysis) must be reviewed by the IRB. A copy of the informed consent form from the original study must be submitted with the new application.
If the IRB finds that the purpose of the secondary data analysis is related to the purpose of the original study and the material in the recordings does not put the participant at risk, the application for secondary data analysis is likely to undergo an expedited review.
If the purpose of the secondary data analysis is found to differ significantly from the purpose of the original study or the material in the recordings could put the participants at risk, the application for secondary data analysis is likely to undergo a full board review. The IRB will determine whether or not secondary analysis of the recordings increases risk to participants and whether or not participants were adequately informed during the original study about the use, confidentiality, and destruction of their recordings. Based on these findings, the IRB may require that informed consent for secondary analysis is obtained from participants.

Use of Research Recordings for Educational Purposes or Presentation Purposes

Use of recordings/segments of recordings for educational or dissemination purposes must be pre-approved by the IRB and included in informed consent information presented to participants. For those investigators wishing to maintain segments of recordings for educational or dissemination purposes:

i.    The use of these segments must be clearly defined in the informed consent form and participants must have the option of whether or not they consent to such uses of the recordings. 

ii.  For example: 

·     ________ I agree that segments of the recordings made of my participation in this research may be used for conference presentations. 

·     ________I do not want segments of the recordings made of my participation in this research to be used for conference presentations.

·     ________ I agree that segments of the recordings made of my participation in this research may be used for education and training of future researchers/practitioners. 

·     ________I do not want segments of the recordings made of my participation in this research to be used for education and training of future researchers/practitioners. 

iii. Once segments have been chosen, the remainder of the recordings must be destroyed (unless approved for archiving). 

iv. Segments cannot be used for any purposes beyond those detailed and consented to in the informed consent form. 

Language adapted from The Pennsylvania State University IRB Guideline XI with permission.

The purpose of these policies and procedures is to help researchers plan, propose, and implement internet-based research protocols that provide the same level of protection of human subjects as more traditional research methodologies.  The IRB must review all research activities involving the use of the Internet consistent with the basic IRB principles applied to all research involving human subjects (45 CFR 46.111). The IRB will review the use of the Internet for research activities to ensure that participation is voluntary, informed consent requirements are met, and measures to maintain the confidentiality of information from or about human participants are appropriate.  The IRB will review all research activities involving the use of the internet with the same considerations and standards for approval of research (45 CFR 46.111) including but not limited to reviewing standard research of human subjects in accordance with exempt, limited, expedited, and full board review policies.  The MU IRB reserves the right to decline use of a platform if it adds risk to the participants.

Recruitment

Internet-based procedures for advertising and recruiting potential human subjects must follow the IRB guidelines for recruitment that apply to traditional media (See section "Recruitment and Advertising"). Internet-based recruitment includes but is not limited to blogs, chatrooms, Facebook, Twitter, email solicitation, webpages etc.  Researchers should submit all recruitment documents that will be used to recruit potential human subjects. For advertisements posted on any website, listserv, or media sites (e.g., Facebook, Twitter) not belonging to the researcher, the researcher must obtain permission from the site gatekeeper (site administrator or owner), and be aware of the site's privacy notices and group policies/rules.  Any research recruitment that utilizes Misericordia University's website, such as MyMu portal, targeted announcements, mass emailings etc., must be approved by the appropriate personnel.
Recruitment made using Social Media sites, including but not limited to Face, LinkedIn, and Twitter, will be allowed including sharing from site to site or person to person.  The researcher must put a disclaimer on any recruitment posting to these social media websites that any questions regarding the research will be directed to the researcher with name and contact information of the primary investigator and that one sharing this post is not supporting or serving as the contact for this research.

Data Collection and Survey Research

Internet data collection is rarely private, anonymous, or even confidential because the Internet is an insecure medium and data in transit are vulnerable.  The ease with which information can be accessed, shared, hacked, and/or replicated is unique to Internet research, and for this reason, investigator responsibilities for good data stewardship, and heightened awareness of subjects' privacy, confidentiality, and identities are critical.  This risk is accentuated if the research involves sensitive data that places subjects at risk of criminal or civil liability or could damage their financial standing, employability, insurability, reputation or could be stigmatizing. The potential source of risk is harm resulting from a breach of confidentiality.  When information collected is sensitive or a breach of confidentiality may involve risk to the participant, the instrument should be formatted in a way that will allow participant participants to skip questions if they wish to, or provide a response like, "I choose not to answer." At the end of the survey, there should be one button to submit the data and another button to discard the data for inclusion in the study.  The purpose of theses buttons is to ensure that the subject may withdraw at any time, and to help them understand that if they withdraw even after completing the survey, their data can be discarded prior to transmission to the researcher.

The level of security should be appropriate to the level of risk.  For most research, standard security measures like encryption and secure socket layer (SSL) will suffice.  This helps ensure that any data intercepted during transmission cannot be decoded and that individual responses cannot be tracked back to an individual respondent.  However, more than minimal risk studies involving the transmission of sensitive information may warrant multiple-factor authentication (MFA), such as passwords delivered by mail or telephone, or via an identity verification software or vendor.  For such studies, it is recommended that the highest level of data Advanced Encryption Standard (AES) be used, within the limits of availability and feasibility. This may require that the study participants be encouraged or required to use a specific type or version of browser software.  Depending on the risk level (e.g., collection of sensitive information) and the specific circumstances of the study, it may be appropriate to provide an alternative means of filling out the survey. For example, allowing the participant to complete a hard copy of the survey and send it postal mail to the researcher.

Researchers are cautioned that encryption standards vary from country to country and that there are legal restrictions regarding the export of certain encryption software outside US boundaries.

If data are collected via the Internet and the subject will participate using a personal home, school, or work computer with an assigned address, participation should not be considered anonymous.  Rather, there are indirect identifiers (e.g., IP Address, Domain Name System, computer name) that may be traceable to the individual location and person. Such participants may be considered confidential if the researchers utilize available data security protections and describe the plan for handling indirect identifiers that may be included with the data.

The server used for online surveys of greater than minimal risk must meet the following criteria:

The server must be administered in accord with current industry and manufacturer best practices by a professionally trained person with expertise in computer and internet security:

i.    Access to the server must be limited to key project personnel and configured to minimize the possibility of external access to the server data 

ii.  The server must be subject to periodic vulnerability assessments to determine that the server is configured and patched according to industry best practices 

iii. The data stored on the server should be stored to the same or higher level of encryption as utilized in transmittal to AES standards 

iv. Security auditing features and settings should be set to determine and/or assist with the determination of a breach 

Please note, most MU systems are administrated by IT (PC Services and Networking Group) or Online Education. It is the responsibility of the researcher to ensure that any system being utilized (an MU system or an outside system) meets the standards outlined above.

Procedures

To post a survey on a website not belonging to the researcher, permission must be obtained from the site gatekeeper (site administrator or owner), and researchers must be aware of the sites' privacy notices and group policies/rules.
When observing a chat room that is not open to the public, researchers must obtain authorization from the chat room manager and inform the participants that an "observation" is taking place, and that any information exchanged may be used for research purposes.
If the research involves collection of publicly available data (e.g. Twitter or some Facebook accounts that are public access such as business pages), the project may not meet the definition of human subject research.  Contact the IRB Office for additional information or visit the IRB website for guidance on what constitutes human subjects research in need of IRB review.

Informed Consent

Research on information that is already available on or via the Internet without direct interaction with human subjects (e.g., harvesting, data mining or scraping data from user profiles, observation or recording of otherwise-existing data sets, chat room interactions, blogs, social media postings, etc.) is becoming common. Access to this information is not a justification for collecting data without consent from the subjects because not all Internet content is "public information". A consent document must be submitted for the study or a waiver of informed consent must be requested. 
An informed consent for Internet based research must fulfill all of the requirements for traditional research. The potential participant must be provided with all of the necessary information and a method to consent to participate in the research. Please see section "Informed Consent" for requirements.
Researchers conducting web-based research should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmission is in question. A statement in the informed consent form indicating the limits to confidentiality is typically required. The following statement may be used: "Your confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties." OR "This research involves the transmission of data over the Internet. Every reasonable effort has been taken to ensure the effective use of available technology; however, confidentiality during online communication cannot be guaranteed."
Documentation of an informed consent is required unless a waiver of documentation of informed consent is applicable, or if a waiver of consent is applicable. If documentation of an informed consent is required, the consent form should be mailed or emailed to the participant and the informed consent should be returned via fax or postal mail before further participation in the research.  In addition a PIN number may be provided to use on an Internet based consent to ensure that person can authenticate the person's identification and ensure documentation of informed consent is provided. 
If a waiver of documentation of informed consent is determined appropriate, it may be appropriate to provide participants with informed consent information, and inform participants that submitting the completed survey implies their consent, or having an "I agree" and "I do not agree" button on the survey to allow participants the active choice of participation.
No matter the consent process determined appropriate for the study, individuals should be provided with an opportunity to have their questions or concerns addressed on an individual basis.

Data Storage and Disposal

If a server is used for data storage, personal identifying information should be kept separate from the data, and all data should be stored in an Advanced Encrypted Standard (AES) format.  It is recommended that AES data backups be stored in a safe location, such as a secure data room that is environmentally controlled and has limited controlled access. It is also recommended that competent data destruction services be used to document and ensure that no data can be recovered from obsolete electronic media. Identifiable information, specifically PHI and/or PII cannot be stored on Misericordia GSuite, personal unencrypted devices, or non-approved cloud storage solutions.

Research with Children

Researchers recruiting and collecting data on children in an online setting are subject to the same policies for Human Subjects Protections as all human subjects. In addition to these policies, researchers must also adhere to the Children's Online Privacy Protection Act (COPPA). This act gives parents control over what information websites can collect from their children. In order to comply with this Act, the research must post a notice about how the information will be used. Secondly, the researcher must get verifiable consent and contact information from the parent/legal guardian prior to collection of any data from the child.

Incentives/Compensation

When using online incentives/compensation for "anonymous" research participation, the researcher must implement a procedure for granting the incentive or compensation without identifying the identity of the participant. An example of this would be to use gift certificates from online retailers and displaying the unique certificate redemption number to respondents at the completion of a questionnaire. This allows the participants to receive an incentive/compensation without revealing their identity.

Deception

When using deception in any setting, the researcher must debrief the participants (See section "Debriefing." This can create complexities in an online environment. The participants may choose to leave the venue before completing the debriefing material, may have an address change, or fail to respond to communications. When completing the IRB application, the researcher must address the potential challenges of debriefing participants in an online research study that is based on deception or incomplete disclosure.

To ensure equitable selection of research participants and to possibly remove bias from a research study, it may be important to include non-English speaking participants in a study.  (The exclusion of non-English speaking participants is acceptable in certain cases such as small pilot studies and studies involving the use of instruments and associated software are only available in English versions.)  It is also important that these participants or their legally authorized representatives are able to understand the consent form (and other potential documents such as recruitment flyers etc.) and have adequate and ongoing opportunities to obtain clarification on the research study. This is achieved through the use of interpreters that are present when informed consent is being obtained and who are available throughout the research study.  In addition, translation of the informed consent to a language that is comprehendible by the non-English speaking participant is required. If such measures are not taken, then any consent obtained is not legally-binding.

When obtaining consent for studies involving non-English speaking participants the researcher must obtain a translation of the informed consent, recruitment flyers, emails, scripts, etc. into language(s) that are comprehendible by the non-English speaking participants by a certified translator.  Researchers must ensure that all required documents are first approved by the IRB before beginning the translation process. All translated documents must subsequently be submitted to the IRB. The certified translator must sign a document stating the translation is accurate and a copy of the translator's certification must be included in the IRB application.  For more than minimal risk studies, translators and interpreters must be members of the American Translators Association or one of equal or higher stature; their areas of specialization must match with the general research area that is the subject of the study. For more than minimal risk studies, any other translators and interpreters must be approved by the IRB.

