Voluntariness of consent to research has not been sufficiently explored through empirical research. The aims of this study were to develop a more comprehensive approach to assessing voluntariness and to generate preliminary data on the extent and correlates of limitations on voluntariness. We developed a questionnaire to evaluate subjects’ reported motivations and constraints on voluntariness. 88 subjects in five different areas of clinical research—substance abuse, cancer, HIV, interventional cardiology, and depression—were assessed. Subjects reported a variety of motivations for participation. Offers (...) of financial incentives were common but not influential, pressures from others were rare, and no threats were reported. However, certain financial incentives and—paradoxically—altruistic motivations led some subjects to feel more constrained. Consistent with previous studies, no one pattern of motivation was common to all research subjects. There was little evidence of constrained voluntariness, but some suggestion of areas of concern. Voluntariness appears to be susceptible to systematic empirical investigation. (shrink)

Genomic research—including whole genome sequencing and whole exome sequencing—has a growing presence in contemporary biomedical investigation. The capacity of sequencing techniques to generate results that go beyond the primary aims of the research—historically referred to as “incidental findings”—has generated considerable discussion as to how this information should be handled—that is, whether incidental results should be returned, and if so, which ones.Federal regulations governing most human subjects research in the United States require the disclosure of “the procedures to be followed” in (...) the research as part of the informed consent process. It seems reasonable to assume—and indeed, many commentators have concluded—that genomic investigators will be expected to inform participants about, among other procedures, the prospect that incidental findings will become available and the mechanisms for dealing with them. Investigators, most of whom will not have dealt with these issues before, will face considerable challenges in framing meaningful disclosures for research participants.To help in this task, we undertook to identify the elements that should be included in the informed consent process related to incidental findings. We did this by surveying a large number of genomic researchers (n = 241) and by conducting in‐depth interviews with a smaller number of researchers (n = 28) and genomic research participants (n = 20). Based on these findings, it seems clear to us that routine approaches to informed consent are not likely to be effective in genomic research in which the prospect of incidental findings exists. Ensuring that participants’ decisions are informed and meaningful will require innovative approaches to dealing with the consent issue. We have identified four prototypical models of a consent process for return of incidental findings. (shrink)

Background Autism self-advocates’ views regarding genetic tests for autism are important, but critical questions about their perspectives arise.Methods We interviewed 11 autism self-advocates, recruited through autism self-advocacy websites, for 1 h each.Results Interviewees viewed genetic testing and its potential pros and cons through the lens of their own indiviudal perceived challenges, needs and struggles, especially concerning stigma and discrimination, lack of accommodations and misunderstandings from society about autism, their particular needs for services, and being blamed by others and by themselves (...) for autistic traits. Their views of genetic testing tended not to be binary, but rather depended on how the genetic test results would be used. Interviewees perceived pros of genetic testing both in general and with regard to themselves (e.g., by providing “scientific proof” of autism as a diagnosis and possibly increasing availability of services). But they also perceived disadvantages and limitations of testing (e.g., possible eugenic applications). Participants distinguished between what they felt would be best for themselves and for the autistic community as a whole. When asked if they would undergo testing for themselves, if offered, interviewees added several considerations (e.g., undergoing testing because they support science in general). Interviewees were divided whether a genetic diagnosis would or should reduce self-blame, and several were wary of testing unless treatment, prevention or societal attitudes changed. Weighing these competing pros and cons could be difficult.Conclusions This study, the first to use in-depth qualitative interviews to assess views of autism self-advocates regarding genetic testing, highlights key complexities. Respondents felt that such testing is neither wholly good or bad in itself, but rather may be acceptable depending on how it is used, and should be employed in beneficial, not harmful ways. These findings have important implications for practice, education of multiple stakeholders, research, and policy. (shrink)

Reply to a commentary by Felicitas Holzer and Ignacio Mastroleoon “Models of Consent to Return of Incidental Findings in Genomic Research.”.

Offering an ambitious study of the aesthetics of violence across art, literature, film and theatre, this volume brings together traditional German aesthetic and social theory with the modern problem of violence in art. Written in an engaging style, the book includes examples range from Homer and Shakespeare to slasher films and performance art.

