Challenges of Student Research

1. Challenges of Student Research • Columbia University IRB Conference Dean Gallant • 31 March 2011 Harvard University

2. Institutional Decisions • Establish separate treatment for student research in P&P • Uncheck the boxes on FWA

3. What is “student research”? • Undergraduates? ✔ • Thesis projects? ✔ • Term papers? ✔ • Class exercises? [Maybe] • Graduate students? No

4. Why are students special? • Little (if any) experience with human subjects research • Little (if any) training • Mostly “small-R” research • Mostly minimal risk (but see (A), above) • Mostly in a hurry

5. Small-R Research • Has the “shape” of research • Does not meet the regulatory definitions: • Not a systematic investigation • Not generalizable • Pedagogical purpose • Design issues • See “Small-R” guidelines

6. Course projects • “Umbrella” application submitted by instructor for IRB approval • Students complete individual applications • Individual applications approved by instructor and teaching staff • Outliers forwarded to IRB for review

7. Training and Advising • Online training--not enough • In-person training whenever possible • Nazis, Tuskegee ... MEGO • Adviser is critical, and often weak, link

8. Training and Advising (cont.) • Adviser must be PI-eligible (ordinarily, a ladder faculty member) and must sign application, including attestation of appropriateness of proposed activities • Day-to-day adviser may be someone other than faculty member • Even so, keep faculty adviser in the loop

9. Secondary issues • Risk to student investigator? • May imply risk to subjects, but may be primarily a College concern • IRB now must assess risk to u/g investigators--Assoc Dean of the College is IRB member • Academic credit may not be possible for research in countries on State Department Warning List (see http://www.fas.harvard.edu/~oip/approved_programs/travel_warnings.html)

10. Email: drg@fas.harvard.edu Committee on the Use of Human Subjects website: http://cuhs.harvard.edu