Incidental Findings and Ancillary-Care Obligations

45 C.F.R. 46 (2007).

One early such study is Katzman G. L. , “Incidental Findings on Brain Magnetic Resonance Imaging from 1000 Asymptomatic Volunteers,” JAMA 282, no. 1 (1999): 36–39.

On this issue of false positives in this connection, see Illes J. , “Ethics: Incidental Findings in Brain Imaging Research,” Science 311, no. 5762 (2006): 783–784.

Report from a WHO/UNAIDS Consultation, Geneva, July 17–18, 2003, “Treating People with Intercurrent Infection in HIV Prevention Trials,” AIDS 18, no. 15 (2004): W1–W4; MacQueen K. M. Karim Q. A. Sugarman J. , “Ethics Guidance for HIV Prevention Trials,” BMJ 327, no. 7410 (2003): 340.

World Medical Association, Declaration of Helsinki (rev. 2004), at para. 29, available at <http://www.wma.net/e/policy/b3.htm> (last visited February 26, 2008).

See, e.g., Tucker T. Slack C. , “Not If, But How? Caring for HIV-1 Vaccine Trial Participants in South Africa,” The Lancet 362, no. 9388 (2004): 995; Shapiro K. Benatar S. R. , “HIV Prevention Research and Global Inequality: Steps towards Improved Standards of Care,” Journal of Medical Ethics 31, no. 1 (2005): 39–47.

One aspect of this tension, as it arises in a closely allied context, is thoughtfully explored in Merritt M. Grady C. , “Reciprocity and Post-trial Access for Participants in Antiretroviral Therapy Trials,” AIDS 20, no. 14 (2006): 1791–1794.

This issue is addressed in Report from a WHO/UNAIDS Consultation, supra note 4, and Tarantola D. , “Ethical Considerations Related to the Provision of Care and Treatment in Vaccine Trials,” Vaccine 25, no. 26 (2007): 4863–4874. For an application to this issue of the approach to ancillary-care obligations that I developed with Leah Belsky and will here be summarizing and elaborating, see Richardson H. S. , “Gradations of Ancillary-Care Responsibility for HIV/AIDS in Developing Countries,” American Journal of Public Health 97, no. 11 (2007): 1956–1961.

Wolf S. M. , “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219–248.

This parenthesis glosses what I take to be the intended import of “reproductive importance,” since the research participant's own reproductive capacities fall within his or her health. Strictly speaking, of course, concerns about the health of already existent children do not fit under the rubric of “reproductive importance.” Still, incidental findings in genetic studies, in particular, can certainly arise that are highly relevant to the future health of already existent children.

To narrow the definition to rule out the IV/drug-abuser case, it would suffice to replace the phrase “in the course of conducting research” with “via the information-gathering means used in conducting research.”12. Ratzen R. M. , “Unsolicited Medical Opinion,” Journal of Medicine & Philosophy 10, no. 2 (1985): 147–162, with a reply by Moseley R. , “Excuse Me, But You Have a Melanoma on Your Neck! Unsolicited Medical Opinions,” at 163–170.

Why not? The answer that will be supported by the substantive view I lay out below is that it is because no permission was needed from the participant in order to walk down the hall with them. For readers in doubt about this, however, I could change the case in the text back to the bus-stop context in order to bring out the ambiguity in question: “In the course of” a study — that is, while it is still ongoing — a researcher might run into one of the participants at a bus stop and while there, notice what looks to be a melanoma on his or her neck.

Richardson H. S. Belsky L. , “The Ancillary-Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking about the Clinical Care that Researchers Owe Their Subjects,” Hastings Center Report 34, no. 1 (2004): 25–33, at 26; cf., Belsky L. Richardson H. S. , “Medical Researchers' Ancillary Clinical Care Responsibilities,” BMJ 328, no. 7454 (2004): 1494–1496, at 1494.

See the discussion of the ethical requirement of “scientific validity” in Emanuel E. J. , “What Makes Clinical Research Ethical?” JAMA 283, no. 20 (2000): 2701–2711.

Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries: A Follow-up Discussion Paper, London, 2005, at 33.

For such reasons, and not merely reasons of limited space, we dropped mention of promises made for recruitment purposes from the definition we give in Belsky Richardson , supra note 14.

For example, although Wolf , supra note 9, note that incidental findings may arise more broadly, that consensus paper concentrates on high-tech imaging and gene assay cases.

Moira Keane's thoughtful presentation at the Minnesota conference suggested this.

Hellström M. , “Extracolonic and Incidental Findings on CT Colonography (Virtual Colonoscopy),” American Journal of Roentgenology 182, no. 3 (2004): 631–638.

On the basis of the analysis of ancillary-care obligations to be put forward in the next section, my position would be that noticing a melanoma during an enrollment physical on some part of the participant's body that is normally covered with clothing, brings it within the scope of the researchers' ancillary-care obligations, although spotting a melanoma on the back of a participant's neck while he or she is walking down the hall does not. While this differentiation may seem counter-intuitive, I explain the basis for the distinction in privacy concerns below.

