While ethical and empirical interest in so-called secondary variants and incidental findings in clinical genetics contexts is growing, critical reflection on the ethical foundations of the various recommendations proposed is thus far largely lacking. We examine and critique the ethical justifications of the three most prominent disclosure positions: briefly, the clinical geneticist decides, a joint decision, and the patient decides. Subsequently, instead of immediately developing a new disclosure option, we explore relevant foundational ethical values and norms, drawing on the normative (...) and empirical ethical literature. Four ethical signposts are thereby developed to help guide disclosure discussions. These are: respectful sharing of the clinician’s expertise; transparent communication; epistemic modesty; and respect for the embedded nature of the patient. We conclude by considering the most common current disclosure positions in the light of the four ethical signposts. (shrink)

BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

Researchers have used drones to track wildlife populations, monitor forest fires, map glaciers, and measure air pollution but have only begun to consider how to use these unmanned aerial vehicles to study human beings. The potential use of drones to study public gatherings or other human activities raises novel issues of privacy, confidentiality, and consent, which this article explores in depth. It argues that drone research could fall into several different categories: non-human subjects research, exempt HSR, or non-exempt HSR. In (...) the case of non-exempt HSR, it will be difficult for institutional review boards to approve studies unless they are designed so that informed consent can be waived. Whether drone research is non-HSR, exempt HSR, or non-exempt HSR, it is important for investigators to consult communities which could be affected by the research. (shrink)

Multiple authorship is becoming increasingly common in bioethics research. There are well-established criteria for authorship in empirical bioethics research but not for conceptual research. It is important to develop criteria for authorship in conceptual publications to prevent undeserved authorship and uphold standards of fairness and accountability. This article explores the issue of multiple authorship in bioethics and develops criteria for determining who should be an author on a conceptual publication in bioethics. Authorship in conceptual research should be based on contributing (...) substantially to: (1) identifying a topic, problem, or issue to study; (2) reviewing and interpreting the relevant literature; (3) formulating, analyzing, and evaluating arguments that support one or more theses; (4) responding to objections and counterarguments; and (5) drafting the manuscript and approving the final version. Authors of conceptual publications should participate substantially in at least two of areas (1)?(5). (shrink)

Advances in genomics have led to calls for developing population-based preventive genomic sequencing programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the (...) sequencing or analysis of specific genomic conditions or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations. (shrink)

Durch genomweite Analysen werden vielfältige gesundheitsrelevante Informationen über eine Person gewonnen. Solche Informationen können die Behandlung von Krankheiten verbessern. Sie ermöglichen aber auch Vorhersagen, ob eine Person und deren Verwandte in Zukunft möglicherweise erkranken werden. Der neuartige Charakter des Informationseingriffs und sein prädiktive Potential bedürfen der ethischen, juristischen und ökonomischen Reflexion, damit diese Technologie zum Wohl der Patienten, der Familienangehörigen und der Solidargemeinschaft eingesetzt werden kann. Die vorliegende Schrift leistet mit ihren interdisziplinären, vom BMBF finanzierten Analysen dazu einen Beitrag. Grundlagen (...) für einen ethisch und juristisch verantwortbaren Einsatz der Genomsequenzierung zu medizinischen Zwecken werden erörtert und Eckpunkte für Kostenanalysen sowie Elemente einer “Guten klinischen Praxis” präsentiert. (shrink)

Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients an...

The “best-medical-interests” standard for reporting findings does not go far enough. Research subjects have a right to know about any comprehensible piece of information about them that is generated by research in which they are participating. An even broader standard may sometimes be appropriate: if subjects agree to accept information that they may not understand, then all information may be disclosed.

