The law of incidental findings in human subjects research: establishing researchers' duties

Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defined set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately offer to disclose IFs of potential clinical or reproductive significance to research participants when they arise.     

Incidental findings in human subjects research: what do investigators owe research participants?

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental findings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental findings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of this professional obligation to respond to incidental findings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship.     

The Management of Incidental Findings in Neuro-Imaging Research: Framework and Recommendations

This paper addresses the question of how incidental findings (IFs) in clinical research should be managed by researchers, focusing in detail on IFs discovered in neuroimaging research. It begins by engaging the larger research ethics issue of whether researchers have any obligations of clinical care to participants, and assesses the content and merits of one particular framework for answering this question, Richardson and Belsky's ancillary care model. From here the paper develops an organizational structure for integrating the ancillary care model with existing research ethics standards, with the aim of better understanding their respective domains. It makes a distinction between incidental findings that are anticipated by informed consent documents, and those that are unanticipated, arguing that this distinction is critical for evaluating researcher obligations. Finally, it takes on the issue of incidental findings in neuroimaging research, translating the standards discussed into recommendations for both unanticipated and anticipated findings.     

Research malpractice and the issue of incidental findings.

Human subject research involving brain imaging is likely to reveal significant incidental findings of abnormal brain morphology. Because of this fact and because of the fiduciary relationship between researcher and subject, board-certified or board-eligible radiologists should review the scans to look for any abnormality, the scans should be conducted in accordance with standard medical practice for reviewing the clinical status of the whole brain, and the informed consent process should disclose the possibility that incidental findings may be revealed and what consequences will follow. In the event such findings are revealed, qualified physicians should explain to the subject the significance of the findings and the alternatives available.     

Understanding incidental findings in the context of genetics and genomics.

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, "incidental" or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power afforded by new genomic analyses may lead to findings of statistical, but not necessarily clinical, significance. This paper addresses the issues to be considered in deciding whether and how to disclose "incidental" findings or other findings of clinical significance that arise in the course of human genomic and genetic research. What research results should be offered, and what should not be offered? For which research should individual results be offered to research participants, when should they be offered, how, and to whom?     

Incidental findings in genetics research using archived DNA

Despite calls by some commentators for disclosing incidental findings in genetics research, several factors weigh in favor of caution. The technology of genetics has the power to uncover a vast array of information. The most potent argument for restraint in disclosure is that much research is pursued without consent so that the individual participant may not know that research is being conducted at all. Often the work is done by investigators and at institutions with which the person has no prior contact. Past practice is also relevant; genetics researchers historically have chosen not to disclose incidental findings, of which misattributed paternity and pleiotropic alleles such as ApoE have been the most common. Many people choose not to have genetic tests when given a choice. It may be desirable to discuss the topic of incidental findings when consent for research is obtained, but given the risk of unwanted surprise when there has been no prior discussion, the potential utility of incidental findings should be very high before they are even offered to individuals.     

Institutional review board approaches to the incidental findings problem

Institutional Review Boards (IRBs) are confronted with new challenges in the face of expanding technologies while fulfilling their existing regulatory mandate to ensure that plans are in place to protect subjects and to inform them of risks and benefits of research participation. Existing regulations and guidance do not address the issue of incidental findings (IFs), thus leaving awareness of the issue and the application of ethical principles to IRB judgment alone. In order to assure that researchers are aware of the potential for IFs, IRBs must identify which studies are likely to identify IFs and establish what plans should be put into place prior to study initiation to assure the subjects are appropriately informed of the likelihood of IFs, how IFs will be communicated to subjects, and whether the burden of follow-up falls on the researchers or is the subject's responsibility.     

Managing incidental findings in human subjects research: analysis and recommendations.

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings 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.     

Incidental findings in pediatric research

The approach to incidental research findings in children emerges by considering the child-parent relationship and balancing divergent interests and preferences. Incidental findings with clear and proximate clinical importance should be disclosed to both. We recommend that particularly sensitive or private information (e.g., pregnancy or drug use) should be disclosed to the adolescent first, while particularly serious information (e.g., cancer) should first be disclosed to the parent. These approaches allow the researcher to form an alliance with one party prior to engaging the other. However, unlike clinical settings, where there may be presumptive expectations of confidentiality about sharing information within the family, in most research settings it is reasonable to plan to disclose such information to both parties. It is important to communicate this plan during the informed consent process separately to adolescents to avoid enrolling adolescents when sensitive incidental findings such as pregnancy and drug use may be detected. The approach to incidental findings without clear and proximate benefit is challenging. Researchers should plan more limited disclosure of such incidental findings for pediatric participants than for adult participants.     

