Lines unclear, community key
Lines unclear, community key
This is an exceedingly complex and multifaceted case. The fine points of regulatory interpretation are interesting and important, but rather than delve into the specific pros and cons of the case, I propose in these comments to direct our attention to what may be learned from it about some fundamental questions of public health ethics.
It is commonplace, although in many ways misleading, to distinguish sharply between the ethics of clinical medicine and the ethics of public health. The former is thought to be resolutely individualistic and patient-rights oriented; the latter supposedly collectivist and utilitarian. (This seems to ignore both the long and respectable tradition of social medicine and the fact that public health, at least in recent years, has hardly been indifferent to human rights; but let this pass.) The wedge between medicine and public health manifests itself once again in tortured attempts to distinguish between those investigative activities that should fall within the domain of protections for human subjects of medical and biomedical and behavioral research and those that should not.
One way to express this is to draw a line between public health “research” on one hand, and public health “practice,”—which nonetheless contains a great deal of knowledge generation and utilization, such as epidemiological surveillance, data collection and analysis, communication and education, and behavior modification—on the other. The regulatory language of the Common Rule (45 CFR 46) tends to define this line on the basis of epistemological considerations—systematic method and general validity and applicability—but I suggest that what is primarily at stake here is ethical rather than epistemological.
I say “ethical” because it comes down to how human beings are going to be used and for what ends. How will an individual’s liberty and privacy be bounded, respected, or overridden? How will others be granted access to the biological and metabolic information obtained from an individual’s body? To what risks will an individual be exposed so that others might benefit?
Born out of scandal and instances of egregious abuse of the bodies and minds of human beings, including the infamous long-term study of syphilis conducted by the U.S. Public Health Service, ethical principles and standards have emerged over the past half-century that create various safeguards for those experimented on or otherwise studied. These safeguards center on requirements for voluntary informed consent and local institutional review, which includes perspectives broader than peer-review within the research community itself. The basic idea behind these vital reforms has come from the tradition of liberalism and civil rights: Yes, it is necessary to use the minds and bodies of individuals to gain knowledge and to advance medicine, but when we do so it should be voluntary, without deception or coercion, and respectful of human beings as persons of intrinsic moral worth who are not simply instrumentally used to promote the interests of others.
Today this Common Rule system functions routinely (how effectively is open to debate) within the area of clinical, bio-medical, and pharmacological research. But it has stumbled in some domains where interventions are social and behavioral rather than biological or pharmacologic, and in domains that are organizational and systemic, such as health care service delivery and quality improvement.1
It stumbles with particularly instructive results for bioethics in the domain of public health. The problem is at once traditional, practical, and conceptual. Traditionally, public health has been an agent of the state and has been granted police powers that may be limited by collective democratic consent, but are not bridled by individual consent, as we now think research ought to be. Public health operates in the zone of the morally mandatory most often, and, as Hans Jonas argued, medical research is not in that zone.
Practically, public health activities deal with large data sets, big numbers drawn from information about the lives of anonymous or non-identifiable people. This type of empirical grounding raises no serious ethical concerns, except the question of what policies and practices should follow from that knowledge base. That question is at the heart of public health ethics, but it is policy ethics, not research ethics. Logistically obtaining ethically meaningful and adequate informed consent in research is difficult, expensive, and labor intensive. The requirement of informed consent in research raises awkward matters of public suspicion, mistrust, and the fact that people leading difficult lives (often the most interesting ones to study) don’t have time or energy to spare, and we ethicists frown on paying them for their time. And, not least, IRBs can raise many objections and change the proposed study in many ways, as the Connecticut Health Department HIC did in this case.
