Researchers do not owe their subjects the same level of care that physicians owe patients, but they owe more than merely what the research protocol stipulates. In keeping with the dynamics of the relationship between researcher and subject, they have limited but substantive fiduciary obligations.

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. I examine (...) two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private-for-profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private-for-profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice-based account of standard of care. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

As I write this, in November 1971, people are dying in East Bengal from lack of food, shelter, and medical caxc. The suffering and death that are occurring there now axe not inevitable, 1101; unavoidable in any fatalistic sense of the term. Constant poverty, a cyclone, and a civil war have turned at least nine million people into destitute refugees; nevertheless, it is not beyond Lhe capacity of the richer nations to give enough assistance to reduce any further suffering to (...) very small proportions. The decisions arid actions of human beings can prevent this kind of suffering. Unfortunately, human beings have not made the necessary decisions. At the individual level, people have, with very few exceptions, not responded to the situation in any signihczmt way. Generally speaking, people have not given large sums to relief funds; they have not written t0 their parliamentaxy representatives demanding increased government assistance; they have not demonstrated in the streets, held symbolic fasts, or done anything else directed toward providing thc refugees with the means to satisfy their essential needs. At thc government level, no govcrmmcnt has given the sort of massive aid that would enable the refugees to survive fm: more than a few days. Britain, for instance, has given rather more than most countries. It has, to date, given £14,750,000. For comparative purposes, B1~itain’s share of thc nonreccverabla development costs of the Anglo-French Concorde project is already in excess of £275,000,000, and on present estimates will reach £440,000,¤00. The implication is that the British government values a supersonic transport more than thirty times as.. (shrink)

: The principle of equipoise traditionally is grounded in the special obligations of physician-investigators to provide research participants with optimal care. This grounding makes the principle hard to apply in contexts with limited health resources, to research that is not directed by physicians, or to non-therapeutic research. I propose a different version of the principle of equipoise that does not depend upon an appeal to the Hippocratic duties of physicians and that is designed to be applicable within a wider range (...) of research contexts and types—including health services research and research on social interventions. I consider three examples of ethically contentious research trials conducted in three different social settings. I argue that in each case my version of the principle of equipoise provides more plausible and helpful guidance than does the traditional version of the principle. (shrink)

BackgroundAlthough the “right not to know” is well established in international regulations, it has been heavily debated. Ubiquitous results from extended exome and genome analysis have challenged the right not to know. American College of Medical Genetics and Genomics Recommendations urge to inform about incidental findings that pretend to be accurate and actionable. However, ample clinical cases raise the question whether these criteria are met. Many incidental findings are of uncertain significance. The eager to feedback information appears to enter the (...) field of IFUS and thereby threaten the right not to know. This makes it imperative to investigate the arguments for and against a right not to know for IFUS.DiscussionThis article investigates how the various arguments for and against a right not to know hold for IFUS. The main investigated arguments are: hypothetical utilitarianism, the right-based argument, the feasibility argument, the value of knowledge argument, the argument from lost significance, the empirical argument, the duty to disclose argument, the avoiding harm argument; the argument from principle, from autonomy, from privacy, as well as the argument from the right to an open future. The analysis shows that both sides in the debate have exaggerated the importance of incidental findings.SummaryOpponents of a right not to know have exaggerated the importance of IFUS, while proponents have exaggerated the need to be protected from something that is not knowledge. Hence, to know or not to know is not the question. The question is whether we should be able to stay ignorant of incidental findings of uncertain significance, if we want to. The answer is yes: As long as the information is not accurate and/or actionable: ignorance is bliss. When answering questions that are not asked, we need to think twice. (shrink)

