A recent Washington Post op-ed by Victoria Phillips—a professor of public health at Emory—notes the disturbing reality that black men are much more likely to die after bypass surgery than white men. Her article is entitled: “What Surgery and Police Have in Common: Both Kill a Disproportionate Number of Black Men.” In response to the medical deaths, Phillips suggests that doctors should examine themselves. In fact, they also should examine the U.S. Department of Health and Human Services (HHS) and its regulation of human-subjects research.

She focuses on bypass surgeries, noting that, as a result of the collection of medical data,

bypass fatalities have fallen substantially, but highly disparately. Over the last decade, the rate for white males declined by 33 percent, while that for black males remained stubbornly steady and fell by only 3 percent, a tenfold difference.

Indeed “the risk-adjusted mortality rate from bypass surgery for black men is 11 percent higher than that for white men of similar health status.”

She urges investigation of two overlooked factors: “the characteristics of surgeons themselves, such as where and when they trained, and the specific settings in which they operate.” This is needed because the data on the risk of death as broken down by race “is not constant across operating rooms.”

She may be right to focus on the doctors, but in addition there is another factor lurking in the regulatory background.

HHS leads government agencies in regulating human-subjects research. Indeed, the department subjects such research to licensing—that is, it requires researchers to get prior permission before they can do such research, let alone publish it. HHS sets minimum standards for the licensing in the so-called “Common Rule,” and it arranges for the licensing to be carried out by Institutional Review Boards (“IRBs”).

Although HHS says IRBs license dangerous conduct, they actually license academic speech. This may seem odd, but in the Common Rule, HHS defines human subjects in terms of “data” and “information,” and this already hints at how the licensing focuses on speech.

HHS holds to the scientific understanding of research and therefore defines research as a systematic attempt to produce “generalizable knowledge”—in other words, a theory. Under this definition, research is understood to be an inquiry that is apt to produce a publishable theory. It therefore is no surprise that the Common Rule requires IRBs to license what researchers say and publish. Notwithstanding the illusion that the Common Rule regulates dangerous conduct, it actually requires prior licensing of speech and publication (including vast amounts of entirely innocent talking and printing) in violation of the First Amendment.

This licensing has profound costs for human life. Although there is no scientifically serious empirical evidence that IRBs save any lives by overseeing research under the human-subjects research regulations, it is abundantly clear that they suppress vast amounts of medical knowledge, and they thereby leave large numbers of individuals without the information they need to live.

Put simply, IRBs kill. Whenever the government suppresses life-saving medical knowledge, it predictably kills those who need it. And nothing is more effective in suppressing such knowledge than the licensing of speech and the press.

This general assault on medical knowledge is probably especially hard on blacks because HHS deliberately discriminates against them. Of course, it does so in the name of protecting them and ensuring that research is “equitable.” According to the Common Rule, IRBs “should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.” The Common Rule does not thereby mention blacks, but everyone knows what it means.

The political support for imposition of the Common Rule came in 1972, when the New York Times broke open what happened at Tuskegee. There, under the old Health, Education and Welfare Department—HHS’s predecessor—the U.S. Public Health Service had for decades studied tertiary syphilis in black men. This, by itself, was not necessarily problematic, but when penicillin became available as a cure after World War II, the Public Health Service did not tell its human subjects, thereby leaving some of them to die earlier than they would have with the drug. This callousness was especially disturbing because the Public Health Service was going through the motions of providing minimal medical care to the men, and it thus had a medical duty to protect them.

The public outcry was justifiably severe, but the government largely escaped blame. In fact, the government deserves special attention, for the most notorious cases of unethical medical research have involved government doctors doing research on wards of government—or at least on persons who, as at Tuskegee, were dependent on government. For example, the Army radiation studies and the Willowbrook hepatitis study similarly involved the unhealthy combination of government doctors and wards of government.

In evading responsibility, the government suggested that there were profound risks not merely in its own medical research, but in all human-subjects research, even private research. It already had been moving toward regulating a broad swath of human-subjects research, and in the 1970s and 1980s it used Tuskegee to suggest that all such research was dangerous. Government reports, publications, and even videos associated the disgrace of Tuskegee with human-subjects research in general, including private research. The government thereby shifted the blame for Tuskegee and justified its imposition of licensing on almost all human-subjects research.

In so doing, it played upon concerns about racial bias. It emphasized the undue burdens that research placed on vulnerable populations, and after Tuskegee, the prototypical such population consisted of black Americans. If human-subjects research was dangerous, then research that focused on blacks or other vulnerable populations carried the risk of being inequitably burdensome on them. On this foundation, the government suggested that blacks and other minorities had to be protected against research that focused too much on them. This was a moving justification for the licensing, but it came with the inevitable risk of impeding research on such groups.

Different populations have different incidences of disease. Blacks and whites, for example, are not equally likely to have coronary disease and may require different treatment. In this context, although it is bad enough that government licensing of speech suppresses medical knowledge, it is even worse when the government discourages medical research on your population. Nonetheless, this is exactly what HHS has done. Through the Common Rule, HHS discourages research that focuses on the diseases faced by black Americans and other “vulnerable populations.”

Of course, the exact effects of the Common Rule in discouraging research on blacks are unknown—not least, because any attempt to study such effects would itself usually be subject to IRB licensing. What is clear, however, is that HHS’s solicitude for “the special problems of research involving vulnerable populations” is apt to discourage medical research that focuses on blacks.

Whatever the extent of the costs, they are not confined to blacks. Take, for example, pregnant women. Such women and their babies respond to treatment differently from other persons, and doctors therefore need to treat them by selecting drugs and adjusting doses with the greatest sensitivity. For decades, however, HHS has required IRBs to take a relatively severe approach to research on pregnant women, regardless of the long-term benefits, and predictably there now is a dearth of information about the proper drugs and dosages for pregnant women. This has long been recognized as a problem for both the women and their babies, but HHS still stands in the way of the necessary research.

Licensing that suppresses medical knowledge is profoundly harmful, often even lethal. And HHS’s licensing of speech is especially dangerous for blacks, pregnant women, and their babies, because the department requires heightened licensing of medical research on them. So if Americans want to know why surgery kills “a disproportionate number of black men,” they cannot simply focus on surgeons. They also must examine HHS.