Genomic research and incidental findings.

The Human Genome Project showed that there is significant genetic variation within the population. Current research is accumulating large databases that may reveal genetic variations associated with disease or health risks, even if not intended as part of the study design. These incidental findings create legal, ethical, and financial challenges for researchers. Current federal and international guidelines are not adequate. Plans for dealing with incidental findings need to be established in the study design and reviewed and approved by the Institutional Review Board.     

Incidental findings and ancillary-care obligations.

Recent work on incidental findings, concentrating on the difficult problems posed by the ambiguous results often generated by high-tech medicine, has proceeded largely independently from recent work on medical researchers' ancillary-care obligations, the obligations that researchers have to deal with diseases or conditions besides the one(s) under study. This paper contends that the two topics are morally linked, and specifically that a sound understanding of ancillary-care obligations will center them on incidental findings. The paper sets out and defends an understanding of ancillary-care obligations, which is based on the idea that when participants signed up for a study they may -- independently of their beliefs and expectations and of those of the researchers -- be taken to have partially entrusted certain aspects of their health into the researchers' hands. This partial entrustment model of ancillary-care obligations, in turn, has substantive implications for how to deal ethically with incidental findings; for instance, it suggests that researchers have no moral obligation to hunt for incidental findings.     

Legal liability and research ethics boards: the case of neuroimaging and incidental findings

Neuroimaging research covers a wide range of intriguing issues from revealing brain structures to investigating what happens in our brain when we lie. The field appears to be thriving, but skepticism and alertness to the various ethical, scientific, policy and philosophical challenges associated with it also appear to be on the rise. One particularly complex issue concerns what to do with incidental findings that emerge during the course of neuroimaging research. Research ethics boards (REBs) play a central role in research oversight. In this paper, we will consider some of the potential issues associated with REB liability in negligence in the context of incidental findings in neuroimaging research.     

Bridging philosophical and practical implications of incidental findings in brain research

Empirical studies and ethical-legal analyses have demonstrated that incidental findings in the brain, most commonly vascular in origin, must be addressed in the current era of imaging research. The challenges, however, are substantial. The discovery and management of incidental findings vary, at minimum, by institutional setting, professional background of investigators, and the inherent differences between research and clinical protocols. In the context of human subjects protections, the challenges of disclosure of unexpected and potentially meaningful clinical information concern privacy and confidentiality, communication, and responsibility for follow-up. Risks, including a blurring of boundaries between research and clinical practice, must be weighed against the possible benefit to subjects and a moral duty to inform. Identification and examination of these challenges have been met by scientific interest and a robust, interdisciplinary response resulting in the pragmatic recommendations discussed here.     

The risks and benefits of searching for incidental findings in MRI research scans.

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

Coordination outside formal organization: consensus-based decision-making and occupation in the Occupy Wall Street movement

Previous work has shown that a vital component for successful collective action is formal organization, in particular because it facilitates internal coordination. But how is coordination achieved in the absence of formal organization? To answer this question, this article presents findings drawn from an ethnographic study on Occupy Wall Street (OWS) in New York City. It first introduces the concept of ‘autonomy’ to discuss the particular challenge faced within the decentralized structure of OWS of developing coordination. It then shows how the practice of holding mass assemblies and the occupation of Zuccotti Park itself each served, in incidental and unintentional ways, as mechanisms of coordination. These findings confirm previous work on the importance of coordination and build upon it by demonstrating that not only is coordination possible outside formal organization, but that it is also in some cases achieved without conscious intention. This suggests the utility of moving beyond an overly rational understanding of social action by acknowledging the inevitability of unforeseen outcomes.     

Reforming Relocation Law: An Evidence‐Based Approach

In recent years, there has been much discussion within international fora about the need for a greater consensus on how to approach relocation cases. Empirical research on the lived experience of parents and children who have been through relocation disputes has an important role to play in providing an evidence base for decisions on policy. In this article, we summarize the findings of a 5‐year prospective longitudinal study of relocation disputes in Australia and make recommendations in the light of this and other research evidence concerning a new approach to relocation law. We argue that there should be no presumptions. Nonetheless there is an appropriate place for legislative or appellate guidance on how to approach these disputes. “Good faith” should be irrelevant to decision making, and children should not be placed in the center of the conflict. The adjudication of relocation disputes should be on the basis of asking three questions: First, how close is the relationship between the nonresident parent and the child and how important is that relationship developmentally to the child? Second, if the relocation is to be permitted, how viable are the proposals for contact with the nonresident parent? Third, if the relationship between the child and the nonresident parent is developmentally important to the child and is likely to be diminished if the move is allowed, then (a) what are the viable alternatives to the parents living a long distance apart? and (b) is a move with the primary caregiver the least detrimental alternative?

