1. Challenges of Student Research Columbia University IRB Conference Dean Gallant 31 March 2011 Harvard University 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 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 Undergraduates? ✔ Thesis projects? ✔ Term papers? ✔ Class exercises? [Maybe] Graduate students? No

4. Why are students special? (A) Little (if any) experience with human subjects research (B) Little (if any) training (C) Mostly “small-R” research (D) Mostly minimal risk (but see (A), above) (E) Mostly in a hurry (A) Little (if any) experience with human subjects research (B) Little (if any) training (C) Mostly “small-R” research (D) Mostly minimal risk (but see (A), above) (E) 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 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 “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 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 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_progra ms/travel_warnings.html) 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_progra ms/travel_warnings.html)

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