I do not mean to assert that this professional obligation of medical researchers lacks analogues in other professions; indeed, I affirm that it does, and describe some analogues below in the text. Even so, this obligation of medical researchers, as I will explain it, seems to me to be self-standing in the sense that even if there were no other professions in which a like responsibility arose, this one would still exist. I am grateful to Franklin Miller for discussion of this point.

See Richardson Belsky , supra note 14, at 26; Belsky Richardson , supra note 14, at 1494.

In a survey in the late 1990s of European adults about the case of a doctor who sees a black spot that he is almost certain is a melanoma on the face of a woman at a bus stop, only a minority of lay people (34 percent) thought the doctor should say something, while even fewer of the doctors surveyed (23 percent) thought so. Zwitter M. , “Professional and Public Attitudes towards Unsolicited Medical Intervention,” British Medical Journal 318, no. 7197 (1999): 251–253. In the text, I have described the example as involving a spot on the back of a person's neck in order to make it seem more likely that the person might not have noticed it.

In saying that there is this line to be drawn, I do not mean to be disagreeing with Sarah Buss's point that, in U.S. culture, the idea of minding one's own business has too much sway, leading us unduly to constrict our interpretation of our general obligations of beneficence. Buss S. , “Appearing Respectful: The Moral Significance of Manners,” Ethics 109, no. 4 (1999): 795–826.

See Richardson Belsky , supra note 14, at 26–27.

Miller F. G. Rosenstein D. L. , “The Therapeutic Orientation to Clinical Trials,” New England Journal of Medicine 348, no. 14 (2003): 1383–1386, at 1385.

Id., at 1386.

Because the paternalism involve in constraining medical research with regard to ancillary care and incidental findings would be “soft” in this way, it would avoid the main brunt of the critical argument in Miller F. G. Wertheimer A. , “Facing Up to Paternalism in Research Ethics,” Hastings Center Report 37, no. 3 (2007): 24–34.

The point of this further stipulation is to put this surgery beyond the reach of the general duty of rescue, which is generally thought of as being limited to relatively easy interventions. If the case still seems to you to fall within the scope of the duty of rescue, please vary the hypothetical facts accordingly.

Herman B. , “The Scope of Moral Requirement,” Philosophy & Public Affairs 30, no. 3 (2001): 227–256, at 231.

My thanks to Aaron Marcu for the example, which I take verbatim from my unpublished essay, “Special Obligations of Beneficence: The Case of Medical Researchers' Ancillary-Care Obligations.”34. Some readers will deny that there is a moral difference between the cases because they hold that, in effect, that Marvin has a duty-to-rescue sort of duty to warn in both cases. To restore the difference between the cases, I would ask these readers please to adjust downward the urgency and stakes of the warning. I do agree that, when the stakes are high enough and the urgency extreme, the duty to rescue will supersede the difference that the two scenarios are designed to highlight.

At the Minnesota conference, Ellen Wright Clayton asked me what I would say about research that is done on the basis of tissues in tissue banks without collecting any permissions. That is an interesting question. If the tissue samples are not fully anonymized, then permissions should have been collected, if not by the researchers using the tissue bank, then at least by the researchers who collected the tissue in the first place. If those latter permissions included permission to do future research using the tissues, then perhaps the research participants should be taken to have waived any further privacy claims that pertain to the tissues. I gather that federal statutes would encourage this reading. If we understand things that way, then the researchers doing the research using the tissue bank may not be the same people as the researchers who agreed to be the recipients of otherwise private information. If that is so, there would be no partial-entrustment relationship of the kind on which my analysis focuses between the tissue-bank researchers and the initial tissue donors.

A principal reason for this rather cumbersome wording is that the permissions that researchers in fact collect from their study participants are often far more sweeping and inclusive than they need to be, whereas our analysis attempts to keep things focused on (1) what actions called for by the study protocol bump up against the participants' bodily and informational privacy rights and (2) what permissions the study design therefore requires the researchers to collect in order to proceed without violating those privacy rights. I come to an additional, complementary reason for this wording in my section in the text on the “Implications of the Partial-Entrustment Model for Incidental Findings.”37. For a much more detailed analysis of some of these “strength” factors in a particularly challenging context, see Richardson , supra note 8.

This is a question on which Participants in the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries, “The Ancillary-Care Obligations of Medical Researchers Working in Developing Countries,” PLoS Medicine, forthcoming 2008, makes a start.

Our analogy to the old common-law idea of bailment in Richardson Belsky , supra note 14, at 28, has the disadvantage that it may suggest this reified interpretation of the scope of entrustment, since bailment is the limited entrustment of some valuable thing, such as an automobile. Our intention, however, was simply to use this analogy to introduce the idea of a limited and partial entrustment. I continue to think the analogy to bailment useful, as it illustrates how obligations can arise from voluntary transactions in a non-promissory way. See my “Special Obligations of Beneficence,” supra note 33.

See Hellström , supra note 20.

“The big muddy,” the unsympathetic reader will nickname it. I cannot claim to have attained ideal clarity about these complex issues. I can only invite this reader to further improve our understanding of how these issues interrelate.