No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

Two potentially lifesaving protocols, emergency preservation and resuscitation and uncontrolled donation after circulatory determination of death, currently implemented in some U.S. emergency departments, have similar eligibility criteria and initial technical procedures, but critically different goals. Both follow unsuccessful cardiopulmonary resuscitation and induce hypothermia to “buy time”: one in trauma patients suffering cardiac arrest, to enable surgical repair, and the other in patients who unexpectedly die in the ED, to enable organ donation. This article argues that to fulfill patient-focused fiduciary obligations (...) and maintain community trust, institutions implementing both protocols should adopt and publicize policies to guide ED physicians to utilize either protocol for particular patients, in order to address the appearance of conflict of interest arising from the protocols' similarities. It concludes by analyzing ethical implications of incentives that may influence institutions to develop the expertise required for uDCDD but not EPR. (shrink)

Volume 20, Issue 7, July 2020, Page 77-80.

This paper argues against considering incidental fndings as potential benefts of research when assessing the social value of proposed research, determining the appropriateness of a study's risk/beneft ratio, and identifying and disclosing the risks and benefts of participation during informed consent. The possibility of generating IFs should be disclosed during informed consent as neither a risk nor beneft, but as a possible outcome collateral to participation. Whether specifc IFs will be disclosed when identifed is a separate question whose answer is (...) material to determining whether IFs constitute a risk or a potential indirect beneft of participation. Finally, three types of IF should be distinguished and treated diferently during informed consent: those that will be routinely generated , those that can reasonably be characterized in terms of their nature and frequency of generation , and those of unpredictable nature and frequency that can be characterized only in general terms. Research protocols should provide a rationale for sharing or not sharing IFs of these three types with participants. Regulatory review of such plans should not, however, be confused with regarding IFs as potential benefts when assessing the study's risk/beneft ratio or merit. (shrink)

The possibility of generating incidental findings — in both research and clinical contexts — has long been regarded as a risk of these enterprises. Should incidental findings in research also be regarded as potential benefits? At first glance, it would seem they ought to be. After all, in particular circumstances or given a particular set of values, any piece of information can be beneficial. Therefore, it may seem incoherent or unduly paternalistic to regard IFs only as risks. Moreover, developments in (...) science and technology increasingly transform what was once of uncertain meaning and dubious value into information that is likely to have clear meaning and potential personal value, if not obvious clinical utility. For these reasons, it would seem that in the future, IFs should be treated as potential benefits in the design and regulation of research. (shrink)

This paper illustrates a role that bioethics should play in developing and criticizing protocols for breast cancer genetic screening. It demonstrates how a critical bioethics, using approaches and reflecting concerns of contemporary philosophy of science and science studies, may critically interrogate the normative and conceptual schemes within which ethical considerations about such screening protocols are framed. By exploring various factors that influence the development of such protocols, including politics, cultural norms, and conceptions of disease, this paper and the critical bioethics' (...) approach it endorses illuminate and critically assess some of the competing worldviews informing protocol development. One of the frequently neglected worldviews in traditional bioethics' treatment of protocols concerning breast care is constituted by women's own views of their breasts and breast cancer, both within the technologically-oriented social practice of American medicine and in light of the social construction of their breasted experience in American society. This paper attempts to redress and critically assess this neglect on the part of traditional bioethics. Finally, in contrast to traditional bioethics, critical bioethics critically interrogates its own normative and conceptual commitments. In this final capacity, a critical bioethics' approach makes a valuable contribution to the evolution of bioethics. (shrink)

Considerations of justice and concern for well-being support conducting mental health research and addressing ethical concerns specific to mental health research are critical. We discuss these concerns, provide recommendations to enable the ethical conduct of mental health research, and argue that participants’ interests should be given primary weight in resolving apparent dilemmas. We also comment on provisions of two legislative actions in India relevant to mental health research: Rights of Persons with Disability Act 2016 and the Mental Health Care Act (...) 2017. Both conform to the 2006 United Nations Convention on Rights of Persons with Disabilities of which India is a signatory. Both provide protections and enumerate rights relevant to people with mental health conditions but with differing focus. The commonalities and differences between the three are discussed in the background of international literature on research in mental health conditions. Studies involving deception and future directions for ethical requirements regarding genetic research are discussed. (shrink)

In late December 1998, Renada Daniel-Patterson's father offered to donate a kidney to his daughter and ignited a controversy in the bioethics community. Renada had been born with only one kidney, which began to fail early in her childhood. At age 6, Renada had to receive dialysis three times a week. She was unable to attend school or venture very far from home. This pattern continued until Renada was 13, when Mr. Patterson called from prison to offer her his kidney. (...) Renada was surprised to hear from her father, who was serving 12 years at California State Prison for burglary and drug convictions. Mr. Patterson was determined to be a compatible donor, and the family proceeded with the transplant operation. As a result of this surgery, Renada was able to live the life of a healthy girl for 2 years. Because the medication to prevent rejection of the transplanted organ made her feel ill and bloated and caused her to develop a hump on her back, Renada gradually began to skip doses. As a result, her donated kidney began to fail. It was under these circumstances that David Patterson offered to donate his second kidney to his daughter in 1998. (shrink)

