Undergraduate projects that are designed with the objective to fulfill a class or thesis requirement do not need to be submitted to the Institutional Review Board (IRB) for review and approval if they meet all of the conditions listed below. The activity is designed for learning purposes only, and the results are not shared outside the classroom. 

• There are no plans to present the results at conferences or similar events, and there is no set timeline for preparing a formal manuscript for a scientific, peer-reviewed journal.
• The way data is collected poses minimal risk* to participants.
• The project does not involve vulnerable populations, such as children, prisoners or individuals with cognitive impairments. Data is collected in a manner that makes participants not identifiable.

*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life of the general population or during the performance of routine physical or psychological examinations or tests (45 CFR 46).

The faculty advisor is responsible for deciding if these conditions are met. If there is any uncertainty, or questions about definitions of minimal risk or identifiable information, please consult the regulatory advising team at reguatoryadvising@brown.edu. 

If the project meets the above listed conditions, the HRPP team strongly suggests the use of the Letter of Introduction for Undergraduate Work Involving Human Subjects to all participants. 

When using the suggested letter template, please only use Brown University contact information. If your faculty advisor does not have an assigned Brown phone number, you can reach out to the Office of Information Technology’s telephone service to receive one. You can also work with OIT to set up a study-specific Brown University email.

• Letter of Introduction for Undergraduate Work Involving Human Subjects Template (Word Doc)

Undergraduate projects involving human subjects where there is the intention of making the results generalizable, and that meet the following conditions, must submit an Undergraduate Research Form for Regulatory Advisory Unit (RACU) clearance or referral to the IRB to regulatoryadvising@brown.edu.

• There are concrete plans to present the results at conferences or similar events, and there is a timeline for preparing a formal manuscript for a scientific, peer-reviewed journal.
• Data collection procedures present potentially more than minimal risk to the subjects. (See definition above).
• Vulnerable populations (i.e., children, prisoners, cognitively impaired) are included in the study population.
• Data is collected in a manner such that the subjects are identifiable or can be re-identified.

Generalizable means the research "is conducted with the intention of drawing conclusions that have some general applicability and uses a commonly accepted scientific method" (OHRP, n.d).

Please note that after the Undergraduate Research Form is completed, the study will most likely require IRB review and timelines for review should be considered when planning the study's initiation. All undergraduate projects in this category must first notify the RAU before submitting to the IRB. 

Undergraduate students are not eligible to serve as PIs on IRB protocol submissions, and a faculty advisor with experience conducting human subjects research must be listed as the study's PI. Please plan accordingly.

• 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 submitting to the IRB if applicable).
• Faculty advisors are responsible for reviewing and making the final determination regarding materials to be submitted to the RAU or the IRB when applicable, including any survey instruments or interview questions.
• Faculty advisors should contact regulatoryadvisory@brown.edu or 401-863-3771 with any questions regarding undergraduate projects involving human subjects.

[Source: HHS, 2018. 45 CFR 46 | HHS.gov]