Boellstorff welcomes the idea of the Excused category and the ANPRM's deemphasis of written consent forms, which, he says, "are often hard to understand and designed more to protect home institutions from liability than truly inform those being studied." He also believes that social scientists may be able to address concerns about data security.
On the other hand, Boellstorff worries that two of the ANRPM's proposals could lead to the same kind of ethics creep we have seen with the current Common Rule.
First, he warns of the ANPRM's handling of "'vulnerable' populations." He writes,
The proposed revisions retain the concept of "vulnerable" populations, but without ever providing a clear definition of what vulnerability might entail. As it stands, the examples provided of vulnerable populations are "children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons." There are at least two issues here. First, social science researchers have long noted that we have a real dearth of quality research on children and prison populations due to the very high barriers IRBs often place on conducting research on such populations, even when it is only informational risk that is at issue. In other words, the notion of "vulnerable" needs to be recalibrated in light of research that carries only informational risk. Often, research on children or prisoners should qualify for Excused status. Second, the notion of "economically or educationally disadvantaged persons" is so broad so as to include a majority of the world's population under its scope. The mere fact of being disadvantaged does not mean someone is "vulnerable" with respect to social science research that carries only informational risk. It is crucial that the ANPRM be revised to reflect this fact. The notion of "competent" may be more useful, though at present it is limited to "adults who would be able to provide 'legally effective informed consent."
Second, Boellstorff worries that ANPRM's Question 16, which envisions stricter scrutiny of "emotionally charged" topics, would hinder legitimate research about sexuality.
My concern is that while it is "sexual abuse" that is named, there is a real danger that this could be taken to mark all research on sexuality as "emotionally charged." Any abuse in theory can be emotionally charged. Marking out sexual abuse (and physical abuse more generally) as emotionally charged can contribute to the singling out of sexuality research as ethically suspect, which is counterproductive for encouraging careful work on this important topic.
I concur with Boellstorff's points and admire the brevity and clarity of his comments.
As of September 9, the ANPRM docket on regulations.gov contained 185 public submissions. I hope to post about more of them soon.