Institutional Review Board (IRB)

Misericordia University established an Institutional Review Board (IRB) to review all research involving human subjects and to implement institutional policies and procedures regarding such research. The use of human subjects in research imposes both ethical and legal responsibilities upon the university, the IRB and those conducting the research to ensure that the rights and welfare of those subjects are adequately protected. The primary function of the IRB is to protect the rights of human subjects. Review and approval by the IRB is meant to aid both the subjects and the researchers by bring scrutiny to research protocols by a group of peers who can objectively assess the potential risk and accommodations made to minimize them.

All research involving the use of human subjects conducted by Misericordia University’s faculty, staff or students 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.

According to 45 CFR 46, research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, and a human subject means a living 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

It is the responsibility of researchers to refer their protocols (planned research studies) to the IRB whenever human subjects are used in research, even if the researcher does not consider the subjects to be at risk. Current law places the burden for negligence and harm directly on the researcher and the university. These policies and procedures are executed for the specific purpose of protecting human subjects.

If you have questions about these policies and procedures, contact the IRB chairperson, the IRB administrator, or any member of the IRB. The names and contact information for these individuals can be found at http://www.misericordia.edu/irb.

IRB Membership

IRB MEMBERSHIP
2019 -2020

 


 

 

Almeky, Ibrahim, Dr. – Member (2018 – 2021)

Board Member since 2018 – 1st Term

(unaffiliated member)

ealmeky@hotmail.com
 

 

Corpus, Larry, Ph.D. – Member (2019-2022)

Board Member since 2016 – 2nd Term

Biology Department – CAS

570-74-8166

lcorpus@misericordia.edu
 

 

Donnelly, Darlene, MSN, CRNP, RNC – Member (2017-2020)

Board Member since 2014 – 2nd Term

Nursing Department – CHSE

570-674-1866

ddonnelly@misericordia.edu
 

 

Jordan, Martha, Rev. Dr. – Member (2018 -2021)

Board Member since 2018 – 1st Term

(unaffiliated member)

mypastormartha@gmail.com
 

 

Kavanaugh, Elizabeth, MSLIS, MSHCI, AHIP – Member (2018-2021)

Board Member since 2018 – 1st Term
Information Literacy and Assessment Librarian
Mary Kintz Bevevino Library
570-674-3032

ekavanaugh@misericordia.edu
 

 

Kisenwether, Jessica Ph.D., Administrator and Chairperson

Board Member 2015 - 2017

Board Chairperson 2019 – 2021 – 2nd Term as Board Chair

Board Chairperson since 2017

Speech-Language Pathology Department – CHSE

570-674-8408

jkisenwether@misericordia.edu
 

 

Sgroi, Melissa, Ed.D. – Member (2019-2022)

Board Member since 2010 – 4th Term

Communications Department – COB

570-674-6744

msgroi@misericordia.edu
 

 

Templeton, Orley, OTD, OTR/L. – Member (2017-2020)

Board Member since 2017 – 1st Term

Occupational Therapy Department – CHSE

570674-8154

otempleton@misericordia.edu
 

 

Tremback-Ball, Amy, Ph.D. – Member (2019 – 2022)

Board Member since 2019 – 1st Full Term

Physical Therapy Department – CHSE

570-674-6328

atball@misericordia.edu
 

 

Wiese, Cosima, Ph.D. – Member (2019 – 2022)

Board Member since 2019 – 1st Full Term

Biology Department – CAS

570-674-6774

cwiese@misericordia.edu
 

 

 

ALTERNATE MEMBERS

 

Baer, Jennifer, Rev. – Member (2018-2021)

Board Member since 2018 – 1st Term

jenniferannbaer@gmail.com

jbaer@misericordia.edu
 

 

Banerjee, Soumendra, Ph.D. – Member (2017-2020)

Board Member since 2017 – 1st Term

Business Department – COB

570-674-8148

sbanerjee@misericordia.edu
 

 

Serino, Anthony, Ph.D. – Member (2017-2020)

Board Member since 2017 – 1st Term – Alternate member for 2019-2020 academic year

Biology Department – CAS

570-674-6259

aserino@misericordia.edu
 

 

