How to Obtain Human Subjects Approval

Human Subject Research Overview

Human subject research is defined as the collection and analysis of data from living persons. This can include interviews, ethnographic observations, review of existing records (such as school transcripts) and experimental medical procedures.

Policies regarding human subjects are intended to minimize risks to subjects. This includes protecting subject confidentiality and ensuring that they are informed of what’s involved with participation, including any risks.

Complete explanation of the human subject procedure is on the Stanford website,

Administrative Panels on Human Subjects. Many undergraduates find the "Tips" section of the Administrative Panels web pages especially helpful.

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Exempt, Expedited and Regular Review

Research projects involving human subjects may undergo three different types of review processes before being approved by the Stanford Administrative Panel. 

  • Exempt Review.  Exempt review is for research studies that federal regulations identify as those that are exempted from Human Subjects Panel review because they entail minimal risk.

In this context, minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research is not greater than the following:

  • That ordinarily encountered in daily life
  • That encountered while performing routine physical or psychological examinations or tests

Most institutions, including Stanford, require a Human Subjects Panel review to determine whether the exemption claim is appropriate and whether it will be granted.

Exempt review does not mean that researcher is exempt from filing a protocol. It means that the protocol is reviewed by one primary reviewer and typically does not involve discussion at a convened Human Subjects Panel meeting. Once exemption is granted, protocols are exempt from continuing Panel review.

  • Expedited Review.  Minimal risk studies that fall under one of the specified categories will receive expedited review. In these cases, protocols are reviewed by one primary reviewer (rather than two) and typically do not involve discussion at a convened Human Subjects Panel meeting. Protocols approved under Expedited Review are subject to continuing Panel review.

Note that expedited review does not mean that the protocol application is processed faster than normal.

  • Regular Review. Studies involving more than minimal risk undergo Regular Review. Protocols that involve no greater than minimal risk, but do not fit into the Exempt or Expedited categories (discussed below), are considered for Regular Review. Protocols are reviewed by two or more primary reviewers and then are discussed and voted on at a convened Human Subjects Panel meeting. Protocols approved under Regular Review are subject to continuing Panel review.

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Undergraduate Research Projects and Human Subject Research Regulations

All Stanford University researchers must comply with the federal regulations of research. This includes students engaged in independent research projects.

If you collect information from human beings as part of your research, you must complete the following two steps to gain University approval.

  1. You must complete the Stanford University online Human Subjects Certification tutorial. This is a one-time requirement that you can do early in your grant preparation process, long before you have designed your research project. Faculty sponsors must complete the tutorial as well, so you may wish to ask your sponsor if he or she is already certified.
  2. You must submit an online Human Subjects Protocol for review by the Stanford Administrative Panel. The panel deadline falls on the first working day of each month (except August). The panel also meets on the last Friday of the month (except August). It can take up to two months from the time you submit a protocol to the time you receive approval from the Panel. Grant approval and / or disbursement of funds may be delayed if you have not complied with these guidelines.

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Further Resources

  • Research Compliance Office and IRB. This website provides an overview of tutorials, forms, policies and procedures assembled by the Research Compliance Office and the IRB.
  • eProtocol Help. Many students find the “Tips” section especially helpful in preparing their protocol.

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