Interpreter(s) must be made present during the process of obtaining consent and made available on an as-needed basis during the research study. During the process of obtaining informed consent, the researcher(s), interpreter, potential participant/legally authorized representative are present. The informed consent document is explained and a dialogue between the researcher(s) and the potential participant/legally authorized representative is facilitated by the interpreter to ensure that there is adequate understanding. Signatures are required of all parties on the informed consent and a signed dated copy is then presented to the participant/legally authorized representative.

The Short Form Method

The informed consent is obtained primarily through oral delivery facilitated by the interpreter in the short form method. This oral delivery contains all the elements of a normal consent form (see guidelines). Dialogue between the participant/legally authorized representative (LAR) and the researcher is again facilitated by the interpreter to ensure adequate understanding of the informed consent. Signatures are required of the interpreter and the participant/LAR and a signed dated copy of both the short form and the English version of the informed consent are then presented to the participant/LAR. Short form method should only be used in extenuating circumstances where there is the unexpected inclusion of a non-English speaking participant in a time-sensitive research study. A post approval modification form must be submitted to the IRB within five days.

Translated Documents and the Use of Interpreters during the Research Study 

Translated documents and interpreters are a crucial part of the obtaining informed consent in studies involving non-English speaking participants and it is necessary to ensure that they are of a certain standard. Researchers must ensure that all required documents are first approved by the IRB before beginning the translation process. All translated documents must subsequently be submitted to the IRB. The translated documents must be signed by the certified translator.

Cooperative Research with Another Institution

All research at MU is now required to use a single IRB-of-Record (sIRB) for inter-institutional research. The sIRB does not need to be MU, but the MU IRB needs to be notified of the research and receive verification of the designated sIRB. MU researchers who are interested or engaged in inter-institutional research and already have IRB approval from another institution should contact the IRB Office to complete the necessary paperwork. Please note that the OHRP form used through the IRB Office is the only appropriate form and signatures from the sIRB of record and the sIRB of record must have an active Federalwide Assurance (FWA) number.

This policy does not apply to the following types of participating sites in multi-site research:

·    VA sites 

·    Foreign sites (though domestic sites of the same study must be reviewed by a sIRB) 

·    Sites involving tribal nations 

·    Sites for which review by the proposed sIRB is prohibited by a federal, tribal, or state law, regulation, or policy 

All research at MU is now required to use a single IRB-of-Record (sIRB) for inter-institutional research. The sIRB does not need to be MU, but the MU IRB needs to be notified of the research and receive verification of the designated sIRB. MU researchers who are interested or engaged in inter-institutional research and already have IRB approval from another institution should contact the IRB Office to complete the necessary paperwork. Please note that the OHRP form used through the IRB Office is the only appropriate form and signatures from the sIRB of record and the sIRB of record must have an active Federalwide Assurance (FWA) number.

This policy does not apply to the following types of participating sites in multi-site research:

·    VA sites 

·    Foreign sites (though domestic sites of the same study must be reviewed by a sIRB) 

·    Sites involving tribal nations 

·    Sites for which review by the proposed sIRB is prohibited by a federal, tribal, or state law, regulation, or policy 

Language adapted from The College of New Jersey Inter-Institutional Research s(IRB) policy with permission.

Please send the following information to the Misericordia University IRB if you have received IRB approval from another institution:

• A signed OHRP form from the sIRB of record. The sIRB of record must have an active Federalwide Assurance (FWA) number. Please contact Misericordia IRB for the OHRP form.
• A copy of the IRB approved protocol and documents (e.g., approved informed consents/assents documents, approved flyers/scripts)
• PI should provide Misericordia University with updates/changes to approved protocol throughout the research project.

Procedures for reviewing research in foreign countries may differ from those set forth in this document and in federal regulations. Such ethical principles as the Nuremberg Code and Declaration of Helsinki present broad policies, but are not considered sufficient for an institution having a FWA. Because of the varied policies and procedures involved with conduct of research in foreign countries, it is best that researchers discuss research projects with the IRB during planning phases, regardless of level of review. Additional resources can be found here.

The MU IRB includes an Administrator, a Chair, an optional Vice-Chair, a Coordinator, an Analyst, and board members.

All IRB members have specific responsibilities related to their role on the IRB. These responsibilities should be accepted with a clear understanding of the critical importance of the activities completed by the IRB. Members are asked to carefully consider these responsibilities prior to assuming the role. If members' responsibilities within the university increase and do not permit full participation in the responsibilities outlined, members should request that they be replaced.

Chair
The Chair of the IRB is appointed by the University President, and the VPAA, following a recommendation from the IRB Administrator and a majority vote from the IRB.  The IRB Chair is appointed for a 3-year term and may be reappointed when the term expires. The outgoing IRB Chair should remain on the board for one year either as ex-officio or as a returning IRB member for a regular term. The IRB Chair can only be removed by the IO with two-thirds IRB member agreement. The IRB Chair may also serve as the IRB Administrator if he/she is a Certified IRB Professional and accepts the responsibilities of both duties, with the approval of the VPAA, the University President, and a majority vote of the full board. 
The IRB Chair must be an affiliate of Misericordia University with at least two years of IRB review experience, a record of research, scholarship, or other ethical expertise.  It is highly recommended that if a faculty member, the IRB Chair be a tenured faculty member to protect from attempts of undue influence and to protect his/her tenure and promotion process.  The IRB Chair must have thorough knowledge of OHRP, DHHS, and/or FDA regulations or willing to acquire as needed. If required knowledge is not possessed at time of appointment, if more than 5 years old, or if training was completed prior to federal regulation changes, the IRB Administrator will identify and assign CITI or PRIMR&R trainings for the incoming IRB member.  The IRB Chair must have a commitment to the advancement of research through the ethical treatment of human research participant and have the ability to work collaboratively with the other IRB members, IO, and related personnel. 

a.   Training 

1.   Demonstrates proficiency in human subjects' research training as identified by the Misericordia University IRB 

2.   Familiar with the policy guidelines of the IRB and the University 

3.   Familiar with the ethical principles of the Belmont Report and other regulatory documents 

4.   Maintains Collaborative Institute Training Initiative (CITI) courses assigned for IRB Members and the IRB Chair 

5.   Provides IRB training/workshops to the Misericordia University community on a limited basis 

b.   Application Review 

1.   Communicates with IRB Administrator in advance of IRB meetings of the IRB Meeting agenda, identifies protocols appropriate for full-board review, and determines that protocols submitted are ready for review

2.   Identifies the need for external consultation 

3.   Identifies conflicts of interest as it relates to applications for self, IRB members, related personnel, or the institution 

4.   Reads proposals thoroughly and evaluates them within the context of the federal regulations, and the ethical standards of Misericordia University 

5.   Determines application type: exempt, limited, expedited, or full board 

6.   Develops a rotating IRB member review schedule for exempt and expedited studies 

7.   Participates as an IRB reviewer as needed for exempt and expedited applications and reviews all full board applications 

8.   Ensures all applications are reviewed expeditiously and reassigns applications to a different reviewer if reviews are not performed in a timely manner as dictated by the policies and procedures 

9.   Communicates with IRB members concerning status of applications 

10. Consults with IRB members regarding application reviews 

11. Prepares correspondence to applicants to denote application status (approved, approval withheld pending revisions, denied) including revisions required or the reason for denial of approval in a timely fashion 

12. Delegates review of annual updates as appropriate by type of review 

13. Informs IRB members of changes in protocol and assign as appropriate 

14. Reviews end of project reports 

c.   Responsibilities in conducting full board meetings 

1.   Collaborates with IRB Coordinator to establish the agenda 

2.   Regularly attends meetings 

3.   Arranges for an interim chair if he/she will be absent or must leave the room due to a conflict of interest on particular applications

4.   Ensures that attendance at the prospective meeting will provide adequate review of all protocols 

5.   Directs the proceedings, discussion, and vote 

6.   Determines that a proper quorum is present 

7.   Convenes meeting 

8.   Executes the agenda 

9.   Promotes discussion of research protocols regarding protection of human research subjects 

10. Endeavors to complete the agenda in a timely manner 

11. Conducts voting and votes in regard to protocol disposition 

12. Reviews and compiles IRB members' recommendations 

13. Protects the confidentiality of all discussions surrounding decisions whether written, electronic, or verbal and adheres to protections afforded under Family Educational Rights and Privacy Act (FERPA), as amended and the Health Insurance Portability and Accountability Act (HIPAA) of 1996 

d.   Quality Assurance Monitoring 

1.   Participates in unanticipated risk to subject deliberations 

2.   Participates in quality assurance monitoring 

3.   Reports allegations, complaints, and noncompliance to the IRB Administrator 

e.   Reporting 

1.   Reports to the IRB Administrator 

2.   Provides evaluative comments about IRB members to the IRB Administrator to maintain an effective/adequate IRB membership 

3.   Prepares other reports as requested for the IRB Administrator, the Institutional Official, and others 

f.    Assurance of IRB Independence 

1.   Reports attempts to exert undue influence on self or others to the IRB Administrator and/or the IO 

g.   Assistance to Faculty and Investigators 

1.   Represents the IRB in discussions with others at the University, including defending or discussing IRB decisions with researchers 

2.   Provides information to investigators about the need for IRB review and IRB Policies and Procedures 

3.   Relays information about faculty and investigator concerns or needs for IRB guidance to the IRB 

h.   Appointment of new IRB Members 

1.   Works with IRB Administrator and IRB Staff to identify and nominate new members for appointment consistent with IRB Member description found in this section 

2.   Discusses potential IRB membership with Chair or appropriate supervisor prior to approval 

i.    Policy 

1.   Complies with and implements federal regulations and Misericordia University Policies and Procedures 

2.   Maintains currency in IRB & FWA regulations. 

3.   Assists IRB Administrator in updating IRB policies and procedures to be in compliance with regulations. 

4.   Facilitates IRB subcommittees to work through large policy revisions 

Vice-Chair
The Vice-Chair of the IRB is appointed by the IRB Chair if the IRB Chair deems the position needed.  The IRB Vice-Chair is appointed for a 3-year term and may be reappointed when the term expires. The IRB Vice-Chair can be removed by the IRB Chair and two-thirds IRB member agreement.
The IRB Vice-Chair must be an affiliate of Misericordia University with at least one year of IRB review experience, a record of research, scholarship, or other ethical expertise.  It is highly recommended that if a faculty member, the IRB Vice-Chair be a tenured faculty member to protect from attempts of undue influence and to protect his/her tenure and promotion process.  The IRB Vice-Chair must have thorough knowledge of OHRP, DHHS, and/or FDA regulations or willing to acquire as needed. If required knowledge is not possessed at time of appointment, if more than 5 years old, or if training was completed prior to federal regulation changes, the IRB Administrator will identify and assign CITI or PRIMR&R trainings for the incoming IRB member.  The IRB Vice-Chair must have a commitment to the advancement of research through the ethical treatment of human research participant and have the ability to work collaboratively with the IRB Chair and other IRB members, IO, and related personnel.  Additional responsibilities, besides that already listed for an IRB member, are outlined below. 

a.   Training 

1.   Demonstrates proficiency in human subjects' research training as identified by the Misericordia University IRB 

2.   Familiar with the policy guidelines of the IRB and the University 

3.   Familiar with the ethical principles of the Belmont Report and other regulatory documents 

4.   Maintains Collaborative Institute Training Initiative (CITI) courses assigned for IRB Members and the IRB Chair 

5.   Provides IRB training/workshops to the Misericordia University community on a limited basis as needed in the absence of the IRB Chair 

b.   Application Review in the absence of the IRB Chair 

1.   Communicates with the IRB Administrator in advance of IRB meetings of the IRB Meeting agenda, identifies protocols appropriate for full-board review, and determines that protocols submitted are ready for review 

