The Common Rule (45 CFR 46) is the regulation that UAMS must follow as it oversees research involving human subjects. It was first published in 1991, when the research environment was much different than what it is today, on multiple levels.
Now, four years after the Office for Human Research Protections (OHRP) indicated that it was planning to update that regulation, OHRP has published for public comment a Notice of Proposed Rulemaking (NPRM), which describes the proposed changes to the Common Rule. And the proposed changes are fairly massive. The Federal Register publication of the proposed changes is 128 pages long, many of which are in that famously tiny Federal Register font. The OHRP webpage has more information and a link to the NPRM.
Some of the more significant elements of the NPRM 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
While reading the entire thing is certainly an option, an upcoming webinar hosted by the Office of Research Compliance will cover the highlights in what promises to be a much more palatable format than reading the Federal Register publication. The webinar, hosted by Public Responsibility in Medicine and Research (PRIM&R), is scheduled for Tuesday, September 15, from 12 to 1:30 pm, in Ed II Room G-137. You can also earn 1.5 hours of CRS credit for attending. Be sure to sign in to receive that credit.
This class is listed in Training Tracker under the course Research Education Q&A as follows:
PRIM&R’s Primer on the Notice of Proposed Rulemaking
ED II G137
9/15/2015 12:00:00 PM
9/15/2015 1:30:00 PM
Research Education Questions and Answers
If/when implemented, this revised rule would mean a lot of changes to how research is done and overseen at UAMS. Staying on top of this proposed rule change would make you an invaluable resource to your research team!