Challenges of Student Research

Columbia University IRB Conference Dean Gallant

31 March 2011 Harvard University

Institutional Decisions

Establish separate treatment for student research in P&PUncheck the boxes on FWA

What is “student research”?

Undergraduates? ✔Thesis projects? ✔Term papers? ✔Class exercises? [Maybe]Graduate students? No

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

Small-R ResearchHas the “shape” of researchDoes not meet the regulatory definitions:

Not a systematic investigationNot generalizable

Pedagogical purposeDesign issues

See “Small-R” guidelines

Course projects

“Umbrella” application submitted by instructor for IRB approvalStudents complete individual applicationsIndividual applications approved by instructor and teaching staffOutliers forwarded to IRB for review

Training and Advising

Online training--not enoughIn-person training whenever possibleNazis, Tuskegee ... MEGOAdviser is critical, and often weak, link

Training and Advising (cont.)

Adviser must be PI-eligible (ordinarily, a ladder faculty member) and must sign application, including attestation of appropriateness of proposed activitiesDay-to-day adviser may be someone other than faculty memberEven so, keep faculty adviser in the loop

Secondary issuesRisk to student investigator?May imply risk to subjects, but may be primarily a College concernIRB 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)

Email: drg@fas.harvard.edu

Committee on the Use of Human Subjects website:

http://cuhs.harvard.edu