A lot has changed in human subject research since 1991. You know, things like the widespread use of electronic systems in research, genetic research and its associated risks, different ways of obtaining informed consent, the rise of central IRB reviews of research, etc. etc.
One thing that hasn’t changed much in the last almost-quarter-century is the regulation that governs human subject research at institutions like UAMS that receive federal research funds. The Common Rule (45 CFR 46) spells out the basic requirements of IRB oversight of research and informed consent of participants, and hasn’t been updated since its 1991 publication.
That may change in the not-too-distant future, however. The federal Office of Human Research Protections (OHRP), four years after initially signaling its intent to update the Common Rule, this month published in the Federal Register a Notice of Proposed Rulemaking (NPRM) describing the proposed changes to the Common Rule and seeking public comment.
The highlights of these proposed changes include:
- Expansion of the categories of research exempt from institutional review board (IRB) review
- Changes to the informed consent process
- Mandate that multi-site research studies rely on a single IRB
- Expansion of the scope of the rule to cover all clinical trials conducted at any US institution receiving federal funding for non-exempt human subjects research, regardless of funding sources
- Changes to the requirements for continuing review
- Consent requirements for the use of stored biospecimens
- Limitation of the use of waivers or alterations of consent for research involving biospecimens
You could try reading the 128-page Federal Register publication of the NPRM (at some risk to your eyesight, as most of it is in that tiny Federal Register type) on your own, or you could get a rundown of the significant proposed changes by attending an upcoming webinar hosted by the UAMS Office of Research Compliance. Presented by Public Responsibility in Medicine and Research (PRIM&R), “PRIM&R’s Primer on the Notice of Proposed Rulemaking (NPRM)” is scheduled for Tuesday, September 15, 12 to 1:30 PM in Ed II, room G-137, on the UAMS campus. We note that if you are on the third-week committee, you could come early that day, attend the webinar, and then head on over to our regular IRB meeting. We’d also like to mention that while the speakers at just about all of PRIM&R’s presentations are excellent, the two presenters scheduled for Tuesday are among their best. Heather Pierce and P. Pearl O’Rourke are both PRIM&R board members and always manage to draw a crowd to their presentations at conferences.
We encourage you to attend to find out more about proposed changes that may affect how we oversee research at UAMS.