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:

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Divided Infringement in Patent Law and the Doctor-Patient Relationship

By Rachel Sachs

Regular readers of this blog (hi, Mom) will recall that I often think and write about the interaction between the divided infringement doctrine in patent law and medical method patents of various kinds.  In previous posts, I’ve written about the Federal Circuit’s efforts to assign liability for divided infringement of method patents and considered the potential impact on medical method patents (here and here) and I’ve more recently examined a district court opinion applying the Federal Circuit’s analysis to a method-of-treatment claim (here).

I’ve just posted a new essay on SSRN (here, forthcoming in IP Theory) specifically considering the role of the doctor-patient relationship in the Federal Circuit’s analysis.  Would the Federal Circuit see the doctor-patient relationship as fitting within the scope of its divided infringement analysis?  Should it?  These questions are timely, as the Federal Circuit is due to take up these issues very soon.  Briefing before the court in the Eli Lilly case I considered in my last blog post has just been completed, and the case will likely be scheduled for argument later this summer.

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NPRM Symposium: So many left behind…

Part Four of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The development of research benefits depends on research participation.  Research participation, in turn, depends on being asked to participate, and how people evaluate what is being asked of them.  This post focuses on a few, not all, of those disproportionately excluded from research through one mechanism or another.  It illustrates some of what the proposed amendments to the Common Rule governing human subjects research will likely mean in practice absent some special vector that changes the outcome.  We will discuss what such a social vector might look like at the end.

We will start with those people who, understanding the real impact and meaning of providing their “blanket consent” to research, and uncomfortable with the sweeping right to invade and permit others to invade their privacy, refuse to sign it.   Who are they? Continue reading