Despite having paved the way for face, womb and penis transplants, hand transplantation today remains a small hybrid of reconstructive microsurgery and transplant immunology. An exceptionally limited patient population internationally complicates medical researchers’ efforts to parse outcomes “objectively.” Presumed functional and psychosocial benefits of gaining a transplant hand must be weighed in both patient decisions and bioethical discussions against the difficulty of adhering to post-transplant medications, the physical demands of hand transplant recovery on the patient, and the serious long-term health (...) risks of immunosuppressant drugs. This paper relates five narratives of hand transplantation drawn from an oral history project to show how narrative methods can and should inform ethical evaluations and the clinical process of hand transplantation. The interviews with patients and their partners analyzed here lead us to suggest that qualitative accounts of patient experiences should be used to complement clinical case studies reported in medical journals and to help develop instruments to assess outcomes more systematically. (shrink)

The possibility of genetic enhancement to increase the likelihood of success in sport and life’s prospects raises questions for accounts of sport and theories of justice. These questions obviously include the fairness of such enhancement and its relationship to the goals of sport and demands of justice. Of equal interest, however, is the effect on our understanding of individual effort, merit, and desert of either discovering genetic contributions to components of such effort or recognizing the influence of social factors on (...) the development and exercise of individual effort. This paper analyzes arguments about genetic enhancement with the goal of raising questions about how sport and justice regard unchosen, undeserved inequalities and what is assumed to be their opposite—namely, the exercise and results of individual effort. It is suggested that contemplating enhancement of natural assets previously outside human control may reinforce recognition of responsibility to intervene with regard to social advantages so as to support individual effort and improve individuals’ life prospects. (shrink)

In April 1992 the Food and Drug Administration (FDA) announced it was restricting the availability of silicone gel-filled breast implants to women enrolled in clinical trials. All candidates for breast reconstruction, but only a "very limited" number of augmentation candidates, would have access to the implants. This policy has been criticized as paternalistic, sexist, and unjustified by scientific data. I examine these charges and conclude that controversy surrounding the scientific data weakens the FDA's paternalistic mandate and that its policy of (...) treating reconstruction and augmentation candidates differently results in increased social injustice and perpetuates cultural biases concerning female beauty and women's rights to control their bodies. I also argue that these cultural biases shape women's subjective experience of their physical selves and should not, contrary to some feminist arguments, be viewed as precluding their giving informed consent to breast surgery. (shrink)

Implementation of guidelines regarding breaches of electronic health information requires an anticipatory stance and physician and patient education regarding security and monitoring measures and methods of redress. Adopting a preventive ethics, rather than a crisis management, model may also increase physician awareness of how the information they choose to include and privilege within the health record may expose patients to added harms if not done mindfully.

In this essay, I argue that the way American bioethics has traditionally conceived of the distinction between public and private has given rise to some ethically problematic blind spots in its analyses to date. Furthermore, I argue that bioethics's view of the public and private spheres has reinforced a shortsighted view of bioethics's analytical sphere of influence. In particular, it has led bioethics to conceptualize issues largely from the perspective of health professionals, eschewing analyses of the problems of health and (...) health information that patients and their intimates face outside of professional relationships and traditional health-care settings. It has also led some bioethical analyses to reflect, and to some degree reinforce, relationships of power that they might instead challenge. (shrink)

Employing the National Institute of Mental Health-funded Prevention of Suicide in Primary Care Elderly Collaborative Trial as a case study, we discuss 2 sets of ethical issues: obtaining informed consent for a clinic-based intervention study and using treatment as usual (TAU) as the control condition. We then address these ethical issues in the context of the debate about the quality improvement efforts of health care organizations. Our analysis reveals the tension between ethics and scientific integrity involved with using TAU as (...) a control condition and the difficulty in designing high-quality research in a community-based setting. (shrink)

Employing the National Institute of Mental Health-funded Prevention of Suicide in Primary Care Elderly Collaborative Trial as a case study, we discuss 2 sets of ethical issues: obtaining informed consent for a clinic-based intervention study and using treatment as usual (TAU) as the control condition. We then address these ethical issues in the context of the debate about the quality improvement efforts of health care organizations. Our analysis reveals the tension between ethics and scientific integrity involved with using TAU as (...) a control condition and the difficulty in designing high-quality research in a community-based setting. (shrink)

Candidate evaluation for breast implantation presents a more important obstacle to the fulfillment of the normative requirements of informed consent than do the social roles of women or cultural norms governing female beauty. I argue that women's decisions to receive breast implants may indeed be informed, competently made, and substantially voluntary, but that the cultural construction of beauty may undermine women's autonomy by influencing the evaluation of surgical candidates and risk disclosure during informed consent.