­­­­­­­­­­­­­­­­­­­

Coordinators

 

Delmar, Jennifer

Executive Administrative Assistant – Office of the VPAA

570-674-6218

jdelmar@misericordia.edu
 

 

Nowalis, Brenda, MS

Administrative Assistant – Office of the AVPAA

570-674-1483

bnowalis@misericordia.edu

 

IRB Contact Information

Jessica Kisenwether, Ph.D., CCC-SLP, CIP
Administrator and Chairperson
570-674-8408
jkisenwether@misericordia.edu

Brenda Nowalis, MS
IRB Coordinator
570-674-1483
bnowalis@misericordia.edu

Jennifer Delmar
IRB Analyst and Staff Member
570-674-6218
jdelmar@misericordia.edu

IRB Meetings

2019 - 2020

PROPOSAL SUBMISSION DATE IS FOR FULL BOARD PROTOCOL REVIEWS

Proposal Submission Dates
Proposal Submission Date IRB Meeting Date Decision Notification Date
August 09 August 23 August 28
September 06 September 20 September 25
October 11 October 25 October 30
November 01 November 15 November 20
November 29 December 13 December 18
January 03 January 17 January 22
January 31 February 14 February 19
February 28 March 13 March 18
April 03 April 17 April 22
May 01 May 15 May 20
     
     

IRB Office Hours Fall 2019

Thursdays, from 10am-1pm:

Aug. 29 CTE - Mercy Hall

Oct. 3 PNC - Mercy Hall

Oct. 24 CTE - Mercy Hall

Nov. 14 CTE - Mercy Hall

Institutional Review Board FAQ

 

What is the Institutional Review Board?

Misericordia University (MU) established an Institutional Review Board (IRB) to review all research involving human subjects and to implement institutional policies and procedures regarding such research. The use of human subjects in research imposes both ethical and legal responsibilities upon the university, the IRB and those conducting the research to ensure that the rights and welfare of those subjects are adequately protected. The primary function of the IRB is to protect the rights of human subjects. Review and approval by the IRB is meant to aid both the subjects and the researchers by bring scrutiny to research protocols by a group of peers who can objectively assess the potential risk and accommodations made to minimize them. The IRB function to support community researchers.

 

 

 

 

What are the IRB's major responsibilities?

 

The IRB’s major responsibly is to assure that the rights of individuals involved in research are protected. The IRB is guided by three ethical principles: respect for persons, beneficence, and justice. These three principals are found in the Belmont Report. A copy of the Belmont Report can be found here. Additionally, the Nuremburg 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.1

 

 

 

How does an investigator assure that the rights of individuals in his/her study are protected?

Investigators should do all that they can to achieve the ethical principles outlined in the Belmont Report. Generally, investigators are to protect the subjects from harm by identifying and minimizing the risks involved in the research; assuring that subjects participation is voluntary; be certain that research subjects are properly informed of what their participation will entail – this is usually conveyed in an informed consent document; selecting subjects fairly – selection should be based on fair procedures so that one group is not overburdened, overused or unfairly favored or discriminated against; and assuring that subjects identities and responses to research procedures are protected.

 

When is IRB approval needed?

All research involving the use of human subjects conducted by Misericordia University’s faculty, staff or students 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.

According to 45 CFR 46, research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, and a human subject means a living 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

 

What is a systematic investigation?

A systematic investigation involves a logical and organized approach to data collection and analysis, developed in advance of project initiation. Qualities of a project involving systematic investigation include:

  • one or more specific questions of interest, often framed as hypotheses, that the project will seek to answer
  • data collection methods appropriate to address the question(s)
  • data analysis plans appropriate for the type(s) of data collected
  • an ability to use the analyzed data to answer the question(s)

 

 

What constitutes a study designed to develop or contribute to generalizable knowledge?

