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 Suject 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 the attachments section of the protocol application).
Common Rule Changes
Common Rule Changes for Medical Research
Common Rule Changes for Social, Behavioral, Educational Research
The IRB’s primary concerns in the review of research are that:
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
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. The reliance terms are outlined in an IRB Authorization Agreement (IAA). 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.
NCI CIRB - the NCI Central IRB Initiative
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