Hot IRB news!
So today a story caught on fire around archivist and historian social media that the Department of Health and Human Services is now officially excluding oral histories from what’s known as the Common Rule, a shorthand for the federal regulations that govern Institutional Review Boards, which are found in hospitals and universities that conduct research with human subjects. I got as excited as anyone else and retweeted the story as well without looking too deeply into it. However, when I started looking into the story posted by Oxford University Press, I couldn’t find any reliable non-historian sources backing the story up, particularly the claim that HHS approved the exclusion on September 8.
Before I go on, here’s my disclaimer: I am not a federal employee, nor an IRB expert. I have read up on some IRB rules in the past for my records management work, but that’s the extent of my knowledge. So if you have information which refutes my understanding below, by all means, please share it.
It turns out that what actually happened on September 8 is that HHS posted to the Federal Register what’s known as a Notice of Proposed Rulemaking (NPRM) — you can read it in all of its dense glory here. The proposal creates a new elevated category called “exclusions” which are a step liberated from “exemptions.” With the latter, you typically submit your research proposal to an IRB, and then the IRB approves the proposal as exempt from further IRB monitoring and oversight. If my understanding is correct, research now falling into the “exclusions” category would be totally free from even a preliminary IRB administrative review.
There is an excellent official HHS webinar which explains the difference between exclusions and exemptions. And here is what I gleaned from the NPRM page on the new exclusions category:
These activities will therefore not have to satisfy any regulatory requirements, nor is it expected (unlike exempt research) that they will undergo any type of review process to determine this status. (https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects#p-404)
From my perspective as an archivist, this is a REALLY REALLY REALLY REALLY good thing to have “Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected” under the exclusions category. I have gone through the IRB process before, and let me tell you, it is a real pain in the ass that you do not want to go through unless you absolutely have to and the ethics of your discipline require it. In addition, many IRB applications are wholly unsuitable for describing any type of archival/oral history activities or research.
Here’s the takeaway: This is still in proposal status, and we are in a 90 day comment period that ends December 7. Most of the comments thus far appear to be from medical schools asking that the comment period be extended. If you want to contribute your own comments, you should definitely do so!
Also, a very hearty thank you to Maarja Krusten who found an IMMENSELY helpful link for me when I started raising my eyebrow on Twitter. She noted the Federal Register had an announcement re: an open hearing that is coming up in Washington DC on October 20. Unfortunately it appears that the deadline to register has passed, but according to the announcement, the session should be live streamed.
What is still mysterious to me is what the timeline would be following the comment period — I’m not sure if there is one. If you know, please leave a comment!
Here’s the tl;dr: There is a proposal to exclude oral histories from IRB oversight. This is not official yet. The comment period is ongoing until December 7.
APPENDIX O’ LINKS:
- Original iffy reporting: http://blog.oup.com/2015/10/oral-history-federal-regulation/ and http://historynewsnetwork.org/article/160885 [NOTE: OUP contacted me on Twitter to mention they are asking their author to update the article]
- Current CFR IRB exemptions: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101
- Federal Register information on proposed rule: http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf
- September 8 publication of proposed rule: https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects
- Town Hall meeting: https://www.federalregister.gov/articles/2015/10/07/2015-25564/public-town-hall-meeting-on-the-federal-policy-for-the-protection-of-human-subjects-notice-of
- NPRM information (this is a really good and readable source): http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html And mention of the 90 day commenting period at the bottom of this: http://www.hhs.gov/news/press/2015pres/09/20150902b.html
- NPRM webinars: http://www.hhs.gov/ohrp/education/training/nprmwebinars.html
- NPRM YouTube video on proposed exemptions: https://www.youtube.com/watch?v=rtwLppFqAnM&index=2&list=PLrl7E8KABz1FtLMpK2zPa8nqV-F-xhW2C This webinar goes into the difference between exemptions and exclusions — my understanding is that the proposed rule would move oral histories into a new category of “excluded” status, which is free of any form of oversight or review whatsoever, according to 1:59 in the above linked YouTube video
- If anyone wants to submit a comment during the 90 day period, here is where you can review other submitted comments: http://www.regulations.gov/#!docketDetail;D=HHS-OPHS-2015-0008 and contribute your own http://www.regulations.gov/#!submitComment;D=HHS-OPHS-2015-0008-0001
- SAA’s RAO roundtable is also sharing more: https://www.facebook.com/Reference-Access-Outreach-Section-of-the-Society-of-American-Archivists-220623404645294/