NPRM Symposium: Quick Take on New Analysis of the Comments on the NPRM to Amend the Common Rule (and the Challenge for Bioethics and the Public)

The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), undertook “to review and analyze the 2,186 public comments submitted in response to the 2015 Federal Policy for the Protection of Human Subjects” or “Common Rule” Notice of Proposed Rulemaking (NPRM).

I am going to discuss some highlights of their just released report, but this is far from exhaustive and you should read the whole report.

For the non-cognoscenti this is the most important revision to the rules for U.S. human subjects research since their inception. The report is largely unfavorable to several key proposed rule changes on my first read, but you should read it yourself to make up your own mind.

I’ll share some choice passages from the analysis

The results of our review (Table 2) find significant opposition to most major proposals, with mixed support for mandated use of a single IRB and extending the Common Rule and greater support for the concept of standard security safeguards. In addition, a number of responses suggested that the NPRM is overly complex, poorly written, and not supported by data; highlighted areas that could have a substantial impact on a final rule but were not included in the NPRM (e.g., proposed security safeguards, a consent template, a list of minimal risk studies and a decision tool); and suggested that some of the proposals would adversely affect human health with little perceived benefit.

Turning to Biospecimens, where we had a conference last year that will soon generate a book with MIT press:

The majority of responses, approximately 1,520, addressed one or more of the proposed changes detailed above involving non-identified biospecimens. Of these responses, 94 – 100% of patients and members of the research community, including researchers, universities, medical centers and industry, opposed the changes. Those commenting suggested that the proposed changes will significantly reduce the availability of biospecimens for research, will have a significant negative impact on medical advances, and will adversely affect human health. Per one patient, “I am asking for life saving policy not life ending policies.” From a biorepository, “Respecting autonomy at the expense of patient lives is a significant ethical concern.”

More surprising was their finding that “Among members of the general public, 55% opposed and 45% supported one or more of the major proposed changes related to biospecimens.” (They do a better breakdown of the various sub-constituencies in the report).

Turning to “broad consent” for biospecimen use:

Fifty-three percent of responses (1,055) included comments on broad consent. Of these, 62% (652 of 1,055) opposed the proposed change, 22% (237 of 1,055) supported it and 16% (166 of 1,055) offered qualified support. Eighty-five to 100% of patients; universities, medical centers and affiliated IRBs; advisory and related groups; and disease registries opposed the proposal to mandate broad consent for the storage and secondary research use of biospecimens.

. . .

Support for broad consent was mixed among the general public with 32% (183 of 562) of the public in support of the proposed change, 15% (83 of 562) offering qualified support and 53% opposed. Fifty-seven percent of advocacy groups and 53% of industry groups supported the proposed change.

To be fair, though, these comments on broad consent have to be understood against the backdrop of how the agency rolled this out: it did not provide templates or other specifics on broad consent, and it is quite possible commentators are responding to what they fear it will look like not what the agency actually has in mind.

There is much more in the report itself. And to be completely clear, there is no doubt that this report is clearly designed to tilt the regulatory process away from the NPRM’s proposal, not an agenda-less public document..

But I think the greater question it raises is how an agency should consider this kind of feedback in the Notice and Comment phase of rulemaking on bioethics. I, among many others, have some wariness about doing bioethics by polling, if you will. The rules that govern the most important aspects of our life should be shaped by careful reflection, argument, etc, not decided through the crude results of our era of instant polling.

But these are not poll numbers. These are comments by individuals who have thought a lot about these changes and have much to gain and lose. How should a responsible regulatory process engage with them? In particular, how should it react when both the regulated entities are strongly opposed to it and the patients on whose behalf it is being promulgated are not themselves very supportive?

Or are these comments actually a distorted mirrors? There is,after all, slippage between who commented (usually those with the largest axes to grind) and what the average person thinks (even after careful deliberation). Would deliberative democracy type models fare better for public bioethics policy-making?

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