2.   Identifies the need for external consultation 

3.   Identifies conflicts of interest as it relates to applications for self, IRB members, related personnel, or the institution 

4.   Reads proposals thoroughly and evaluates them within the context of the federal regulations, and the ethical standards of Misericordia University 

5.   Determines application type: exempt, limited, expedited, or full board 

6.   Develops a rotating IRB member review schedule for exempt and expedited studies 

7.   Participates as an IRB reviewer as needed for exempt and expedited applications and reviews all full board applications 

8.   Ensures all applications are reviewed expeditiously and reassigns applications to a different reviewer if reviews are not performed in a timely manner as dictated by the policies and procedures 

9.   Communicates with IRB members concerning status of applications 

10. Consults with IRB members regarding application reviews 

11. Prepares correspondence to applicants to denote application status (approved, approval withheld pending revisions, denied) including revisions required or the reason for denial of approval in a timely fashion 

12. Delegates review of annual updates as appropriate by type of review 

13. Informs IRB members of changes in protocol and assign as appropriate 

14. Reviews end of project reports 

c.   Responsibilities in conducting full board meetings in the absence of the IRB Chair 

1.   Collaborates with IRB Coordinator to establish the agenda 

2.   Regularly attends meetings 

3.   Arranges for an interim chair if he/she will be absent or must leave the room due to a conflict of interest on particular applications 

4.   Ensures that attendance at the prospective meeting will provide adequate review of all protocols 

5.   Directs the proceedings, discussion, and vote 

6.   Determines that a proper quorum is present 

7.   Convenes meeting 

8.   Executes the agenda 

9.   Promotes discussion of research protocols regarding protection of human research subjects 

10. Endeavors to complete the agenda in a timely manner 

11. Conducts voting and votes in regard to protocol disposition 

12. Reviews and compiles IRB members' recommendations 

13. Protects the confidentiality of all discussions surrounding decisions whether written, electronic, or verbal and adheres to protections afforded under Family Educational Rights and Privacy Act (FERPA), as amended and the Health Insurance Portability and Accountability Act (HIPAA) of 1996 

d.   Quality Assurance Monitoring  

1.   Participates in unanticipated risk to subject deliberations 

2.   Participates in quality assurance monitoring 

3.   Reports allegations, complaints, and noncompliance to the IRB Administrator 

e.   Reporting 

1.   Reports to the IRB Chair 

f.    Assurance of IRB Independence 

1.   Reports attempts to exert undue influence on self or others to the IRB Administrator and/or the IO 

g.   Assistance to Faculty and Investigators in the absence of the IRB Chair 

1.   Represents the IRB in discussions with others at the University, including defending or discussing IRB decisions with researchers 

2.   Provides information to investigators about the need for IRB review and IRB Policies and Procedures 

3.   Relays information about faculty and investigator concerns or needs for IRB guidance to the IRB 

h.   Policy in the absence of the IRB Chair 

1.   Complies with and implements federal regulations and Misericordia University Policies and Procedures 

2.   Maintains currency in IRB & FWA regulations 

Members/Alternate Members
IRB members are recommended by the IRB Chair to the VPAA, the IRB Administrator, and the University President.  The University President, the VPAA, and the IRB Administrator have the responsibility of approving or disapproving the recommendations forwarded to him/her.  IRB members are appointed for a 3-year term and may be reappointed when the term expires.  No more than 1/3 of the IRB membership may be replaced annually.
Recommendations are made in accordance with 45 CFR 46 Section 46.107, which requires members of the IRB be sufficiently qualified through experience or expertise and diversity of its membership including consideration of race, gender, cultural backgrounds, and sensitivity to issues of community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.  In addition, every effort should be made to ensure that IRB members are balanced with regard to background (no IRB can consist entirely of members of one profession).  
The IRB must include at least one member whose primary concerns are in a scientific area and at least one whose interests are in a non-scientific area.  The IRB shall also include at least one member who is not otherwise affiliated with the institution and who is not of the immediate family of a person who is affiliated with the institution.
There must be at least five members on the Misericordia University IRB.  Every effort will be made to include members from each of the colleges of the University. 
The IRB may, in its discretion, invite individuals with competence in a special area to assist in the review of issues, which require expertise beyond or in addition to that available on the IRB.  These individuals may not vote.
The IRB must include at least one alternate member.  An alternate member is eligible to replace an IRB regular member when he or she is unable to attend. Before an alternate can act on behalf of a regular member, he/she must have attended at least two meetings as an observer.  The IRB Chair will determine which member(s) is/are alternates.
All IRB members have specific responsibilities related to their role on the IRB.  These responsibilities should be accepted with a clear understanding of the critical importance of the activities completed by the IRB.  Members are asked to carefully consider these responsibilities prior to assuming the role. If members' responsibilities within the University increase and do not permit full participation in the responsibilities outlined, members should request that they be replaced. Members who miss two consecutive meetings or fail to complete two reviews by the stated deadline can be asked by the IRB Chair to relinquish their appointment.  
In the unlikely event that a member of the IRB should conduct him/herself in a manner contrary to the policies and ethical and professional responsibilities of the IRB, such member can be removed from the board at any time by the IRB Chair and two thirds IRB agreement, with the approval of the IO.
For an IRB member who is faculty or professional staff, he/she must have a record of research, scholarship, or other ethical expertise. Community representatives must have a commitment to the advancement of research and the ethical treatment of human subjects research participants.  All IRB members must have the ability to work collaboratively with other board members and IRB administration and staff, and a willingness to serve on one of the busiest committees at Misericordia University. 

a.   Training 

1.   Must display proficiency in human subjects research training as identified by the Misericordia University IRB 

2.   All members of the IRB will maintain the Collaborative Institute Training Initiative (CITI) IRB educational certificate specific to IRB Members. 

3.   Participates in ongoing continuing education related to IRB matters 

4.   Expected to be familiar with the ethical principles of the Belmont Report and other regulatory documents, including the Misericordia University IRB Policies and Procedures 

b.   Proposal review 

1.   Reads assigned proposals/annual reviews/changes of protocol thoroughly and evaluates them within the context of the federal regulations and the Misericordia University IRB Policies and Procedures in a timely manner 

2.   Suggest to IRB Chair that a consultant is needed if s/he considers a proposal to be outside the expertise of the Misericordia University IRB 

3.   Identifies and reports conflicts of interest to the IRB Chair for self, the investigator, or the institution. 

4.   Participates in the discussion of whether the proposal provides adequate protection for human research participants.  This includes a judgment about whether the application has sufficient scientific merit for the involvement of human subjects. 

5.   May suggest the shift of submitted protocols from one review category to another as deemed appropriate by the committee 

6.   Performs review of proposals outside of regular area of application type when circumstances warrant doing so and asked by the IRB Chair 

7.   Follows normal procedures for proposal review, including, but not limited to requesting a consultant 

8.   Seeks consultation as necessary with IRB members, IRB Chair, or the IRB Administrator 

9.   Serves as an advocate during review of the community or designated vulnerable population, if needed. Advocates (an individual that represent the population) may be needed when an application is relevant to a certain population (incarcerated, individuals, elderly, pregnant women, etc.).  In certain circumstances, an advocate is either required or recommended to be present during the review of the application to help the board understand in greater detail that population and how they may best be safeguarded through the proposed research. 

10. Reviews and votes on applications submitted fo full board review 

11. Protects the confidentiality of all discussions surrounding decisions whether written, electronic, or verbal and adheres to protections afforded under Family Educational Rights and Privacy Act (FERPA), as amended and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 

c.   Quality Assurance Monitoring 

1.   Participate in unanticipated risk to subject deliberations 

2.   Participate in quality assurance monitoring 

3.   Reports allegations, complaints, and noncompliance to the IRB Chair and IRB Administrator 

d.   Meetings 

1.   Attends IRB meetings regularly.  Communicates anticipated absences to IRB Chair or IRB Coordinator prior to meetings 

2.   Votes on IRB-related matters as they arise 

3.   Engages in discussion regarding protocols and IRB-related matters 

e.   Assistance to Faculty and Investigators 

1.   Provides information to investigators about the need for IRB review, perspectives, and resources 

2.   Offers support to Misericordia University potential, present, and past applicants by answering questions and providing tips for successful application approval 

3.   Acts as a college liaison for the IRB 

4.   Relays concerns from students, faculty, staff, external principal investigators, or the public to the IRB Chair 

f.    Assurance of IRB Independence 

1.   Reports attempts to exert undue influence on self or others to the IRB Administrator and/or the IO 

Administrator
The IRB Administrator is appointed by the University President and the Vice President of Academic Affairs.  The IRB Administrator is appointed for a 3-year term and may be reappointed when the term expires.  The IRB Administrator can be removed by the IO and two-thirds IRB agreement.  He or she must be an affiliate of Misericordia University with a record of research, scholarship, or other ethical expertise.  It is highly recommended that if a faculty member, the IRB Administrator be a tenured faculty member to protect from attempts of undue influence and to protect his/her tenure and promotion process.  The IRB Administrator must have thorough knowledge of OHRP, DHHS, and/or FDA regulations or willing to acquire as needed.  It is highly recommended the IRB Administrator be a Certified Institutional Review Board Professional (CIP).  The IRB Administrator must have a commitment to the advancement of research through the ethical treatment of human research participants and the ability to work collaboratively with the IRB Chair and other IRB members, IO, and related personnel. 

a.   Training 

1.   It is highly recommended that the IRB Administrator be a Certified IRB Professional (CIP). 

2.   Must demonstrate proficiency in human subjects' research training as identified by the Misericordia University IRB 

3.   Maintain the Collaborative Institute Training Initiative (CITI) IRB educational certificate specific to IRB Members and the IRB Administrator 

4.   Expected to be proficient with the policy guidelines of the Office of Human Research Protections and the University 

5.   Expected to be proficient with the ethical principles of the Belmont Report and other regulatory documents 

6.   Identifies training for IRB members, staff, and researchers, and ensures all participate in initial and continuing education 

7.   Provides IRB training/workshops to the Misericordia University community on a limited basis 

8.   Prepare reports for the IRB or report on scientific, ethical, and existing and proposed regulatory topics 

b.   Online Submission System 

1.   Maintains and updates the online submission system as needed 

2.   Develops new versions of applications to meet the IRB's needs 

3.   Troubleshoots the online submission system for the IRB, applicants, and IRB Administration 

4.   Provides system support for applicants 

c.   Reporting 

1.   Reports to the Institutional Official 

d.   Quality Assurance Monitoring 

1.   Assure IRB compliance with FWA regulations.

2.   Maintain currency in IRB & FWA regulations. 

3.   Participate in unanticipated risk to subject deliberations as needed 

4.   Participate in quality assurance monitoring as needed 

5.   Make recommendations to improve IRB functioning 

6.   Independently review correspondence to the IRB, review and approve administrative and procedural modifications, reconcile proposals for funding with approved IRB applications, and facilitate approval for emergency research 

7.   Advises IRB members of review requirements based on policy, regulation, statue, and legal precedent; monitors changes and recommends appropriate revisions in policy and procedures 

8.   Provides advice on regulatory compliance to deans, directors, chairs, and the office of the president within the university and federal regulatory agencies as requested 