ABSTRACT:Drawing on insights from feminist epistemology and experience in genomics-related bioethics research, this essay offers three suggestions that may enable bioethics to contribute more persuasively to urgent issues affecting the health and well-being of individuals, communities, and the world they inhabit. First, it suggests that bioethics pay more attention to people's feelings, particularly those that help constitute their self-identities, and to the role of those feelings in their health-relevant behaviors. Further, it proposes conceiving of health-relevant behaviors expansively. Second, it suggests (...) that bioethics advocate for a longer time horizon for the conduct of empirical bioethics research and other types of research addressing complex, systemic factors influencing health. Third, it suggests that bioethics play a larger role in illuminating and applauding the evolving nature of scientific knowledge. (shrink)

Individual and institutional conflicts of interest arise with increasing frequency and negative sequelae as universities and their principals, as well as individual faculty members, engage in research with support from profit/not-for-profit entities. This essay examines how institutional and individual conflicts of interest arise for ethics centers and their faculty/staff, respectively. It defines COI, endorses a reasonable person standard for determining when COI exist, and considers problems that arise when disclosure of COI is embraced as a remedy for them. It argues (...) that transparency and disclosure are generally inadequate measures to address COI, especially those of ethics centers. It concludes by sketching other measures that may be ingredients in attempts to avoid, manage, or mitigate the COI of ethics centers and their faculty/staff. (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)

Personalized medicine with its promise of developing interventions tailored to an individual's health need and genetically related response to treatment might seem a promising antidote to the documented underutilization of standard depression treatments by African Americans. In addition, understanding depression not merely in biochemical terms but also in genetic terms might seem to counter cultural beliefs and stigma that attach to depression when conceived as a mood or behavioral problem under an individual's control. After all, if there is one thing (...) for which a person is not responsible and cannot be blamed, it is her genes. Nevertheless, for multiple reasons, a personalized medical approach to depression treatment, and its attendant conceptualization of depression and treatment response as genetically influenced, present the risk of exacerbating well-documented disparities in access to, and utilization of, treatment for depression among African-American and Caucasian elderly adults. (shrink)

Depression is often diagnosed in patients nearing the end of their lives and medication or psychotherapy is prescribed. In many cases this is appropriate. However, it is widely agreed that a health care professional should treat sick persons so as to improve their condition as they define improvement. This raises questions about the contexts in which treatment of depression in late life is appropriate. This article reviews a problematic case concerning the appropriateness of treatment in light of the literature in (...) bioethics. Specific attention is paid to the concept of authenticity and the role of suffering. Suffering is often the result of a situation in which one's self is damaged. In some circumstances, this suffering should not be seen as a symptom of illness but as a reflection, in a difficult life context, of the individual's authentic nature. Assessment of depression in the elderly must go beyond a symptom list and must consider both the context of the individual's situation and his or her authentic self. When the symptoms reflect the individual's assessment of the situation in the context of the authentic self, they may be "appropriate." However, even when the symptoms are appropriate, if they interfere with life assessment and adjustment, treatment should be considered. (shrink)

In 1951 Henrietta Lacks felt a lump in her cervix, entered Johns Hopkins Hospital, and was examined in a colored-only exam room by a physician who biopsied the lump. Called back to Hopkins for treatment of diagnosed carcinoma of the cervix, Henrietta signed a one-line “Operation Permit,” and under general anesthesia received her first round of radium treatment. Before sewing a tube of radium into her cervix, the surgeon on duty took samples of tumor and healthy tissue, and as with (...) many other samples taken from charity patients at Hopkins, handed the samples to researchers trying to develop an immortal human cell line (an important research tool, an immortal cell line is a population of cells from a multicellular .. (shrink)

Rebecca Skloot, The Immortal Life of Henrietta Lacks, New York: Crown Publishers, 2010, reviewed by Lisa S. Parker.

This paper describes the first three-year experience of the Consortium Ethics Program (CEP-1) of the University of Pittsburgh Center for Medical Ethics, and also outlines plans for the second three-year phase (CEP-2) of this experiment in continuing ethics education. In existence since 1990, the CEP has the primary goal of creating a cost-effective, permanent ethics resource network, by utilizing the educational resources of a university bioethics center and the practical expertise of a regional hospital council. The CEP's conception and specific (...) components stem from recognition of the need to make each hospital a major focus of educational efforts, and to provide academic support for the in-house activities of the representatives from each institution. (shrink)