Large-scale sequencing tests, including whole-exome and whole-genome sequencing, are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute and National Cancer Institute have funded studies on clinical and research sequencing under (...) the Clinical Sequencing Exploratory Research program as well as studies on return of results. Most of these studies use sequencing in real-world clinical settings and collect data on both the application of sequencing and the impact of receiving genomic findings on study participants. They are occurring in the context of controversy over how to obtain consent for exome and genome sequencing. (shrink)
Research on human genetic variation can present collective risks to all members of a socially identifiable group. Research that associates race or ethnicity with a genetic disposition to disease, for example, presents risks of group discrimination and stigmatization. To better protect against these risks, some have proposed supplemental community-based reviews of research on genetic differences between populations. The assumption behind these appeals is that involving members of study populations in the review process can help to identify and minimize collective risks (...) that otherwise could go unnoticed. In contrast to this position, critics have argued that supplemental community-based reviews are unnecessary, impractical, and morally problematic. This paper is our attempt to advance this debate by distinguishing the various goals of community review and the forms that it can take. (shrink)
It is generally accepted that appropriate documentation of activities and recommendations of ethics consultants in patients’ medical records is critical. Despite this acceptance, the bioethics literature is largely devoid of guidance on key elements of an ethics chart note, the degree of specificity that it should contain, and its stylistic tenor. We aim to provide guidance for a variety of persons engaged in clinical ethics consultation: new and seasoned ethics committee members who are new to ethics consultation, students and trainees (...) in clinical ethics, and those who have significant experience with ethics consultation so that they can reflect on their practice. Toward the goal of promoting quality charting practices in ethics consultations, we propose recommendations on a broad array of questions concerning clinical ethics consultation chart notes, including whether and when to write a chart note, and practical considerations for the tenor, purpose, and content of a chart note. Our broader aim is to promote discussion about good charting practices in clinical ethics, with the hope of contributing to clear standards of excellence in clinical ethics consultation. (shrink)
Research on human genetic variation can present collective risks to all members of a socially identifiable group. Research that associates race or ethnicity with a genetic disposition to disease, for example, presents risks of group discrimination and stigmatization. To better protect against these risks, some have proposed supplemental community-based reviews of research on genetic differences between populations. The assumption behind these appeals is that involving members of study populations in the review process can help to identify and minimize collective risks (...) that otherwise could go unnoticed. In contrast to this position, critics have argued that supplemental community-based reviews are unnecessary, impractical, and morally problematic. This paper is our attempt to advance this debate by distinguishing the various goals of community review and the forms that it can take. (shrink)
:Academic Medical Centers offer patient care and perform research. Increasingly, AMCs advertise to the public in order to garner income that can support these dual missions. In what follows, we raise concerns about the ways that advertising blurs important distinctions between them. Such blurring is detrimental to AMC efforts to fulfill critically important ethical responsibilities pertaining both to science communication and clinical research, because marketing campaigns can employ hype that weakens research integrity and contributes to therapeutic misconception and misestimation, undermining (...) the informed consent process that is essential to the ethical conduct of research. We offer ethical analysis of common advertising practices that justify these concerns. We also suggest the need for a deliberative body convened by the Association of American Medical Colleges and others to develop a set of voluntary guidelines that AMCs can use to avoid in the future, the problems found in many current AMC advertising practices. (shrink)
Growing ties to private industry have prompted many to question the impartiality of academic bioethicists who receive financial support from for-profit corporations in exchange for ethics-related services and research. To the extent that corporate sponsors may view bioethics as little more than a way to strengthen public relations or avoid potential controversy, close ties to industry may pose serious threats to professional independence. New sources of support from private industry may also divert bioethicists from pursuing topics of greater social importance, (...) such as the needs of medically underserved communities. To inform ongoing debates about the financing of bioethics and its transparency to those concerned about potential sources of bias, we examined funding disclosures appearing in original research reports in major bioethics journals. Reviewing research published over a 15-year period, we found little evidence that for-profit corporations are influencing bioethics research directly. Instead, we found evidence that a great number of organizations, both public and private, support bioethics research. These findings suggest that worries about the cooption of bioethics research by a few interested stakeholders are greatly overstated and undersupported by available data. (shrink)