9.   Provides consultation, assistance, and dissemination of information regarding the review process 

10. Supervises ethical and technical review of proposals meeting criteria for exempt and expedited review 

11. Participates in form development/revision and web page set-up and maintenance 

e.   Handling Allegations, Complaints, and Noncompliance 

1.   Reports allegations, complaints, and noncompliance to the IO 

2.   Works with the IO to apply University Policies regarding noncompliance, including the IRB Policies and Procedures 

f.    Assistance to Faculty and Investigators 

1.   Provides information to investigators about the need for IRB review and IRB Policies and Procedures 

2.   Relays information about faculty and investigator concerns or needs for IRB guidance to the IRB 

3.   Provide regulatory, ethical, and method advice to individual faculty, staff, and students in preparation of applications for research proposals involving human subjects and consent documents 

g.   Assurance of IRB independence 

1.   Reports and responds to notice of any attempts to exert undue influence on self, investigators, or IRB members to the IO 

h.   Management of Staffing and Infrastructure 

1.   Attend IRB meetings and serve as non-voting member of IRB 

2.   Oversees IRB staff and manages all aspects related to carrying out of the day to day operations and performance 

3.   Directs, coordinates, and supervises the administrative and clerical functions of the IRB office 

i.    Personnel and Members 

1.   Works with IRB staff for effective IRB Administration 

2.   Addresses concerns raised by IRB Staff, and if needed, communicates with IO to address areas of improvement 

3.   Issues informal written warnings to IRB members for correcting misconduct 

4.   Documents instances of IRB member misconduct 

5.   Reports instances of an IRB member and IRB staff misconduct to the IO 

i.    IRB Member has the opportunity to respond to written warning of misconduct 

ii.  Makes recommendations for remedies of misconduct to the IO 

iii. The outcome will be communicated to the IRB member 

j.    Budget 

1.   Works within a budget to pay for software, compensation, training, and additional expenses incurred by the board 

k.   Policy 

1.   Administers, interprets and applies federal and state laws, regulations, institutional policies, and guidelines to protect human subjects to ensure institutional competence 

2.   Writes and suggests policies for adoption by the board and in consultation with the board 

3.   May facilitate IRB subcommittees to work through large policy revisions 

l.    Representation 

1.   The IRB chair must represent the IRB in discussions with other segments of the University, in discussion with federal, state, and local authorities, and in defending or discussing IRB decisions with researchers. 

2.   Serves as contact person with U.S. Office of Human Research Protections 

IRB Coordinator
The IRB Coordinator must be an affiliate of Misericordia University with a record of ethical expertise.  The IRB Coordinator must have thorough knowledge of OHRP, DHHS, and/or FDA regulations or willing to acquire as needed.  If required knowledge is not possessed at time of hire, or if training was completed prior to federal regulation changes, the IRB Administrator will identify and assign CITI or PRIMR&R trainings for the incoming IRB Coordinator.  The IRB Coordinator must have a commitment to the advancement of research through the ethical treatment of human research participant and have the ability to work collaboratively with the IRB Administrator, IRB Chair and other IRB members, IO, and related personnel.  

a.   Training 

1.   Must display proficiency in human subjects research training as identified by the Misericordia University IRB 

2.   Maintain the Collaborative Institute Training Initiative (CITI) IRB educational certificate specific to IRB Members 

3.   Participates in ongoing continuing education related to IRB matters 

4.   Expected to be familiar with the ethical principles of the Belmont Report and other regulatory documents, including the Misericordia University IRB Policies and Procedures 

b.   Proposal review 

1.   Screens new and renewal applications, including determination of application type: contact and advise investigators in preparation and completion of application process 

2.   Assist with developing a rotating IRB member review schedule for exempt and expedited studies. 

3.   Reads assigned proposals/annual reviews/changes of protocol thoroughly and evaluates them within the context of the federal regulations and the Misericordia University IRB Policies and Procedures in a timely manner 

4.   Suggest to IRB Chair that a consultant is needed if s/he considers a proposal to be outside the expertise of the Misericordia University IRB 

5.   Identifies and reports conflicts of interest to the IRB Chair for self, the investigator, or the institution. 

6.   Participates in the discussion of whether the proposal provides adequate protection for human research participants.  This includes a judgment about whether the application has sufficient scientific merit for the involvement of human subjects. 

7.   May suggest the shift of submitted protocols from one review category to another as deemed appropriate by the committee 

8.   Performs review of proposals outside of regular area of application type when circumstances warrant doing so and asked by the IRB Chair 

9.   Follows normal procedures for proposal review, including, but not limited to requesting a consultant 

10. Seeks consultation as necessary with IRB members, IRB Chair, or the IRB Administrator

11. Serves as an advocate during review of the community or designated vulnerable population, if needed. Advocates (an individual that represent the population) may be needed when an application is relevant to a certain population (incarcerated, individuals, elderly, pregnant women, etc.).  In certain circumstances, an advocate is either required or recommended to be present during the review of the application to help the board understand in greater detail that population and how they may best be safeguarded through the proposed research. 

12. Reviews applications submitted fo full board review 

13. Close out applications: prepare final reports for closure 

14. Manage electronic data files of protocols 

15. Protects the confidentiality of all discussions surrounding decisions whether written, electronic, or verbal and adheres to protections afforded under Family Educational Rights and Privacy Act (FERPA), as amended and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 

c.   Quality Assurance Monitoring 

1.   Participate in unanticipated risk to subject deliberations 

2.   Participate in quality assurance monitoring 

3.   Reports allegations, complaints, and noncompliance to the IRB Chair and IRB Administrator 

4.   Assist with all maintenance of records 

5.   Assist internal and external sponsors to assure human subjects compliance 

6.   Maintain FWA 

7.   Provide administrative support for the IRB and IRB Office 

8.   Direct, coordinate, and supervise administrative and clerical functions of the IRB office. 

9.   Manage records of educational certificates for IRB members. 

10. Assist with monitoring IRB budget including annual contract payments. 

d.   Meetings 

1.   Attends IRB meetings regularly.  Communicates anticipated absences to IRB Chair or IRB Coordinator prior to meetings 

2.   Prepare meeting agendas 

3.   Complete meeting minutes 

4.   Engages in discussion regarding protocols and IRB-related matters 

5.   Develop IRB meeting schedule and make room reservations. 

e.   Assistance to Faculty and Investigators 

1.   Provides information to investigators about the need for IRB review, perspectives, and resources 

2.   Offers support to Misericordia University potential, present, and past applicants by answering questions and providing tips for successful application approval 

3.   Acts as a college liaison for the IRB 

4.   Relays concerns from students, faculty, staff, external principal investigators, or the public to the IRB Chair 

5.   Provide consultation, assistance, and dissemination of information regarding the review process. 

6.   Assist with preparation of correspondence. 

7.   Assist with policy and technical consultation. 

8.   Provide advisement on regulatory compliance to administration. 

f.    Assurance of IRB Independence 

1.   Reports attempts to exert undue influence on self or others to the IRB Administrator and/or the IO 

IRB Analyst
The IRB Analyst must be an affiliate of Misericordia University with a record of ethical expertise.  The IRB Analyst must have thorough knowledge of OHRP, DHHS, and/or FDA regulations or willing to acquire as needed.  If required knowledge is not possessed at time of hire, or if training was completed prior to federal regulation changes, the IRB Administrator will identify and assign CITI or PRIMR&R trainings for the incoming IRB Analyst.  The IRB Analyst must have a commitment to the advancement of research through the ethical treatment of human research participant and have the ability to work collaboratively with the IRB Administrator, IRB Chair and other IRB members, IO, and related personnel.  

a.   Training 

1.   Must display proficiency in human subjects research training as identified by the Misericordia University IRB 

2.   Maintain the Collaborative Institute Training Initiative (CITI) IRB educational certificate specific to IRB Members 

3.   Participates in ongoing continuing education related to IRB matters 

4.   Expected to be familiar with the ethical principles of the Belmont Report and other regulatory documents, including the Misericordia University IRB Policies and Procedures 

b.   Proposal review 

1.   Assist in screening new and renewal applications, including determination of application type: contact and advise investigators in preparation and completion of application process 

2.   Assist with developing a rotating IRB member review schedule for exempt and expedited studies. 

3.   Reads assigned proposals/annual reviews/changes of protocol thoroughly and evaluates them within the context of the federal regulations and the Misericordia University IRB Policies and Procedures in a timely manner 

4.   Suggest to IRB Chair that a consultant is needed if s/he considers a proposal to be outside the expertise of the Misericordia University IRB 

5.   Identifies and reports conflicts of interest to the IRB Chair for self, the investigator, or the institution. 

6.   Participates in the discussion of whether the proposal provides adequate protection for human research participants.  This includes a judgment about whether the application has sufficient scientific merit for the involvement of human subjects. 

7.   May suggest the shift of submitted protocols from one review category to another as deemed appropriate by the committee 

8.   Performs review of proposals outside of regular area of application type when circumstances warrant doing so and asked by the IRB Chair 

9.   Follows normal procedures for proposal review, including, but not limited to requesting a consultant 

10. Seeks consultation as necessary with IRB members, IRB Chair, or the IRB Administrator

11. Serves as an advocate during review of the community or designated vulnerable population, if needed. Advocates (an individual that represent the population) may be needed when an application is relevant to a certain population (incarcerated, individuals, elderly, pregnant women, etc.).  In certain circumstances, an advocate is either required or recommended to be present during the review of the application to help the board understand in greater detail that population and how they may best be safeguarded through the proposed research. 

12. Reviews applications submitted for full board review 

13. Close out applications: prepare final reports for closure 

14. Manage electronic data files of protocols 

15. Protects the confidentiality of all discussions surrounding decisions whether written, electronic, or verbal and adheres to protections afforded under Family Educational Rights and Privacy Act (FERPA), as amended and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 

c.   Quality Assurance Monitoring 

1.   Participate in unanticipated risk to subject deliberations 

2.   Participate in quality assurance monitoring 

3.   Reports allegations, complaints, and noncompliance to the IRB Chair and IRB Administrator 

4.   Assist with all maintenance of records 

5.   Assist internal and external sponsors to assure human subjects compliance 

6.   Maintain FWA 

7.   Assist with administrative support for the IRB and IRB Office 

8.   Assist with administrative and clerical functions of the IRB office. 

9.   Assist with monitoring IRB budget including annual contract payments. 

d.   Meetings 

1.   Attends IRB meetings regularly.  Assist with meeting agendas 

2.   Assist with meeting minutes 

3.   Engages in discussion regarding protocols and IRB-related matters 

4.   Assist with developing IRB meeting schedule and room reservations. 

e.   Assistance to Faculty and Investigators 

1.   Provides information to investigators about the need for IRB review, perspectives, and resources 

2.   Offers support to Misericordia University potential, present, and past applicants by answering questions and providing tips for successful application approval 

3.   Acts as a college liaison for the IRB 

4.   Relays concerns from students, faculty, staff, external principal investigators, or the public to the IRB Chair 

5.   Provide consultation, assistance, and dissemination of information regarding the review process. 

6.   Assist with preparation of correspondence. 

7.   Assist with policy and technical consultation. 

8.   Provide advisement on regulatory compliance to administration. 

f.    Assurance of IRB Independence 

1.   Reports attempts to exert undue influence on self or others to the IRB Administrator and/or the IO 

New Members and Staff
Training requirements for all new IRB members and staff adhere to the standards and regulations set forth by the Office of Human Subjects Research Protection (OHRP) of the United States Department of Health and Human Services (DHHS) as required under the University's federal wide assurance (FWA).  New members will be required to complete the following training requirements: 

a.   Orientation to electronic systems, including Collaborative Institute Training Initiative (CITI) training and online management system 

b.   Orientation to the IRB's website, including all documents and attachments to that site.  These materials may include: IRB Policies and Procedures; the Belmont Report; and the Code of Federal Regulations (CFRs) 

c.   Co-review ten (10) protocols sampling from all three protocol categories (exempt, expedited, full board) 

d.   New members will be paired with a standing member having a minimum of one-year experience for a mentor-trainee relationship 

Standing Members and Staff - Continuing education will be assigned by the IRB Chairperson, including the renewal of CITI certification (three-year expiration), updates, and regulatory training. 

