Goodbye to All That: The End of Moderate Protectionism in Human Subjects Research

Moreno, Jonathan D., The Hastings Center Report

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it is wise to do so, remains to be seen.

In May 2000 the Department of Health and Human Services announced new regulatory and legislative initiatives concerning federally sponsored research involving human subjects. In September, the Office for Protection from Research Risks was reconstituted as the Office for Human Research Protections and, with a new director, completed its transition to the Office of the Secretary at DHHS. In the months leading up to these changes, both the OPRR and the Food and Drug Administration had been increasingly active in levying sanctions against institutions whose ethics institutional review boards were malfunctioning or that had engaged in questionable research practices, especially in human genetics trials.

Weeks after DHHS secretary Donna Shalala's announcement, a bipartisan group of congressional sponsors led by Congresswoman Diane DeGette, Democrat from Colorado, introduced the Human Research Subjects Protections Act of 2000. Among other reforms, the act would extend informed consent and prior review requirements to all human subjects research, regardless of funding source. Senator Ted Kennedy, Democrat from Massachusetts, introduced a bill that would establish steep civil penalties for investigators and institutions that broke the rules. Leading up to all this activity, there had been since 1997 several congressional hearings on human subjects research as well as numerous reports and recommendations by public and private panels concerning the state of the regulatory system.

All these hearings, bills, and reports had one thing in common: They all found or presupposed a need to strengthen the human subjects protections system. Although some individuals representing the community of scientific investigators raised their voices in objection to increased regulation--especially the psychiatric community in response to the National Bioethics Advisory Commission's recommendations concerning research involving persons with mental disorders--theirs were largely lonely voices. Protests that new measures would block important research seemed hard to sustain in light of two decades of remarkable advances under the current system, which at the time of its introduction was itself described as being so burdensome that it would threaten medical progress. Reservations about increased bureaucracy, or even the question whether the proposals being advanced would have avoided any actual patient or subject injuries, were overwhelmed by a historical tide that presages a new era in the history of human subjects regulations, an era that I call "strong protectionism."

A New World Order

The essence of strong protectionism is the minimization of clinical researchers' discretion in governing their conduct with regard to human subjects. Among the measures implied by strong protectionism are concurrent third party monitoring of consent and study procedures, disclosure of financial arrangements or other potential conflicts of interest, required training of investigators in research ethics and research regulations, and independent review of the decisionmaking capacity of potential subjects. All these and other measures have been proposed, and many may be implemented, in spite of the additional costs in time and money they represent, and regardless of the inference an observer may draw that clinical researchers are simply not to be trusted.

In this article my purpose is neither to challenge nor defend these early stirrings of what I believe to be a new era in the history of human subjects protections. It is, rather, to note how inured we have become to this grim view of investigator discretion, and how far we have traveled to reach this pass. The current transition to strong protectionism builds on two previous stages. During the first, singularly important period, lasting roughly from 1947 to 1981, the ancient tradition of weak protectionism, which granted enormous discretion to physician experimenters, began to break down. Following that was the era that is now passing away, a compromise between physician discretion and modest external oversight that I call moderate protectionism.

Perhaps it was inevitable that moderate protectionism could last only about twenty years. It was a compromise that combined substantial researcher discretion with rules enforced by a minimal bureaucracy. An important part of this compromise was that researchers for the most part had the prerogative of identifying potential conflicts of interest themselves, without external review. Researchers' use of human subjects was approved before and after it actually took place, and only very rarely was there third party observation of research activities themselves.

The moderately protectionist era might have lasted longer had the research environment not changed so much, had so much money not poured into research as the result of promising new areas for investigation and investment, had the proportion of private funding not increased so drastically, and had the number and complexity of studies not grown so rapidly. Together, these elements strained the twenty-year compromise and may have caused its collapse, even though it was a period little blemished by harms to persons, at least as compared with the scandalous era that immediately preceded it.

Weak Protectionism: Virtue Has Its Day

Concerns about the involvement of human beings in research are at least a century old. In the nineteenth century, many institutionalized children in Europe and the United States were subjects in vaccine experiments, and by the 1890s antivivi-sectionists were calling for laws to protect children. At the turn of the century the Prussian government imposed research rules and Congress considered banning medical experiments for certain populations, such as pregnant women, in the District of Columbia. In the ensuing decades there were occasional well-publicized scandals, mostly involving child subjects, and the first attempt to test a polio vaccine was stopped after the American Public Health Association censured the program.[1]

Prior to World War II, however, medical researchers were largely inoculated against regulation by the nearly legendary status of the self-experimentation conducted by members of the Yellow Fever Commission, led by U.S. Army physician Walter Reed. One of the commissioners, Dr. Jesse Lezear, died after subjecting himself to the bite of the mosquito that transmits the disease. Lezear thereby helped to confirm the hypothesis of the disease's spread. …

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Publication information: Article title: Goodbye to All That: The End of Moderate Protectionism in Human Subjects Research. Contributors: Moreno, Jonathan D. - Author. Journal title: The Hastings Center Report. Volume: 31. Issue: 3 Publication date: May 2001. Page number: 9. © 1999 Hastings Center. COPYRIGHT 2001 Gale Group.

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