Human Subjects

Human Subjects Research Overview

Human subjects 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 is involved with participation, including any risks.

An Institutional Review Board (IRB) is a federally mandated panel that is charged with overseeing the protection of human participants in research. At Stanford, the IRBs are formally known as Administrative Panels for the Protection of Human Subjects. Stanford IRB procedures are spelled out on the Stanford website, Human Subjects Research and IRB. Many undergraduates find the "For Researchers" and FAQs sections of the IRB web pages especially helpful.

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 your research involves human subjects, complete the following two steps by the time you submit your application for a UAR Student Grant:

  1. You must complete the Stanford University online Human Subjects Certification tutorial (CITI training). This is a one-time requirement that you can do early in your project preparation process, long before you have designed your research project. Your faculty mentor must also complete the tutorial in order to be your sponsor for the Human Subjects Protocol, so be sure to check with your mentor if he or she is already certified, or give him/her adequate notice to complete the tutorial.
  2. You must submit an online Human Subjects Protocol (eProtocol) for review by the Stanford Administrative Panel. Note the protocol submission deadlines and your planned Student Grant proposal submission. It can take up to two months from the time you submit a protocol to the time you receive approval from the Panel. UAR Student Grant approval and/or disbursement of funds may be delayed or may expire if you have not complied with these guidelines.

If you and your faculty mentor have questions about whether your project involves human subjects research, or whether it needs IRB review, consult with Stanford IRB at irbeducation@lists.stanford.edu. You must have IRB approval or exemption in hand before grant funding can be awarded.

 

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. The FAQs section is helpful when preparing your protocol.