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

DOES YOUR PROJECT NEED IRB 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 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?
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.
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                               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

  

IRBNet Applications & Guidance                                                                                                                  

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 IRB Application (IRB only)

Expedited or Full Review IRB Application (IRB, DRB)

See the University's IRB Policies and Procedures Manual for further information regarding exempt, expedited or full review. Note that current, University approved IRB training must be documented for all individuals involved in the research protocol as part of the application.

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

Exempt research does not mean that the project is “exempt” from IRB review and approval. Rather, it means that the research project, which must qualify as no risk or minimal risk to subjects, is exempt from selected federal human subjects’ protection regulations.  The University’s IRB policy adds an additional requirement – to qualify as exempt, the research project must not include personally identifiable data about or from participants. An exempt research project still requires review and approval via the process described in the University’s IRB policy.

 

Informed Consent                                                                                                                                          

Consent Forms must have the following. Further guidance can be found here.

“Key information” to be presented at the beginning of the consent form: This part of the informed consent must be organized and presented in a way that facilitates comprehension, and provide sufficient information that a “reasonable person” would want to have. You must address the following five elements:

  • That consent is being sought for research and that participation is voluntary
  • The purposes of the research, duration of participation, and study procedures
  • Foreseeable risks or discomforts
  • Potential benefits to subjects or others
  • Alternatives to participation

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. 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.
Submitting revisions training: IRBNet Training Energizers for creating a subsequent package when revisions to an initial package are required: Subsequent package training

The University of Scranton IRB Policies and Procedures Manual (2018)

The University of Scranton IRB COVID-19 Guidance (Fall 2022)

OHRP - Office of Human Research Protections, DHHS Comprehensive site for all federal regulations and guidance

The Common Rule

HIPAA - Health Insurance Portability and Accountability Act, DHHS Health records privacy regulations and information

FERPA - Family Educational Rights and Privacy Act 

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.

IRB Education Requirements

Anonymous, Confidential, or De-Identified? Understanding Key Terms

"Do You Need the IRB?" Info Sheet

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