IRB Home > For Researchers

  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 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:

• 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. However, it is not yet known whether these changes will be implemented or rolled back by the new Federal Administration.

  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?
• 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?

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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

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Nonmedical Research 

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

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

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