Human Subject Research (HSR) Determination
To submit a 'Determination of Human Subject Research form in eProtocol, select 'Create a Protocol' on the 'My Dashboard' webpage. After completing the requested information, select 'Human Subject Research (HSR)' as your type of review. Complete the application and attach the Human Subject Research (HSR) Determination Form for review (there is also a link to this form in the attachments section of the protocol application).
Common Rule Changes
On January 19, 2017, OHRP published the Final Rule for the Protection of Human Subjects in research. This is the first major revision of the Common Rule since 1991. The Rule was to become effective on 1/19/2018 and has been delayed to 1/21/2019. The Stanford Common Rule page provides implementation information.
Do I need an IRB Submission?
Does My Project Need IRB Review? (pdf)
Determination of Human Subject Research Application (pdf) This form should be submitted in eProtocol as a Human Subjects Research (HSR) Determination.
IRB Review Type: What is it and why do I need to know?
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Forms and Processes
Forms & Consent Templates
Emergency Use of a Test Article
Extended Approval Period for some Research (Triennial review)
The approval period is extended for qualifying non-federally sponsored research, involving no more than minimal risk (as defined by 45 CFR 46.102), to researchers conducting:
- Nonmedical studies, (effective10/1/2011)
- Medical human subject chart review studies, (effective 3/1/2013)
as long as certain conditions are met. Certain changes in these studies may change the triennial IRB review requirement to annual review. See Extended Approval Policy.
Medical Application Process
Filling out the Medical Protocol Application
Sample Medical eProtocol applications
Clinical trial documents: The following checklists are from the FDA E6 Consolidated Guidance for Good Clinical Practice:
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Nonmedical Application Process
Information about eProtocol Sections for Nonmedical Applications
Sample Nonmedical eProtocol applications
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Single IRB (sIRB)
NIH Funded Studies
NIH policy on the Use of a Single Institutional Review Board for Multi-Site Research will be effective January 25, 2018.
- All sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH must use a single IRB (sIRB). Applicants must include a plan for the use of a sIRB in their applications/proposals submitted to the NIH on or after January 25, 2018.
- Guidance on Exceptions to the NIH Single IRB Policy (NOT-OD-18-003)
- Guidance of Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (NOT-OD-18-004)
- Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research (NOT-OD-16-109)
Stanford as Prime or Lead Site
When Stanford is the Prime Awardee or the lead site on a multi-site study requiring sIRB, you will need to consider the following reviewing IRBs to include in your proposal submitted to the NIH for the use of an sIRB:
- Commercial IRB, e.g., Quorum Review IRB
- Trial Innovation Network Central IRB
- Another academic IRB (i.e., one of the other participating institutions)
Will the single IRB that is identified in the NIH application/proposal be evaluated during peer review?(NIH FAQs)
- No. The proposed single IRB will not be evaluated as part of the peer review process and will not affect the overall assigned score of an application/proposal or the overall rating of the acceptability of the Protection of Human Subjects section. Peer reviewers may note if the plan to comply with the NIH single IRB policy is not included in the application/proposal but this will not impact the score.
Per NIH's Single IRB and Exception Process Webinar (October 18, 2017), the sIRB of record does not have to be the IRB of the parent award.
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Relying on a Single IRB (sIRB)
Stanford's IRB may agree to rely on a single IRB (sIRB) for multisite studies to provide initial and ongoing regulatory reviews. Presently, Stanford does not permit sIRB when Stanford is the only study site. The reliance terms are outlined in an IRB Authorization Agreement (IAA), e.g, Stanford has signed on to SMART IRB, which supports IRB reliance across the nation. The sIRB is responsible for reviews required by federal regulations at 45 CFR 46, and 21 CFR 50 and 56 (initial review, continuing review, modiciations, reportable events). When Stanford IRB relies on a sIRB, Stanford's local IRB still retains responsibility to ensure investigator compliance with the protocol, the sIRB's determinations, applicable federal and state regulations, and Stanford policy. Stanford's IRB bears responsibility for the local conduct of these studies, e.g., managing noncompliance and unanticipated problems, ensuring training, and study monitoring. In addition, local ancillary requirements, managing reliance agreements, and handling study specific issues that arise are Stanford's responsibility.
The Protocol Director (PD) is required to submit a sIRB eProtocol application to request reliance on a sIRB. When the (1) sIRB eProtocol application and the (2) reliance IAA are complete, a Reliance Letter will be issued through eProtocol. Please see the sIRB SOP for more detailed information.
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NCI CIRB - the NCI Central IRB Initiative
Protocols Qualifying for CIRB Review
The Adult and Pediatric CIRBs are the IRBs of record for certain adult and pediatric national multi-center cooperative oncology group cancer treatment trials.
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