All students planning to conduct research involving human subjects, no matter how seemingly innocuous, are required to submit a decision form through the Undergraduate Research Training Portal so that a determination can be made about whether or not they need to apply for formal approval from Harvard’s Institutional Review Board (IRB).
Please note that under the very specific directives governing the federal government’s definition of what actually constitutes research, most senior thesis projects are not expected to require review by the IRB (also known as the Committee on the Use of Human Subjects, or CUHS).
In order to submit a decision form, students need to have a well-formulated methodology and be able to identify who will be studied, where the study will take place, how subjects will be recruited, what will be asked of them, and what measures will be taken to protect confidentiality.
Students will also need to have completed the CUHS-led undergraduate training workshop or an online human subjects training (CITI or NIH, both of which are available on the CUHS website).
Government students should consult with the Assistant Director of Undergraduate Studies (ADUS), Dr. George Soroka, if they have any questions about how to fill out the decision form. They should also list him as their secondary advisor so that he will be notified once a determination has been made.
Be aware that undergraduates receiving funding from the University are not allowed to conduct research in regions that are deemed “high risk” by Harvard’s Global Support Services (GSS) office. Undergraduates conducting research in locations deemed “elevated risk” by GSS will be required to consult with the GSS Travel Safety and Security team.
Projects not requiring CUHS approval that could still potentially do harm:
Each year, a small number of College students conduct research that is determined not to need IRB/CUHS approval but that nonetheless has the potential to put the student or the research subjects at risk. Harvard has an institutional obligation to take reasonable steps to reduce risks for the student and the research subjects. As such, students in this category will need to meet with a representative from the Office of Undergraduate Research and Fellowships (URAF) to discuss their research. If you have been told or believe your project falls into this category, please make an appointment with the Dept.’s ADUS to discuss the matter.
Student projects that do need CUHS review:
Students required to submit a formal CUHS application need a “faculty sponsor” (usually this is your primary thesis adviser; note that all ladder [i.e., tenured or tenure-track] faculty, as well as senior lecturers and some lecturers who have received an advising waiver are eligible to serve as faculty sponsors provided they have completed the CITI or NIH ethics training). If your thesis adviser is an ineligible lecturer or a Ph.D. candidate, please contact the Dept.’s ADUS for information on how to proceed. Be advised that even an expedited review process may require several weeks. In those exceptional cases where full IRB review is needed, this process may take a month or more to complete. Plan accordingly!
The information above is excerpted from the Guide to Writing a Senior Thesis in Government, p. 13.