Key Points for the Family Court Community
• Describes the findings of empirical research on relocation disputes in Australia on the lived experience of children and families postrelocation disputes.
• Reviews various features of relocation law and proposals for reform in the light of this research evidence.
• Proposes an approach to deciding relocation cases based upon three essential questions.

     

The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research

This article examines the legal status of "soft law" in the fields of medicine and medical research. Many areas of clinical practice and research involve complex and rapidly changing issues for which the law provides no guidance. Instead, guidance for physicians and researchers comes from what has often been called "soft law"--non-legislative, non-regulatory sources, such as ethics policy statements, codes, and guidelines from professional or quasi-governmental bodies. This article traces the evolution of these "soft law" instruments: how they are created, how they are adopted within the professional community, and how they become accepted by the courts. It studies the relationship between soft law instruments and the courts. It includes an examination of the approaches to judicial analysis used by the courts in theory and in practice. The authors then examine the jurisprudence to see how courts will adopt professional norms as the legal standard of care in some circumstances and not others. They consider the legal concerns and ethical issues surrounding the weight attached to professional practices and norms in law. The authors demonstrate how practices and policies that guide professional conduct may ultimately bear weight as norms recognizable and enforceable within the legal sphere.     

Practical guidelines on incorporating “partnering” within IT agreements for public sector bodies

“Partnership” and “partnering” are two of the most frequently used terms in public sector procurement. They may be used by both customers and suppliers to justify their respective negotiating positions. A supplier may argue that, since the agreement is a “partnership agreement”, there should be no service credits or liquidated damages payable. The customer on the other hand, may argue, on similar grounds, that it wants to benchmark the supplier and have a broad right to audit every aspect of the supplier’s business.But despite being well used phrases, most guidance relating to these concepts does not define how “partnerships” or “partnering” is to work in practice. While most talk of the supplier and the customer working together “in partnership” with common aims, there is little information available as to how this will be incorporated into agreements, particularly in the context of large scale IT procurements.¹ The purpose of this article is to review the available guidance and detail some of the ways in which this guidance can be incorporated into legal agreements.     

The Value of CCTV Surveillance Cameras as an Investigative Tool: An Empirical Analysis

There has been extensive research on the value of closed-circuit television (CCTV) for preventing crime, but little on its value as an investigative tool. This study sought to establish how often CCTV provides useful evidence and how this is affected by circumstances, analysing 251,195 crimes recorded by British Transport Police that occurred on the British railway network between 2011 and 2015. CCTV was available to investigators in 45% of cases and judged to be useful in 29% (65% of cases in which it was available). Useful CCTV was associated with significantly increased chances of crimes being solved for all crime types except drugs/weapons possession and fraud. Images were more likely to be available for more-serious crimes, and less likely to be available for cases occurring at unknown times or in certain types of locations. Although this research was limited to offences on railways, it appears that CCTV is a powerful investigative tool for many types of crime. The usefulness of CCTV is limited by several factors, most notably the number of public areas not covered. Several recommendations for increasing the usefulness of CCTV are discussed.     

Intoxicated eyewitnesses: prevalence and procedures according to England’s police officers

Despite the apparent role alcohol plays in criminal offences, there is at present no evidence available as to the extent of the problem of intoxicated witnesses within England. To address this lack of research, police officers from seven constabularies completed an online survey addressing issues such as the prevalence of intoxicated witnesses, how officers determine intoxication, the procedures employed and their effectiveness. Officers indicated that intoxicated witnesses were a common, to very common, occurrence with most officers determining intoxication through physical symptoms and the witness’s own admission. In terms of interviewing witnesses, the majority of officers indicated that initial details were taken whilst witnesses were intoxicated, but the evidential interview was taken when sober. Officers also indicated that if the witness was intoxicated then the case was less likely to proceed to court and that officers viewed the witness as less accurate. These findings are considered from a criminal justice perspective and discussed in relation to future research.