Washington, DC—The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), today released a comprehensive review and analysis of 2,186 public comments on the Obama administration’s 2015 Notice of Proposed Rulemaking (NPRM) for revising the “Federal Policy for the Protection of Human Subjects,” better known as the “Common Rule.”
In addition to comments that came from the general public, submissions came from patients and members of the research community — researchers, physicians, universities, medical centers, and industry – as well as associations, advocacy and advisory groups and others. Most focused on the proposals to: change the definition of “human subject” to include biospecimens, such as tissue, blood and urine, from which any personally identifiable information has been removed; require broad, non-specific consent for storage and possible secondary research use of all biospecimens; and restrict institutions’ discretion to waive consent for biospecimens that have been stripped of identifying information and where data security plans have been proposed and approved by institutional review boards (IRBs).
The analysis found that over 95 percent of patients and members of the research community were opposed to one or more of the major proposed changes.
“There is broad consensus that the proposed regulations regarding biospecimens, as written, would be damaging to science, medicine and human health and would not improve participant safety and autonomy,” COGR, APLU, and the Association of American Universities (AAU) said in a joint statement.
“There is no question that protocols must be in place to safeguard biospecimens and any resulting data. 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 proposal would reduce the number and diversity of biospecimens available for disease research; potentially place significant limitations on research using existing identified biospecimens for which consent has been obtained; and dramatically increase the cost of conducting research, effectively reducing research funding without providing additional protections for research participants.”
Key findings of the analysis included:
The analysis, including data tables, data summaries by respondent category, and an overview and summary of all findings are available on the COGR website.
Additional details on APLU engagement on the regulation of human subject protections can be found here.