Institutional Review Board For The Protection Of Human Subjects (IRB)

What is the IRB? 

The Institutional Review Board (IRB) reviews all research activities that involve human subjects.

An institutional review board, or IRB, is a body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.  IRBs are mandated by, and their general scope/structure defined, under regulations issued by the U.S. Department of Health and Human Services (HHS). The regulation is generally known as “The Common Rule,” and was most recently updated in 2018. In addition, IRB's address the principles of the Belmont Report and other ethical and OHRP guidelines.
IRBs have the responsibility to review and approve all research activities that involve human subjects under their institutional scope. The IRB is primarily concerned with assuring the welfare, rights, and privacy of those subjects, and that all investigators are taking appropriate precautions to minimize any potential risks or losses of benefit that may be part of participation. The IRB has the authority to exempt, approve, disapprove, monitor, require modifications to, or suspend human subjects’ research (HSR) activities that fall within its scope as specified by both federal regulations and its own home institution’s policy, as well as commonly accepted ethical standards. The IRB conducts analysis of each HSR application to consider these and other issues as they may relate to the research activity, its design and procedures, and all aspects of subject participation.


DOES YOUR PROJECT NEED IRB REVIEW and APPROVAL?

  • Are you conducting research that involves gathering information from, or about, living human beings?
  • Do you or your students plan to publish or present the results of a project involving human subjects research?
  • Do you or your students use human subjects in class research assignments?
  • Do you or your students conduct surveys involving any persons or institutions in or outside of the University of Scranton community?
  • Have you been contacted by any persons outside of the University who wish to use members of the University of Scranton community as research subjects?

  If you answered YES to any question above - YOU DO NEED THE IRB!

Click to download the "Do You Need the IRB" Info Sheet
All research projects using human subjects, classroom assignments as well as individual research, must be submitted to the IRB for review. No phase of a project may begin until approval is obtained. Changes to currently approved projects must also be reviewed before they can proceed.

Meeting Schedule


Current Members

IRB Committee Members: Academic Year 2023-2024
Bryan Burnham, Ph.D., Chair Psychology
Sabine Charles, M.D., Dr. PH. Epidemiologist, Lackawanna County (Community Representative)
Carol A. Coté Ph.D., OTR Occupational Therapy
Mary Jane DiMattio, Ph.D. Nursing
Marian Farrell, Ph.D. Nursing
William Miller, Ph.D. Health Administration and Human Resources
Joshua Reynolds, Ph.D. Psychology
Andrew Venezia, Ph.D. Health and Human Performance
Kathryn Yerkes, M.A., M.S. Assistant Provost, Planning & Institutional Effectiveness and IRB Administrator

IRB Forms

IRBNet

The University uses the IRBNet platform to gather and process IRB applications of all types. All applications for human subjects' research must be submitted via IRBNet. Click below to learn more about how to navigate the IRBNet system.

Click to log in to IRBNet, or to set up your account

Getting Started training:  

  • IRBNet Training Energizers to help you get started can currently be found at the following link:  http://www.irbnetresources.org/tresources/vd/r1.html.   When prompted, please enter the institutional login -- Username: scranton and Password: training.  You may log in to the training system at any time to begin training.

Submitting revisions:

CITI Training

All investigators (i.e., Principal Investigators (PI), faculty advisors, and other persons including student researchers) actively engaged in human subject research are required to complete and maintain human subjects research training requirements. Engagement in the project typically means they are interacting directly with human subjects, or have access to data about/from those subjects.

Training must be completed no less than three (3) years prior to submission of the IRB application, and must remain current through the research project. Members of the University's IRB Committee, and members of Departmental Review Boards (DRBs), are also required to maintain current training requirements.

Training is available for members of the University of Scranton community through a contract with the CITI (Collaborative IRB Training Initiative) program. University personnel and students have unlimited access, so we encourage faculty members to use this online training for Research Methods Classes.  Please note, if a research project is grant funded, those involved in the project may need to complete additional CITI Responsible Conduct of Research (RCR) training modules. 

Instructions for Renewing Training for Previously Completed Courses


Required IRB Training Program (CITI)

Policies & Regulations

University of Scranton IRB Policy:

Federal Regulations:

IRB Guidance and Resources

IRB Review Process Flowchart

University of Scranton IRB Education Requirements

About Informed Consent in Human Subjects Research

Surveys in Human Subjects Research

About the IRB: Information and Guidance for Student Researchers

"Do You Need the IRB?" Info Sheet

External Guidance

About Informed Consent


Informed Consent From HHS: "The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements."

The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Consent may only be sought after IRB approval is obtained.

Informed consent language must be organized and presented in a way that facilitates comprehension, is in clear and non-technical language  appropriate to the subject, and is at an appropriate reading level. Informed consent materials should provide sufficient information that a “reasonable person” would want to have in order to make a choice about whether or not to take part in the research activity.

Investigators have the responsibility to seek informed consent "only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence." (34 CFR 46.116). 

Informed consent materials, where printed or verbal, must address the following elements:

  • That consent is being sought for research
  • The purposes of the research, duration of participation, and study procedures
  • That participation is voluntary, subjects may end participation at any time, and there is no penalty or loss of benefit not taking part
  • a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  • Any potential foreseeable risks or discomforts (remember - there is never "no risk" to participating, though risk may be no more than that encountered during every day activities)
  • Potential benefits to subjects or others, if any
  • Alternatives to participation, if any, and
  • Other elements that may apply based upon the nature of the research

Review by other Research Committees and University Personnel

As described in the IRB Policy,

  • In addition to IRB review, review by other research committees may be necessary depending upon the type of research to be undertaken. These committees include but are not limited to the Institutional Biosafety Committee (IBC), and Institutional Animal Care and Use Committee (IACUC). Researchers are responsible for consulting the Chairpersons of committees to determine if additional review and approval is required.
  • IRB approval for a research activity does not constitute approval to utilize University programs, facilities, or services for research purposes. Researchers should consult with relevant University administrators to secure any other approval or permission required.
  • IRB approval is separate from approvals or requests to use University data, such as student or employee email addresses, for research purposes. IRB approval does not constitute approval for these activities or access to such data.

Contact

General questions about IRB, and questions related to a specific IRB protocol may be directed to Kate Yerkes, IRB Administrator, at kathryn.yerkes@scranton.edu, or to the IRB Committee Chair, Dr. Bryan Burnham, at bryan.burnham@scranton.edu.

Other Research Resources

Research Compliance Home: IRB, IACUC, IBC, and RSC Committees

Office of Research and Grants Support

Internal Grants and Research Funding, Office of the Provost

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