The IRB meets monthly from August until May. One meeting will be held during the summer months, typically in June. A schedule of meeting dates is available on the MU IRB website.

Minutes will be taken at all IRB meetings. Records will be retained for at least three years.

The IRB's responsibility includes the review of research which would normally be viewed as biological, behavioral, or psychological investigations involving human subjects.

The IRB is responsible for review of all research activities that involve human subjects including research:

·    conducted at the University or its sites; 

·    by any employee or student whose research commences during the time of his or her employment or affiliation with the University, 

·    and who represents him or herself to the subjects or to the population to which the results will be disseminated, as an affiliate of the University. This includes master's theses or doctoral dissertation research conducted by faculty, staff or students; 

·    conducted by external researchers who wish to have access to Misericordia University students, faculty or staff as part of their subject pool. 

Human subjects research includes not only studies involving adults and children, but also:

1.   use of graphic, written, or recorded information about individuals even when this information has been collected by other institutions or researchers; 

2.   investigations of prenatal life; 

3.   studies or procedures utilizing organs, tissues or body fluids of humans; and 

4.   investigations of organizations. 

The IRB has the responsibility to review research protocols and the authority to approve, require modifications, or disapprove all research activities conducted by Misericordia University faculty, students or staff even if the research is not conducted at the University.

The IRB will require that information given to subjects as part of informed consent is in accordance with 46.116 of 45 CFR 46. The IRB may require that information, in addition to that specifically mentioned in 46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.

The IRB will require documentation of informed consent or may waive documentation in accordance with 46.117 of 45 CFR 46.

The IRB will notify researchers and the institution in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

The IRB will conduct continuing review of all approved protocols at intervals appropriate to the degree of risk, but not less than once per year, and has the authority to observe or have a third party observe the consent process and implementation of the protocol.

IRB members will not review protocols initially or for continuing review for which a conflict of interest can be construed.

The IRB also has responsibility for assuring adequate monitoring of the quality of research which it has improved. This responsibility for monitoring resides with the IRB administrator or designee. Reports of protocol monitoring activities must be made at least annually to the IRB.

Conflict of Interest

The IRB may not have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

Confidentiality of IRB Proceedings

Through its policies and procedures, the IRB seeks to maintain the fundamental principle of openness in research and, at the same time, to protect personal privacy and proprietary information. The value of openness with respect to the business of the IRB must be limited by considerations of the privacy of human participants in research, the confidentiality of proprietary data, the need to encourage free discussion at IRB meetings, and the desire to promote cooperation in carrying out the responsibilities of the IRB.

The following policy guidelines have been established to promote a balance between openness and privacy concerns:

a.   Responsibility of IRB Members to Maintain Confidentiality of Proceedings
Members of the IRB and administrative staff who attend meetings are responsible for maintaining the confidentiality of all IRB deliberations and discussions. They shall not discuss the protocols or the discussions of the protocols with others outside the IRB other than the research team of the proposal unless identifiers have been removed. They shall take care to properly store and dispose of materials that are discussed at meetings. A confidentiality statement must be signed by the IRB members or invited guests prior to the first meeting they attend. A confidentiality statement may be signed by other professionals of close proximity to the IRB or those related to IRB business. 

b.   Attendance at Regular IRB Meetings 
IRB meetings are closed to the public and individuals must be invited by the IRB to attend. 

c.   Minutes of IRB Meetings 
In order to encourage open and frank discussion at IRB meetings and to have detailed records of IRB business (including confidential issues and matters under investigation), minutes of IRB meetings are not made available to others outside the Vice President of Academic Affairs office unless otherwise required by law or external regulations. Individual IRB members are not identified in the minutes in relation to discussions of research protocols, unless that IRB member requests to be identified. 

d.   Protocols, Study Documents and Informed Consent Forms 
The IRB shall consider a research protocol and all associated application materials to be confidential documents. 
Requests to release a protocol or a consent form should be directed to the relevant Principal Investigator. Such requests must state the reason for the release of the protocol or consent form. 
The IRB maintains the right to allow the following individuals access to protocols and related study documents:  

i.    IRB members 

ii.   IRB Staff 

iii. Institutional Official (IO) and/or his/her designee 

iv. OHRP or other federal authorities responsible for Human Subject Protections 

v.   Invited individuals with specialized knowledge concerning research procedures or populations to assist in the review of complex issues that require expertise beyond or in addition to that available to the IRB. Invited individuals will only be provided with the minimum necessary details or documentation to allow for their guidance. The PI will be notified that an outside expert will be used in the review. 

Language adapted from the Montclair University IRB Policies and Procedures

The IRB meets monthly, excluding the summer months. Protocols for review are to be submitted using the online submission system. Full board protocols are to be submitted not less than two weeks before the meeting date of the IRB. All protocols will be assigned to IRB members based on the type of review required. Outcomes will be communicated to the researcher in writing and are reported to the IRB at its regularly scheduled meetings. Additionally, the researcher will receive a copy of the informed consent form which is date stamped. This is the approved form and the only one that is to be used. Please note, other study documents may also be stamped and those forms are the only ones that are to be used. If revisions/amendments are requested by the IRB, they must be received within 60 days or IRB approval/the application will be terminated and a new application will be required.

The Office of the Vice President of Academic Affairs prepares and maintains Misericordia University IRB Policies and Procedures and the IRB membership list, research protocols and all related documentation outside of the online submission system (for a period of three years after the date of study completion). Minutes of IRB meetings are stored within the online submission system.

All IRB members have access to IRB membership, Misericordia University Policies and Procedures, the Common Rule document (45 CFR 46), the Belmont Report, monthly minutes, and other documents related to its work as they become available.

The researcher may submit a letter to the IRB chairperson requesting another review and provide the rationale for the request. Every attempt will be made to resolve the identified problem(s). However, the IRB retains the responsibility for determining the risk to human subjects.

Please note, this is not a formal appeal procedure associated with IRB review. An IRB ruling is not subject to a formal appeal nor can it be overturned by another group or person(s). Only the IRB can alter its previous determination. The IRB is not a judicial body, but a review board empowered to consider and uphold the rights, welfare and protection of human subjects in research. A disapproved project can be altered so that it may secure approval.

Language modified from the Montclair State University IRB Policies and Procedures pre-2018.

 

All Misericordia University faculty, staff, students, individuals obtaining consent, or key research personnel are required to complete training in the protection of human research participants, specifically Collaborative Institute Training Initiative (CITI) courses, prior to obtaining IRB approval. The IRB reserves the right to require CITI training for the individuals listed on the protocol application. This training is required regardless of level of review (exempt, limited, expedited, or full). Certificates will need to be renewed every three years. CITI training certificates for all research personnel listed on an application must accompany the IRB application. Applications that include research personnel without the appropriate training certificate, as outlined above, will not be reviewed until this requirement is satisfied.

If an investigator is not associated with, or external to Misericordia University, s/he must submit proof of having completed human participants protection training. However, the IRB reserves the right to require the external investigator to complete some or all of the elements of the training module used to satisfy the Misericordia University requirement.

Language adapted from the University of Connecticut Policies and Procedures

 

The MU IRB has the responsibility and authority to observe ongoing research projects and the consent process, as well as conduct continuing review of the project, including audits of research records. The IRB can audit research records randomly, for cause (such as, but not limited to, an unanticipated problem or adverse event), and based on the compliance records of the investigators. Full cooperation by the responsible principal investigator and other members of the research team (if necessary) is expected.

On-site audits are conducted as part of the Human Research Protection Program's (HRPP) continuing compliance oversight in accordance to Federal regulations. The purpose of the audit procedure is to ensure protection of the human subjects participating in research. The information gathered during the audit is for the IRB to use to monitor the implementation of approved protocols, identify areas that need improvement, correction or targeted education, and to gather information for continuous improvement on ways to improve the audit tool or the audit process. Investigators are notified, generally by e-mail, at least 2-5 days prior to the conduct of the audit.

Who can perform an audit?

·    Federal agency overseeing the research (OHRP) 

·    Research study sponsor if applicable (funding agency) 

·    IRB (IRB Administrator, IRB Chair, IRB Member, IRB staff) 

Procedures

The MU IRB has the authority or may designate a third party to:

·    Observe the conduct of any research activity, 

·    Review at any time all research records, including but not limited to consent documents, regulatory files, IRB files, subjects' research and medical records, clinical materials, record storage, computer files, and results of procedures and tests performed during the course of the research, 

·    Observe the consent process, and 

·    Interview subjects either during or after their participation in research activities. 

The IRB administrative staff will schedule audits of previously approved research studies.

Criteria for choosing studies for audit include, but are not limited to, the following:

·    Random selection; 

·    Sufficient cause as determined by the IRB; 

·    High risk studies as designated by the IRB; 

·    Any report of suspected noncompliance; 

·    Research terminated by the IRB due to failure by the investigator to submit the study for continuing review or failure to respond to a request for information from the IRB; 

·    Verification of continuing review reports; and 

·    Studies reporting a large number of unanticipated problems, including adverse events and/or protocol deviations. 

Prior to initiation of an audit, the investigator will be notified by the IRB staff. An acceptable date and time will be identified for the audit.

The MU IRB audit form will be used and may be amended to capture all required information.

Audit reviews may include:

·    Any study/research-related documents and source documents, such as medical records or data collection sheet(s); 

·    Specimens and associated collection processes; and 

·    Computer hardware and/or software associated with the research. 

The principal investigator will be requested to provide a list of all study participants to the auditor.

If the number of subjects enrolled is large, the auditor will select at random 20-30% of the subject population to be audited. Otherwise, all records will be reviewed.

In the case of a for cause audit, the IRB may request a 100% audit of study participants' records.

A pre-audit interview may be conducted with the investigator or other key research personnel to document the delegation of authority related to the following activities:

·    Regulatory affairs/IRB submissions; 

·    Obtaining of consent; 

·    Recruitment of study participants; 

·    Reporting of Adverse Events/protocol deviations;

·    Reporting of injury or other unforeseen events to the IRB/sponsor; 

·    Maintaining study documentation; 

·    Data accountability; 

·    Monitoring by the sponsor, if applicable; and 

·    Verification of continuing review reports. 

A report of audit findings will be prepared and submitted to the IRB Administrator or his/her delegate for review and action. The Administrator may consult with the full board regarding corrective action plans necessary to correct deficiencies identified at audit. A copy of the audit report and a letter indicating any necessary corrective actions will be sent to the PI, PI's supervisor/Department Chair, Dean, and IO.

If the results of the audit identify outstanding issues, a letter outlining the basis for the findings and requesting needed explanations, corrective action plans and/or study revisions will be sent to the PI, PI's supervisor/Department Chair, Dean, and IO.

If preliminary findings so indicate, the IRB may suspend the study enrollment or activities or terminate the study and take appropriate action to ensure the safety and welfare of the subjects.

The PI may be required to appear before the full board to address issues identified at audit. The PI may not have other witnesses present at the meeting. Please see Ethical Concerns section of this policy.

The IRB may engage any outside consultant or expert as necessary to conduct the audit.

If subjects are considered at risk due to the actions of the PI or other key research personnel, the IO will be notified, and appropriate action will be taken to ensure the safety and welfare of the subjects.

Audit reports, corrective action plans, and correspondence with investigators will be transmitted to the IO to assure proper protection for the rights and welfare of human subjects.

Copies of audit reports and correspondence will be placed in the study files, as well as being included in the minutes of the next scheduled meeting of the full board.

Follow-up audits will be scheduled when substantial deficiencies have been identified whose correction is crucial in providing adequate protection for the rights and welfare of subjects.