Five years ago, an article co-written by two of us (Joly and Simard) presented an emerging trend to disclose certain individual genetic results to research participants. Since then, both technologies and research practices have evolved significantly. Given this rapid evolution, our goal is to provide updated and thorough guidance on this issue. Our paper begins by identifying the ethical principles that support the return of results: justice, beneficence, and respect for persons. Then, it presents the results of an analysis of (...) international norms on the return of results, covering both general and individual research results. It reveals existing divergence and consensus on these topics within the international community. With the goal of promoting greater harmonization, we conclude by proposing a flexible framework for the return of individual research results. (shrink)

BackgroundA fundamental ethical challenge in conducting genomics research is the question of what and how individual level genetic findings and aggregate genomic results should be conveyed to research participants and communities. This is within the context of minimal guidance, policies, and experiences, particularly in Africa. The aim of this study was to explore the perspectives of key stakeholders' on returning genomics research results to participants in Kenya.MethodsThis qualitative study involved focus group discussions and in-depth interviews with 69 stakeholders. The purposively (...) selected participants, included research ethics committee members, community members, community resource persons, and researchers. A semi-structured interview guide was used to facilitate discussions. Six FGDs and twenty-five were conducted among the different stakeholders. The issues explored in the interviews included: views on returning results, kind of results to be returned, value of returning results to participants, and challenges anticipated in returning results to participants and communities. The interviews were audio-recorded, transcribed verbatim, and coded in Nvivo 12 pro. Thematic and content analysis was conducted.ResultsParticipants agreed on the importance of returning genomic results either as individual or aggregate results. The most cited reasons for returning of genomic results included recognizing participants' contribution to research, encouraging participation in future research, and increasing the awareness of scientific progress. Other aspects on how genomic research results should be shared included sharing easy to understand results in the shortest time possible and maintaining confidentiality when sharing sensitive results.ConclusionsThis study identified key stakeholders’ perspectives on returning genomic results at the individual and community levels in two urban informal settlements of Nairobi. The majority of the participants expect to receive feedback about their genomic results, and it is an obligation for researchers to see how to best fulfil it. (shrink)

Mit der Vielzahl von Daten aus genetischen Untersuchungsverfahren wächst das Problem von „Zufallsbefunden“, d. h. von zufällig erhobenen Nebenbefunden, die mit der ursprünglichen Fragestellung nicht in Verbindung stehen und dennoch eine Bedeutung für Gesundheit und Reproduktionsverhalten der untersuchten Person selbst oder ihrer Anverwandten haben. In Ermangelung nationaler oder internationaler Richtlinien greifen die Autoren die aktuelle Diskussion um den Umgang mit genetischen Zufallsbefunden in Behandlungs- und Forschungskontext auf. Dabei nehmen sie auf die für Deutschland relevanten rechtlichen und ethischen Rahmenbedingungen Bezug. Nach (...) Gendiagnostikgesetz (GenDG) muss in Deutschland im Rahmen eines Behandlungsvertrages auf die Möglichkeit von Zufallsbefunden hingewiesen werden. Es ist Bestandteil der Aufklärung und Einwilligung, inwieweit Zufallsbefunde mitgeteilt werden, wobei das Recht auf Nichtwissen und der Schutz nicht-einwilligungsfähiger Personen berücksichtigt werden müssen. Im Forschungskontext greift das GenDG nicht, aber auch hier sollte über mögliche Zufallsbefunde aufgeklärt werden, wenngleich eine Rückmeldung nicht zwingend, aber bei Befunden mit hohem klinischen Nutzen ethisch geboten sein kann. Folgende Aspekte sind im Umgang mit Zufallsbefunden zu berücksichtigen: 1) Art und Umfang der Aufklärung und Einwilligung bei einer unüberschaubaren Zahl von möglichen Befunden. 2) Einordnung der klinischen Bedeutung einer genetischen Veränderung im Sinne von gesichertem, wahrscheinlichem, möglichem oder fraglichem/unbekanntem klinischen Nutzen. 3) Prozessierung des Informationsrückflusses für Gegenwart und Zukunft. 4) Ressourcenplanung im Hinblick auf die klinische Validierung, die Erläuterung von Befunden und den Transfer in die klinische Praxis. Im Umgang mit genetischen Zufallsbefunden besteht erheblicher empirisch-ethischer Forschungs- und politischer Regelungsbedarf. Zeitgleich ist es unabdingbar, die Wahrnehmung und das Verständnis der untersuchten Personen sowie die Grundhaltung gegenüber Zufallsbefunden im Rahmen von Studien zu beleuchten und entsprechende Bildungs- und Kommunikationswerkzeuge zu entwickeln. (shrink)