Participants in clinical studies are frequently unable to remember study information for the duration of their participation in the research. Along with a nine-member work group and a seven-member advisory group, we determined that six elements of consent are necessary to uphold the validity of consent over time: awareness of ongoing participation; understanding the right to withdraw; understanding that withdrawal will not influence other treatment options; knowledge of the general purpose of the research; knowledge of potential risks of participation; and (...) understanding of the differences between traditional, individualized clinical care and standardized treatment during research participation. Based on these important elements, we developed an Assessment of Sustained Informed Consent as a tool to periodically review a protocol’s essential elements with its participants. We hope this will be a useful means of confirming research participants’ continued knowledge of the critical elements of consent, and of identifying those subjects who need reminding. (shrink)

Institutional review boards are almost universally considered to be overworked and understaffed. They also require substantial commitments of time and resources from their members. Although some surveys report average IRB memberships of 15 people or more, federal regulations require only five. We present data on IRB meetings at eight of the top 25 academic medical centers in the United States funded by the National Institutes of Health. These data indicate substantial contributions from primary reviewers and chairs during protocol discussions but (...) little from other members, which implies that it may be possible for smaller IRBs to accomplish the same tasks with no reduction in the quality of review. (shrink)

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that (...) acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved. (shrink)

ABSTRACT:A wide range of research uses patterns of genetic variation to infer genetic similarity between individuals, typically referred to as genetic ancestry. This research includes inference of human demographic history, understanding the genetic architecture of traits, and predicting disease risk. Researchers are not just structuring an intellectual inquiry when using genetic ancestry, they are also creating analytical frameworks with broader societal ramifications. This essay presents an ethics framework in the spirit of virtue ethics for these researchers: rather than focus on (...) rule following, the framework is designed to build researchers’ capacities to react to the ethical dimensions of their work. The authors identify one overarching principle of intellectual freedom and responsibility, noting that freedom in all its guises comes with responsibility, and they identify and define four principles that collectively uphold researchers’ intellectual responsibility: truthfulness, justice and fairness, anti-racism, and public beneficence. Researchers should bring their practices into alignment with these principles, and to aid this, the authors name three common ways research practices infringe these principles, suggest a step-by-step process for aligning research choices with the principles, provide rules of thumb for achieving alignment, and give a worked case. The essay concludes by identifying support needed by researchers to act in accord with the proposed framework. (shrink)

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB (...) process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials. (shrink)

In one accessible, beautifully designed and illustrated volume, scholars have gathered the major theories and key ideas of world's greatest thinkers. The presentation of material sets this reference apart from other philosophy books by providing both the historical and cultural context of the ideas being explored, and by giving visual expression to the arguments and insights themselves through the artwork of the time. Immerse yourself in both Eastern and Western philosophy, spending time with Plato on knowledge, Aquinas on ethics, Marx (...) on religion, and Confucius on human destiny. Designed for maximum flexibility of use, all thinkers and issues are cross-referenced, enabling you to move within or across branches of philosophy and historical periods, to get either a broad overview of the whole world of philosophy, or a more detailed exploration of a particular thinker or approach. (shrink)

Theory of Mind is the ability to predict and understand the mental state of another. While ToM is theorized to play a role in language, we examined whether such a mentalizing ability plays an important role in establishing shared understanding in conversation. Pairs of participants engaged in a Lego model building task in which adirectorinstructed abuilderon how to create duplicate models from a prototype that only the director could see. We manipulated whether the director could see or could not see (...) the builder’s workspace. As predicted, the Mind in the Eyes test predicted accuracy when the workspace was hidden. A high mentalizing ability was an advantage when instructing, resulting in fewer errors, but may be a disadvantage when following instructions. This research indicates that ToM plays a key role in communicating information effectively in conversation. (shrink)

Theory of Mind is the ability to predict and understand the mental state of another. While ToM is theorized to play a role in language, we examined whether such a mentalizing ability plays an important role in establishing shared understanding in conversation. Pairs of participants engaged in a Lego model building task in which a director instructed a builder on how to create duplicate models from a prototype that only the director could see. We manipulated whether the director could see (...) or could not see the builder’s workspace. As predicted, the Mind in the Eyes test predicted accuracy when the workspace was hidden. A high mentalizing ability was an advantage when instructing, resulting in fewer errors, but may be a disadvantage when following instructions. This research indicates that ToM plays a key role in communicating information effectively in conversation. (shrink)

