Wednesday, March 19, 2014

McCarthy's Mysterious Mythmaking

PRIM&R has launched "People & Perspectives (P&P)," described as a "digital story-telling library." The site features a blurb by Joan Rachlin, PRIM&R's soon-to-retire executive director, who calls it "an enduring and dynamic record of our historical antecedents, how and when we come together."

But is anyone going to vet the accuracy of stories posted on the site?

That question is raised by a 4-minute clip (taken from a much longer November 2013 interview) with Charlie McCarthy, director of the Office for Protection from Research Risks from 1978 to 1992.

I have not watched the full interview (not transcribed, and therefore a chore). But the four minutes and 12 seconds on "social-behavior research" is by itself a disturbing stew of faulty memory and misinformation.

Here are some of the key inaccuracies.

"Social science and behavioral science."

The segment begins (0:14) with McCarthy saying that "the [National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research] was well aware that the law called on them to issue statements and guidance on social science and behavioral science."

McCarthy also made this claim in his 2004 interview with OHRP. It's still not true.

Public Law 93-348, the National Research Act of 1974, is there for all to read, including Title II, Part A, which established the National Commission and enumerated its duties. The law calls upon the commission to

(i) conduct a comprehensive investigation and study to identify the basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects, (ii) develop guidelines which should be followed in such research to assure that it is conducted in accordance with such principles, and (iii) make recommendations to the Secretary (I) for such administrative action as may be appropriate to apply such guidelines to biomedical and behavioral research conducted or supported under programs administered by the Secretary, and (II) concerning any other matter pertaining to the protection of human subjects of biomedical and behavioral research.

The phrase, "biomedical and behavioral research," appears three times in that charge, as well as in the commission's own name. At no point does the law call on the commission to issue statements or guidance on social science.

"Extended another year"

McCarthy (0:31): "They anticipated that at the end of their four years they would be extended another year to do the social science."

The National Research Act [sec. 204(d)] authorized the commission for only 24 months. In October 1976, Congress bumped that up to 36 months, and in November 1977 to 42 months, for a final termination date of 1 November 1978.

Already by July 1977, Sen. Edward Kennedy had introduced legislation to replace the National Commission with a President's Commission, so at no point could the commissioners have had any reason to believe that the commission would last for more than four years. And while I can't say I read every word of the commission meeting transcripts, I never saw any suggestion that the commission would last past 1978.

[For a chronology, see Vikki A. Zegel, Biomedical Ethics: Human Experimentation (Congressional Research Service, 1978).]

"They were going to . . . hear some of the best social scientists in the country."

McCarthy (0:50): "They were going to . . . hear some of the best social scientists in the country. As it happened, when they completed four years, they were disbanded. I think it was not their intent to do that. But it is true that they did not have many social scientists. The issues of the day--that were publicly debated--were primarily medical. I think, by hindsight, they probably made a mistake by putting off the social science issues until the end. And then ran out of time. They were not continued for one more year as expected. That work never was completed."

It's quite true that the the issues of the day "were primarily medical," and that the commission "did not have many social scientists." (In fact, none of the commissioners were social scientists, as opposed to behavioral scientists, though the National Research Act required it.)

But McCarthy is wrong to suggest that the commission never heard from social scientists. In the spring of 1977, the commission held hearings in Chicago, San Francisco, and Bethesda. Social scientists used these occasions to voice their displeasure with IRB review. For example, Hans Mauksch, executive officer of the American Sociological Association, argued, "Requiring a premature formulation of a specific research proposal has been a very important obstacle to qualitative research."

[Transcript of the public hearings of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 5, April 15, and May 3, 1977 on Institutional Review Boards (Bethesda, Maryland, 1977), 656.]

It's not that the commissioners failed to hear social scientists. They failed to listen.

"Three more reports"

McCarthy (1:48): "I think they had drafted, or at least planned to draft, three more reports on social science research. They never saw the light of day, and I don't know what they would have said."

Well, neither do I. And at no point in my research did I find a whisper of a suggestion that the commission planned a single report on social science research. Staff memos, yes. But no reports.

A professor from the University of Chicago, a meeting in New Mexico

McCarthy (2:02): "They did get some guidance. They had a professor from the University of Chicago, who represented the social sciences. He held one meeting in which--he chaired a meeting outside the commission meetings, just to gather opinions. I attended that meeting, and I think something might have come of it. He had eight or ten top social science researchers at that meeting, which was held down in New Mexico, by the way, but the commission supported it. As often happens, it was the Tower of Babel. They had so many opinions, many of which were well worth following up on. But since there was no follow-up meeting, I don't think very much came of it. There was an effort made, or at least initiated, but not followed through."