A study designed to develop or contribute to generalizable knowledge intentionally links to, applies, and/or expands upon existing knowledge. The methods allow for replication and for comparisons with data collected from different samples of the same population, and the results apply to people beyond those directly studied. Qualities of a project designed to develop or contribute to generalizable knowledge include:

  • basis in a theoretical framework of established knowledge
  • identification of a gap in knowledge that the project plans to address
  • identification and description of one or more specific populations of interest
  • unbiased sampling methods (i.e. random or probability sampling), when feasible, that allow for the recruitment of samples representative of the population(s)
  • operationalization of variables and constructs
  • data collection plans employing measurement tools and techniques with established and satisfactory reliability and validity
  • data analysis plans using techniques consistent with those employed in the literature of the theoretical framework and considered appropriate for the type(s) of data collected
  • an ability and plan to use the collected and analyzed data to draw meaningful conclusions about the result and link these back to the theoretical framework and identified gap in knowledge

 

 

What is institutional research?

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:

 

1. 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, employ-ability or financial standing; or

2. it is anticipated that the data generated will be used for research, the results of which will be disseminated outside of the University.

 

What if I get a survey from an outside agency which collects data on the College which might very well end up in a publication?

The question to be considered is whether the information is reported anonymously - no student, staff or faculty names will be attached AND whether the information would in any way be damaging to an individual as described above. Again, the information has to have an INSTITUTIONAL purpose. A researcher who sends you surveys to distribute to your class/employees which asks their opinion about something is not necessarily of value to the institution. Therefore if you receive a survey like this and you are unsure of whether it has an institutional purpose, you should contact the IRB Office for an opinion.

 

What training/education is required for the researcher(s)?

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. Information on this training can be found under the "CITI Training Information" tab. All MU affiliates have free access. Please note, all students must have a faculty advisor to conduct research at Misericordia University.

 

How do I submit an application?

All researchers need to submit applications using a new online system, iMedRIS. Please see iMedRIS tab on the IRB website for details.

 

Who do I contact if I have questions?

You may contact any of the IRB staff with questions:

Additionally, you may contact any member of the IRB. Names and contact information are listed at http://www.misericordia.edu/irb.

 

Appeal Process

If the protocol is disapproved, the researcher has the right to appeal the decision. The researcher must 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.

 

1 Bankert, E. A., & Amdur, R. J. (2006). Institutional review board: Management and function (3rd ed.). Boston, MA: Jones & Bartlett.

2 Information reproduced from Viterbo University, Institutional Review Board, with permission.

 

IRB Policies and Procedures

iMedRIS

You must use Google Chrome as your internet browser.

Click this link to log into iMedRIS

All full-time and part-time faculty members have accounts using their Misericordia University ID as a login and a temporary password of "temp_password." You will be prompted to change your password the first time you log-in. Students, staff, and agents of Misericordia University that are not considered full-time and part-time faculty must request an account by emailing Brenda Nowalis at bnowalis@misericordia.edu.

Click here to view the Training Video - Introduction to iRIS and How to Submit a New Application

Guidance Documents:

CITI Training Information

All new institutional review board (IRB) applications must have the CITI training certificate accompanying the application starting Wednesday, September 26th, 2018. A CITI training certificate for each researcher on the protocol will be required for review of all application types (exempt - Type 1, expedited - Type 2, full board - Type 3).

 

Current protocols under review and not yet approved do not need to submit CITI training certificates to continue review.

 

All currently approved protocols will need to submit the CITI training certificate for each researcher on the application to either continue the protocol when it expires or at the time of the annual review to proceed with IRB approval.

 

 

Please note, CITI training certificates will need to be renewed every 3 years.

The Collaborative Institutional Training Initiative (CITI Program) is dedicated to promoting the public’s trust in the research enterprise by providing high quality, peer-reviewed, web-based educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and other topics pertinent to the interests of member organizations and individual learners.

To begin the training process, you must register as a first time user by visiting this link.

Please see additional instructions below to help guide your first time user registration.


If you have any questions, please reach out to the IRB Office:

Jessica Kisenwether, Ph.D.
Administrator and Chairperson
jkisenwether@misericordia.edu

Brenda Nowalis, MS
IRB Coordinator
bnowalis@misericordia.edu

 

Jennifer Delmar
IRB Analyst and Staff Member
jdelmar@misericordia.edu


Step 1) Select Misericordia University as your organization affiliation and agree to Terms of Service & Privacy Policy.

Step 1 in registration Step 1 in registration

Step 2) Fill in personal information.

