RSRB (IRB) Exemptions
OHSP policy requires Institutional Review Board (IRB) review of all human subject research conducted or supported by employees or agents of the University of Rochester. This includes research that falls into one of the exemption categories defined by Department of Health and Human Service (HHS) regulation (45 CFR 46.104).
Based on review requirements, ‘IRB exemption’ does not mean that review by the Research Subjects Review Board (RSRB), the University’s IRB, is not required. Rather, ‘exempt’ means that once the RSRB confirms the research meets exemption criteria, further reporting to the RSRB in not required (provided there are no changes to the research, nor reports of new information).
For a description of RSRB (IRB) exemption categories, review our Exempt Status Guidance.
RSRB (IRB) submission requirements and review process
All proposals must be submitted for review via Click IRB.
The Investigator submitting the research must meet the qualifications and requirements of Principal Investigator, as defined in OHSP Policy 901: Investigator Responsibilities.
For student projects, faculty mentors must be included as study team members and be identified as PI Proxy.
Minimally, all submissions must include a study protocol and completed Data Security Assessment Form . Study protocol templates are available as follows:
- For research involving a secondary analysis, specimens/records review, or retrospective chart review, use the Specimen & Record Review Protocol Template.
- For all other research that falls into one of the exemption categories, use the Exemption Request Protocol Template. If you are unsure whether or not your research qualifies for exemption, use the Social-Behavioral-Educational Research Protocol Template.
As applicable, submissions must also include:
- All direct advertisements for potential subjects (i.e., recruitment materials intended to be seen or heard by potential subjects).
- All study measures that will be completed by, or include questions that will be asked to, subjects (such as questionnaires, assessments, interview scripts or subject diaries).
- Method for informing subjects of the research and obtaining voluntary consent to participate, when the research involves subject interaction (including electronic communications/interactions).
- Minimally, this process must include informing subjects that the activity involves research and that participation is voluntary, a description of study procedures, and the name/contact information of the Principal Investigator.
- In most circumstances using one of the following Information Sheet templates is acceptable. All information sheets should be submitted on University of Rochester letterhead.
- Data collection sheet (or list of variables), when the research involves a secondary analysis/records reviews.
- For a comprehensive study submission checklist, reference our IRB Submission Checklist page.
All individuals engaged in the research must be identified as study team members and complete (and maintain) Human Subject Protection (HSP) training.
More information:
Post-IRB review need-to-knows
Read your exemption determination letter. This letter includes valuable information regarding compliance with OHSP Policy 901: Investigator Responsibilities; all Investigators are responsible for complying with this policy. Compliance with other institutional policies pertaining to data security, privacy, and the Health Insurance Portability and Accountability Act (HIPAA) may also be required, based on the nature of the research.
Investigators are strongly encouraged to request a Post-Approval Consultation prior to initiating their research.
Once a proposal has been deemed ‘exempt’ by the RSRB (IRB), the study team is permitted to conduct the research as defined by the study protocol and all supporting materials reviewed by the RSRB (IRB), e.g., submission contents, surveys, information sheets, study team members, data security assessment form.
When/if modification to the study protocol and/or any other supporting materials is necessary, a modification must be submitted for RSRB (IRB) review. This is required to confirm the research still meets exemption criteria given the proposed revisions; proposed revisions cannot be implemented until the RSRB (IRB) has completed their review.
Instructions for submitting modifications are included in the Click IRB Study Staff User Guide.
Once a proposal is determined to be exempt, the RSRB applies an ‘RSRB Approved’ watermark to all consent forms, information sheets, and/or recruitment materials. Study teams are required to use the watermarked version of these materials when engaging with (or recruiting) potential subjects. For more information, reference our Watermarked Documents page.
Investigators are required to report all research events, as defined by OHSP Policy 801: Reporting Research and the corresponding OHSP Guideline for Reporting Research Events.
Continuing reviews (i.e., progress reports and/or study closure) are not required for research deemed exempt.