Stanford IRB - For Researchers

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For Researchers

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

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:

risks are minimized for participants and are reasonable when compared to benefits to the individual and/or to society;
participant selection is equitable so that the benefits and burdens of research are equitably shared;
privacy and confidentiality are protected (see SoM Privacy Office tips); and
participants are adequately informed of what their participation will entail so that they can make an informed decision about whether to participate.
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 7/19/2018. It is still not yet known whether these changes will be implemented or further rolled back by Department of Health and Human Services (DHHS).
This information is being presented for your information only. No changes in IRB procedures should be made at this time.

Training

"Let the IRB Staff Come to You!": Researchers can arrange for 1-on-1 or group sessions

Research on Medical Practices (ROMP). New Resources and videos for patients and others. For research participants, patients, and others interested in medical practice research - a new resource on the Spectrum website: Research on Medical Practices (ROMP) and ROMP Videos.

Quick Links

What’s New at the IRB
Do I need an IRB Submission?
Research at non-Stanford facilities: Can Stanford human subject, animal subject or human stem cell studies be conducted at non-Stanford facilities?
Forms and Processes
Medical Research

Nonmedical Research
Training - what does the IRB require?
Single IRB (sIRB)
Relying on a Single IRB (sIRB)
FAQs
Presentations (education) provided to the research community
IRB Contacts

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?

Forms and Processes

Forms & Consent Templates

Consent

Recruitment

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 Research

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:

Checklist: Before the Clinical Phase of the Trial Commences (section 8.2) - Documents on file before the trial formally starts

Checklist: During the Clinical Conduct of the Trial (section 8.3) - Documents added to the files during the trial

Nonmedical Research

Nonmedical Application Process

Information about eProtocol Sections for Nonmedical Applications

Sample Nonmedical eProtocol applications

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.

Costs associated with the sIRB review may be included as direct costs in the application budget. Work with your Research Process Manager prior to submitting your proposal to NIH. NIH FAQs on sIRB costs.

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)

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.

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.

Instruction Manual for Worksheet Completion in IRBManager

Quick links

NCI CIRB Website

CCTO SoP for relying on a Central IRB