Step 2 in registration

 

Step 3) Create unique username and password. This is what you will use to access future trainings.

Step 3 in registration

Step 4 & 5) Continue filling in necessary information including if you are interested in receiving Continuing Education Unit (CEU) for completed CITI Program courses.

Step 4 & 5 in registration

 

Step 6)Fill in additional information including Department, Role of Research (i.e. primary investigator, undergraduate student, graduate student, etc.), and optional address information.

Step 7) *Important - When selecting your group to be enrolled in the correct courses, please select Researcher.

Step 7 in registration

Confirm the list of courses and select interest for optional training.

Step 7 in registration

Step 7 in registration

After completing Step 7, you will see a message noting that your registration is complete along with your course listings.

After completion of Step 7 in registration

When you select a course, you will see various course requirements.

Various Course Requirements

*Important - before entering a course you must complete the Integrity Assurance Statement.

Assurance Statement

Example Course View:

Example Course View

Reviewer's Checklist

Revised Common Rule Guidance

 

Download a pdf of the revised common rule guidelines.

 

On January 19, 2017, the Office of the Federal Register published a revised Federal Policy for the Protection of Human Subjects, the first significant change to the Common Rule since 1991. After two delays, the implementation date for the revised Common Rule is January 21, 2019 (with the exception of cooperative research which has a compliance date of January 20, 2020). All new IRB submissions, starting on Jan. 21, 2019, will be approved under the new rules. All protocols approved prior to Jan. 21, 2019 will remain under the old rules. These protocols retain their IRB requirements, including continuing review, and will be provided information on transitioning to the new rules at the time of continuing review.

This guide serves to assist researchers at Misericordia University (MU) understand the revised Common Rule and how it will be implemented. This is not an exhaustive list of the changes, but rather it highlights the areas most important to and those relevant to researchers at MU. Please note, some changes will result in a reduction of burden while others will result in additional work for researchers and the Institutional Review Board (IRB).

Definitions

Topic

Rule Change

Definition of Research

 

Now specifically includes categories deemed not to be research:

 

  • Scholarly and journalistic activities, including oral history, journalism, biography, literary criticism, legal research, and historical scholarship
  • Public health surveillance activities
  • Criminal justice activities
  • National security missions

 

Definition of a Human Subject

 

The old rule defined a human subject as: “a living individual about whom an investigator (whether professional or student) con- ducting research obtains data through intervention or interaction with the individual, or identifiable private information.”

 

The new rule defines a human subject as: “A living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

 

Definition of a Clinical Trial

 

The old rule did not provide a definition of a clinical trial.

 

 

 

The new rule defines a clinical trial as: “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.”

 

Definition of a Benign Behavioral Intervention

 

The old rule did not provide a definition for benign behavioral intervention.

 


The new rule defines a benign behavioral intervention as: “Brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.”

Examples 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.

Definition of “in writing”

 

The old rule did not define “in writing.”

 

 

 

“In writing” in the new rule refers to writing on a tangible medium (e.g., paper) or in an electronic format.

 

Definition of Vulnerable Populations

 

The old rule defined vulnerable populations as: “children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.”

 

The new rule defines vulnerable populations as: “children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.”

 

Exempt Categories

Topic

Change

Determination

 

There is no change to determinations. The exemption must be made by the IRB Chair or member of the IRB.

 

Exempt Categories

 

The exempt categories have been revised as noted below. The (*) items represent the change for revised categories.

 

REVISED Exempt category 1 – research in educational settings
*Revised to include that the research does not adversely affect students’ opportunity to learn required educational content or the assessment of educators who provide instruction.

 

REVISED Exempt category 2 – research involving educational tests, survey procedures, interview procedures, or observations of public behavior
*Revised to include limited IRB review for privacy and security of data and that harm may result from potential damage to the subjects’ educational advancement.

