The ancillary-care responsibilities of medical researchers. An ethical framework for thinking about the clinical care that researchers owe their subjects.

Malaria researchers may detect that their juvenile subjects are suffering from schistosomiasis, a serious parasitic disease common in many malarial areas. Do the researchers have a responsibility to treat the schistosomiasis? Functional brain scans collected for research purposes may contain information that would enable the appropriate specialist to diagnose a subject with a condition unrelated to what is being studied. Is there a responsibility to have images that were collected for research purposes read diagnostically? Such questions about researchers' responsibilities to provide ancillary clinical care arise pervasively, yet there is an almost total absence of guidance. Providing guidance requires confronting some very basic questions about the relationship between researcher and subject. What sort of care, if any, ought medical researchers provide their subjects, beyond what is necessary to implement a study's design safely and validly? Ought they respond to their subjects' needs as fully as a physician would to a patient's? If they owe less than that, what ethical principles explain the proper bounds of researchers' ancillary-care responsibilities? To address these questions, we develop an ethical framework that will help individual investigators, institutional review boards, and policy-makers anticipate the ancillary-care responsibilities that will arise during a given study and ensure that enough research funds are earmarked to meet them. This framework is intended as a first step in what will need to be an ongoing process of working out further guidance. What Is Ancillary Care? Defining "ancillary care" in the context of clinical research requires examining the rationale of the care. Ancillary care is that which goes beyond the requirements of scientific validity, safety, keeping promises, or rectifying injuries. Stabilizing subjects to get them on a protocol is not ancillary care, since it is required for carrying out the study. Monitoring subjects' drug interactions also does not count as ancillary care, since it is typically required in order to minimize risks caused by the study. Two additional rationales for care need to be excluded. In order to recruit and enroll a sufficient number of subjects, it is sometimes pragmatically necessary to promise potential subjects extra care that would not be required by science or safety. Of course, anything can be promised; but we are examining the ethical reasons to provide extra care whether one has promised it or not. Further, even when careful safety measures are in place, research participation can cause injury to subjects. Although participants sustaining research injuries are generally owed care, we set compensation for research injury aside as a separate ethical question. Ancillary care, then, is care not required by sound science, safe trial conduct, morally optional promises, or redressing subject injury. This ethically neutral definition allows us to pursue the ethical question of what sorts of extra clinical care researchers ought to provide and to raise (and reject) the hypothesis that the extra care they ought to provide is just what is "research-related." It allows that any given instance of "ancillary care" may or may not be morally required (or even morally permissible) and may or may not be "research-related." The General Duty of Rescue Before we come to the responsibilities that are specially incumbent on clinical researchers, we should note that all moral agents, whether individual or collective, have duties to rescue those in need. For instance, everyone has a duty to help a person who is in need and whom no one else can help, at least when one can provide the help without serious sacrifice or risk. (1) Even if one's ability to help is not strictly unique, an urgent need can generate a duty to help when it is predictable that no one else will. (2) These duties are quite general and generate moral demands not only on individual researchers' medical skills but also on the collective financial and political resources of the research team and its sponsors. …