Incidental Findings and Ancillary-Care Obligations

Author:

Richardson Henry S.

Abstract

This paper explores the convergence of two recent and growing streams of bioethical work and concern. Each has originated independently, but each arises from the fact that the Common Rule that has shaped medical research ethics, as institutionalized in the United States and also abroad, is largely silent about what needs to be done in response to researchers’ positive obligations. One stream concerns what to do about the sometimes vast range of findings that may arise incidentally to performing research procedures. The other asks whether medical researchers owe their study participants any “ancillary care” — that is, medical care that their study participants need but that goes beyond what is required to do the science safely.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference41 articles.

1. 39. Our analogy to the old common-law idea of bailment in Richardson, and 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.

2. 21. 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.

3. 31. 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.

4. 28. Id.

5. 10. 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.

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