This paper argues against considering incidental fndings as potential benefts of research when assessing the social value of proposed research, determining the appropriateness of a study's risk/beneft ratio, and identifying and disclosing the risks and benefts of participation during informed consent. The possibility of generating IFs should be disclosed during informed consent as neither a risk nor beneft, but as a possible outcome collateral to participation. Whether specifc IFs will be disclosed when identifed is a separate question whose answer is (...) material to determining whether IFs constitute a risk or a potential indirect beneft of participation. Finally, three types of IF should be distinguished and treated diferently during informed consent: those that will be routinely generated , those that can reasonably be characterized in terms of their nature and frequency of generation , and those of unpredictable nature and frequency that can be characterized only in general terms. Research protocols should provide a rationale for sharing or not sharing IFs of these three types with participants. Regulatory review of such plans should not, however, be confused with regarding IFs as potential benefts when assessing the study's risk/beneft ratio or merit. (shrink)

We weigh the presumed benefts of routinely searching all research scans for incidental fndings against its substantial risks, including false-positive and false-negative fndings, and the possibility of triggering unnecessary, costly evaluations and perhaps harmful treatments. We argue that routinely searching for IFs may not maximize benefts and minimize risks to participants.

The emerging international biomedical law tends to recognise the right not to know one’s genetic status. However, the basis and conditions for the exercise of this right remain unclear in domestic laws. In addition to this, such a right has been criticised at the theoretical level as being in contradiction with patient’s autonomy, with doctors’ duty to inform patients, and with solidarity with family members. This happens especially when non-disclosure poses a risk of serious harm to the patient’s relatives who, (...) without that vital information, could be deprived of preventive or therapeutic measures. This paper argues, firstly, that individuals may have a legitimate interest in not knowing their genetic make up to avoid serious psychological consequences; secondly, that this interest, far from being contrary to autonomy, may constitute an enhancement of autonomy; thirdly, that the right not to know cannot be presumed, but must be “activated” by the individual’s explicit choice, and fourthly, that this is not an absolute right, in the sense that it may be restricted when disclosure to the patient is necessary in order to avoid a risk of serious harm to third persons. (shrink)

The possibility of generating incidental findings — in both research and clinical contexts — has long been regarded as a risk of these enterprises. Should incidental findings in research also be regarded as potential benefits? At first glance, it would seem they ought to be. After all, in particular circumstances or given a particular set of values, any piece of information can be beneficial. Therefore, it may seem incoherent or unduly paternalistic to regard IFs only as risks. Moreover, developments in (...) science and technology increasingly transform what was once of uncertain meaning and dubious value into information that is likely to have clear meaning and potential personal value, if not obvious clinical utility. For these reasons, it would seem that in the future, IFs should be treated as potential benefits in the design and regulation of research. (shrink)

The question of how to handle incidental findings has sparked a heated debate among neuroimaging researchers and medical ethicists, a debate whose urgency stems largely from the recent explosion in the number of imaging studies being conducted and in the sheer volume of scans being acquired. Perhaps the point of greatest controversy within this debate is whether the magnetic resonance imaging scans of all research participants should be reviewed in an active search for pathology and, moreover, whether this search should (...) be performed by a radiologist. Resistance to routine readings performed by radiologists, as opposed to selective review of those scans on which investigators have spotted a possible IF, has been fueled in part by the obvious and enormous cost — financial and logistical — of engaging radiologists to read massive numbers of scans. This cost would be especially burdensome, even prohibitive, to investigators who are not affiliated with a medical center, because of their limited access to radiologists and other medical expertise. (shrink)

How far does a researcher’s responsibility extend when an incidental finding is identified? Balancing pertinent ethical principles such as beneficence, respect for persons, and duty to rescue is not always straightforward, particularly in neuroimaging research where empirical data that might help guide decision making are lacking. We conducted a systematic survey of perceptions and preferences of 396 investigators, research participants, and Institutional Review Board members at our institution. Using the partial entrustment model as described by Richardson, we argue that our (...) data supports universal reading by a neuroradiologist of all research MRI scans for incidental findings and providing full disclosure to all participants. (shrink)