Bioethics and feminist scholarship has explored various justice implications of nonmedical sex selection and family balancing. However, prospective users’ viewpoints have been absent from the debate over the socially acceptable bounds of nonmedical sex selection. This qualitative study provides a set of empirically grounded perspectives on the moral values that underpin prospective users’ conceptualizations of justice in the context of a family balancing program in the United States. The results indicate that couples pursuing family balancing understand justice primarily in individualist (...) and familial terms rather than in terms of social justice for women and girls or for children resulting from sex selection. Study participants indicated that an individual’s desire for gender balance in their family is ethically complex and may not be inherently sexist, immoral, or socially consequential, particularly given the social context in which they live. Our findings suggest that the social conditions that contribute to prospective users’ desires for gender balance in their families may direct them away from recognizing or engaging broader social justice concerns relating to sexism and stratified reproduction. (shrink)
Strategies for protecting historically disadvantaged groups have been extensively debated in the context of genetic variation research, making this a useful starting point in examining the protection of social groups from harm resulting from biomedical research. We analyze research practices developed in response to concerns about the involvement of indigenous communities in studies of genetic variation and consider their potential application in other contexts. We highlight several conceptual ambiguities and practical challenges associated with the protection of group interests and argue (...) that protectionist strategies developed in the context of genetic research will not be easily adapted to other types of research in which social groups are placed at risk. We suggest that it is this set of conceptual and practical issues that philosophers, ethicists, and others should focus on in their efforts to protect identifiable social groups from harm resulting from biomedical research. (shrink)
Academic medical centers and drug manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health. Consequently, when medical institutions forge research collaborations with industry they should be mindful of (...) the potential for these relationships to erode public confidence in the integrity of clinical research.Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers, scandals at the nation's largest funder of biomedical research, and evidence of fabricated research findings in prominent medical journals. These unfortunate events have prompted many to re-examine strategies for managing industry relationships and the financial conflicts of interest they may create. (shrink)
ABSTRACT There is limited guidance about whether and how to provide psychological assessment results to research participants. This paper considers several ethical challenges associated with offering individual research results in psychological assessment research. Additionally, the process used to return individual results within a study examining neurodevelopmental effects of anesthesia exposure in children and adolescents is described. Almost all participants requested to know if results were concerning; however, only around a third of those with concerning findings sought additional feedback. Ongoing research (...) and guidance are necessary to establish evidence-based practices and manage challenges that may emerge when disclosing such results. (shrink)
For decades, the Belmont Report—and the associated regulatory framework it inspired—has been a cornerstone in the ethical conduct of research involving human subjects. Despite its canonic status, t...
Growing ties to private industry have prompted many to question the impartiality of academic bioethicists who receive financial support from for-profit corporations in exchange for ethics-related services and research. To the extent that corporate sponsors may view bioethics as little more than a way to strengthen public relations or avoid potential controversy, close ties to industry may pose serious threats to professional independence. New sources of support from private industry may also divert bioethicists from pursuing topics of greater social importance, (...) such as the needs of medically underserved communities. To inform ongoing debates about the financing of bioethics and its transparency to those concerned about potential sources of bias, we examined funding disclosures appearing in original research reports in major bioethics journals. Reviewing research published over a 15-year period, we found little evidence that for-profit corporations are influencing bioethics research directly. Instead, we found evidence that a great number of organizations, both public and private, support bioethics research. These findings suggest that worries about the cooption of bioethics research by a few interested stakeholders are greatly overstated and undersupported by available data. (shrink)
Although bioethics consultation has always drawn the ire of critics, its extension into areas such as paid consultation with private industry has raised new concerns. Critics of consulting relationships with industry question the sincerity of for-profit corporations who seek ethical advice, alleging that a desire for improved public relations is a primary motivation of these corporations. They also question whether compensation for ethical advice creates insuperable conflicts of interest that bias the work produced. The decision of two influential professional societies (...) to establish a joint task force to examine bioethics consultation with industry reflects the seriousness of these and other concerns about this practice. The report of this task force, although controversial, has stimulated broad discussion about the ethical commitments of bioethicists and highlighted the need for clearer professional standards of conduct. (shrink)
