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June 7 — The language of the proposed new Common Rule suggests federal agencies are mulling different options to the largest update to human subjects regulations in three decades, the attorney with a federal office on research protections said June 6.
“If you look at the preamble to the NPRM, there are a lot of questions being asked about alternatives to the NPRM proposals,” Laura M. Odwazny said at a research compliance conference in Baltimore. “So that’s sort of an indication that the federal agencies may be thinking of other ways of implementing changes to the Common Rule—not just what made it in the proposed changes into the codified regulatory text.”
Odwazny is a senior attorney with the Health and Human Services Office of General Counsel who advises the Office for Human Research Protections, the HHS office that administers the Common Rule. Her comments came amid a presentation on the notice of proposed rulemaking, “Federal Policy for the Protection of Human Subjects” (45 C.F.R. 46), which most people in the research community refer to as “the NPRM.” Released last September, the 519-page proposed rule would reclassify all biospecimens as human subjects, require a single institutional review board (IRB) for multisite studies, add a new category of excluded activities and require shorter consent forms, among other changes (9 LSLR 1031, 9/18/15). Nearly 20 federal agencies have signed on to the Common Rule, which the federal government published in 1991.
“This is the biggest document in the last 30 years,” she said. “Just the fact that we got this far is amazing.”
The regulatory agenda lists this September as a date for a final rule (RIN:0937-AA02) .
“This isn’t a promise. It’s just a projection,” Odwazny said. “But this is the projection that everyone has been definitely trying to make a reality.”
When addressing the next steps for the proposed rule, Odwazny acknowledged that several questions linger:
While she said it's hard to say how the final rule will play out, “There's a lot of flexibility actually between what’s been posted in the NPRM and what the agency can provide as the corresponding final rule.”
“What’s important to understand is that the final rule has to be a logical outgrowth of the scope of the notice of proposed rulemaking proposals,” Odwazny said. “So that means that a regulated entity or interested party has to be able to reasonably anticipate from the NPRM proposals and the preamble language describing those proposals what the final rule will look like.”
Public comments play a critical role in this process of considering what constitutes a logical outgrowth of the proposed rule, Odwazny said. The OHRP received more than 2,100 comments, a strong majority of which objected to the proposed biospecimen provisions (10 LSLR 02, 1/22/16).
“All of your efforts in writing of the comments was not in vain,” she said. If a public comment suggested a “possible reasonable alternative” to the language in the NPRM, the final rule could possibly incorporate that suggestion if it is logical outgrowth of the NPRM, she said.
“The public comments are an important part of the process in assessing what the logical outgrowth will be of this NPRM and that will be the final rule—if there is one” she said.
At the same time, Odwazny said, rulemaking isn't a democratic process. “Even if every single proposal was thumbs down, the federal Common Rule agencies could go ahead with the NPRM proposals as published in the final rule.” Further, the government couldn't adopt a public comment that fills in gaps in the NPRM, even if that proposal was a “great, amazing scheme,” because that would fall outside of the scope of the proposed rule.
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More information on the Health Care Compliance Association conference is available at http://www.hcca-info.org/Events/EventInfo.aspx?sessionaltcd=003_RC0616.
The proposed new Common Rule is available at http://www.hhs.gov/ohrp/regulations-and-policy/regulations/nprm-home/.
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