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
2018 -2019


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

Board Member since 2018 – 1st Term

(unaffiliated member)

ealmeky@hotmail.com

Corpus, Larry, Ph.D. – Member (2016-2019)

Board Member since 2016 – 1st Term

Biology Department – CAS

570-674-8166

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


Edwards, Nicola, Ph.D. – Member (2016–2019)

Board Member since 2015 – 1st Full Term

Chemistry Department – CAS

570-674-6340

nedwards@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. – Member (2015–2017)

Board Member since 2015 – 1st Term

Board Chairperson 2017 – 2019 – 1st Term as Board Chair

Speech-Language Pathology Department – CHSE

570-674-8408

jkisenwether@misericordia.edu

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

Board Member since 2017 – 1st Term – Sabbatical Fall 2018

Biology Department – CAS

570-674-6259

aserino@misericordia.edu

Sgroi, Melissa, Ed.D. – Member (2016-2019)

Board Member since 2010 – 3rd 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

570-674-8154

otempleton@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

­­­­­­­­­­­­­­­­­­­

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 Sofranko Kisenwether, Ph.D.
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

2018 - 2019

PROPOSAL SUBMISSION DATE IS FOR FULL BOARD PROTOCOL REVIEWS

Proposal Submission Dates
Proposal Submission Date IRB Meeting DateDecision Notification Date
August 24September 07September 12
September 21October 05
October 10
October 19November 09
November 14
November 23December 07
December 12
January 04January 18January 23
February 01February 15
February 20
March 01March15March 20
March 29
April 12April 17
April 26
May 17
May 22
May 31
June 14
June 19



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)2


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 knowledge2


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 biospeicmens.

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.


IRB Resources

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