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An inter-agency taskforce is proposing a comprehensive overhaul of “Federal Policy for the Protection of Human Subjects” in today’s issue of the Federal Register (comments close on 12/7/2015).  See 80 Fed. Reg. 53933 (Sept. 8, 2015). The proposal is 130 pages long, but most of it won’t have much relevance to product liability, except insofar as a plaintiff might have been injured during the course of a clinical trial.  In the past we’ve been interested in clinical trial regulations primarily for three reasons: (1) if they allow plaintiffs to argue that entities other than treating physicians (usually hospitals) have informed consent obligations; (2) if they clearly distinguish between off-label and “investigational” use of prescription medical products, and (3) preemption.

With that in mind we’ve looked through the new proposal.

Informed Consent:

We don’t see much in the new rule expanding who is required actually to obtain informed consent – only that the informed consent requirement would be extended to a lot more types of research, such as that involving “biospecimens” lacking individualized identifying information.  That seems like a lot more work in situations without additional risk of physical injury to research subjects, id. at 54028, but precisely because of the low risk of harm inherent in most biospecimen situations, we doubt it will have much impact on product liability.  It could increase other kinds of litigation, however, such a privacy (won’t keeping all these informed consent forms effectively re-identify the specimens?) and intellectual property (identifiable research subjects are more likely to want a piece of the economic “pie” created through research using their specimens).

Looking at the proposed regulation itself, §5F5F.116 (80 Fed. Reg. at 54052-53), it might even be an improvement, from the defense perspective, over current law.  It’s all about “investigators” – that is to say, attending physicians −  and not “institutions” (hospitals):

Except as provided elsewhere in this policy, no investigator may involve a human subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.  An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. . . .  In obtaining informed consent, the investigator must present first the information required by this section, before providing other information, if any, to the subject or the representative.

(Emphasis added).

Adverse Event Reporting:

Since plaintiffs now attempt to assert claims based solely on the reporting (or not) of adverse events, it’s of interest to us that the new regulations would impose real-time reporting of adverse events upon clinical trials.. 80 Fed. Reg. at 54038.  A single, mega-database that would include all research-related ADEs is under active consideration.  Id.  So that’s out there.  No evident thought has been given to liability issues.

Off-Label Use:

The proposal envisions changing the definition of “research.”  However, off-label use is not mentioned at all, although conceivably it could be encompassed by “health care operation,” which is a proposed exclusion.  Id. at 54040.  Right now, we’d say that the new rules don’t propose any change that (at least overtly) impinges on a physician’s right to engage in off-label use for therapeutic purposes.  One reason is probably that the definition of “clinical trial“ excludes off-label use, since therapy is inherently inconsistent with the sort of “prospective“ assignment that the regulations envision:

Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

§5F5F.102(b) (80 Fed. Reg. at 54047).


Finally, there’s not a word about preemption in the proposal.  Section 5F5F.101(f) indicates the contrary:  “This policy does not affect any state or local laws or regulations that may otherwise be applicable and that provide additional protections for human subjects.” 80 Fed. Reg. at 54046.  So as to any preemption defenses, the proposal is currently a dry hole.