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Commentary: Physicians and the Risk of Malevolent Use of Research

Published online by Cambridge University Press:  09 August 2006

Benjamin J. Krohmal  and
Gregory K. Sobolski
Benjamin J. Krohmal
Affiliation:
Department of Clinical Bioethics of the National Institutes of Health, Bethesda, Maryland
Gregory K. Sobolski
Affiliation:
Department of Clinical Bioethics of the National Institutes of Health and the National Human Genome Research Institute's Social and Behavioral Research Branch, in Bethesda, Maryland
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Extract

Although research findings have always been subject to abuse, scientific advances and recent events have increased concern about the perils of some biomedical knowledge. The Council on Ethical and Judicial Affairs (CEJA) addresses this potential in its guidelines for physician–researchers (PRs). The guidelines do not advance many novel ideas or provide substantive guidance for PRs. Advocacy for professionalism, weighing costs and benefits, and balanced oversight are uncontroversial and have been proposed before. The difficult task is to define what they require, and here the guidelines are vague. We discuss critically two issues that deserve careful attention.Authors contributed equally to this work. The views expressed herein are the authors' own and do not necessarily reflect the views of the National Institutes of Health, U.S. Public Health Service, or the Department of Health and Human Services.

Type
SPECIAL SECTION: BIOETHICS AND WAR
Information
Cambridge Quarterly of Healthcare Ethics , Volume 15 , Issue 4 , October 2006 , pp. 441 - 447
Copyright
© 2006 Cambridge University Press

Although research findings have always been subject to abuse, scientific advances and recent events have increased concern about the perils of some biomedical knowledge. The Council on Ethical and Judicial Affairs (CEJA) addresses this potential in its guidelines1

Green SK, Taub S, Morin K, Higginson D. Guidelines to Prevent Malevolent Use of Biomedical Research. Cambridge Quarterly of Healthcare Ethics, this issue, 432–447.

for physician–researchers (PRs). The guidelines do not advance many novel ideas or provide substantive guidance for PRs. Advocacy for professionalism, weighing costs and benefits, and balanced oversight are uncontroversial and have been proposed before.2

Starting in 1972 with the Biological and Toxin Weapons Convention (BTWC), later in 1993 with the Chemical Weapons Convention (CWC), and most recently in 2004 with the National Research Council's Biotechnology Research in an Age of Terrorism, there have been mounting efforts to codify legal norms and ethical guidelines.

The difficult task is to define what they require, and here the guidelines are vague. We discuss critically two issues that deserve careful attention.

Guidance for Regulators

CEJA deems inadequate the National Research Council's categorization of “dual use” research because there is no obvious way to delineate the scope of risky research. This is like saying that the Department of Homeland Security should not single out any potential terrorist targets for heightened attention because terrorists could strike anywhere. CEJA also contends that all biomedical research should undergo security review, analogous to IRB review. Such extensive review would be extremely expensive and time-consuming, and could impede research progress. Considering that most biomedical research poses minimal risks of abuse, reviewing all of it does not seem cost beneficial. Although no list of high-risk categories of research can be exhaustive, limiting automatic oversight to research that falls under an adaptive, expert-derived high-risk classification scheme balances risk reduction with budgetary constraints and research efficiency.

As a further precaution, CEJA proposes ethics training for all PRs. Ethics training may impress upon PRs their obligation to consider the effects of unintended uses of their research. But the cornerstone of ethical assessments of sensitive research is weighing potential risks and benefits, and normative training will not better equip PRs to make the necessary empirical assessments. “More responsible assessments” might be achieved with instruction in biosecurity,3

The World Medical Association makes a related recommendation in E.16(c) of The WMA Declaration of Washington on Biological Weapons. See http://www.wma.net/e/policy/b1.htm (accessed Jun 27, 2005).

but it would be more practical to provide access to biosecurity experts than try to hone the risk assessment skills of every PR. A committee of scientists and security experts, possibly organized by the National Science Advisory Board for Biosecurity (NSABB),4

The NSABB addressed related issues in its first meeting, archived at http://www.biosecurityboard.gov/meetings_archive_062005.asp (accessed Sep 10, 2005).

should be available for researchers, journal editors, and others to anonymously query regarding concerning research not subject to mandatory review.

Guidance for PRs

Concern about the abuse of research has typically been framed as an ethical issue affecting all scientists, regardless of discipline. But CEJA implies that different ethical issues arise when the scientists are physicians. When performing research with the potential for malevolent misuse, or “dual use” research, PRs must both “meet responsibilities of the scientific community” and the “ethical obligations of the medical profession.” Why might PRs have different duties than nonphysicians when conducting the same research? And what are the implications of the difference?