Theories of discourse bring to realism new ideas about how knowledge develops and how representations of reality are influenced. We gain an understanding of the conceptual aspect of social life and the processes by which meaning is produced. This collection reflects the growing interest realist critics have shown towards forms of discourse theory and deconstruction. The diverse range of contributions address such issues as the work of Derrida and deconstruction, discourse theory, Eurocentrism and poststructuralism. What unites all of the contributions (...) is a sense that it is essential to provide a realist alternative to the hitherto dominance of social constructionism, hermeneutics and postmodernism, over many of the issues discussed. By developing a realist perspective the different authors attempt to embed discourse within the structured nature of the reality of the world. Realism can situate language, discourse and ideology within context specific, or 'causally efficacious' circumstances. Realism can help to uncover issues of power, representation, and subjectivity and how discursive and other social practices produce real effects. This can help us understand the manner in which social structures are reproduced through various forms of ideology and discourse. And by knowing this, we can start to address questions concerning human emancipation and how the world is to be transformed. (shrink)

Winner of the 1975 National Book Award, this brilliant and widely acclaimed book is a powerful philosophical challenge to the most widely held political and social positions of our age--liberal, socialist, and conservative.

Volume 19, Issue 5, May 2019, Page 22-24.

In their fine overview of supported decision making for persons with dynamic cognitive and functional impairments “at the margins of autonomy,” Peterson, Karlawish, and Largent query whether...

In this consensus report by a diverse group of academics who conduct and/or are concerned about social and behavioral genomics (SBG) research, the authors recount the often‐ugly history of scientific attempts to understand the genetic contributions to human behaviors and social outcomes. They then describe what the current science—including genomewide association studies and polygenic indexes—can and cannot tell us, as well as its risks and potential benefits. They conclude with a discussion of responsible behavior in the context of SBG research. (...) SBG research that compares individuals within a group according to a “sensitive” phenotype requires extra attention to responsible conduct and to responsible communication about the research and its findings. SBG research (1) on sensitive phenotypes that (2) compares two or more groups defined by (a) race, (b) ethnicity, or (c) genetic ancestry (where genetic ancestry could easily be misunderstood as race or ethnicity) requires a compelling justification to be conducted, funded, or published. All authors agree that this justification at least requires a convincing argument that a study's design could yield scientifically valid results; some authors would additionally require the study to have a socially favorable risk‐benefit profile. (shrink)

Robert Stern investigates how scepticism can be countered by using transcendental arguments concerning the necessary conditions for the possibility of experience, language, or thought. He shows that the most damaging sceptical questions concern neither the certainty of our beliefs nor the reliability of our belief-forming methods, but rather how we can justify our beliefs.

This is a paradigmatic work of contemporary philosophy.

