Tuesday, February 12, 2013

Puglisi: ANPRM Is Stalled; Write Your Own Common Rule

Tom Puglisi, director of the Office of Research Oversight in the Department of Veterans Affairs and former director of human subject protections at OHRP, writes that the Common Rule needs reform but believes that the ANRPM is "stalled." He offers the Veterans Health Administration's interpretation of the Common Rule as a partial fix, but he does not address the implications of letting agencies rewrite the Common Rule for their specific needs.

[Puglisi, Tom. “Reform Within the Common Rule?” Hastings Center Report 43, no. s1 (2013): S40–S42. doi:10.1002/hast.140.]

Puglisi writes that the ANPRM is more or less dead:
Sadly, recent proposals to modify the Common Rule have become stalled, at least for the foreseeable future, if not permanently. Given the current political climate and the often divergent interests of the seventeen agencies that adhere to the rule, meaningful systemic modernization of the Common Rule is not likely to occur any time soon.
The article offers no explanation of this pessimism, though one can guess that Puglisi has been involved in internal federal discussions of the ANPRM process and has his reasons to doubt its progress.

In any case, Puglisi thinks we need to do the best we can with a flawed system of regulation and review:

All the same, modernization of the Common Rule is desperately needed. Regulatory requirements have become so complicated that most researchers cannot fully understand or remember them, and thus cannot draw the connections between many of these requirements and the goal of protecting subjects. In my experience, all but a relative handful of research investigators embrace the need to protect human subjects from reasonably foreseeable risks of harm, understand the need to protect subjects’ privacy and the confidentiality of subjects’ data, and genuinely want to comply with regulatory requirements. However, these requirements are now so detailed that they frustrate investigators (and IRB members) and undermine the respect needed to foster compliance and ensure meaningful protections for human subjects.

In addition, the IRB system has been stretched well beyond its limits. Poorly resourced and still largely dependent on the dedication of its volunteer members, IRBs are expected to do too much with too little. Regulatory requirements must be simplified so investigators can understand and respect them, and so IRBs can spend their valuable time and resources on activities that genuinely protect subjects. So how can the much-needed reform be accomplished, given current practical and political realities?

In the short term, the agencies responsible for implementation of the Common Rule—particularly the Department of Health and Human Services and its Office for Human Research Protections—must be willing to develop practical guidance for implementing the current regulatory requirements in a way that promotes clarity and understanding and allocates human and fiscal resources based on the level of risk to subjects.

As an example, he offers the Veterans Health Administration Handbook 1058.05, “Operations Activities That May Constitute Research,” October 28, 2011.

That handbook offers the following definitions:

a. Generalizable Knowledge. For purposes of this Handbook, generalizable knowledge is information that expands the knowledge base of a scientific discipline or other scholarly field of study. Systematic investigations designed to develop or contribute to generalizable knowledge constitute research. Thus, systematic investigations designed to produce information to expand the knowledge base of a scientific discipline or other scholarly field of study constitute research . .

d. Research. Research is a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge. Thus, for purposes of this Handbook, and in accordance with the definition of generalizable knowledge in subparagraph 4a, research may be defined as a systematic investigation designed to produce information to expand the knowledge base of a scientific discipline (or other scholarly field of study). NOTE: Research typically involves the testing of concepts by the scientific method of formulating a hypothesis or research question, systematically collecting and recording relevant data, and interpreting the results in terms of the hypothesis or question to expand the knowledge base of a field of study.

I offer some observations.

First, the VHA definition of generalizable knowledge departs from what I would consider commonly understood meanings of "generalizable." For example, the findings of researchers investigating the recently exhumed bones of Richard III ("a large skull fracture behind the left ear that was consistent with a crushing blow from a halberd") certainly expand the knowledge base of historians of the 15th century, but in what sense are they generalizable?

Second, the VHA definition of generalizable knowledge departs from the Belmont Report's hint at what that term means. Belmont states that " the term 'research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships)." The VHA definition makes no mention of theories, principles, or statements of relationships.

Third, even as it ignores the second half of the passage of the Belmont Report quoted above, the VHA relies on the first part about testing hypotheses, something that does not appear in the regulatory definitions of research.

The VHA definitions track neither those of 45 CFR 46 nor those of the Belmont Report. They are, effectively, a new Common Rule, written by the VHA for its own purposes. And the VHA comes close to admitting this, stating that the definitions "are intended for use only within this Handbook."

I take this to mean that the VHA is willing to let other federal agencies make their own guesses about what the Common Rule might mean while it finds its own modus vivendi with the incomplete definitions in the regulations. That's not terribly different from the approach taken by USAID, which has posted the unofficial guidance of a 1999 working group as its version of the Common Rule.

Such an approach might work for federal agencies and the research they directly support, since each agency could effectively write its own version of the Common Rule that makes sense for the kind of research (and non-research) it conducts. It won't do much for researchers at universities and other federally supported institutions who do not receive direct funding and thus may be left squabbling with their IRBs about which Common Rule to apply.


Unknown said...

Thanks for the post and the heads-up on the "stalling" of ANPRM! I'd be interested in hearing more about what's going on with ANPRM and why.
Sarah Babb, Boston College

Melora Norman said...

Thanks so much for your updates on this important subject. It's sad to think that a consensus on a more sensible and functional framework may be postponed indefinitely. If that is the case, journalism and history will surely continue to be impoverished while biomedical research continues to be unevenly reviewed.
-Melora @ Unity