Following the World Medical Association, CEJA suggests that PRs have a special duty not to conduct offensive CBTW research because it is “antithetical to the professed duties of physicians” and to “the foundations of the medical profession.” Most offensive CBTW research is impermissible because of international weapons conventions and concern for public welfare. CEJA contends that PRs are further constrained by the Hippocratic duty of nonmaleficence—the medical injunction against inflicting harm. Just as physicians cannot justify imposing harms or risks on patients by appealing to the public welfare, PRs may not justify harms or risks that their research imposes on individual members of the public by appealing to the aggregate public good.

Such a duty would have implications beyond PRs' participation in offensive CBTW research. Most obviously, PRs could not participate in some potentially ethical but intentionally offensively biomedical research, possibly including research on nonlethal chemical calmatives for use in hostage rescues,5

The Chemical Weapons Convention has an exception for nonlethal agents used in “law enforcement.” Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction, (CWC), Jan 13, 1993, Article II, Paragraph 9d.

nociception for the development of microwave-based crowd control,6

The future of crowd control. The Economist 2004 Dec 2. Available at: http://economist.com/science/tq/displayStory.cfm?story_id=3423036 (accessed Jun 27, 2005).

or neuroscience-based methods to improve remote control of military robots.7

Ling G. Human-assisted neural devices. Available at: http://www.darpa.mil/dso/thrust/biosci/hand.htm (accessed Jun 27, 2005).

Although a duty of nonmaleficence would limit PRs' participation in intentionally offensive research, it is a contentious matter whether or not nonmaleficence might also preclude some actions that impose risks that are foreseeable but unintended.8

Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 5th ed. New York: Oxford University Press; 2001.

All researchers have duties to the public welfare and to weight risks and benefits. However, if medical nonmaleficence bears upon the foreseeable risks of research, PRs could not justify unintended security risks to some by weighing them against expected benefits for others—and CEJA contends that all biomedical research is subject to foreseeable but unintended abuse by malevolent third parties. For this reason, the significance of unintended but foreseeable risks will have a profound impact on the scope of biomedical research that PRs may ethically conduct, assuming PRs' laboratory work is constrained by a duty of nonmaleficence.

However, the basis of a medical duty of nonmaleficence that extends to physicians' work in the laboratory is unclear. One explanation might be that the duty arises from PRs' use of medical skills and knowledge. But the knowledge that physicians use in conducting biomedical research is not different than that used by their nonphysician colleagues, who are presumably not bound by Hippocratic duties. Traditionally, the medical duty of nonmaleficence arises from the nature and goals of the relationship between physicians and their patients: Patients make themselves voluntarily vulnerable to physicians, and physicians rely on patients' trust. There is no such relationship between physicians in the laboratory and the unidentified individuals that their research might harm. Debate lingers over whether physicians have a duty of nonmaleficence to their human research subjects,9

For example, there is no consensus over whether it can be ethical for physicians to intentionally infect research subjects with an illness. See Miller FG, Grady C. The ethical challenge of infection-inducing challenge experiments. Clinical Infectious Diseases 2001;33:1028–33.

let alone to strangers.

PR's use of medical knowledge does invoke special obligations, but not of nonmaleficence. As CEJA notes, physicians must act to preserve trust in the medical profession, and physicians' activities reflect most strongly upon the medical profession when they involve the use of medical training, equipment, or procedures. CEJA is wrong to imply that a duty of nonmaleficence prevents PRs from conducting potentially harmful biomedical research,10

Although, in rare cases a duty of nonmaleficence may constrain an individual PR when research poses disproportionate risks to his or her own patients. For instance, nonmaleficence might preclude a doctor serving prisoners of war from conducting otherwise ethical research on interrogation strategies.

but a duty to preserve trust in medicine might preclude involvement in research likely to appear medically improper. On the other hand, CEJA agrees that nonphysician scientists also have an obligation to preserve public trust. In the conduct of dual use laboratory research, any difference between the duties of researchers with M.D.s and those with Ph.D.s is likely to be negligible and stem only from differences in public perception of medicine and general science. This suggests that if a sensitive research project is ethical for nonphysician scientists to conduct, it is ethical for PRs, too.

Conclusion

CEJA is laudable for acknowledging that the prospect of misuse makes some research too risky to conduct or disseminate, that PRs who fail to exercise due care can be blameworthy for harms resulting from misuse of their findings, and that some regulation of research is warranted. But to have practical significance, elaborations on risk management proposals and the particular requirements of medical professionalism are essential.