Over the past decade, there has been an extensive debate about whether researchers have an obligation to disclose genetic research findings, including primary and secondary findings. There appears to be an emerging (but disputed) view that researchers have some obligation to disclose some genetic findings to some research participants. The contours of this obligation, however, remain unclear. -/- As this paper will explore, much of this confusion is definitional or conceptual in nature. The extent of a researcher’s obligation to return (...) secondary and other research findings is often limited by reference to terms and concepts like “incidental,” “analytic validity,” “clinical validity,” “clinical relevance,” “clinical utility,” “clinical significance,” “actionability,” and “desirability.” These terms are used in different ways by different writers to describe obligations in different sorts of cases. -/- Underneath this definitional confusion is a general notion, supported by much of the literature, that findings only need to be disclosed when they surpass certain presumably objective or measureable thresholds, such as medical importance or scientific reproducibility. The problem is that there is significant variability in the way that these terms and concepts are used in the literature and, as such, in defining the scope of an obligation to return findings that surpasses the relevant thresholds. -/- The goal of this paper is to analyze the definitional muddle underlying the debate about returning genetic research findings, with the hope of answering a few questions. First, what is the range of definitions being used in this debate? Based on an extensive literature review, Part 1 will lay out a range of articulated definitions for each relevant term, with the goal of categorizing them into a handful of distinct types. Part 2 explains the definitional redundancy and confusion in the current literature, and, drawing from the terminological patterns identified in Part 1, outlines more cohesive building blocks to inform the development of future disclosure frameworks.Our minimum goal in articulating these conceptual building blocks is to promote clearer articulations of, and distinctions between, future disclosure frameworks. More ambitiously, we suggest which definitions and conceptualizations we consider most appropriate to use in future disclosure frameworks. Here, we seek to balance benefits to participants through the disclosure of important information with the minimization of undue burdens on individual researchers and the research enterprise more generally. -/- Our analysis builds upon the central philosophical distinction between concepts and conceptions. The basic idea is that the “concept” of X refers to the general (and relatively uncontroversial) structure/shape of X, while various “conceptions” of X are more particular, filled out, and controversial elaborations of the concept. In other words, “concepts” of X will be formal representations of X, while “conceptions” of X will be substantive interpretations of the key elements and relationships operating within that formal framework. (Implicit in this distinction is an important point about the nature of disagreement – namely, that in order for two or more parties to “disagree” about X as opposed to simply talk past one another, there must be at least enough shared agreement about X to know that the parties are referring to the same thing. A concept of X provides this point of common agreement, while competing conceptions of X mark the areas where disagreement arises.) In this paper, we will employ this distinction in a fundamental way to clarify exactly where the primary disagreements arise in the debate over disclosing genetic research findings. -/- We propose that, underlying all the seeming confusion and disagreement, there are three central and widely agreed upon concepts at work in this debate—validity, value, and volition. The first two concepts concern the nature of the information itself. An obligation to disclose only exists when findings are valid and have value but there are competing conceptions of how to determine or define validity and valuableness. The third concept—volition—pertains not to the information but rather to the person to whom it will be disclosed. Does that person want or not want the information, and what is the best way of determining this? Here, too, competing conceptions arise. Our key point, though, is that almost all of the ethical disagreement arises because of competing conceptions of these three concepts. Understanding and appreciating this key point can help to refocus the substantive debate by providing some common ground to start from in determining how best to interpret these shared concepts. This refocusing can, ideally, produce more productive debate and facilitate some progress in resolving it. (shrink)

Should innovative therapy occur only within a research paradigm and under institutional review board oversight? The health risks from current human embryonic stem cell clinical applications have raised again a fundamental question addressed first in papers submitted to inform the writing of the Belmont Report. Revisiting the thinking underlying the Belmont Report, together with examining changed circumstances since then, leads to a new model for overseeing innovative therapy based on its unique risks and context, important changes since the Belmont Report, (...) and new opportunities for addressing risks through safety and quality systems in health care. (shrink)

Recent scientific and technological developments have promoted the emergence of biobanks on a population scale. Although the storage of human biological material has taken place for a long time, it is only recently that biobanks have acquired a broader scientific significance, especially for genomic research. The increase in biobanks creates many ethical dilemmas, such as the protection of privacy, and creates the need for a new regulatory framework, which must enable the sustainable development of biobanks while also protecting the rights (...) of research subjects and biobank participants. (shrink)

