草榴社区

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.
  • 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 or terminate 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. In addition to University policy requirements, the Common Rule outlines issues that the IRB must consider as part of approval.


DOES YOUR PROJECT NEED IRB REVIEW and APPROVAL?

  • Are you conducting a research project that involves human beings?
  • Do you or your students use human subjects in research projects, and/or class research assignments?
  • Do you or your students conduct surveys with any persons or institutions in or outside of the 草榴社区 community for research purposes?
  • Do you or your students plan to publish the results of a project involving human subjects' research?
  • Have you been contacted by any persons outside of the University who wish to use members of the 草榴社区 community as research subjects?

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

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

                                            2024-2025 Academic Year IRB Meeting Schedule

Current Members

IRB Committee Members: 2024-2025 Academic Year
Andrew Venezia, Ph.D., Chair Health and Human Performance
Carol A. Coté, Ph.D., OTR/L Occupational Therapy
Sabine Charles, M.D., Dr. PH. Epidemiologist, Lackawanna County; Community Member
Mary Jane K. DiMattio, Ph.D. Nursing
William Miller, Ph.D. Health Administration and Human Resources
Joshua Reynolds, Ph.D. Psychology
Kathryn Yerkes, M.A., M.S. Assistant Provost and IRB Administrator
John Ruddy, D.P.S. Economics & Finance
Kelly Filchner, Ph.D. Nursing
Brooke Leonard, M.L.I.S. Director, Office of Research & Sponsored Programs

IRB Forms

IRBNet: Submission of IRB Materials

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.

Getting Started training:  

  • IRBNet Training Energizers to help you get started can currently be found at the following link:  .   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:

IRB Education Program: 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.

Training is available for members of the 草榴社区 community through a contract with the CITI (Collaborative IRB Training Initiative) program. All persons involved in human subjects research must complete the Group 1: Basic Human/Behavior training course; however, depending upon the nature of the project, other training may be needed or acceptable.

  • 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.
  • Outside investigators are required to provide human subjects research training materials. The IRB administrator will review these materials to verify if they meet the University's training standards.

University personnel and students have unlimited access to the CITI (Collaborative IRB Training Initiative) program, 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. Contact the ORSSP for more information.

Instructions for Renewing Training for Previously Completed Courses

IRB Policies & Regulations

草榴社区 IRB Policy:

Federal Regulations:

  • , DHHS Comprehensive site for all federal regulations and guidance
  • , DHHS Health records privacy regulations and information
  •  

IRB Guidance and Resources

草榴社区 IRB Education Requirements

International Research Guidance

Recruitment of Students in Human Subjects Research

Electronic Survey Guidance 

About the IRB: Information for Student Researchers

External Guidance

  • U.S. OHSS, Office for Human Research Protections:

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  and  describe the informed consent requirements."

The Common Rule contains many requirements surrounding informed consent. 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. 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 for not taking part
  • Any 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
  • Alternatives to participation, if any, and
  • Other elements that may apply based upon the nature of the research

Documentation of informed consent must be obtained for every participant, and, in the case of minors, must include both participant consent and parental/legal guardian assent.

Although documentation of informed consent may not be required for Exempt research projects, informed consent information must still be provided to participants.

Review by other Research Committees and University Personnel

IRB review and approval is limited to IRB policy and areas of oversight. Your research project may require other institutional approvals. 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 the Institutional Biosafety Committee (IBC), and Institutional Animal Care and Use Committee (IACUC). Researchers are responsible for consulting the Chairpersons of these committees to determine if IBC and/or IACUC review and approval is required.
  • IRB review & approval for a research activity does not constitute approval to utilize University programs, facilities, or services/practices for research purposes. Researchers should consult with relevant University administrators to secure any other approval or permission required. In addition, applications involving off-campus sites for research purposes may require a letter of support or approval from the site(s).
  • IRB review & approval is separate from approvals or requests to obtain or use University data, such as student or employee email addresses, for research purposes.  This permission must be obtained from the relevant University department. Contact the Office of Data Analytics & Institutional Reporting for more information about such data requests.
  • IRB review is separate from sabbatical, internal research, or other internal research approval processes. Applications for these and other internal supports may require verification of IRB review and/or approval as part of the application process, or as a condition of funding approval. Faculty applying for these or other internal research supports should consult with the IRB Administrator if their application involves research including human subjects.

Departmental Review Boards

As described in the University's IRB Policy, the University's IRB delegates review and approval of certain research activities to Departmental Review Boards (DRBs) in those departments which routinely conduct human subjects' research. DRBs are approved to operate by the Associate Provost/Director of Research, in consultation with the IRB administrator. All approved DRBs must maintain documented procedures describing their activities in compliance with University IRB policy.

All human subjects' research applications must be submitted via IRBNet, and will be routed as appropriate by the IRB Administrator based upon review type determinations. DRBs may not review Exempt research applications. A DRB may review research that falls under the classifications of (1) Expedited or (2) Full Committee Review, unless that research includes vulnerable participants. See additional DRB review limitations below.

The following departments are currently approved to operate DRBs: Communication & Media; Counseling and Human Services; Education; Health Administration/Human Resources; Nursing; Physical Therapy/Occupational Therapy; Psychology; and Political Science/Sociology & Criminal Justice. Applications from all other departments require review by the IRB.

  • Applications for review by a DRB may be submitted only by the respective department's faculty, staff, and students. If a research project includes researchers from multiple departments, the protocol may be reviewed by the primary investigators’ DRB unless that DRB recommends review by the IRB.
  • DRBs may not review Exempt research applications, Full review applications which include vulnerable participants, or research projects
    • For which the IRB provides notice to the investigator or department that the IRB is exercising its oversight responsibility and requires IRB review and approval, or
    • For which an investigator requests IRB review in addition to, or in substitution for, the departmental review process, even if this activity falls within the departmental Under these conditions, the DRB chair will be advised of the IRB determination and will be provided with a copy of the protocol.
    • Research that is to be submitted for extramural funding or support.
    • Research requiring waivers of any part of informed consent, unless approval authorization is granted by the IRB for specific circumstances.

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. Andrew Venezia, at andrew.venezia@scranton.edu.
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