Undergraduate Admissions
Contact Us:
- Office of the Provost/SVPAA
- St. Thomas Hall
- 901 Linden Street, Room 5124
- 草榴社区, PA 18510
- The 草榴社区
- Phone: 570.941.7520
- Fax: 570-941-4386
- provost@scranton.edu
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!
Meeting Schedule
IRB Meeting Date: | Applications Due by 4:30 pm |
Tuesday, September 17, 2024 | Tuesday, September 10, 2024 |
Tuesday, October 22, 2024 | Tuesday, October 15, 2024 |
Tuesday, November 19, 2024 | Tuesday, November 12, 2024 |
Tuesday, December 17, 2024 | Tuesday, December 10, 2024 |
Tuesday, February 18, 2025 | Tuesday, February 11, 2025 |
Tuesday, March 25, 2025 | Tuesday, March 18, 2025 |
Tuesday, April 22, 2025 | Tuesday, April 15, 2025 |
Tuesday, May 20, 2025 | Tuesday, May 13, 2025 |
Current Members
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
IRB applications can be found below or at IRBNet.org. All protocols (including new proposals, revisions, renewals, and departmental review board applications) must be submitted electronically via IRBNet. Applications for Exempt or Expedited review (which includes applications that may meet Federal limited IRB review thresholds) are reviewed on a rolling basis on the timeline described in the IRB Policy. Applications that require Full IRB review must be submitted no later than seven (7) days before each scheduled IRB Committee meeting. See the IRB meeting schedule above for these dates.
It is the role of the IRB, not the researcher, to determine which classification of review is required for a research project. See the University's IRB Policies and Procedures Manual for further information regarding Exempt, Expedited or Full review categories and processes.
Current, University approved IRB training must be documented for all individuals involved in the research protocol as part of any application.
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 or from participants is included in any aspect of the study. Exempt research may not include participants from vulnerable populations (such as minors).
"Exempt" does not mean that the research project is "exempt" from IRB review. Exempt research is still research. Exempt status means that the project is exempt from selected federal human subjects' research protection regulations. An exempt project still requires review and approval via the processes described in the IRB policy. Exempt studies must still include basic information about informed consent.
- Applications for exempt research must comply with other institutional standards as defined in IRB Policy; all of the research procedures fit must fit within one or more of the exemption categories in the federal IRB regulations.
- Applications that may fulfill federal "limited" review thresholds, where personally identifiable data is used for certain purposes, are reviewed using the Expedited review process.
- Under the University's IRB policy, if your research project includes personally identifiable information about human subjects (such as name, email address) for any portion of the project, the study is not anonymous and therefore will not qualify as Exempt. Please use the Expedited or Full application (below).
- Even if a project is classified as Exempt, any changes to the research process could potentially change the project to a nonexempt classification. Investigators must notify the IRB of any changes to an exempt research study.
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 . Expedited research may not include participants from vulnerable populations.
- Even if a project is classified as Expedited, any changes to the research process could potentially change the project classification. Investigators must notify the IRB of any changes to an approved research study.
- 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) in certain circumstances. Consult the University's IRB policy for details.
Other Forms
- Is another institution, or individual outside of the University, part of your project? The Revised Common Rule requires what is called Single IRB Review for all federally funded projects, beginning in 2020. Regardless of funding source, the University's IRB encourages the use of Single IRB Review procedures wherever possible. This means that, generally speaking, only one IRB will review a project where there are collaborators at multiple institutions, using what is called a Reliance Agreement. This can take the form of an IRB of Record, or Individual Investigator Agreement:
- Does your project include a researcher from another institution with their own IRB? If yes, and you intend to use the 草榴社区'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.
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.
- From IRBNet: Subsequent package training
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:
- The 草榴社区 IRB Policy (updated spring 2023)
- The 草榴社区 IRB COVID-19 Guidance (updated Fall 2022)
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
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.