Disparities in access to, and utilization of, treatment for depression among African-American and Caucasian elderly adults have been well-documented. Less fully explored are the multidimensional factors responsible for these disparities. The intersection of cultural constructs, socioeconomic factors, multiple levels of racism, and stigma attending both mental health issues and older age may help to explain disparities in the treatment of the depressed elderly. Personalized medicine with its promise of developing interventions tailored to an individual's health needs and genetically related response (...) to treatment might seem a promising antidote to the documented underutilization of standard depression treatments by African Americans. However, this paper examines the multidimensional factors associated with disparities in effective treatment of depression among African-American and Caucasian elderly adults and argues the scientific and ethical importance of pursuing various paths to address multiple levels and sources of stigma and mistrust if pharmacogenomics is to help, rather than exacerbate, disparities in depression treatment. Seven recommendations are offered to increase the likelihood that developments in pharmacogenomics will reduce disparities in depression treatment. (shrink)

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES (...) FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. (shrink)

We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased participants, and the IRB's role in addressing these issues. Given a particular hypothetical scenario, respondents favored offering results to participants but not family members, giving choices at the time of initial consent, and honoring elicited choices. They felt IRBs should have authority regarding the process issues, but a more limited role in medical and scientific issues.

Research biobanks are heterogeneous and exist to manage diverse biosample types with the goal of facilitating and serving biomedical discovery. The perspectives of biobank managers are reviewed, and the perspectives of two biobank directors, one with experience in institutional biobanks and the other with national cooperative group banks, are presented. Most research biobanks are not designed, nor do they have the resources, to return research results and incidental findings to participants or their families.

Determining what constitutes an anticipatable incidental finding from clinical research and defining whether, and when, this IF should be returned to the participant have been topics of discussion in the field of human subject protections for the last 10 years. It has been debated that implementing a comprehensive IF-approach that addresses both the responsibility of researchers to return IFs and the expectation of participants to receive them can be logistically challenging. IFs have been debated at different levels, such as the (...) ethical reasoning for considering their disclosure or the need for planning for them during the development of the research study. Some authors have discussed the methods for re-contacting participants for disclosing IFs, as well as the relevance of considering the clinical importance of the IFs. Similarly, other authors have debated about when IFs should be disclosed to participants. However, no author has addressed how the “actionability” of the IFs should be considered, evaluated, or characterized at the participant's research setting level. This paper defines the concept of “Actionability at the Participant's Research Setting Level” for anticipatable IFs from clinical research, discusses some related ethical concepts to justify the APRSL concept, proposes a strategy to incorporate APRSL into the planning and management of IFs, and suggests a strategy for integrating APRSL at each local research setting. (shrink)

Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation.

This article argues for the importance of conceptual clarity in the debate about the so-called right not to know. This is vital both at the theoretical and the practical level. It is suggested that, unlike many formulations and attempts to give effect to this right, what is at stake is not merely an aspect of personal autonomy and therefore cannot and should not be reduced only to a question of individual choice. Rather, it is argued that the core interests that (...) can be protected by the right not to know are better conceived of as privacy interests rather than autonomy interests. This not only helps us to understand what is in play but also informs regulatory, professional, and legal responses to handling information and taking decisions about whether or not to disclose information to persons about themselves. The practical implications of this conceptualization are explored in the context of feedback policies in health-related research. (shrink)