In lieu of an abstract, here is a brief excerpt of the content:Ought We to Require Emotional Capacity as Part of Decisional Competence?Paul S. Appelbaum* (bio)AbstractThe preceding commentary by Louis Charland suggests that traditional cognitive views of decision-making competence err in not taking into account patients’ emotional capacities. Examined closely, however, Charland’s argument fails to escape the cognitive bias that he condemns. However, there may be stronger arguments for broadening the focus of competence assessment to include emotional capacities, centering (...) on the ways in which emotions aid humans in processing information. Before emotional capacities are added to the list of functions essential for decisional competence, though, the feasibility and utility of such a reorientation must be demonstrated.To what extent ought persons’ capacities to experience emotion be taken into account when determining whether they should be deemed competent to make their own decisions? In the previous article, Louis Charland (1998) argues that traditional models of decision-making competence—of which the MacArthur Competence Treatment Study is a typical example—are mistaken in focusing narrowly on persons’ cognitive abilities to the neglect of emotional factors. In contrast, he suggests, constructs of competence ought explicitly to require a capacity to experience emotions, which he believes is central to meaningful decision making, before deeming persons competent.Charland, as he acknowledges, is not the first to suggest that the presence of some degree of emotional capacity is a necessary element of competence, but his argument is among the most elaborate to date and is certainly worth closer examination. Looked at carefully, however, Charland’s argument does not make quite the case for the determination of emotional capacity in competence assessment that he claims for it. Indeed, as I demonstrate below, Charland may share the same “pernicious [End Page 377] cognitive bias” that he ascribes to more traditional approaches. However, despite what I identify as the problems in Charland’s argument, others have raised more disturbing questions about the lack of attention to emotional issues in competence assessment. Thus, I am not ready to reject entirely the possibility that determinations of decisional competence ought to consider emotional factors. I conclude by outlining the questions that remain to be answered to identify more clearly the potential benefits of such an approach.The Construct of Decision-Making CompetenceSome preliminary comments about the nature of the dominant construct of decision-making competence may provide a useful frame for my response to Charland’s paper. Contemporary ideas of competence are tied inextricably to the ideal of self-determination in modern Western societies. Such societies are committed to respect for individual choice, both as a good in its own right and on the grounds that each person knows best what choices will maximize his or her own welfare. In general, therefore, states will not intervene to prevent persons from acting on their decisions, even when the choices they make—like the decision to smoke or to refuse potentially life-saving medical care—may objectively be thought to be detrimental to them.In some cases, however, the presumption that people will act in their own interests, as well as the notion that there is something intrinsically valuable in respecting their choices, fails (Buchanan and Brock 1989). When people’s minds are so disordered that they cannot be said to be making meaningful choices, other values come into play. Such people are called “incompetent.” When persons reach that point, the state’s interest in protecting its citizens becomes primary and someone else must make decisions on their behalf. Note that the size of this group must be sharply limited, lest a liberal society’s commitment to self-determination be undermined: There is no more profound infringement of the rights of citizens than the determination that they are incompetent. Thus, the criteria for incompetence must be selected in a deliberately narrow fashion—alternately, one might say that the standards for competence are made intentionally broad—so that all but a tiny percentage of citizens will be permitted to make decisions on their own.In the Anglo-American world, the process of formulating criteria of competence by and large has been left to the common law courts. Over the course of centuries they have identified the capacities that are, in... (shrink)

Fodor argues that speech perception is accomplished by a module. Typically, modular processing is taken to be bottom-up processing. Yet there is ubiquitous empirical evidence that speech perception is influenced by top-down processing. Fodor attempts to resolve this conflict by denying that modular processing must be exclusively bottom-up. It is argued, however, that Fodor's attempt to reconcile top-down and modular processing fails, because: (i) it undermines Fodor's own conception of modular processing; and (ii) it cannot account for the contextually varying (...) top-down influences that characterize speech perception. (shrink)

(2002). Clarifying the Ethics of Clinical Research: A Path toward Avoiding the Therapeutic Misconception. The American Journal of Bioethics: Vol. 2, No. 2, pp. 22-23.

Robert Hanna presents a fresh view of the Kantian and analytic traditions that have dominated continental European and Anglo-American philosophy over the last two centuries, and of the connections between them. But this is not just a study in the history of philosophy, for out of this emerges Hanna's original approach to two much-contested theories that remain at the heart of contemporary philosophy. Hanna puts forward a new 'cognitive-semantic' interpretation of transcendental idealism, and a vigorous defense of Kant's theory (...) of analytic and synthetic necessary truth, making this compelling reading for all who are interested in these fundamental philosophical issues. (shrink)

The United States’ ambitious Precision Medicine Initiative proposes to accelerate exponentially the adoption of precision medicine, an approach to health care that tailors disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It aims to achieve this by creating a cohort of volunteers for precision medicine research, accelerating biomedical research innovation, and adopting policies geared toward patients’ empowerment. As strategies to implement the PMI are formulated, critical consideration of the initiative's ethical and sociopolitical dimensions is needed. (...) Drawing on scholarship of nationalism and democracy, we discuss the PMI's construction of what we term “genomic citizenship”; the possible normative obligations arising therefrom; and the ethical, legal, and social challenges that will ensue. Although the PMI is a work in progress, discussion of the existing and emerging issues can facilitate the development of policies, structures, and procedures that can maximize the initiative's ability to produce equitable and socially sensitive outcomes. Our analysis can also be applied to other population-based, precision medicine research programs. (shrink)