Language adapted from the University of Missouri Kansas Audit Procedures with permission.

ADVERSE EVENT: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.

APPROVED RESEARCH PROTOCOL: The information included in the final approved IRB application, including any attachments, addenda, or appendices. Subsequent modifications and applications for continuing review are included in this definition. A copy of the approved protocol is provided to the PI along with an IRB approval letter when IRB review is complete.

Language adapted from the University of Iowa Institutional Review Board Policy on IRB Review of Protocol Deviations and Noncompliance for Non-exempt Research with permission.

ASSENT: This is the child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

ASSURANCE: A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance is achieved. This is also known as Federal Wide Assurance (FWA).

AUTONOMY: Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.

BELMONT REPORT: A report upon which the Department of Health and Human Services regulations are based. It describes the ethical principles and guidelines for the protection of human subjects in research.

BENEFICENCE:  An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do no harm; and (2) protect from harm by maximizing anticipated benefits and minimizing possible risks of harm.

BENEFIT: A benefit in research is a valued or desired outcome enjoyed by the subject (therapeutic benefit), or accruing to a group under study, or to their family members, or to scientific knowledge (nontherapeutic benefit).

CERTIFICATION: The official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of 45CFR46, that a research project or activity involving human subjects has been reviewed and approved by an Institutional Review Board in accordance with an approved assurance.

CHILD or CHILDREN: These are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research is conducted.

CLINICAL TRIAL: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related incomes.

COMMON RULE: The "Common Rule" refers to Federal statutes governing the protection of human subjects in research, enacted in 1991 and adopted by 17 Federal agencies. The Common Rule is set forth in the Code of Federal Regulations, 45 CFR Part 46, and covers all federally funded research supported by the Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and DHHS, as well as NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission. The provisions are identical to the DHHS Regulations (45 CFR Part 46, Subpart A). [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html]

CONFIDENTIALITY: Protection of human subjects in a research study so that their individual identities will not be linked to information they provide and will never be publicly shared.

CONFLICT OF INTEREST: Situations in which financial or other personal considerations may compromise, or have the appearance of compromising, a researcher's professional judgment in conducting or reporting research.

Language adapted from the University of California, San Francisco "Conflict of Interest in Research" website.

CLINICAL TRIAL: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

DATA: Multiple facts (usually, but not necessarily, empirical) used as a basis for inference, testing, analysis, etc. or used as the basis for decision-making.

DATA AND SAFETY MONITORING PLAN: A plan with a general description of data and safety monitoring of a clinical research study. The plan is developed by the researcher, included in the protocol, and submitted to the IRB for review and approval before the study begins. An appropriate plan reflects the risks of the study, including its size and complexity.

DEBRIEFING: Communication with study subjects usually after they have participated in study activities regarding various aspects of the study.

DECLARATION OF HELSINKI: Statement of ethical principles for human participation in biomedical research. The Declaration was first adopted in 1964 by the World Medical Association. It has been revised five times, most recently in 2000. Like the Nuremberg Code that preceded it, the Declaration of Helsinki makes consent a central requirement of ethical research. The Declaration initially established a distinction between the standards for therapeutic and non- therapeutic research; however, this has been eliminated in recent revisions.

DEPARTMENT or AGENCY HEAD: The head of any Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated.

DOUBLE MASKED DESIGN OR "DOUBLE BLIND" DESIGN: A research study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects.

EXPEDITED REVIEW: Review of proposed research by the IRB Chair or a designated voting member or group of voting members rather than the entire IRB.

EXCLUSION CRITERIA: The list of elements in a person's medical history that would prevent an individual from participating in a specific research study.

FEDERAL DEPARTMENT OR AGENCY: A federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or other regulates (e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency).

GUARDIAN: According to Pennsylvania State Law a guardian is a person lawfully invested with the power, and charged with the duty, of taking care of and managing the property and rights of another person, who, for some peculiarity of status, or defect of age, understanding or self-control, is considered incapable of administering his or her own affairs

HUMAN PARTICIPANT, RESEARCH PARTICIPANT, HUMAN RESEARCH PARTICIPANT, PARTICIPANT, HUMAN SUBJECT, RESEARCH SUBJECT, HUMAN RESEARCH SUBJECT, SUBJECT: These interchangeable terms refer to a living human individual about whom an investigator (whether professional or student) conducting research: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

IDENTIFIABLE BIOSPECIMEN: A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

IDENTIFIABLE PRIVATE INFORMATION: Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

INCLUSION CRITERIA: The list of elements in a person's medical history necessary to allow an individual to participate in a specific research study.

INFORMED CONSENT: A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research. Informed consent also refers to the process of information exchange between researcher and subject prior to participation in research. The information to be conveyed to the subject is factual information, including an assessment of the risks of participation, eight specific elements required by federal regulations, a description of the procedures that will be performed, and the persons responsible. The information conveyed by the subject to the researcher is an indication of his or her comprehension of the process, the voluntary nature of participation, and understanding of his or her rights, including the right to withdraw.

The informed consent form is a written document, signed by subjects in research studies prior to commencement of the study. The form is presented to and signed by the subject, who should have a chance to ask questions regarding the research prior to the commencement of the study.

INSTITUTIONAL REVIEW BOARD (IRB): A specially constituted review body established to protect the welfare of human subjects in research. Federal law states that all institutions supported by a federal department or agency to which the Common Rule applies must establish an Institutional Review Board to review and approve research involving human subjects.

IRB APPROVAL: The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

INTERACTION: Includes communication or interpersonal contact between investigator and subject.

INTERNET PROTOCOL (IP): a unique identifier associated with every computer connected to the internet. On many networks, the IP address of a computer is always the same, i.e. fixed or static. On other networks, a random IP address is assigned each time a computer connects to the network, i.e., dynamic. Knowing a fixed IP address is equivalent to knowing the identity of its users, and is thus considered protected health information.

INTERVENTION: This includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

INSTITUTION: Any public or private entity, or department or agency (including Federal, state, and other agencies).

INVESTIGATOR: In research studies, an individual who actually conducts an investigation [21 CFR 312.3]. Any interventions (e.g., drugs) involved in the research study are administered to subjects under the immediate direction of the Investigator.

IN WRITING: Writing on a tangible medium (e.g., paper) or in an electronic format.

JUSTICE: An ethical principle discussed in the Belmont Report requiring fairness in the distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.

LEGALLY AUTHORIZED REPRESENTATIVE: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research.

MINIMAL RISK: The probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or test.

MINOR: According to the Pennsylvania Code, Rule 801, a minor is a person under the age of 18.

NORMAL "CONTROL" VOLUNTEERS: Volunteer subjects used to study normal physiology and/or behavior or who do not have the condition under research study in a particular protocol.

Normal volunteers may be studied for comparison with subjects who have the condition under study.

NONCOMPLIANCE: Failure to adhere to federal regulations or IRB and/or University requirements for human subjects research, including intentional protocol deviations, unless such deviations are necessary to eliminate apparent immediate hazards or risks to research subjects. Noncompliance can be minor, serious, and/or continuing.

Language adapted from the University of Iowa Institutional Review Board Policy on IRB Review of Protocol Deviations and Noncompliance for Non-exempt Research with permission.

NURENBERG CODE: A code of ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects during research.

OFFICE FOR HUMAN RESEARCH PROTECTION ("OHRP"): The office within the Department of Health and Human Services responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects. The OHRP has direct oversight and educational responsibilities wherever DHHS funds are used to conduct or support research involving human subjects. Additionally, it serves as a research, guidance and educational resource for all institutions involved in conducting research that involves human partnership, regardless of the funding status of the research.

PARENT: A child's biological or adoptive parent.

PERMISSION: This is the agreement of a parent or guardian to the participation of their child or ward in research.

PREGNANCY: The state of a female after conception or implantation until the birth of a baby or expulsion of the fetus.

PRINCIPAL INVESTIGATOR OR RESEARCHER: The scientist or scholar with primary responsibility for the design and conduct of a research study.

PRISONER: An individual involuntarily confined or detained in a penal institution or an alternative facility including those detained pending arraignment, trial or sentencing.

PRIVACY: Control over the extent, timing, and circumstances of sharing oneself (intellectually, physically, behaviorally) with others.

PRIVATE INFORMATION:  This includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which as been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g. medical records, social security and financial account numbers, passwords to websites and other venues).

QUORUM: A simple majority of the IRB members qualified to vote.

RANDOMIZATION: Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics). Random assignment of subjects to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.

RECRUITMENT: The act of selecting and enrolling research subjects for a research study using proper inclusion criteria.

RESEARCH: Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research: 1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. 2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identity, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). 3.Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. 4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

RESEARCHER: The individual who conducts and directs the research study and carries the primary responsibility for the research. The Researcher is referred to as the "Principal Investigator" when acting as the leader of a research team.

RESEARCH PROTOCOL: The formal design or plan of an experiment or research activity: specifically, the plan submitted to the IRB or designated representative for review.

RESPECT FOR PERSONS: An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.

RISKS: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.

RISK/BENEFIT ANALYSIS: An analysis of the potential risks to subjects considered against the potential benefits to the individual or to the research objectives of the research study.

SENSITIVE INFORMATION: is private information which if released could reasonably place subjects at risk of criminal or civil liability or could damage their financial standing, employability, insurability, reputation or could be stigmatizing. This includes, but are not limited to sexual attitudes, preferences or practices, use or treatment for alcohol, drugs, or other addictive products, illegal behaviors, certain health information, including psychological or mental health.

SOCIAL MEDIA: are forms of electronic communication (such as websites for social networking and microblogging) through which users create online communities to share information, ideas, personal messages, and other content (such as videos and pictures) (Merriam Webster, 2018)

SPONSOR: An individual, company, institution, or organization that initiates and finances a research study. A sponsor is not necessarily the entity that conducts the research.

THERAPY: Treatment intended and expected to alleviate a disease or disorder.

UNANTICIPATED PROBLEM: According to OHRP, the incident or outcome must meet ALL of the following criteria: (1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB- approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; (2) related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and (3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

UNIVERSAL DECLARATION OF HUMAN RIGHTS: An international declaration adopted in 1948 by the United Nations as the first comprehensive agreement among nations as to the specific rights and freedoms of all human beings.

VOLUNTARY: A subject's decision to participate (or continue to participate) in a research activity that is made free of coercion, duress, or undue inducement.

VULNERABLE SUBJECTS/POPULATION: Individuals or groups of subjects who, by reason of disability, illness, age, or other status exhibit diminished personal autonomy. Neither the federal regulations nor ethical codes, including the Belmont Report, proscribe inclusion of vulnerable persons as research subjects. However, DHHS regulations mandate special justification for research involving fetuses, pregnant women, and human in vitro fertilization [45 CFR Part 46, Subpart B]; prisoners [45 CFR Part 46, Subpart C]; and children [45 CFR Part 46. Subpart D].

Prior to submitting an application, be sure that you have carefully reviewed Misericordia University's IRB Policies and Procedures. Researchers are requested to determine the level of review that their proposal will require. Ultimately, the final determination will be made by the IRB chairperson, or delegate, in consultation (as necessary) with the IRB administrator. Research involving human subjects may not be initiated until you have received notification of IRB approval and agree to comply with the contingencies in connection with that approval.

The electronic proposal application must be completed. Please visit the IRB website for instructions on submitting your IRB application.

Please note, researchers must retain the approved application and signed consent forms for a minimum of three years following the completion of the study. HIPAA Authorization forms must be kept for six years. For student research studies, the faculty must retain the approved application and signed consent forms. The IRB may request these.

Types of Review

Protocols can be submitted for review by faculty, staff, students, and agents of Misericordia University. Student submissions must be accompanied by a faculty sponsor. Similarly, those from outside of the institution who wish to conduct research at Misericordia University must secure a sponsor from within the institution.