I can't guess whom McCarthy is thinking of with the University of Chicago reference. A social science professor from the University of Chicago? Too vague.

I do have a guess about the "New Mexico" conference.

As noted above, the National Commission did hold hearings in Chicago and San Francisco, but not in New Mexico. In 1979, Tom Beauchamp organized a conference at Georgetown University that eventually produced the volume, Ethical Issues in Social Science Research. That's not near New Mexico either.

But in April 1983, NIH sponsored a conference on the protection of human subjects in behavioral and social science research, hosted by the University of Texas at Dallas. McCarthy was there, and Texas is at least New Mexico-adjacent.

Could this be the conference McCarthy was thinking of? If so, he's talking about a conference held more than four years after the expiration of the National Commission.

Which leads us to the next clue:

"The Reagan years"

McCarthy (3:12): "I think it is a legitimate criticism of the commission, but I'm quite sure where the blame should lie. I certainly don't blame the commissioners. They had no control over how long they were going to stay in existence. I think it was more a matter of a change in politics. Consequently, in the Reagan years, I don't think that the commission was favored by the new administration. So the funding dried up, and the commission disbanded. And with it went the social science issues that might have been addressed but never actually were."

The reference to the Reagan years strongly suggests that McCarthy is mixing up the history of two commissions: the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978) and the Presidential Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1978-1983).

Reagan did not take office until January 1981, so obviously he played no role in the National Commission's 1978 demise; that was the product of congressional action. The latter commission did indeed endure into the Reagan years. Albert Jonsen, who served on both commission, notes that Reagan appointed commissioners to the Presidential Commission who disagreed strongly with some of the Carter appointees, resulting in "decidedly bland" recommendations. (Jonsen, Birth of Bioethics, 114-115)

A confusion between the two commissions may explain why McCarthy thought the Texas (a.k.a. New Mexico) conference took place during the operations of the National Commission. In fact, it convened just after the demise of the Presidential Commission in March 1983.

"Where the blame should lie"

McCarthy is not a young man, and he's speaking of events thirty or forty years in the past. So we should cut him some slack when he mixes up two commissions with some overlapping duties and membership.

But some of McCarthy's claims, particularly about the three phantom reports, don't make sense for either commission. And keep in mind that social scientists who dealt with McCarthy in the 1970s and 1980s didn't find him a reliable narrator even at the time. Moreover, McCarthy's misremembering here has a decided political slant: "I certainly don't blame the commissioners." This deflects blame from the National Commission onto the Reagan administration, allowing PRIM&R listeners to continue in the pleasant fantasy that the National Commission, even in its failures, was on the right track. No need, then, to question the divine wisdom of the sacred Belmont Report.

Which brings us to the question of how an interview like this should be presented.

Ideally, the interviewer would have prepared for the interview well enough to interrupt with a gentle, "Dr. McCarthy, might you be thinking of the Presidential Commission?" But that could have required PRIM&R to engage a historian to conduct its historical interviews. Instead, they asked Dave Borasky, an IRB administrator.

In the absence of such intervention during the interview itself, PRIM&R still could present the interview in a way that would correct McCarthy's misstatements. It could, for example, commission a historian to prepare an annotated transcript. Or, at the very least, it could refer website visitors to more scholarly histories of the commission.

Instead, PRIM&R has posted McCarthy's inaccurate narrative without any warning to viewers that much of what they are hearing is not the truth. Is this the sort of publicly responsible research PRIM&R wishes to promote?

1 comment:

Unknown said...

Thanks for this disturbing exposé. You are right to call it “faulty memory and misinformation.”

It is no surprise, however. Will van den Hoonaard has pointed out that IRB scholars and supporters live in a bubble in which genuine academic debate is not only absent but unwelcome. “No critical self-reflection about the work and nature of ethics committees. Participants of both conferences lived in a bubble of compliance. Unlike academic conferences, there were no voices of dissent, nor were any expected.” (The Seduction of Ethics: Transforming the Social Sciences. Toronto; Buffalo: University of Toronto Press, p. 285)

Readers who want to learn more about the sordid history of McCarthy’s tenure at OPRR should check the meticulous reconstruction you provide in Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009. It is a shocking story of deceit and double-dealing by McCarthy and his federal colleagues.

Ethics, indeed.

Simon Whitney
Baylor College of Medicine, Houston, TX
Suffocated Science and Scholarship