 

NEW Exempt category 3 – research involving benign interventions (as defined above)
*This research cannot involve deception unless the deception is authorized by the participant

 

REVISED Exempt category 4 – secondary research for consent is not required of identifiable private information or identifiable biospecimens
*Revised to remove word ‘existing’ and to allow for a HIPAA exemption
*Information must be publicly available, or not identifiable by the investigator directly or through links, the investigator will not contact subjects, and will not re- identify subjects;

 

REVISED Exempt category 5 – research and demonstration projects conducted or supported by a federal department or agency
*Revised to allow for easier applicability

 

Unchanged Exempt category 6 – taste and food evaluations

 

Exempt Research and Vulnerable Populations

 

Pregnant Women (Part B)– All exemptions may apply if the condition of the exemption is met.

 

Prisoners (Part C) – None of the exemptions apply, except for research aimed at involving a broader subject population and only incidentally includes prisoners.

 

Children (Part D)– Exemptions (d)(1) and (d)(4-8) may involve children. Exempt (d)(2) (research on educational tests, surveys, interviews or observations) may include children, but:

 

*Exempt (2)(i) and (ii) only apply to educational tests or observation of public behavior when the investigator(s) do not participate in the activities being observed; and
*Exempt (2)(iii) is not applicable to research with children. This exemption is where the investigator can readily ascertain the identity of the child.

Limited IRB Review

 

The old rule did not include limited IRB review for exempt research. The new rule outlines exempt categories that require an increased level of review by the IRB for data security and privacy protections.

 

The exempt categories subject to limited IRB review are:

 

  • Exempt (d)(2) research involving interviews, observations, surveys, interviews that are identifiable
  • Exempt (d)(3) research involving benign interventions that are identifiable (directly or through links) and the responses may be damaging to the subject’s reputation, financial standing, employability, educational advancement, criminal or civil liability.

 

The Office for Human Research Protections will provide additional guidance that will provide more details about what is expected for this review.

 

  • The extent to which identifiable private information is or has been de- identified and the risk that such de-identified information can be re- identified;
  • The use of the information;
  • The extent to which the information will be shared or transferred to a third party or otherwise disclosed or released;
  • The likely retention period or life of the information;
  • The security controls that are in place to protect the confidentiality and integrity of the information; and
  • The potential risk of harm to individuals should the information be lost, stolen, compromised, or otherwise used in a way contrary to the contours of the research under the exemption.

 

Limited IRB review will be conducted by the IRB Chair and/or at least one member of the IRB.

HIPAA exemption for identifiable secondary research of PHI that was collected for some other purpose or intent than the proposed study

 

Informed consent is not required for research limited to identifiable secondary research utilizing Protected Health Information (PHI), including identifiable biospecimens (exempt category 4). A HIPAA authorization is required for future and secondary use, or a waiver of authorization is granted by the IRB/Privacy Board.

MU IRB will require a waiver of authorization be granted by the IRB upon submission of the request for access to the PHI, or the individual’s written authorization is obtained.

Exempt Amendments

 

Exempt research subject to limited IRB review will be required to submit amendments to research projects to determine if there are changes that affect the limited review.

 

Continuing review

 

The MU IRB will continue to annually review all exempt, expedited, and full board studies per institutional policy.

 

Informed Consent

   

Topic

Change

Informed Consent Requirements

 

The informed consent requirements have been highly modified. A brief explanation of the changes are noted, with more detailed explanation in the following sections:

 

  • Significant changes to the content, organization, and presentation of information and process to facilitate a subject’s decision about whether to participate;
  • Changes to the basic and additional elements of consent;
  • Changes in the criteria for the waiver or alteration of consent;

New provisions that allow IRBs to approve research for which investigators obtain information or biospecimens without consent for the purposes of screening, recruiting, or determining the eligibility of prospective subjects provided certain conditions are met

Informed Consent Elements

 

NEW required element of informed consent for studies involving collection of identifiable private information or identifiable biospecimens. One of the following statements must be in the informed consent:

 

  • A statement that the identifiers might be removed from the information, and after such removal, the information could be used for future research studies or distributed to another investigator for future research without additional informed consent; OR
  • A statement that the subject’s information or specimens, even if identifiers are removed, will not be used or distributed for future research.

 

NEW additional elements of informed consent will be required for applicable research studies. These additional elements are:

 

  • A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
  • A statement regarding whether clinically relevant research results; including individual research results, will be disclosed to subjects, and if so, under what conditions; and

For research involving biospecimens, whether the research (if known) or might include whole genome sequencing.

