Â鶹´«Ã½

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:

• From IRBNet: Subsequent package 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 Â鶹´«Ã½ 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

Â鶹´«Ã½ IRB Policy:

• The Â鶹´«Ã½ IRB Policy (updated spring 2023)
• The Â鶹´«Ã½ 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
•  

Â鶹´«Ã½ IRB Education Requirements

International Research Guidance

Recruitment of Students in Human Subjects Research

Electronic Survey Guidance 

About the IRB: Information for Student Researchers

• Spring 2024 IRB Information Session Presentation

External Guidance

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

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.

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.

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.