Slightly modified excerpt from the section 13.4 Zusammenfassung und Ausblick (translated into englisch): This chapter is based on an analysis of ethical debates on epigenetics and genome editing, debates, in which ethical arguments relating to future generations and justice play a central role. The analysis aims to contextualize new developments in genetic engineering, such as genome and epigenome editing, ethically. At the beginning, the assumptions of "genetic determinism," on which "genetic essentialism" is based, of "epigenetic determinism" as well as "genetic" (...) and "epigenetic exceptionalism" are analyzed and critically discussed. The remarks on the ethical discourse on epigenetics show that the notion of "epigenetic determinism" can sometimes be discerned not only in popular scientific discourse but also in ethical discourse. Ethical debates on epigenetics, however, have distanced themselves from this deterministic understanding. As a result, the focus in the ethical discourse on epigenetics shifts from responsibility for one's own health and that of subsequent generations to justice. What is meant here is justice, for example, in terms of access to healthy environmental conditions, regardless of whether these contribute to health with or without epigenetic agency. An analysis of the discourse on genome editing reveals that it is primarily germline interventions that are being ethically examined, with a concentration on the aspect of inheritance. The question is whether this is accompanied by an implicit "genetic determinism" or even a "genetic essentialism": the determinism could lie in the centrality of the aspect of heritability, since only genetic information is inherited. Does the aspect of heritability and genome modification play a more decisive role in debates on genome editing than the safety issue? Is the problem of embryos and their potential offspring not being able to consent to germline intervention given such a high priority because it is a genetic intervention? Under such a premise of "strong genetic determinism" supplemented by "epigenetic determinism," not only genome editing but also epigenome editing would be ethically relevant precisely because it too would have an influence on the genome. How this influence of genome editing and epigenome editing is ethically evaluated in each case therefore depends initially on whether the assumptions of "genetic" and "epigenetic determinism" are advocated. These assumptions are increasingly viewed critically in ethical discourse because they cannot be confirmed from a scientific perspective. In popular scientific debates in particular, however, they seem to persist, which ultimately also influences the public discussion. Since a broad public discussion is required especially on genome editing, a reflective approach to the various "-isms" analyzed in this chapter is central. DOI: 10.5771/9783748927242. (shrink)

This article examines the complex and contemporary issue of the return of research results in biobanks. After suggesting the exclusion of some adjacent issues usually flanking the debate, this article reviews the current practices of biobanks on the disclosure of research results to participants. It then focuses more specifically on the debate in the literature before turning to a review of the typology of recent reforms being put forward.

Rapid growth in structural and functional brain research has led to increasing ethical discussion of what to do about incidental findings within the brains of healthy neuroimaging research participants that have potential health importance, but which are beyond the original aims of the study. This dilemma has been widely debated with respect to general neuroimaging research but has attracted little attention in the context of neuromarketing studies. In this paper, I argue that neuromarketing researchers owe participants the same ethical obligations (...) as other neuroimaging researchers. The financial resources available to neuromarketing firms and the social value of neuromarketing studies should command greater attention to the elucidation and management of incidental findings. However, this needs to be balanced against finite resources available within most public health systems. (shrink)

Technology has expanded genomic research and the complexity of extracted gene-related information. Health-related genomic incidental findings pose new dilemmas for nurse researchers regarding the ethical application of disclosure to participants. Consequently, informed consent specific to incidental findings is recommended. Critical Social Theory is used as a guide in recognition of the changing meaning of informed consent and to serve as a framework to inform nursing of the ethical application of disclosure consent in genomic nursing research practices.

Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both (...) health care and legal actors to address and manage those liability risks. (shrink)

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

Participant-driven research is a burgeoning domain of research innovation, often facilitated by mobile technologies. Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.

Five years ago, an article co-written by some of us presented an emerging trend to disclose some individual genetic results to research participants within the international research community. At the time, ethical norms and scholarly publications on the return of results often did not distinguish between the return of research results in general and the return of unexpected results. Both technologies and research practices have evolved significantly. Today whole genome and exome sequencing are increasingly affordable and frequently used in genetic (...) research. Because these techniques produce a vast amount of interpretable and non-interpretable data about an individual, the issue of how to manage information generated by such technologies needs to be considered. However, the development of international ethical guidelines has not kept up with the rapid pace of technological progress. Indeed developments in genomic biobanking also challenge the duty to disclose research results. (shrink)

In 2009, Time magazine named “biobanks” as one of the 10 ideas changing the world. These organized collections of human biological material and associated data have been identified as “vital research tools in the drive to uncover the consequences of human health and disease.” Since their inception, however, biobanks have faced ethical and legal challenges. Whether these pertain to informed consent, access by researchers, commercialization, confidentiality, or governance, biobanks must continue to address jurisdictional matters, operational difficulties, and normative frameworks that (...) strive to stay abreast of current scientific innovation. Yet, with some biobanks now having completed their recruitment objectives and with research currently being performed on their data and samples, one topic has become the focus of ongoing debates: the return of research results to participants. (shrink)

This paper addresses the question of how incidental findings 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. (shrink)

