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
2017 - 2018

Corpus, Larry, Ph.D. – Member (2016-2019)
Board Member since 2016 – 1st Term
Biology Department - CAS
570-674-8166
lcorppus@misericordia.edu

Donnelly, Darlene, M.S.N. – Member (2017-2020)
Board Member since 2014 – 2nd Term
Nursing Department - CHS
570-674-1866
dkuchins@misericordia.edu

Edwards, Nicola, Ph.D. – Member (2016-2019)
Board Member since 2015 – 1st Term
(2015-2016 Fulfilled remainder of Christopher Stevens term)
Chemistry Department - CAS
570-674-6340
nedwards@misericordia.edu

Kisenwether, Jessica, Ph.D. – Member (2015 – 2018)
Board Member since 2015 – 1st Term
Speech-Language Pathology Department - CHS
570-674-8408
jkisenwe@misericordia.edu

Lewis, William - Retired Clergy – Public Member (2017-2020)
Board Member since 2008 – 4th Term
133 Kingswood Drive, Dallas, PA 18612
570-674-6837 (HM) / 570-650-9398 (Cell)
wlew65@hotmail.com

Manasco, McKinley Hunter, Ph.D. – Member (2016-2018) BOARD CHAIR
Board Member since 2009 – One term as Board Member
Board Chairperson since 2012 – 3rd Term as Board Chair
Speech-Language Pathology Department - CHS
570-674-8108 / 205-529-5018 (Cell)
mmanasco@misericordia.edu

Sgroi, Melissa, Ed.D. – Member (2016-2019)
Board Member since 2010 – 3rd Term
Communications Department - CPSSS
570-674-6744
msgroi@misericordia.edu

Welsh, Pam, M.S.N., CRNP, RN - Member (2017-2020)
Board Member since 2014 – 2nd Term
Nursing Department - CHS
570-674-6177
pwelsh@misericordia.edu

ALTERNATE MEMBER

Lewis, Sharon – Alternate Public Member (2017-2020)
Board Member since 2008 – 4th Term
133 Kingswood Drive, Dallas, PA 18612
570-674-6837
momrme420@msn.com



COORDINATOR

Nowalis, Brenda M., MS
bnowalis@misericordia.edu



IRB Contact Information

McKinley Hunter Manasco, Ph.D.
Chairperson
570-674-8108
mmanasco@misericordia.edu

Patricia Thatcher, Ph.D.
Compliance Officer
570-674-8185
pthatche@misericordia.edu

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

IRB Meetings

2017 - 2018

Proposal Submission DateIRB Meeting DateDecision Notification Date
August 14August 28September 04
August 18September 01September 06
September 20October 04October 09
October 27November 10November 15
November 24December 08December 13
January 05January 19January 24
February 02February 16February 21
March 02March 16March 21
April 06
April 20April 25
May 4
May 18
May 23
June - TBD
June - TBDJune - TBD

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

On-Line Human Subjects Protection Educational Certificate

The IRB requires researchers for Type II and Type III studies to complete the on-line Human Subjects Protection Education Program available at this web address: http://phrp.nihtraining.com/users/login.php

IRB Instructions

Reviewer's Checklist

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