In their comments on the NPRM, SACHRP and PRIM&R oppose the proposed exclusion of “Research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators” (§ ll.101(b)(2)(i)); they want such research to be moved from the excluded to the exempt category. But they differ in what they think the consequences of such a move would be; SACHRP thinks that researchers would face low barriers, while PRIM&R sees a chance for its members to continue to exert more control than is authorized by regulations. Both groups fail to represent the researchers most likely to conduct these kinds of studies.
Fears of interview trauma
Since the exclusion would only apply to research with a low risk of privacy breach, either because the subjects could not be identified or because the information they share is not sensitive, PRIM&R and SACHRP attack it on the grounds that risks other than privacy are at stake.
PRIM&R’s draft comments explicitly worry that interviews are traumatic:
Comprehensive ethics review of the sort envisioned in the Belmont Report requires thoughtful and experienced individuals to weigh the benefits and harms of each research project in terms of beneficence, justice, and respect for persons. Consider, for instance, a study in which college-aged victims of sexual trauma suffering from post-traumatic stress disorder are interviewed about their experience. Under the proposal at §__.101(b)(2)(i), this study may not be subject to the regulatory requirements of the Common Rule if the data are not recorded in an identifiable manner or if the researcher determines that disclosure of “responses outside the research would not reasonably place the subject at risk of criminal liability or be damaging to the subject’s financial standing, employability, reputation, educational advancement, or reputation” [§__.101(b)(2)(i)].
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.