Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...
The Council on Governmental Relations, with support from the Association of Public and Land-grant Universities, analyzed all 2,186 comments the Department of Health and Human Services received in response to the federal government's first-ever effort to revise the regulations governing research involving humans (45 C.F.R. Part 46), which is known as the Common Rule.
Lisa Nichols, director of research and regulatory reform for COGR, told Bloomberg BNA concerns about the proposed changes for biospecimens prompted COGR to undertake the 3.5-month project of combing through the thousands of responses to the proposed rule. Given that the final rule would have a broad impact, she said, the analysis allows for all the comments to be considered before the HHS moves forward to a final rule. But she said COGR tried to keep its own concerns out of the analysis.
“We just wanted to make sure we understood what the comments were,” she said. It was very helpful for us to see that the research community really was aligned on this, and also to see the perspective of patients.
The 519-page proposed rule released last September would reclassify all biospecimens as human subjects, require a single institutional review board (IRB) for multisite studies, add a category of excluded activities and require shorter consent forms, among other changes (9 LSLR 1031, 9/18/15).
Members of the Obama administration have indicated they want to finalize the new Common Rule this year, before President Barack Obama leaves office (10 LSLR 09, 4/29/16).
Lizbet Boroughs, associate vice president for federal relations at the Association of American Universities, said May 9 she wasn't surprised by the findings, which were in line with her own group's concerns about the biospecimen provisions.
“We are hoping that seeing the analysis of the comments will help inform the final rule,” Boroughs told Bloomberg BNA.
The analysis found broad consensus in the responses that the proposed regulations regarding biospecimens would be damaging to science, medicine and human health and wouldn't improve participant safety and autonomy, COGR, APLU and the AAU said in a joint statement May 9.
“There is no question that protocols must be in place to safeguard biospecimens and any resulting data,” the joint statement said. “But the administration’s primary proposal to make currently unidentified biospecimens, the majority of which will never be used in research, subject to consent is a dramatic shift in policy that would unnecessarily impede much-needed research aimed at unlocking cures and treatments to the most devastating diseases and illnesses.”
The analysis also found:
The COGR analysis includes data tables, data summaries by respondent category and an overview and summary of all findings.
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The COGR analysis is available at http://www.cogr.edu/Human-Subjects-and-Animal-Research.
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