Misericordia University's IRB will make the final determination on the type of research review required. Therefore, all human subjects research protocols should be submitted to the IRB for review.

Certain research may be determined exempt from review by the IRB under 45 CFR 46:101(b). Although minimal risk, it is still the ethical responsibility of the researcher to protect human research subjects, and all researchers must apply and receive approval for exempt status before initiating the research study. Exempt applications will be reviewed by the chair or at least one member of the IRB. The reviewer(s) will determine whether the submission meets the criteria for exemption. The reviewers(s) may exercise all the authorities of the IRB except to disapprove the research. A research activity may be disapproved only after a review by the convened IRB.

Research exempt from full IRB review must meet the following guidelines:

1.   Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 

2.   Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, if at least one of the following criteria is met: 

1.   The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

2.   Any disclosure of the human subjects' responses outside the research would not reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or 

3.   The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 46.111(a)(7). 

3.   Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written response or audiovisual recording if the subject prospectively agrees to intervention and information collection and at least one of the following criteria is met: 

1.   The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to them; 

2.   Any disclosure of the human subjects' responses outside the research would not reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement or reputation; or 

3.   The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 46.111(a)(7).
 
For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
 
If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. 

4.   Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: 

1.   The identifiable private information or identifiable biospecimens are publicly available; 

2.   Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; 

3.   The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under CFR Parts 160 and 164 (the Health Insurance Portability and Accountability Act), for the purposes of "health care operations", or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or, 

4.   The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Govemment Act of 2002,44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. 

5.   Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public health benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers or otherwise mandatory requirements using authorities such as sections 1115 and 1115A or the Social Security Act, as amended.
 
Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. 

6.   Taste and food-quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environment Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. 

These exemptions do not apply to research involving prisoners, exempt for research aimed at involving a broader subject population that only incidentally includes prisoners. Further, exemption 2 a and c may only apply to children in research involving educational tests or the observations of public behavior when the investigators (s) do not participate in the activities being observed.

Limited Review 
Certain exempt categories require a limited review by the IRB to ensure adequate protections are in place for protecting privacy and maintaining confidentiality. Limited review will be conducted by the chair and/or at least one member of the IRB. Under limited review, the IRB does not need to make the determinations at 46.111 paragraphs (a)(1) through (6). The reviewers(s) may exercise all the authorities of the IRB except to disapprove the research. A research activity may be disapproved only after a review by the convened IRB. 

An IRB may use the expedited review procedure to review the following:

1.   Some or all of the research appearing on the list described in this section, unless the reviewer determines that the study involves more than minimal risk; 

2.   Minor changes in previously approved research during the period for which approval is authorized; or 

3.   Research for which limited IRB review is a condition of exemption 

The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve more than minimal risk to human subjects. Expedited applications will be reviewed by the chair and/or at least one member of the IRB. The reviewer(s) will determine whether the submission meets the criteria for expedited review. The reviewers(s) may exercise all the authorities of the IRB except to disapprove the research. A research activity may be disapproved only after a review by the convened IRB.

The categories in this list apply regardless of the age of subjects, except as noted.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. If the reviewer determines the research to be more than minimal risk, documentation of such is required.

The expedited review procedure may not be used for classified research involving human subjects.

Research Categories

1.   Clinical studies of drugs and medical devices only when condition (a) or (b) is met. 

1.   Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) 

2.   Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. 

2.   Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 

1.   from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or 

2.   from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. 

3.   Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. 

4.   Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
 
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. 

5.   Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4) (. This listing refers only to research that is not exempt.) 

6.   Collection of data from voice, video, digital, or image recordings made for research purposes. 

7.   Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45CFR 46.101 (b)(2) and (b)(3). This listing refers only to research that is not exempt.) 

8.   Continuing review of research previously approved by the convened IRB as follows: 

1.   where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or 

2.   where no subjects have been enrolled and no additional risks have been identified; or 

3.   where the remaining research activities are limited to data analysis. 

9.   Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. 

Unless research qualified for exempt or expedited as described previously, it requires full board review. Full board review means that each member of the IRB is responsible for reviewing the entire protocol. Following the review, an in-depth discussion will occur among the IRB members at a scheduled meeting. The majority must be present for the vote and a least one nonscientist must be present for the discussion and vote. A majority decision must be achieved for the proposal to be approved. For a full board protocol, the full board will make one of the following determinations: 1) approved; 2) approval withheld pending submission of revision and/or additional information; 3) disapproved. If a protocol is determined to need revision, the researcher cannot collect data until the full board has re-reviewed the protocol and voted to approve it. At the time of the approval vote, the IRB will determine if continuing review will be required in less than one year. As a matter of course, review must occur at least once a year. The IRB will use the skills of its membership to determine if more frequent review is required. This will be based on the IRB concluding that there is adequate risk to require more frequent review.

In order to approve research, the IRB will be certain that all of the following requirements are satisfied:

1.   Risks to subjects are minimized: 

1.   By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and 

2.   whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. 

2.   Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. 

3.   Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. 

4.   Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 46.116 

5.   Informed consent will be appropriately documented, in accordance with, and to the extent when appropriate, the research plan makes adequate provision for monitoring the data 

6.   collected to ensure the safety of subjects. 

7.   When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, individuals with impaired decision-making ability, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

The IRB can request a review sooner than one year if it deems appropriate. More frequent review is required for proposals that the IRB determines to be of more than minimal risk. This will be determined on an individual basis and investigators will be notified of the dates of protocol review at the time of approval. Please note: approved IRB protocols maintaining identifiable data must be kept open until these data have been destroyed for monitoring purposes, even if the recruitment and data collection period has ended.

For research projects that continue beyond the initial approved period, they must indicate 1) the number of subjects accrued; 2) a summary of adverse events and any unanticipated problems (see section 2.6.4) involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since the last IRB review; 3) a summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review; 4) any relevant multi-center trial reports (if applicable); 5) any other relevant information, especially information about risks associated with the research; and 6) a copy of the current informed consent document and any newly proposed consent documents. The IRB may request revisions/changes that are required for continuation. A continuation/annual update or end of protocol form must be submitted prior to the expiration date of the study approval. If the researcher fails to complete the required form by the expiration date, IRB approval will be terminated and a new application will be required. If revisions/amendments are requested by the IRB, they must be received within 60 days or IRB approval will be terminated and a new application will be required.

Level of review will be determined by the IRB chairperson or delegate. Review will be conducted following the procedures for initial review: exempt - IRB chair or at least one member of the IRB; limited - IRB chair and/or at least one member of the IRB, expedited - IRB chair and/or at least one member of the IRB; and full board review. All documentation related to the protocol will be available for reviewers.

Note: From time to time, the IRB during its review process may determine that additional information is necessary in order to assure adequate review. The additional information may take the form of that which the investigator can provide or that which requires verification from sources other than investigator. When information is to be requested from outside sources, the investigator will be notified via a letter that verification is being sought.

The determination of the need for verification from sources other than the investigator to assure that the protocol has been implemented as approved can be conducted using the following criteria: (1) randomly selected projects; (2) complex projects involving unusual levels or types of risk to subjects; (3) projects conducted by investigators who previously have failed to comply with federal or local IRB requirements or IRB determinations; and (4) projects where concern about possible material changes occurring without IRB approval have been raised based upon information provided in continuing review reports or from other sources.

Principal investigators (PIs) are responsible for ensuring their research is conducted in accordance with the protocol approved by the MU IRB and with applicable University policies and non-University regulatory requirements. Failure to do so can have a negative effect on research participants. Deviations from the approved protocol can jeopardize the safety, rights, and welfare of participants. Additionally, these deviations can place the University at risk of federal sanctions, up to and including losing the right to receive federal funding for human subjects research.

The MU IRB recognizes that deviations from the approved protocol may occur during the course of a research study. All such deviations to protocols of all levels of review must be promptly reported to the IRB. This policy outlines the responsibilities for reporting deviations and the process by which these deviations will be reviewed.

1. Reporting Changes in a Research Protocol

Researchers must submit all proposed changes to an approved protocol for review and approval prior to instituting the change. Examples of changes requiring approval include but are not limited to: submission for external funding, increase in risk, change in subject recruitment criteria, and inclusion of vulnerable populations. The only exception is in the event that the immediate change is necessary to eliminate a hazard to subjects. However, the IRB must still be notified within five days. The IRB may request revisions to proposed changes before implementation is approved.

Once received, the IRB chairperson or delegate will determine the appropriate level of review. Following the review, the investigator will be notified in writing of the IRB's decision regarding the change(s). If revisions/amendments are requested by the IRB, they must be received within 60 days or new application for modifications will be required.

2. Procedures for Reporting Unanticipated Risks to Subjects

Researchers are required to notify the IRB Office within three working days of any identified unanticipated risks or adverse events to subjects or to others and the proposed action to correct the situation via the electronic reporting system. The investigators will also notify subjects. The IRB administrator will report to the IRB and to the IO within three working days of this notification, the identified unanticipated risk and the plan for correction of the problem. The IRB, and the IO if deemed appropriate by the IRB, will jointly determine the effectiveness of the plan. The investigator will be notified within 48 hours of review of the action of the acceptableness of the plan or additional information and/or actions to be taken. The IRB can choose one of three actions: (1) approve plan as submitted; (2) ask for modifications to the plan to assure protection of human subjects, or (3) refuse to accept the plan of action and direct the researcher to halt all research activities and notify study subjects.

When applicable, notification will also be made by the IRB Office to the appropriate federal agency or department and OHRP with 14 days of investigator notification of approval of the correction plan.

3. Non-Compliance or Research Misconduct

A noncompliance is a failure to adhere to federal regulations or IRB and/or University requirements for human subjects research, including intentional protocol deviations, unless such deviations are necessary to eliminate apparent immediate hazards or risks to research subjects. Noncompliance can be minor, serious, and/or continuing as defined below.

1.   Minor noncompliance: A minor noncompliance typically involves administrative oversights, non-substantive changes, etc. Any noncompliance that does, or reasonably may, adversely affect the rights, safety, or welfare of research subjects is not minor, even if no actual harm has occurred. Examples of minor noncompliance include, but are not limited to: implementing non-substantive changes to approved procedures without IRB approval, such as: 

·    Re-wording survey or interview questions where the meaning and scope of the question does not change; 

·    Wording changes in recruitment materials or consent documents that do not change the meaning of the information provided or result in excluding any required element(s) of consent; 

·    Changing the order in which study conditions are administered, as long as a specific order is not necessary to minimize risk; 

·    Enrolling subjects who do not meet the inclusion or exclusion criteria, except in the circumstances described as serious noncompliance below. 