Waiver or Alteration of Informed Consent

 

Investigators will be required to provide justification for a NEW required element for obtaining a waiver of consent:

If the research involves using identifiable private information or biospecimens, the research could not practicably be carried out without using such information in an identifiable format.

Screening, Recruiting, or Determining Eligibility of Prospective Subjects

 

The new rule specifically states that an IRB can approve access to identifiable information or identifiable specimens without the prospective informed consent of the subject for purposes of screening, recruiting, or determining eligibility if:

 

  • The investigator obtains information through oral or written communication with the prospective subject; OR
  • The investigator obtains identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

 

A waiver of informed consent will no longer be required to access identifiable information for determining eligibility. However, a waiver of PHI authorization will still be required as the HIPAA rule does not allow such access without prior written authorization or a waiver of authorization.

 

Is My Project Human Subjects Research?

Please review the following definition to determine whether your activity is human research. Note that publication/dissemination is not a determining factor for whether an activity is human research requiring review and approval by the Institutional Review Board (IRB).

“Human Research” (according to Department of Health and Human Services (DHHS)): The definition includes two components:

  • “Research”: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  • “Human Subject”: A living 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. For the purpose of this definition:
    • Intervention: Physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
    • Interaction: Communication or interpersonal contact between investigator and subject.
    • Private Information: 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 has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
    • 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.
    • 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.

If your activity does not meet both of these components, then it is not Human Research according to DHHS and does not need to be submitted to the IRB for review and approval.

A project is considered human research when there is a systematic investigation that intends to develop or contribute to generalizable knowledge about people or human behavior.

It’s human research when:

  • Living individuals about whom information is obtained through intervention or interaction; OR
  • Identifiable private information is collected

You may conduct a systematic investigation that involves collecting information from people, but it may not be generalizable about people or human behavior. i.e.: quality assurance, quality improvement, program evaluation, documentaries, case studies, etc.

Research that is about a program, process, course, a device, etc. is not typically about the people.
 

Examples of activities that are generally considered not to be Human Research

The following are examples of activities that are generally considered not to be Human Research according to the definitions above. If your activity is limited to one of the examples below, then it is likely not Human Research which would need to be reviewed by the IRB. Note that publication/dissemination is not a determining factor for whether an activity is Human Research.

1. Program Evaluation/Quality Assurance Review/Quality Improvement Project: The activity is limited to program evaluation, quality assurance, or quality improvement activities designed specifically to evaluate, assure, or improve performance within a department, classroom, or hospital setting.

Note: The purpose of a QA study is to assure known quality. The purpose of Program Evaluation (PE) is to assess that a program is doing what it is intended to do. Generally QI is designed for the purpose of improving the quality of a service, a program, a process, etc.. A QA, QI or PE study should present NO CHANGE in RISK to participants. These studies are mechanisms to assure that a service, a program or process functions optimally. Such projects are usually for internal auditing purposes only.

If you can answer "yes" to all of the following questions, the activity is most likely not human research:

  1. Will you simply monitor an existing process for which there will be no manipulation of the existing process?
  2. For QA or PE studies, will physicians or caregivers (parents, teachers, therapists, etc.) provide usual and customary care regardless of the conduct of the study?
  3. Does the study involve collection of data to which the investigator routinely has access as part of his or her responsibilities within the institution to monitor data associated with, for example: treatment, cost containment, performance, or compliance?

Note that an evaluation, assurance review, or improvement project designed specifically for a particular setting may yield useful information for similar entities, and may still not the definition for Human Research.

2.Case Report: The project consists of a case report or series which describes an interesting treatment, presentation, or outcome. A critical component is that nothing was done to the patient(s) with prior “research” intent.

Note that HIPAA or other state or local laws may still apply to this activity. Please consult the entity from which you received or accessed the information contained in the report for further guidance.

3.Course-Related Activity: The project is limited to one or more course-related activities designed specifically for educational or teaching purposes where data are collected from and about students as part of routine class exercises or assignments and otherwise do not meet the definition of Human Research.
Note that some course-related activities, even those conducted by students, may yield information suggesting additional investigation or analysis. If an additional activity entails Human Research, then it must be submitted to the IRB Office for review.

