Advanced Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule

The U.S. government is considering significant changes to the current guidelines for human subjects research. From the Office for Human Research Protections website (OHRP):

The U.S. Department of Health and Human Services has announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations – which have been in place since 1991 and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register.  The proposed changes are designed to strengthen protections for human research subjects.

The OHRP has provided an overview webpage of the proposed changes and also a table highlighting how the newly proposed rules will change existing policies. The government is presently soliciting comments on the proposed changes from the general public.

There has been national news coverage of this topic, and the LSA is examining how it might best respond to the proposal. Members of the LSA can also, of course, submit comments on their own as members of the general public. According the the OHRP website, “The ANPRM comment period closes 5:00 p.m. Monday, September 26, 2011.” (This appears to be sixty days after the posting of the proposal in the Federal Register, which occurred on July 26 rather than July 25 as indicated in the quote above).

Update: It appears that the deadline for comments has been extended to October 26.

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8 Responses to Advanced Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule

  1. The “How to Submit Comments” page at http://www.hhs.gov/ohrp/humansubjects/submitanprmcomment.html notes that the comment period closes on 26 September 2011. It says 5:00 pm but the actual submission website says 11:59 pm so it may be prudent to submit a day earlier at the latest. Individual comments are apparently just as welcome as comments from organizations and institutions. Comments can be submitted using a web form which is limited to 2000 characters, but the form also includes a way to upload files in addition. The same page for submitting comments also allows anyone to browse through other submitted comments.

    Many of the proposed changes sound like definite improvements at least for fieldworking linguists. The perspective is, as usual, heavily slanted towards biomedical research. I am particularly concerned about a couple of passages, with this particular one bothering me the most:

    13. “Six categories of studies qualify as “exempt” from the regulations, meaning that they do not have to comply with any of the requirements of the regulations. These studies would no longer be fully exempt from the regulations. In particular, they would be subject to the new data security protections described above, and for some studies (e.g., those using biospecimens) new consent requirements would apply. It is appropriate that all research that might pose informational risk to subjects should adhere to reasonable data security protections.”

    This sounds as if we’ll be required to adhere to requirements that we’ve been exempted from, which makes no sense. It needs some serious clarification since this sounds like for example we’d be required to deal with already published data in the exact same way that newly collected data would have to be treated, which is at the very least an onerous responsibility.

    Another serious issue is that we need clarification on what “biospecimens” refer to. Just tissue samples and the like, or does this include instrumental measurements?

  2. I am also especially concerned about the proposed requirement for _all_ research projects, even no-risk tiny, short-term ones done by graduate students, to comply with HIPAA regulations about data privacy. They are clear that even “excused” projects (similar to “exempt” now) will be required to follow HIPAA procedures, which I think is nearly impossible.
    Otherwise, many of the changes sound great.

  3. jcgoodethics says:

    I spoke with a member of my institution’s IRB, and he, too, immediately saw the potential negative consequences if this approach to data security were indiscriminately extended to linguistic research. So, this is hopefully a case where any comments we might make on the proposed changes will get a fair hearing. One thing we can try to push might be to make sure that, whatever changes are made, IRBs are explicitly given the authority to waive any “standard” data security requirements when this seems warranted on research grounds and the risk to subjects of data exposure is minimal.

  4. I think it would be a good idea not to just have the ability to wave security requirements, but to have an established class of research where the requirements are automatically excused and instead “best practices as currently employed in the field” are prescribed instead. In any case, this sort of wording makes it very clear that the authors have not considered the impacts on social science research at all. They may not even realize that their proposal has any effect on linguists, anthropologists, sociologists, economists, etc.

    I note that already one officially submitted comment is complaining that there is not adequate time to address this new proposal. The LSA should probably file the same comment, and we should encourage other social science research organizations to do so as well. That comment should be pretty simple to put together.

  5. Jeff Good says:

    A useful “Quick Guide to the ANPRM” has been posted here: http://www.institutionalreviewblog.com/2011/08/quick-guide-to-anprm.html

    It looks to me like this might be a better place to start than the official document to become informed about the proposed changes.

  6. Lise Dobrin says:

    Since the comment period on the ANPRM has been extended through October 26th, I hope many more individuals and groups will write strong, detailed responses. This is our chance to shape the proposal before it’s too far down the road to come back. Consider pulling together a response to submit on behalf of your department!

    Most everyone I talk to is getting the picture that a massive generalized HIPAA would be an absolute nightmare for nonmedical research and would create paperwork on a scale now hardly even imaginable. I hope everyone will speak out against this terrible idea.

    I am with James. Individual IRBs need the freedom to let researchers follow standard disciplinary practices. And I believe Jeff has the right idea about the regulatory mechanism that would enable this, e.g., allowing boards to waive documentation of consent without having to justify their decision. More reliance on local knowledge, more local control.

  7. […] alone in submitting comments on the Advanced Notice of Proposed Rulemaking that has been discussed previously in this blog. The AAA, for example, submitted a very detailed response which is likely to be of […]

  8. […] Here, I discuss one of the report’s recommendations, which is relevant for linguists, but wasn’t the focus of the LSA’s official response to the ANPRM.  I hope this can start a conversation following up on the earlier (August 2011) discussion on this blog. […]

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