It is interesting to note in passing that a researcher would submit a protocol calling for the review of clinical test results and the collection of biological samples without providing a well-thought out rationale. There is a wide gap between what investigators are worried about and what ethicists are worried about. At the same time, IRBs can be intimidated by the prospect of undermining the methodological validity of a protocol (standardized questionnaires must be used), and their moral intuitions, rooted perhaps in local cultures and lifeworlds, can easily be overridden. Such localism is a strength as well as a flaw in the Common Rule system. A nightmare for multi-site trials is the need to accommodate the sometimes conflicting and inconsistent concerns and judgments of numerous separate IRBs.
Finally, the conceptual problem is perhaps the most interesting. Many in the public health community regard as self-evident the difference between protecting and promoting the health of the population and discovering new generalizable knowledge. If it is not, then an alternative is the line of reasoning suggested by the NBAC, but is their distinction between benefitting people locally and benefiting people far away really a solution to the conundrum, or merely a restatement of it? The notion is that public health practice functions to protect a population within the jurisdiction of a given public health authority, and empirical investigation in the service of that is not research in the sense that it does not fall within the regulation of the Common Rule. Surely, however, this argument relies too heavily on the dubious idea that we can isolate public health benefits that stop at political and geographical boundaries. It also adopts a rather outmoded and narrow conception of what public health “practice” involves. In an age of rapid transportation, mass population migrations, zoonotic disease, and climate change, such boundaries are increasingly irrelevant from a public health point of view. What happens, public health wise, in Las Vegas doesn’t stay in Las Vegas anymore. If Connecticut public health practitioners learn things that will help people outside of the state, is that a reason for requiring them to adhere to the protections and restrictions of the Common Rule? And if they admit to a more national or global benevolence, should that admission trigger more ethical regulatory requirements than they would face if they were more parochial?
We return, then, to the fundamental ethical question. How much is the medical privacy of individuals (in this case those with an unspecified communicable disease) worth relative to what we can learn from their example to improve our public health responses and practices in the future? In the domain of infectious disease, there is no doubt that careful surveillance, (involving direct contact between public health workers and affected individuals and the use of detailed questionnaires) has made an important difference in improving the public health response to developing pandemic situations, such as the public health strategies concerning HIV in parts of Africa.2 The right ethical answer to this question is not self-evident.
Such is the lesson of this quite detailed and technical case for the broader discourse of public health ethics. Cases like this remind us of the fact that public health does challenge our civil libertarian tradition, and it does challenge the neo-Kantian autonomy and respect for persons based ethic upon which so much of the bioethics of human subjects’ research has been based. However, making that challenge credible will take more than a facile utilitarian ethic or a traditional appeal to a public health authoritarianism that is ill suited to society today.
That deeper foundation for a new public health ethics must be built, I believe, on a sense of common problems and common purpose, a broadening of the moral imagination to see the interdependencies among individuals and communities that public health threats so often illustrate.
As a plain citizen of a health polity, why should I open the privacy of my records and share details of personal history with a stranger, and even give blood to him? Not because that stranger is a snooping agent of the state, which is still a liberal state, after all; and certainly not because he is using me—my body, my behavior—as an object from which to obtain information - no, not for those reasons, or at least not primarily for them. But I should do it because the stranger’s work provides a bridge from private trouble to public purpose, from a trouble that is mine, but also ours, to a purpose that is ours, but also mine. I should do it because that stranger offers me a link of solidarity with some other stranger who shares my illness, shares my need.
If that is what participants in this study were being offered—or more precisely if that is the way public health practitioners and researchers understood what they were doing—maybe it would be alright to call recruits twenty times, and maybe it would be alright for the IRB to let them leave those messages.
1. I think it is instructive to consider analogous issues in the regulation of quality improvement studies and public health research. See Joanne Lynn, Mary Ann Baily, Melissa Bottrell, et al. “The Ethics of Using Quality Improvement Methods in Health Care,” Annals of Internal Medicine, 146:9 (May), 666-673.
2. Cf. UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance, Guidelines for conducting HIV sentinel serosurveys among pregnant women and other groups. Geneva: UNAIDS, 2003.