·    Exceeding the approved number of subjects in a study 

2.   Serious noncompliance: Noncompliance that compromises the safeguarding of the rights, safety or welfare of human research subjects, or that does or may reasonably adversely affect the rights, safety, or welfare of human research subjects, even if no actual harm occurred. Acts that are determined by the IRB to be a flagrant or intentional violation of IRB requirements may also constitute serious noncompliance. The IRB will consider the circumstances surrounding the case when making a decision related to serious noncompliance. In general, examples of serious noncompliance include, but are not limited to: 

o   Failure to obtain IRB approval prior to initiating research activities with human subjects; 

o   Allowing unqualified or untrained individuals to perform research procedures or monitor subject safety; 

o   Failure to provide participants with all information necessary to constitute meaningful "informed consent" unless a waiver has been granted by the IRB; 

o   Failure to report or minimize conflicts of interest; 

o   Enrolling a child in a research study without the informed consent of a parent or legal guardian unless parental consent was waived by the IRB; 

o   Enrolling subjects from a vulnerable population (i.e., children, prisoners, cognitively impaired individuals, etc.) when their inclusion is not described in the IRB-approved protocol and appropriate protections are not in place; 

o   Enrolling subjects who do not meet the approved eligibility criteria when doing so compromises the safety or well-being of the subjects; 

o   Failure to follow approved measures for protecting privacy and confidentiality when the failure presents any risk of harm to the research subject (such as harm to their reputation, social or psychological harm, risks of legal or civil liability, embarrassment, harm to workplace or family relationships, etc.); 

o   Implementation of changes to procedures, without prior IRB approval, that increase risks to participants or adversely affect their rights, safety, or welfare (e.g., adding survey questions that collect sensitive information, substantially increasing the duration or intensity of exercise activities, adding plans to collect data from private records without subject consent, changes to confidentiality protections, etc.); 

o   Failure to report adverse events or unanticipated problems involving risks to subjects or others as required by IRB policy; 

o   Instructing or knowingly allowing subordinates (e.g., students, research assistants, employees, etc.) to engage in activities that are contrary to IRB or institutional policies or regulatory requirements; 

o   Providing false or intentionally misleading information to the IRB 

o   Multiple protocol deviations suggesting a lack of oversight, inaction, or negligence such that research subjects' rights, safety, or welfare could be adversely affected. 

3.   Continuing noncompliance: Repeated acts of noncompliance in the conduct of human subjects research suggesting a pattern indicative of a lack of understanding or attention to adequate safeguarding of the rights, safety, or welfare of human subjects or of University policies and/or non-University regulatory requirements for the conduct of human subjects research. Continuing noncompliance is characterized by the frequency rather than the magnitude of the noncompliance. Examples of continuing noncompliance include, but are not limited to: 

1.   Repeated failure to obtain IRB approval prior to initiating human subjects research activities; 

2.   Continually late submissions of continuing review applications resulting in repeated lapses in approval; 

3.   Multiple instances of serious or minor noncompliance; this includes multiple incidents within a single project or multiple incidents by a single investigator across more than one project. 

All members of the University community bear responsibility for compliance with IRB policies and procedures related to research that includes human subjects. If anyone identifies an activity or activities that violate these policies and procedures, the individual has the responsibility of reporting this to the IRB Administrator or the IRB chair. The PI may self-report such instances and is encouraged to do so. Self-reporting will be looked upon favorably during assignment of corrective actions. In other cases, a research subject may submit a complaint, a member of the research team may report an incident, or an incident may be discovered during IRB review or post-approval monitoring. A report may be brought to the IRB in a number of ways including but not limited to self-report, audits conducted by the IRB, or by another member of the University community. Written reports are preferred, although reported by telephone are acceptable. Instances involving actual or imminent harm to research subjects or others must be reported immediately.

Once a report is received, the IRB Chair will report these to the IRB Administrator and the IRB Administrator will report these to the IO. In instances where the IRB Chair and Administrator are the same person, the IRB Chair/Administrator will report directly to the IO. The IRB Chair and/or Vice-Chair, if appointed, will meet with a minimum of two additional board members for an initial review to conduct a preliminary evaluation of the allegations/concerns to determine whether the allegations are based in fact. It may be decided that no additional action is needed, that further inquiry is necessary, or that the issue should be presented to the convened IRB. Temporary suspension of IRB approval may be enacted by the parties involved in the initial review if deemed necessary to prevent harm to subjects. The individuals present for the initial review should also determine whether the incident constitutes a minor noncompliance or a serious and/or continuous noncompliance. If the incident is determined to be a minor noncompliance, corrective actions will be determined to resolve the noncompliance during this initial review. These actions will be recommended to and subsequently imposed by the IO. Such actions may include, but are not limited to:

·    Acknowledgement of the report with no further action needed; 

·    A warning or reminder to the PI with instructions on how to avoid future incidents, clarifications regarding requirements and rules, etc.; 

·    Requiring additional training regarding human subjects research; 

·    Requiring submission of a modification application or report of an adverse event/unanticipated problem; 

·    Requiring the PI to submit a corrective action plan; 

·    Directing post-approval monitoring visits or compliance audits. 

If the PI complies with these actions, additional review by the convened IRB is not required. A report summarizing these incidents and the outcomes will be provided to the convened IRB but will not require IRB action. If the convened IRB disagrees with the determination of minor noncompliance, it may request additional information or further review. If the PI does not comply with these actions, additional review by the convened IRB is required and outlined below.

The incident will be referred to the convened IRB for review in the following circumstances: 1. If it is determined during the initial review that the incident involves serious or continuing noncompliance; 2. If there is uncertainty or disagreement by the initial reviewers about the level of noncompliance; 3. if the investigator fails to cooperate with the actions required to correct minor noncompliance; or 4. If the IRB disagrees with the determinations made during the initial review.

A report describing the potential noncompliance, along with relevant materials will be shared with the IRB to allow the committee to review and assess the case. The PI will be informed of the committee review and invited to attend the meeting and discuss the report with the IRB. To avoid undue influence, only the PI and/or members of the research team for the incident in question may attend the meeting (see section "Confidentiality of IRB Proceedings"). Reasonable efforts will be made to accommodate scheduling needs of the PI. Actions by the IRB will include a formal determination of the type of noncompliance (i.e., serious and/or continuing). If the IRB determines that neither serious nor continuing noncompliance has occurred, the IRB may dismiss the allegations or determine the noncompliance is minor and recommended corrective actions given to and subsequently imposed by the IO. In cases where the IRB determines that serious and/or continuing noncompliance has occurred, the IRB will recommend corrective actions to be considered for implementation by the IO. When appropriate, a reasonable timeframe for implementation of these actions should also be established. Such actions may include, but are not limited to:

·    A warning or reminder to the PI with instructions on how to avoid future incidents, clarifications regarding requirements and rules, etc. 

·    Requiring additional training regarding human subjects research 

·    Requiring the investigator to submit a corrective action plan 

·    Disallowing use of the data collected as a result of the non-compliant actions 

·    Directing post-approval monitoring visits or compliance audits 

·    Restrictions on serving as an investigator on human subjects protocols (e.g., requiring a supervising co-PI, barring future eligibility as PI, etc.) 

·    Notification of study participants 

·    Requirement that participants re-consent to participation 

·    Disclosure to publication editors or presentation editors that the data were collected without approval from Misericordia University IRB 

The IRB may also require modifications to the protocol or informed consent process, more frequent review, or that all future submissions be reviewed by the convened IRB. The IRB may also suspend or terminate approval of protocols found to be noncompliant if deemed necessary to protect human subjects. The welfare of currently enrolled subjects will be taken into account when considering suspension or termination of approval.

The IRB may refer the issue to other organizational entities, such as legal counsel, the Vice President of Academic Affairs, Human Resources, etc., in lieu of or in addition to the recommended corrective actions.

The PI will be invited to address the IRB during the meeting where the noncompliance review occurs. A report summarizing the IRB's determinations and recommended corrective actions will be provided to the PI for review and comment prior to submission to the Institutional Official for consideration of corrective actions. Comments must be provided by the deadline established by the IRB. The PI's comments will be forwarded to the IRB for reconsideration if the comments reveal new factual information or other circumstances that are reasonably likely to affect the IRB's determinations or recommendations as determined by the IRB Administrator and/or his/her designee.

In cases of serious or continuing noncompliance, the IO will receive a final report documenting the noncompliance review process, the IRB's recommendations, and any response to these recommendations by the PI. The IO may accept, revise, add to, or reject any or all of the IRB's recommended corrective actions but may not change the IRB's determinations related to the level of noncompliance or overturn the IRB's decision to suspend or terminate IRB approval, to require modifications to the approved protocol, or to require more frequent or higher level IRB review. The final report documenting the IO's actions will be provided to the PI, the PI's department chair/program director, the PI's Dean, the VPAA, the IRB Administrator, the IRB Chair or his/her designee, and the IRB Office. PI appeals/grievances in response to the mandated sanctions must be submitted to the IO. The IO is responsible for responding to any submitted appeals/grievances. Investigators are responsible for ensuring the corrective actions outlined in the final noncompliance report are implemented by the timeframes established in the report. Failure to meet the conditions established in the report will result in additional review by the IRB and possibly termination or suspension of IRB approval. The IRB will meet and vote to determine if corrective actions have been satisfied.

When applicable, incidents of serious or continuing noncompliance must be reported to the Office of Human Research Protections per the requirements set forth in 45 CFR 46.103(b)(5) and the funding agency or sponsor in accordance with their requirements.

Language adapted from the University of Iowa Institutional Review Board Policy on IRB Review of Protocol Deviations and Noncompliance for Non-exempt Research with permission.

When the research study is completed, the researcher must submit and end of project report on the electronic system. The completion of protocols will be reported to the IRB at its monthly meetings. Failure to complete this report by the study approval expiration date will result in a termination of IRB approval.

A case report is a retrospective report on an interaction with no more than three clinical cases. A case report of one, two, or three clinical cases does not meet the definition of research according to 45 CFR 46: DHHS Regulations for the Protection of Human Subjects. According to 45 CFR 46, “research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (§46.102, l). If a case report involves greater than three clinical cases this constitutes research as there is analysis for the purpose of contributing to generalizable knowledge. A case report that only includes three cases or fewer does not meet the requirements for research, and therefore completion of this scholarly activity does not fall under the purview of the Institutional Review Board. When conducting a case report, the author must adhere to all institutional policies (where the clinical cases were experienced), including adherence to privacy, confidentiality, HIPAA regulations, and other institutional policies related to dissemination of a case report.

The author of the case report is responsible for:

·         Determining if they are conducting a case report or completing research. If it is determined that they are engaging in research, the author must submit and receive appropriate IRB approval. If the author is unsure, it is the author’s responsibility to reach out to the identified IRB.

·         Assuring that all protections (e.g., confidentiality, privacy) related to the subjects in the case report are upheld (e.g., Institutional policies, HIPAA regulations)

The primary investigator (PI) must submit a personnel change form if a member/members of the research team is/are no longer participating in the research in any capacity and if the PI would like to add a member or members to the research team.  

If the PI would like to add researcher/researchers to the project, the PI will need to submit a personnel change form to the Misericordia University IRB. When adding another researcher, the PI must ensure the researcher has their CITI training completed and the informed consents/assents and any other applicable materials are updated to include the additional researcher(s).  The new researcher(s) cannot participate in the research in any capacity until the Misericordia University IRB has approved the personnel change. 

A PI will not be able to add a researcher/researchers to the project while the Misericordia University IRB is reviewing the protocol. They must await approval of the study and then submit this personnel change. If the addition of a researcher is a part of a stipulation, then the PI is responsible for submitting the personnel change within 10 business days of the provisional approval date.  The PI would receive a provisional approval based on the submission of the personnel change within 10 business days. If the PI fails to submit this personnel change form within the 10 business days, the protocol will be closed, and the PI will be required to resubmit the IRB protocol.   

Change in Primary Investigator:

When a primary investigator (PI) departs from a study, determination must be made whether or not the study continues. If the study is stopped, all forms to close a study must be submitted and approved by the IRB.
If the study continues, the following must be addressed:

1.      Completion of the necessary personnel change form/documents, indicating a new PI for the study

2.      Secure transfer of all documents related to the study. The location and security assurances related to the maintenance/storage of documents (e.g., Informed Consent, Assent, and HIPAA related documents) must be clearly stated. If these changes alter the study protocol or procedures the change(s) must be submitted for IRB approval.

3.      Change(s) may require document (e.g., consents, assents, HIPAA documents) alterations

4.      Study participants may need to be informed of these changes

Department chairs are responsible to address these changes within the personnel change process. The IRB will assist in study closure or continuation.

These are the conditions that a primary investigator may need to be changed: PI leaves the university, death or illness of primary investigator, or other extenuating circumstances. PI changes should be reviewed with IRB chair or administrator.