 

4.Journalistic or Documentary Activity (including Oral History): The activity is limited to investigations or interviews (structured or open-ended) that focus on specific events (current or historical), views, etc. Such investigations or interviews may be reported or published in any medium, e.g, print newspaper, documentary video, online magazine.

 

5.Research Using Public or Non-Identifiable Private Information about Living Individuals: The activity is limited to analyzing data about living individuals (1) where the data have been retrieved by the investigator from public, non-restricted data sets or (2) where the private data have been provided to the investigator without any accompanying information by which the investigator could identify the individuals.
Note that “de-identified data” according to HIPAA may be identifiable according to the DHHS definition of “Human Subjects.” Please contact the IRB Office with any questions regarding research with data.

 

6.Research Using Health Information from Deceased Individuals: This activity is limited to analyzing data (identifiable or not) about deceased individuals.

Note that deceased individuals cannot be Human Subjects according to DHHS. Note also that HIPAA or other state or local laws may still apply to this activity. Please consult the entity from which you received or accessed the information contained in the report for further guidance.

7.Instrument/Questionnaire Development: This activity is limited to interacting with individuals in order to obtain feedback on the types of questions which could or should be used to develop an instrument or questionnaire. The focus is on the development and construction of a data collection tool and not on the individuals who are providing the feedback on the questions being developed. This will be true even when the feedback may be specifically sought from an identified group of people most likely to be affected by the topic of the instrument, survey or questionnaire. The instrument/questionnaire development process will apply to many aspects of reliability and validity testing of the instrument or questionnaire. Note that once the process gets to the level of testing discriminant, concurrent or predictive validity, the activity may need to be reclassified as human subject research.

Note: If the participant is asked to provide additional information unrelated to instrument/questionnaire construction, such as demographic information that will be analyzed as part of a research study, the project may need to be submitted to the IRB for review.

If, after reviewing the information above, (1) you are unclear as to whether your activity is Human Research and would like for the IRB Office to make a determination for you or (2) you believe that your activity is not Human Research but would like for the IRB Office to provide documentation that it agrees with your assessment, then please contact either Brenda Nowalis, IRB Coordinator, bnowalis@misericordia.edu, or Jessica Kisenwether, IRB Administrator, jkisenwether@misericordia.edu.

2019: Adapted with permission from Northwestern University

Preparing an IRB Application

  1. Use language that is understandable to an unfamiliar reader. Do not use acronyms, abbreviations, or language specific to your discipline.
  2. List all personnel involved in the human subjects research on the application. Be sure all researchers listed on the application have up to date CITI training or approved equivalent for non-MU affiliates.
  3. Make sure to prepare the right type of consent for your study. Use the templates provided on the IRB website under “IRB Resources.” Consents must specify all procedures listed in the protocol.
  4. A single protocol must only represent one study. A single study may have multiple conditions or phases, but a protocol should not describe “multiple studies” or “versions of studies.”
  5. Always err on the side of giving us more detail about what you are doing with participants (you can go light on the background/literature review). Thoroughly explain procedures in a detailed, step-by-step fashion.
  6. For every recruitment method mentioned in the protocol, be sure to upload the associated material (script, flyer, etc.) Information about what to include on recruitment materials can be found under the help button in section XX of the IRB application.
  7. The IRB generally needs to see everything a participant will see over the course of study participation. Supporting Documents can include: survey instruments, interview guides, images/video clips, letters of support, relevant permission/approval letters, training documents for any external personnel, certificates of translation, and debriefing forms.
  8. Double check all portions of the application, attachments, and consents for consistency (description of the procedures, duration of the procedure, risks, benefits, etc.).

Please contact the IRB office if you have any questions or need specific guidance.

Turn Around Time

  • Every project is reviewed on its own merit!
  • There are many factors that impact how long it takes for a study to get approved:
    • IRB work load
    • Type of IRB review
    • Involvement of vulnerable populations
    • Procedures that require the use of a consultant
    • Submission quality
    • Reliance Agreements (IRB Authorization Agreements, Individual Investigator Agreements, etc.)
    • Etc.

 

IRB Resources

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