Some survey items cover sensitive topics like students' debt as well as their experiences with sexual harassment. Of more concern is the coercive nature of enlisting student participation: Some medical schools require students to complete in order to graduate. The AAMC provides medical schools with the names of students who haven't responded and some schools penalize students for noncompliance. In addition, students aren't provided with enough information about how the data from the survey will be used. Some of the data have been published in journal articles, but participants aren't informed of this, according to the letter submitted by the Public Citizen to the Office for Human Research Protections. The letter calls for review of the questionnaire and it's use by an institutional review board (IRB), an oversight board.
The AAMC defends the questionnaire, explaining that its IRB has begun reviewing the survey approximately 8 months ago. Moreover, the AAMC argues that survey is useful for individual schools in monitoring and improving the medical school curriculum, which doesn't fit the definition of "research" under federal guidelines.
How does the Office for Human Research Protections define "research?" That's complicated.
- According to Title 45, Code of Federal Regulations, Part 46 (46.101), survey research that doesn't directly identify participants (i.e., that is anonymous and therefore protects participant privacy) is exempt from IRB review and is not regulated under 45 CFR, Part 46. However, given the web-based nature of the survey and the admission by the AAMC that schools are notified of nonparticipants, it appears that students can be identified and linked with their data.
- Also according to (46.101), , educational research, that is "conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods" is exempt from IRB review and is not regulated under 45 CFR, Part 46. The AAMC survey isn't examining educational practices per se, but students' experiences and opinions.
This case will be under investigation for months or years from the Office for Human Research Protections, but it brings up an important questions for researchers (and participants and consumers of research): How do we define research? When does human subjects research fall under "research" and thereby require IRB approval? These are difficult questions that have recently received a great deal of attention in social science circles. Stay tuned, as this isn't the last you'll hear (or read!) about ethical issues in human subjects research.
