Saturday, July 23, 2011

Feds Ponder Biggest IRB Rules Changes in 30 Years!

On Friday, the U.S. Department of Health and Human Services posted an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, to be published in the July 25 Federal Register.

The ANPRM seeks to "enhance the effectiveness of the research oversight system by improving the protections for human subjects while also reducing burdens, delays, and ambiguity for investigators and research subjects." In 92 pages, it suggests dozens of potential changes, some of them quite major. They would represent the biggest regulatory changes to the US IRB system since the revision of 45 CFR 46 in 1981.

Watch this space for extensive and frequent commentary on specific provisions in the proposal as I draft comments prior to the end of the 60 day comment period. (September 22? How do they count these things?)

For now, I will just register my delight that the federal government has finally acknowledged that the flaws in the present system are not mere anomalies, but represent systematic problems that demand regulatory reform.

Oh, and thanks for the three citations to my work! Attention has been paid!


Melora Ranney Norman said...

Hope this turns out to be great news--thanks for all your advocacy, Zach!

Anonymous said...

As chair of a university IRB I think these proposed changes are excellent.

Zachary M. Schrag said...

Thanks for these comments. I think the more comments HHS receives in the next 60 days, the better. I will be posting drafts of mine--section by section--on this blog as they are ready.

Anonymous said...

I work in the IRB world and have experience in large IRBs and small ones--as an Administrator, and as a Chair of an IRB. I'm very research friendly and don't really think there needs to be much review of social science research. Unfortunately, I think that the review of social science research is going to be just as problematic under the proposed/new regulations as the old regulations...sorry. For example, the first regulatory change is about protecting identifiable data. Since the identifiability of the data will be the deciding factor, the "risk" (whatever that really means--sensitivity of the data) won't be taken into account? Studies that used to be Exempt, even if they were identifiable, may still be exempt, but they will have to meet the security standards set for studies that have much more sensitive data. For example, identifiable data fro an online survey, in say, linguistics, will have to have the same level of security (likely encryption, etc.) as identifiable data about drug users. I can imagine that this might put an incredible (financial)burden on researchers, particularly social science researchers. How's this going to work with fieldwork studies?

Zachary M. Schrag said...

I agree that imposing the HIPAA standards on social science research, without any modification, would cause more problems than it solved. I had focused on the restriction on geographical identifiers, and I had overlooked the suggestion that "data security standards could require the use of reasonable and appropriate encryption for data maintained or transmitted in electronic form and strong physical safeguards for information maintained in paper form, audit trails, and access controls that allow only authorized personnel to have access to the information." Thank you for catching this.

I put little faith in the "reasonable and appropriate" qualifier, so I think you are right to worry about this suggestion.

ANPRM question 59 does ask if the HIPAA standards are "appropriate not just for studies involving health information, but for all types of studies, including social and behavioral research? Or might a better system employ different standards for different types of research?" I hope you will submit a comment in response to this question, drawing on your experience.