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.

Research is defined by the Common Rule also know as 45 CFR 46 as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." It includes research that is conducted on or off campus by university employees. Questionnaires, interviews, surveys, tests, observations and experiments constitute research even if the work is preliminary (pilot work) to a more extensive study. It also includes systematic collection of data from human subjects that occurs in conjunction with classroom projects, unless the work is done as a learning exercise for the student and will never be published or presented outside of the course.

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 Compliance Officer in the Office of the Vice President of Academic Affairs, or any member of the IRB. The names and contact information for these individuals can be found through the IRB Membership tab below.

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

Dwyer, Pamela, DNP, CRNP, NP-C – Member (2017–2020)

Board Member since 2014 – 2nd Term

Nursing Department – CHSE

570-674-6177
pdwyer@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

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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 IRB Meetin 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 research?

  • Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

What does it mean that research is a systematic investigation?

  • You may ask questions in order to find something out, however if your questions are not adequately organized, it may not be research. For example, you want to know if the students on campus like the food. If you randomly introduce this into conversation and you don’t do it consistently or with forethought, you are most likely NOT conducting research. However, if you have a prior plan for finding out about foods students like, such as a list of questions you plan to ask or a written questionnaire, it is most likely that you are conducting research.

What research needs IRB review?

  • All research completed by Misericordia University, faculty, students and staff needs IRB review, even if you are completing the research off campus as part of your masters or dissertation work, even when another institution’s IRB has been approved the study. Finally, researchers from other institutions who wish to conduct research on our campus with plans for using our faculty, staff, or students as subjects must contact the Office of Sponsored Research. Departments or individual faculty or staff should not agree to participate in research sponsored by other institutions without approval. If you have questions, you should feel free to contact the Office of Sponsored Research or the Chair of the IRB. If you neglect to share your research activities with the IRB, you may be prohibited from conducting any future studies.

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 person, beneficence and justice. These three principals are found in the Belmont Report. A copy of the Belmont Report can be found at http://ohsr.od.nih.gov/OHSR/index.php.

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.

What are the most common problems that delay protocol approval?

  • All researchers and sponsors have not initialed the conflict of interest questions.
  • Missing signatures on the Assurance Form (Students, faculty, staff and outside data collectors must all sign the form)
  • Missing IRB education certificates (Students, faculty, staff and outside data collectors must meet the educational requirement)
  • Missing letters of support from data collection site(s).
  • Missing elements of informed consent.
  • For studies that involve children: Missing assent or incomplete assent forms (Need to be written in age appropriate language).

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, employability 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 Office of Sponsored Research for an opinion.

IRB Policies and Procedures

IRB Forms

Click on the download link to download the file to your hard drive


APPLICATION COVER SHEET

TYPE 1 JUSTIFICATION FORM

RESEARCHER ASSURANCE FORM

TYPE 1 CONTINUATION/END OF PROJECT REPORT FORM

TYPE 2/3 ANNUAL UPDATE/CONTINUATION FORM

TYPE 2/3 END OF PROJECT REPORT FORM

REQUEST FOR CHANGE IN PROTOCOL FORM

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

IRB Instructions

Reviewer's Checklist

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