With improved diagnostic capability and accuracy, the fields of medicine, neuroscience, psychiatry, and psychology have benefitted remarkably from the dramatic advancements in neuroimaging technology. Not only can surface and subsurface structures of the brain be mapped with incredible anatomical detail, now neural activity can be imaged across time as the brain responds to different stimuli. These sophisticated techniques have been a vital element in the recent increase in neuroimaging-based research. This increase, while producing new diagnostic techniques and improved treatment mechanisms (...) for neurological disease, has also led to a new dilemma for human subjects researchers: how should incidental findings be managed? An incidental finding is a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of this study. (shrink)

This paper reports from an ongoing multidisciplinary, ethnographic study that is exploring the views, values and practices (the ethical frameworks) drawn on by professional staff in assisted conception units and stem cell laboratories in relation to embryo donation for research purposes, particularly human embryonic stem cell (hESC) research, in the UK. We focus here on the connection between possible incidental findings and the circumstances in which embryos are donated for hESC research, and report some of the uncertainties and dilemmas of (...) our staff participants. We explore the views of our study participants in relation to two themes: (1) rights to information and anticipating how donors might be informed about future research findings and (2) occupational work goals and trust. (shrink)

Innovative therapy is the name we give to novel medical interventions, radically different from the standard of care, provided in order to benefit a patient, rather than to acquire new knowledge. They are paradigmshifting, not incremental, responses to serious patient problems that standard medical care inadequately addresses. Innovative therapies are often devised by clinicians, not basic science researchers; they do not follow the linear model of basic research, to translation, to clinical research, to application. Instead, they come from thinking backwards (...) from the patient’s circumstances, and forward from deep knowledge of how the body functions, to challenge the limits of current mechanisms for effecting cures. (shrink)

Neuroimaging research regularly yields “incidental findings”: observations of potential clinical significance in healthy volunteers or patients, but which are unrelated to the purpose or variables of the study.

Genomic research can reveal ‘unsolicited’ or ‘incidental’ findings that are of potential health or reproductive significance to participants. It is widely thought that researchers have a moral obligation, grounded in the duty of easy rescue, to return certain kinds of unsolicited findings to research participants. It is less widely thought that researchers have a moral obligation to actively look for health-related findings. This paper examines whether there is a moral obligation, grounded in the duty of easy rescue, to actively hunt (...) for genomic secondary findings. We begin by showing how the duty to disclose individual research findings can be grounded in the duty of easy rescue. Next, we describe a parallel moral duty, also grounded in the duty of easy rescue, to actively hunt for such information. We then consider six possible objections to our argument, each of which we find unsuccessful. Some of these objections provide reason to limit the scope of the duty to look for secondary findings, but none provide reason to reject this duty outright. We argue that under a certain range of circumstances, researchers are morally required to hunt for these kinds of secondary findings. Although these circumstances may not currently obtain, genomic researchers will likely acquire an obligation to hunt for secondary findings as the field of genomics continues to evolve. (shrink)

Developing ethical standards for clinical use of large-scale genome and exome sequencing has proven challenging, in part due to the inevitability of incidental or secondary findings. Policy of the American College of Medical Genetics and Genomics has evolved but remains problematic. In 2013, ACMG issued policy recommending mandatory analysis of 56 extra genes whenever sequencing was ordered for any indication, in order to ascertain positive findings in pathogenic and actionable genes. Widespread objection yielded a 2014 amendment allowing patients to opt-out (...) from analysis of the extra genes. In 2015, ACMG published the amended policy, providing that patients could opt out of the full set of extra genes, but not a subset. In 2016, ACMG enlarged the set and indicated planned expansion of the roster of extra genes to include pharmacogenetic findings. ACMG policy does not protect the respect for patient choice that prevails in other domains of clinical medicine, where informed consent allows patients to opt in to desired testing. By creating an expanding domain of genomic testing that will be routinely conducted unless patients reject the entire set of extra tests, ACMG creates an exceptional domain clinical practice that is not supported by ethics or science. (shrink)

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. (shrink)

Recent work on incidental fndings, concentrating on the difcult 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 specifcally that a sound understanding of ancillary-care obligations will center them on incidental fndings. 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 fndings; for instance, it suggests that researchers have no moral obligation to hunt for incidental fndings. (shrink)