Undergraduate Work Involving Human Subjects 

Learning how to conduct ethical research with human subjects is a vital part of many students’ educational experience.  Often undergraduate student projects do not meet the federal definition of human subjects research, and it is important that each student project be evaluated against the following criteria:

  • A human subject is defined by federal regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f)(1)(2))

  • Federal Regulations define research as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)).

Importantly, one’s ambition to publish the results of a project in a journal does not in and of itself make the project “research.” 

To facilitate interpretation and application of this definition in the context of undergraduate work involving human subjects, and to ensure the ethical and safe treatment of human participants, the IRB in collaboration with the HRPP provides the following guidance

I. Undergraduate work that does not require any IRB/HRPP oversight

Undergraduate projects that are designed with the objective of providing students with training about and experience with human subjects research do not require IRB review if all of the following conditions are met:

  • The activity is designed for learning purposes only

  • Results of the project are not presented outside of the classroom

  • Data collection procedures present no more than minimal risk to the subjects

  • Vulnerable populations (children, prisoners, cognitively impaired individuals) are not used

  • Data is collected in a manner such that the subjects are not identifiable 

If the project meets these conditions, please provide The Letter of Introduction for Undergraduate Work Involving Human Subjects to all participants.

II. Undergraduate work that requires IRB/HRPP notification (but not a protocol)

If the intent of the undergraduate project is to present the information at Brown (e.g., in a department, school, or symposium) and it meets the following conditions, then an Undergraduate Project Involving Human Subjects  form must be submitted to the HRPP for its review and records.

  • The project is designed for the purposes of the student's educational experience/completing a thesis

  • Data collection procedures present no more than minimal risk to the subjects

  • Vulnerable populations (i.e., children, prisoners, cognitively impaired) are not used

  • Data is collected in a manner such that the subjects are not identifiable or their confidentiality is protected

If the project meets these conditions, please provide The Letter of Introduction for Undergraduate Work Involving Human Subjects to all participants.

III. Undergraduate work that requires a standard protocol submission

Any undergraduate project involving human subjects that falls outside of the above conditions requires a standard IRB protocol submission with the Faculty Advisor acting as the Principal Investigator.

Responsibilities of Faculty Advisors

  • Faculty Advisors have the primary responsibility for ensuring that human subjects are treated ethically.

  • Faculty Advisors must mentor their student researchers regarding ethical principles for the protection of human subjects, which includes completion of the CITI training course (required for all undergraduates whose work does not meet the criteria in Section I. above).

  • Faculty Advisors are responsible for reviewing and making the final determination regarding materials to be submitted to the IRB, including any survey instruments or interview questions.

  • Faculty Advisors should contact the HRPP (irb@brown.edu or 863-3050) with any questions regarding undergraduate projects involving human subjects.