Recent studies indicate that patients who are diagnosed with vegetative states may retain more awareness than their clinical assessments suggest. Disorders of consciousness traditionally have been diagnosed on the basis of outwardly observable behaviors alone, but new functional imaging studies have shown surprising levels of brain activity in some patients, indicating that even higher-level cognitive functions like language processing and visual imagery may be preserved. For example, one recently developed method purports to detect voluntary mental imagery solely on the basis (...) of neural response patterns observed with functional magnetic resonance imaging. This line of research has already led to some widely reported cases of patients who were discovered to have more brain activity than expected. In November 2009, Rom Houben, a Belgian man who was thought to be in a coma for 23 years, was diagnosed with locked-in syndrome through the use of neuroimaging; however, that assessment was later overturned by further testing. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Examining the Ethics of Human Subjects ResearchPaul S. Appelbaum (bio)The work of the Advisory Committee on Human Radiation Experiments confirms once again the value of combining empirical and normative approaches to problems in clinical and research ethics. The Committee, like its predecessor, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, spent relatively modest sums of money gathering targeted data to (...) inform its deliberations. The results of the Committee’s research, which are discussed by Nancy Kass and Jeremy Sugarman in this issue of the Kennedy Institute of Ethics Journal, enhance our understanding of the current ethical status of human subjects research, helping to focus attention on areas of particular concern, and lay the basis for future research and policy development.My comments here focus on the two major empirical studies conducted by the Committee—the Research Proposal Review Project and the Subject Interview Study. I will underscore just a few of the primary findings from these studies, consider their limitations, and explore their implications. Readers interested in the details of the studies should consult the Committee’s Final Report (ACHRE 1995), on which I rely in part and which provides additional information on the methodology and findings of the studies.Research Proposal Review ProjectWhat can be learned from the Committee’s review of 125 federally-funded human research studies? In answering that question, one cannot ignore the irony inherent in the Committee’s decision to review documents related to institutional review board (IRB) consideration of the selected protocols. The single most frequent complaint about the current system for protecting human subjects is that IRBs focus almost exclusively on review of consent forms and other research documents, as if they bore some close relationship to what actually transpires between investigators and potential research subjects. Only a small number of studies examine the research consent process. Nevertheless, existing data strongly [End Page 283] suggest that subject recruitment often involves an extended process of courtship, during which the information contained in consent forms is only a small part of the information passed between investigators and subjects (Benson, Roth, and Winslade 1985; Lidz et al. 1984).Indeed, the second of the Committee’s studies—the Subject Interview Study, which is discussed below—appears to confirm these findings. In-depth interviews with 99 individuals who reported that they were former or current research subjects suggest that “[f]or many, the decision to participate seemed to have been made before the consent form was given to them, and they signed it almost as a formality” (ACHRE 1995 [GPO, p. 742; Oxford, p. 471]). 1 Why, then, did the Committee focus its attention on documents that in many cases seem to play only a tangential role in the consent process? As is the case with IRBs around the country, the answer appears to be that consent forms and related documents are the only easily available window on consent transactions. In addition, under the current system, consent forms constitute the part of the process that IRBs can influence most easily. Consequently, it suits almost everyone’s needs—except perhaps those of the research subjects—to pretend that they reflect what actually transpires in the recruitment process. To the Committee’s credit, it was well aware of this dilemma. Nonetheless, it struggled to wring valid lessons from these limited data in its Final Report.Perhaps the most interesting finding from the Research Proposal Review Project is just how poor so many consent forms are. Given the disproportionate emphasis that many IRBs place on the content of the forms, one would expect that investigators by now would have learned to design documents that meet objective standards of adequacy, such as those applied by the Committee. Indeed, except in the most unusual circumstances, doing so would virtually guarantee that the IRB will ask no further questions about subject recruitment procedures. Although the data justify the inference that many investigators do not yet understand which information is essential to communicate to potential subjects, nor have learned how to do so effectively, they also force us to a still more radical conclusion. If the IRBs were doing their jobs, the Committee... (shrink)