Monday, August 1, 2011

ANPRM's Problem Statement: Helpful but Incomplete

One of the many remarkable sections of the July 26 advance notice of proposed rulemaking (ANPRM) is its admission that the Common Rule is flawed.

(Note: I have added a link to the ANPRM at the top of the link list in the sidebar.)

Since the 1970s, IRB apologists have claimed that federal regulations are flexible enough, and that local IRBs are to blame for any problems. In 2007, for example, Jerry Menikoff quoted with approval Jeffrey Cohen's 2006 claim that "the regulations provide sufficient flexibility for the efficient and appropriate review of minimal risk research. IRB review of such research does not have to be burdensome or unreasonable if IRBs appropriately utilize the flexibility in the regulations." Menikoff reiterated his claim of "flexibility within the system" in his 2009 speech, “The Legal Assault on the Common Rule."

After thirty years of such claims, it is wonderfully refreshing that the ANPRM takes so seriously many of the critiques leveled at the federal regulations themselves. And the ANPRM helpfully organizes those critiques into seven general categories.

On the other hand, ANPRM's problem statement (pages 44513-44514 in the Federal Register version) overlooks some major critiques. Fortunately, some of those critiques are implicitly recognized by some of the ANPRM's proposals.

The ANPRM acknowledges seven critiques of the current regulations.

  1. "The system has been criticized as not adequately calibrating the review process to the risk of research. . . . Over-regulating social and behavioral research in general may serve to distract attention from attempts to identify those social and behavioral research studies that do pose threats to the welfare of subjects and thus do merit significant oversight."
  2. "The inefficiencies of review by multiple IRBs for multi-site studies . . . add bureaucratic complexity to the review process and delay initiation of research projects without evidence that multiple reviews provide additional protections to subjects."
  3. "In some research studies, consent forms have become lengthy and are often written in highly technical terms. Many also claim that consent forms have evolved to protect institutions rather than to actually provide salient information to potential human subjects.
  4. "Increasing use of genetic information, existing (i.e., stored) biospecimens, medical records, and administrative claims data in research has changed the nature of the risks and benefits of research participation."
  5. "Current regulations do not provide an ideal mechanism for the collection of information that would allow evaluation of the effectiveness of the research oversight system in protecting human subjects."
  6. "Only some research studies funded by certain Federal agencies or those that involve the development of products subject to regulation by the FDA, are subject to the Common Rule or similar protections. As a result, there are many studies that are not subject to any such Federal oversight, even though they may involve substantial risks to the subjects.
  7. "The multiple, differing regulatory requirements that can apply to a single research study have been criticized as complex, inconsistent, and lacking in clarity, which results in unwarranted variability across institutions and their IRBs in how the requirements are interpreted and implemented."

That's a pretty good list, and I am especially pleased that the over-regulation of social and behavioral research takes first place. But I am concerned about item 6, which threatens greater regulation rather than less.

Moreover, I can think of at least four major critiques not mentioned directly in this problem statement:

Lack of Expertise

The Common Rule requires that
IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas.

Does this make any sense? Can a group of researchers and laypeople, haphazardly drawn from an institution and the surrounding community, be expected to possess expertise in the wide range of studies--some of them in esoteric new areas--that can be expected from a research university or hospital?

Carl Elliott, "Alice Dreger, and "Laura Stark say no. So do I. And so, for that matter, does Ezekiel Emanuel, presumably one of the ANPRM's authors. In 2002, he co-authored a paper arguing that "A single IRB often reviews research on a wide variety of scientific topics and research settings, some of which are not aligned with the scientific expertise of the board members . . . It is fair to say that IRBs are relatively passive, responding to the information provided rather than actively seeking information in addition to that submitted in the research protocol. Under these circumstances, IRBs can make poor decisions about the permissibility of a study that can sometimes result in avoidable harms to participants."

The ANPRM mentions this critique only briefly, noting that "IRB review or oversight of research posing informational risks may not be the best way to minimize the informational risks associated with data on human subjects. It is not clear that members have appropriate expertise regarding data protections." (44516) The ANPRM does not raise the more general question of whether IRBs have appropriate medical, psychological, ethical, legal, or any other form of expertise sufficient to the grave duty with which they are charged.


Given Menikoff's awareness of the "Legal Assault on the Common Rule," the ANPRM curiously neglects charges by Philip Hamburger, Robert Kerr, and others that the regulation of speech--such as interviews, surveys, and focus groups--violates the First Amendment.

This is especially significant given the ANPRM's threat to extend regulatory reach to all research at federally funded institutions, not just research sponsored by a Common Rule agency.

Lack of Attention to Critical Inquiry

Since the 1970s, IRB critics have complained that the medical ethics of the Belmont Report leaves no room for research--such as "muckraking sociology"--that may intended to criticize its subjects.

Canada's 2010 TCPS makes a start at recognizing the legitimacy of such research, noting that "Research in the form of critical inquiry, that is, the analysis of social structures or activities, public policies, or other social phenomena, requires an adjustment in the assessment of consent. Where the goal of the research is to adopt a critical perspective with respect to an institution, organization or other entity, the fact that the object of the research may not endorse the research project should not be a bar to the research receiving ethics approval."

But even that provision doesn't go far enough in recognizing the legitimacy of critical writing about individuals, as expressed recently by Anthony Langlois.

Fortunately, ANPRM's Question 25 aks if their are fields that "may be more appropriately covered by ethical codes that differ from the ethical principles embodied in the Common Rule?" So someone is aware of the critique; it just didn't make it into the introductory section.

Procedural Injustice

Finally, the problem statement ignores the wish--so eloquently expressed by Jack Katz--for a "culture of legality," in which IRBs would be required "to recognize formally that they cannot properly demand the impossible . . . to invite public discussion of policy alternatives, and . . . to open their files to public oversight."

The ANPRM's Question 28 does touch on one matter of procedural justice, when it asks, "Should the Common Rule include a requirement that every institution must provide an appropriate appeal mechanism?" And Question 29 asks if IRBs should be required to announce when they are departing from the requirements of federal regulations. These questions suggest that the authors of the ANPRM are aware that, having been granted unchallenged power, some IRBs and IRB offices abuse that power. I only wish that this awareness had been made explicit in the problem statement itself.

Again, this cup is well over half full. But as people prepare their comments, they should note that the ANPRM has not acknolwedged the full range of flaws in the present regulations.


Harry Perlstadt said...

Not only does Canada’s TCPS recognizes the legitimacy of critical research and public policy analysis, it specifically mentions academic freedom, freedom of inquiry, freedom to challenge conventional through and freedom from institutional censorship.

TCPS states that in return researchers are expected to ensure that research involving human subjects meets high scientific and ethical standards. In addition, the peer review of research proposals, the findings and their interpretation contribute to accountability, both to colleagues and society.

Should a revision of the Common Rule explicitly acknowledge these freedoms as well as the obligations of researchers to high scientific and ethical standards? If so, it still is necessary to ensure that the review process is reasonable and decisions reviewable.

Harry Perlstadt, Dept of Sociology, Michigan State University

Zachary M. Schrag said...

Great comment! I hope you send it in to OHRP.