Studies that meet the definition of human subject research must be submitted to the IRB and must receive IRB approval before any study activities take place. Use the chart, form, and policy found on the RCO (Research Compliance Office) website to determine whether and what type of review your research requires.  See RPH 5: Human Subjects and Stem Cells in Research

The Proposal Process

Is your study using Human Subjects or data derived from living human participants? Studies that meet the definition of Human Subject Research must be submitted to the Stanford Institutional Review Board (IRB) and must receive IRB approval before any study activities take place and before the associated grant or contract can be endorsed by the University and approved in SeRA.

The Proposal Development Routing Form (PDRF) in SeRA prompts you to disclose if human subjects will be used in the performance of the study. While IRB approval is not required at the time of proposal submission, a protocol will need to be submitted for IRB review before an early PTA can be approved. Only one early PTA can be approved for a study that still has an IRB protocol pending review. An actual award notice can be released in SeRA once an approved protocol has the correct SPO number listed as a funding source in the eProtocol system. You should work with the study coordinator to make sure that the correct SPO number is listed as a funding source.

While the human subject research in your project might not start until well into the sponsored project’s period of performance, IRB approval is still required before an award notice can be approved in SeRA. A protocol should be submitted exactly as the project is expected to be performed. The Stanford IRB will issue an approval notice for protocols that do not include human subject research at the beginning of the project, based on future human subject activities as described in the project. A revised protocol must be approved prior to the time human subject research actually begins.

A single protocol can be supported by multiple funding sources, and a single funding source can support multiple protocols. Feel free to coordinate with the appropriate IRB panel manager if you have any questions as to whether a SPO can be added as a funding source to an existing protocol, or if a new protocol must be submitted for full review. A revised protocol can be submitted at almost any time to add a SPO number as a funding source, and these types of revised submissions do not need to wait for the convened meeting to be approved when there is no change in the use of human subjects.

If your project includes Subrecipients, check with your PI if their work will be subject to IRB review as well. To ensure uninterrupted processing of setting up a Subaward, collect the Subrecipient’s own IRB approval letter and include it as an attachment in Stanford’s own IRB protocol submission. Continued review of the Subrecipient’s approval is required as a part of Stanford’s compliance responsibilities. A revised protocol can always be submitted to add any attachments as necessary. A Subaward Agreement cannot be signed by OSR until the Subrecipient’s approval letter is uploaded to the Stanford protocol and the revised submission is approved by the Stanford IRB. It is recommended that IRB letters be collected and submitted for Stanford IRB approval before a Subaward requisition is routed for OSR processing.

In an effort to reduce duplicative IRB review of the same protocol by multiple sites the National Institutes of Health (NIH) issued a new policy regarding the use of a single IRB (sIRB) for multi-site studies, effective May 2017. The policy allows for a single site to be designated as the sIRB. The other participating sites may rely on the sIRB’s review and approval. In the event a Stanford study will rely on another site, a local (Stanford sIRB) protocol must be submitted to the Stanford IRB for review and approval. These studies will receive an Administrative approval letter from the Stanford IRB and must be tracked in SeRA per usual processing.

While human subject research requires absolute compliance with numerous policies and regulations, the Stanford IRB and your OSR or RMG representative are here to help.  IRB questions about reliance on a sIRB can be directed to Celia.Molvin@stanford.edu or 650-723-0082.

Triennial Approval

The IRBs began to permit a triennial approval period for certain non-medical protocols and for medical chart review protocols that involve no more than minimal risk to human subjects and are not federally funded or supported.  

Effective October 1, 2011: Non-medical Extended (Triennial) Approval - Read the Memo from Dr. Arvin dated 9/30/2011

Effective March 1, 2013: Chart Review Extended (Triennial) Approval - See the Memo from Dr. Arvin dated 3/1/2013

Visit IRB: Human Subjects Research site

Visit SCRO: Stem Cell Research Site

Any work using biological agents classified as BSL-2 (Biosafety 2) or above must have APB (Administrative Panel on Biosafety) approval prior to commencing work. BSL designations are based on risk determinations, as well as information available from resources such as the NIH, CDC or American Biological Safety Association (ABSA); BSL designations from commercial companies must be confirmed with Biosafety prior to use of the agent(s).

Any work using rDNA that is deemed by the NIH to be non-exempt from the rDNA Guidelines must have APB approval prior to commencing work.

To determine if your research requires APB approval, check:

• NIH rDNA Guidelines
• CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
• American Biological Safety Association
• Public Health Agency of Canada Pathogen Safety Data Sheets

You can also check with the biosafety personnel at Environmental Health and Safety (EH&S) (biosafety@lists.stanford.edu).

Viruses and viral vectors have become a staple of the molecular biology community. As such, it is important for users to understand the origins of these tools and potential implications of their use. The following viral vector-related documents are available:

• Working with Viral Vectors - Sections for each virus contain information on virology, clinical features, epidemiology, treatment, laboratory hazards, Personnel Protective Equipment (PPE), disinfection, and use with animals.
• Recombinant Viral Vector Biosafety Levels - Information on recombinant viral vectors and the resulting biosafety levels.
• The APB uses the eProtocol Biosafety application process, a web-based system that coordinates new protocols, updates, renewals and reminders. To learn more about eProtocol biosafety and access the system, go to eProtocol Biosafety
• Human subjects protocols involving gene transfer, gene therapy or infectious agents must be reviewed and approved by the Panel prior to initiation of protocol.
• Applications to the APB must be under the name of a faculty member

visit Environmental health & safety site