Institutional Review Board For The Protection Of Human Subjects (IRB)
The Institutional Review Board (IRB) reviews all research activities that involve human subjects.
DOES YOUR PROJECT NEED IRB REVIEW and APPROVAL?
- Do you or your students use human subjects in research or class research assignments?
- Do you or your students conduct surveys with any persons or institutions in or outside of the University of Scranton community?
- Do you or your students use members of the University of Scranton community outside of your own classes?
- 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 University of Scranton community as research subjects?
Meeting Schedule
Current Members
| IRB Committee Members | |
| Academic Year 2022-2023 | |
| Bryan Burnham, Ph.D., Chair | Psychology |
| Ovidiu Cocieru, Ph.D. | Management, Marketing, and Entrepreneurship |
| Sabine Charles, M.D., Dr. PH. | Epidemiologist, Lackawanna County |
| Marian Farrell, Ph.D. | Nursing |
| William Miller, Ph.D. | Health Administration and Human Resources |
| Kathryn Yerkes | Assistant Provost, Planning & Institutional Effectiveness and IRB Administrator |
| Andrew Venezia, Ph.D. | Health and Human Performance |
| Donald Bergmann** | Chief of Police |
| Therese Kurilla** | Grants Mgr., Research and Sponsored Programs |
|
**Non-voting |
|
IRB Forms
IRB Applications can be found below or at IRBnet.org. All protocols (including new protocols, revisions and renewals, and Departmental Review Board protocols) must be submitted electronically via IRBNet seven (7) days before IRB meeting. See the IRB meeting schedule for dates.
Exempt Research Applications:
Exempt IRB Application (IRB only): Exempt application only applies to research that is (1) minimal risk (no greater risk of harm or discomfort than that encountered during every day life), and (2) anonymous, for which no personally identifiable information about participants is included in the study. Exempt research may not include participants from vulnerable populations. Applications for exempt research must comply with other institutional standards as defined in IRB Policy.
- If your research project includes personally identifiable information about human subjects (such as name, email address) it is not anonymous and therefore will not qualify as Exempt under federal regulation and the University's IRB policy. Please use the Expedited or Full application (below).
Expedited or Full Review Applications:
The Expedited or Full application should be used when a research project meets the criteria for either Expedited or Full review as defined in the federal regulation and the University's IRB policy.
- Expedited research is that for which there is (1) no more than minimal risk to participants, and (2) the only involvement of participants is in one or more federally defined categories. Expedited research may not include participants from vulnerable populations.
- Full review research is that for which there is more than minimal risk and special precautions need to be taken to protect the rights and welfare of participants. A research project including vulnerable populations will be reviewed via the Full review process.
Some expedited and full applications may be reviewed by approved departmental review boards (DRBs). Consult the University's IRB policy for details.
See the University's IRB Policies and Procedures Manual for further information regarding exempt, expedited or full review categories and processes. The University IRB will ultimately determine what classification of review is required for any human subjects research activity.
Note that current, University approved IRB training must be documented for all individuals involved in the research protocol as part of any application.
Other Forms
- Does your project include a researcher from another institution with their own IRB? If yes, and you intend to use the University of Scranton's IRB as the IRB of record, you will need to submit this form: IRB of Record Form.
- Does your project include a researcher from an agency or entity without an IRB? If yes, they will need to submit an Individual Investigator Agreement Form.
- Are you translating research materials to any language other than English? If yes, submit the Certification of Translation form along with your IRB application.
CITI and IRBNet 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 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.
The University's approved educational training is offered to 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.
Required IRB Training Program (CITI)
IRBNet TRAINING
The University uses the IRBNet platform to gather and process IRB applications of all types. 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: 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.
Policies & Regulations
University of Scranton IRB Policy:
- The University of Scranton IRB Policy (spring 2023)
- The University of Scranton IRB COVID-19 Guidance (updated Fall 2022)
Federal Regulations:
- The Common Rule
- OHRP - Office of Human Research Protections, DHHS Comprehensive site for all federal regulations and guidance
- HIPAA - Health Insurance Portability and Accountability Act, DHHS Health records privacy regulations and information
- FERPA - Family Educational Rights and Privacy Act
Contact
IRB Guidance and Resources
Anonymous, Confidential, or De-Identified? Understanding Key Terms
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."
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
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 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 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.
- 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.
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