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)

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)

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)

Like many trained in philosophy, we greatly value the work of those scholars with the courage to espouse contrarian views, particularly when the ideas in dispute lie at the very heart of entrenched...

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)

In lieu of an abstract, here is a brief excerpt of the content:The Environmental Genome Project and BioethicsRichard R. Sharp (bio) and J. Carl Barrett (bio)Eight years ago, the Kennedy Institute of Ethics Journal published a brief selection by Eric Juengst (1991) entitled “The Human Genome Project and Bioethics.” That essay introduced and described the Ethical, Legal, and Social Implications (ELSI) Program at the National Center for Human Genome Research. 1 Since that time, the ELSI program has grown to (...) become one of the largest and most well regarded bioethics programs in the country, sponsoring the work of hundreds of researchers and coordinating bioethics activities both nationally and internationally (Marshall 1996; Meslin, Thomson, and Boyer 1997). In 1991, however, Juengst, the first director of the ELSI program, had no way of anticipating these developments. Juengst’s goal in his essay was simply to highlight some of the moral and social issues that were emerging as focal points for the ELSI program. Looking back, the issues he outlined may seem vague and overly broad. At the time, however, the essay served an important purpose, to identify areas requiring additional study and thereby to serve as a guide to others interested in joining in these discussions.In many ways, Juengst’s article serves as an inspiration to those of us working on a new bioethics project. The National Institute of Environmental Health Sciences (NIEHS) recently launched a multi-year project aimed at better understanding genetic influences on environmentally associated diseases (Albers 1997; Brown and Hartwell 1998; Cannon 1997; Kaiser 1997). This project, known as the Environmental Genome Project (EGP), plans to identify and study a number of common genetic variants that may play an important role in determining how individuals respond to environmental exposures. NIEHS hopes that the information learned through the EGP will be instrumental in developing more effective disease-prevention strategies and intervention programs. Following the precedent developed in connection with the Human Genome Project, NIEHS also plans to address the moral and social implications of the EGP. Efforts in this regard include sponsoring workshops and conferences to address such issues, as well as supporting research on the ethical, legal, and social implications of the EGP. Through this work, NIEHS hopes to anticipate potential problems before [End Page 175] they arise and to develop policies that maximize the benefits of the research while avoiding potential misuses of the information learned.In exploring the social implications of the EGP, we at NIEHS are very fortunate to be able to draw upon the work being done by the ELSI program at the National Human Genome Research Institute (NHGRI), as well as the ever-expanding bioethics literature that has been sparked by the ELSI program. Still, there is much to be done and this is an exciting time for those of us involved with the EGP. Many of the ethical, legal, and social implications of the project are only beginning to become clearer, and several of these issues appear quite different from the sorts of concerns that have previously been discussed in connection with other types of genetic research.This essay highlights some of the ethical, legal, and social implications that are emerging as important focal points for the Environmental Genome Project. Like Juengst’s 1991 paper, the goal of this article is to provide an overview of current areas of interest and to encourage others to join us in thinking about these difficult issues.The Environmental Genome ProjectIndividuals differ greatly in their responses to chemicals, drugs, radiation, smoking, alcohol, and other environmental exposures. These differential responses are the result of complex interactions between many factors, including an individual’s genetic make-up, age, sex, nutritional status, and overall health. The EGP aims to better understand the genetic basis of differential responses to environmental exposures. The vast majority of diseases, many forms of cancer, for example, are the consequence of both environmental and genetic contributions (Perera 1997). Hence, understanding the relationships between genetic variation and response to environmental exposure is important for understanding the causes of human disease and is crucial for the development of effective disease-prevention strategies.The EGP and projects like it represent a new stage of genomic research. It is expected that the Human Genome Project will complete... (shrink)

While consensus exists among many practitioners of ethics consultation about the need for and identification of core competencies and standards, there has been virtually no attempt to determine how these competencies and standards are best taught and assessed. We believe that clinical ethics consultation has reached a state of sufficient maturity that expert practitioners can evaluate those who are new to the field. We will outline several steps that can facilitate the creation of a certification process for clinical ethics consultants, (...) assuring the competency and quality of consultation for the patients, families, and healthcare professionals who utilize ECSs. (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)

Volume 20, Issue 2, February 2020, Page 1-4.

Empirical bioethics research has become an established field of study, with its own unique goals, vocabulary, and methods, and wi...

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)

We describe the ethics consultation service (ECS) at the Cleveland Clinic and report on its activities over a 24-month period in which 478 consultations were performed. To our knowledge, this is the largest case series of ethics consultations reported to date. Established more than 25 years ago, the ECS at the Cleveland Clinic is staffed by multiple consultants with advanced training in bioethics. Several of these ethicists work closely with specialized clinical units and research departments, where they participate in multidisciplinary (...) meetings and provide specialized assistance. This combination of historical experience, large numbers of consultation requests, and specialized clinical ethicists suggests that the experience at the Cleveland Clinic may be helpful to ethicists and others who may be considering how to structure and sustain a vibrant ECS. Our results highlight the diversity of activities performed by a high-volume ECS at a tertiary care facility. Our hope in sharing the inner workings of the ECS at the Cleveland Clinic is to promote dialogue on common practices and approaches across medical institutions that support ethics consultation. (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)

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...

: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)

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)

Hastings Center Report, Volume 52, Issue 1, Page 51-58, January/February 2022.

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)

Good listening is an essential element in the provision of quality healthcare (Attree 2001). Good listening also supports accurate diagnosis, patient adherence to medical recommendations, and stron...

Dismantling Contemporary Deficit Thinking provides comprehensive critiques and anti-deficit thinking alternatives to this oppressive theory by framing the ...