Oxford University Press's
Academic Insights for the Thinking World

Medical research ethics: more than abuse prevention?

By Henry S. Richardson

Scholarly and regulatory attention to the ethics of medical research on human subjects has been one-sidedly focused on the prevention of moral disasters. Scandals such the US Public Health Service (PHS)’s Tuskegee syphilis experiments, which for decades observed the effects of untreated syphilis on the participants, most of whom were poor black sharecroppers, rightly spurred the broad establishment of a regulatory regime that emphasized the importance of preventing such severe harming and exploitation of the human subjects of research. Revelations in 2011 about a similarly horrific set of studies conducted by the PHS from 1946 to 1948 on sexually transmitted diseases has renewed this kind of concern, which has been strongly underlined in a recent report by the Presidential Commission for the Study of Ethical Issues. The regulations motivated by such abuses have established a two-pronged set of institutional protections well designed to make a recurrence of such horrors unlikely: (1) all plans (“protocols”) for research involving human subjects must be approved by “Institutional Review Boards” (United States) or “Research Ethics Committees” (elsewhere), and (2) ordinary consent to participate will not suffice; instead, subjects may be enrolled only if they give their “informed consent.”

Staff and researchers checking equipment in biotech industryImportant as this concern is and as valuable as these institutionalized responses are, they dominate thinking about the ethics of medical research so much that the result is unbalanced. In particular, the “helping people” side of morality, which philosophers label with the word “beneficence,” has been left undeveloped. The principles articulated in the Belmont Report, published in 1979 in response to the Tuskegee scandal by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, included beneficence, alongside respect for persons and justice, as one of its three guiding principles. In practice, however, the aspect of beneficence that has seen the fullest development, in this area, is that of non-maleficence — not hurting people — which many consider a principle distinct from that of beneficence.

This complaint of one-sidedness would be empty if there were not important ethical challenges for medical research involving human subject that arise from beneficence. Central among such challenges is the issue of researchers’ obligations to provide “ancillary care” — medical care that their research subjects need but that is not necessary to conducting worthwhile and sound research in a safe manner. The issue of ancillary care is important in all contexts of medical research, from research on neglected diseases in developing countries to the most advanced, high-tech medical research on genetics or imaging technologies at tertiary hospitals in the developed world. A researcher studying extremely drug-resistant tuberculosis in southern Africa may discover that one of her participants is HIV-positive. Does this researcher have any moral responsibility to help with this person’s HIV care? A genetics researcher working with banked DNA samples may discover a genetic anomaly that poses a dangerous threat that might be averted by clinical treatment. Does this researcher have any moral responsibility to communicate these results to a donor he has never met?

The medical research ethics community has been slow to recognize the challenge posed by the ancillary care issue, no doubt due in large part to that community’s focus on the prevention of moral disasters. The so-called “standard of care” debate regarding medical research in developing countries burst onto the scene with an article and an accompanying editorial in the New England Journal of Medicine in 1997. At issue was whether it was ethical to give only placebos to those in the control arms of studies in Africa intended to determine the effectiveness of shorter administrations of the drug AZT in controlling the transmission of HIV from mother to fetus, despite the fact that the effectiveness of longer, carefully monitored administrations of that same drug had already been proven effective. One would not do that in the United States, so how can it be acceptable to do that in Africa? This important issue lies at the cusp between beneficence and non-maleficence. Using the longer AZT treatment for the controls would have helped them. Yet the thinking about this issue did not break out of the non-maleficence box, for the dominant reasoning seems to be that since participation in medical research unavoidably involves some risk, it is morally wrong to subject people to that risk unless there is a sound scientific reason for it. Where it is already known that a treatment is effective, some special argument would have to be made to explain why one should compare the new, proposed treatment to placebo rather than to the proven treatment.

