Bioethics Blogs

Will Cures Act Replace Common Rule Reform?

As of November 15, POLITICO thinks that Common Rule reform is dead:

HHS’s controversial revision of the Common Rule, the regulations that protect participants in clinical research, still hasn’t been sent to OMB for review. That’s not likely to get finished under Obama’s watch.

(David Pittman, “Obama’s HHS, Congress at Potential Odds over Pending Rule,” POLITICO, November 15, 2016)

On the other hand, Congress just passed the 21st Cures Act, which includes a provision for a Research Policy Board designed, as Science puts it, to “examine excessive regulation of research.”

In his September 29 testimony before the Subcommittee on Research and Technology, James Luther of Duke University suggested that the congressional effort could replace the executive one. He complained “that HHS is still trying to move forward with a final rule [for human subjects research] for which many of the proposals remain unchanged from the ANPRM despite overwhelmingly negative comments” about its provisions on biospecimens. And he suggested that a Research Policy Board might do a better job.

Perhaps such a board would attend to questions of concern to the social sciences and humanities, but I am not hopeful. Luther’s testimony cites the May 2016 analysis by the Council on Governmental Relations (COGR) and the Association of Public and Land-grant Universities (APLU) and the June report by the National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements. Both of those documents mostly ignored the social sciences and humanities.

The sun never sets on the Ethical Empire.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.