Nonmedical Research

• Human Subject Research
• Recruitment, and information about involving Stanford students
• Protocol submission
• Schedule of submission deadlines and meeting dates.
• Protocol review
• Downloadable forms

Human Subject Research

All protocols involving both "research" and "human subjects" must be reviewed and approved by the IRB before recruitment and data collection may start.

For some protocols it might be difficult to tell whether they qualify as human subject research. Please consult the guidance
Does My Project Need IRB Review?

For further assistance contact the Research Compliance Office, or submit a Determination of Human Subject Research - Application to the IRB.

If the proposed activity clearly does not involve "research" and "human subjects", it does not require submission to the IRB. In some circumstances, an investigator might have need for a written determination from the IRB that an activity does not constitute "human subject research" and is not subject to IRB review. In such cases, a Determination of Human Subject Research - Application to the IRB must be submitted.

Primary concerns of the IRB are that risks are minimized for subjects and are reasonable when compared to benefits, participant selection is equitable, privacy and confidentiality are protected, participants are adequately informed of what their participation will entail (e.g., risks and benefits) including written and signed informed consent in most cases, and a plan for monitoring research is developed. This is true for both medical and non-medical protocols.

The Human Research Protection Program (STANFORD HRPP) contains policies and procedures for researchers, administrators, students, participants, and staff involved in human subject research. All researchers working with human subjects must complete a tutorial on the protection of human subjects in research. (See related policy.)

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Recruitment, and information about involving Stanford students

See the Recruitment page.

Protocol Submission

Protocol submission is done online, using the "eProtocol" system. To use eProtocol, you need a SUNet ID, Internet Explorer (for PCs) or Safari (for MACs), and all pop-up blockers must be off.  See eProtocol Help and Tips for Success in eProtocol for more information.
Before a research protocol can be approved by the IRB, investigators must first identify the appropriate Review Type, i.e., whether the protocol qualifies for Exempt, Expedited or Regular Review. To assist in preparing your answers, please see a list of Sample eProtocol Nonmedical Application Questions. Once the review type has been identified, the application must be completed online using the eProtocol Submission System.

More information on using the eProtocol Submission System for non-medical research protocols.

Protocol Review

Protocols are first reviewed by the IRB staff and then the IRB members, who will make the final decision as to review type. IRB comments and questions are distributed to the investigator to be addressed prior to a convened meeting. All Regular protocols must be presented, discussed and voted on at a convened meeting of the IRB. This process generally takes 4 to 6 weeks from the deadline date for new protocols; click here for a schedule of submission deadlines and meeting dates. [Schedule will open in a separate browser window.]

Under no circumstances may you begin your research until you have been notified of IRB approval. Approval may be confirmed by email, phone, Interdepartmental Campus Mail (I.D.), or U.S. Mail.

In addition, Stanford University requires that all researchers working with human subjects complete a tutorial on the protection of human subjects in research. (See related policy.) This tutorial is also linked to each of the primary pages of this site on the menu panel on the left side of the page.

Protocol Status and Historical Information

The eProtocol system is now the system of record, and should be accessed for information on current protocols.


Some historical information about events prior to 3/8/08 is available from the previous system - <click here>.
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Downloadable Forms and other information

Downloadable Sample Consents, Assents, Report Form, and other forms

Consent Form Language HIPAA

In order to comply with HIPAA requirements (see the HIPAA section).