The standard-of-care debate rages on, addressing these and other complexities pertaining to the kind of care medical researchers owe to their subjects for the disease or condition under study. The ancillary care issue, by contrast, concerns questions about what medical care researchers may owe to their subjects for other medical needs that may arise during a study. Sometimes, clinical physicians enroll their own patients in research studies. In those cases, they owe these people a doctor’s full panoply of duties towards their patients — which may sometimes awkwardly conflict with these doctors’ obligations as researchers. If we confine our attention to medical researchers who enroll subjects who are not (otherwise) their patients, however, we might wonder why they owe them any special help. The enrollment transaction is not merely a consenting one, but one held to a much higher standard than is buying a car or signing up for a white-water rafting trip. Why can’t medical researchers just stipulate how much care they propose to provide for their subjects’ ancillary needs? In developing country settings, it is likely that the research team is automatically providing their subjects more clinical services than are usually available to them. Why think that the researchers might be specially obligated to do any more than that?

To answer these questions, one needs to understand how medical researchers become morally entangled with the lives and needs of their research subjects.

Henry S. Richardson is a Professor of Philosophy, Georgetown University. He is the author of Moral Entanglements: The Ancillary-Care Obligations of Medical Researchers and Democratic Autonomy. His next article for the OUPblog on how medical researchers become morally entangled will appear next week.

Subscribe to the OUPblog via email or RSS.
Subscribe to only health and medicine articles on the OUPblog via email or RSS.
Image credit: Laboratory technicians at work in medical plant with machinery and computers. © diego_cervo via iStockphoto.

Recent Comments

  1. Peter Aleff

    Let me begin with a reality check to Professor
    Richardson’s assertion that “the ethics of medical
    research on human subjects has been one-sidedly focused on the prevention of moral disasters”.

    Unfortunately, the main focus of “bioethics” (which is
    the opposite of real ethics) is rather the cover-up of
    such present disasters and continuing atrocities while
    condemning abuses from many decades ago to convey an image of concern. Bioethicists deny the current ethics violations and thereby prevent their prevention.

    Right while so-called bioethicists make unctuous “never
    again” speeches about the syphilis studies in Tuskegee and Guatemala they defend the recent SUPPORT experiment of suffocating premature babies that was conducted in the U.S. from 2005 to 2009 and predictably killed 23 “extra” children in its low-oxygen group. They falsely pretend now that the researchers had no way of knowing the risks although these had openly predicted a increase of four percent in mortality and severe brain damage for that group.

    Some of those same bioethicists also make knowingly
    misleading statements that the babies enrolled in that experiment fared better than those not enrolled, omitting to mention that the not enrolled ones had been
    sicker to begin with and could not be used honestly for
    such a biased comparison.

    The U.S. Office for Human Research Protection held a public hearing this August 28 on why the parental consent forms for this cruel experiment had lied by
    hiding the known risks for the babies, but that Office
    carefully avoided addressing the even more burning question why the researchers had been allowed to kill human infants for their misguided “research”.

    The Institutional Review Boards at all the 22 study sites had rubberstamped this deliberately lethal protocol and thereby proved that this alleged safeguard against Pre-Nuremberg-style abuses is merely a Potemkin
    facade. And the editor at the NEJM that published the
    results defended that predictably lethal experiment as
    necessary for comparative effectiveness research, never mind the collateral damage in human lives.

    Moreover, the Director of the U.S. National Institutes of Health and two of its Department Directors defended this protocol and willfully misquoted that ultra-low oxygen levels are safe for premature babies, thereby inducing gullible practitioners to kill and maim more babies every day.

    For a documentation of these facts, see
    searchSubjects.htm as well as the rest of that site.

    The consumer advocacy organizations Public Citizen and Alliance for Human Research Protection have meanwhile pointed out additional ongoing experiments on premature babies with the same disregard for their lives and health.

    Proposing that medical researchers should discuss what additional levels of care not related to their research they should provide seems to miss their main obligation to abide by the “first-do-no-harm” rule. In this context, this otherwise valid point of research ethics
    merely serves to divert attention from their routine
    gross violations of that rule.

    Respectfully submitted,
    Peter Aleff
    [email protected]

  2. […] buy now read more Posted on Sunday, October 27th, 2013 at 6:30 am […]

Comments are closed.