Ethical issues surrounding forced, mandated, or coerced treatment.
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Biomedical subjects
Publications and source records attributed to Arthur L Caplan.
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INTRODUCTION: Recent reports have linked the use of phosphodiesterase type 5 (PDE-5) inhibitors with increased rates of high-risk sexual behavior and HIV transmission in some individuals. AIM: A National Institute of Mental Health (NIMH)-funded, multidisciplinary conference was convened to evaluate scientific research, clinical and ethical considerations, and public policy implications of this topic. MAIN OUTCOME MEASURES: Published and unpublished findings on effects of PDE-5 inhibitors on sexual behavior; published guidelines and management recommendations. METHODS: Leading investigators in relevant disciplines (e.g., public health, epidemiology, medical ethics, urology, psychology) participated in a 2-day meeting, including representatives of government, scientific, and regulatory agencies (the Centers for Disease Control, Food and Drug Administration, NIMH, and the National Institute on Drug Abuse). Panelists provided critical reviews of substantive areas of research, followed by question and answer sessions on each topic. On the second day, working groups were convened to identify critical gaps and priorities in three major areas: (i) research and evaluation needs; (ii) prevention strategies and clinical management issues; and (iii) policy and prevention implications. RESULTS: Research needs and priorities were categorized into four specific areas: (i) basic and clinical/laboratory research; (ii) epidemiology and risk factors; (iii) social-behavioral processes and interventions; and (iv) prevention/policy and educational needs. Identified gaps in the available data include populations at risk (e.g., risk among heterosexuals, risk profiles among subpopulations of men who have sex with men) and the specific role of PDE-5 inhibitors in HIV seroconversion. Specific areas of emphasis were the need for safer sex counseling, comprehensive sexually transmitted infection (STI) screening and follow-up when indicated, avoidance of potentially dangerous drug interactions, and potential benefits of testosterone replacement for HIV-positive men with decreased androgen and other symptoms of hypogonadism. Conclusions. A conference was convened on the topic of PDE-5 inhibition and HIV risk. This "white paper" summarizes the findings of the conference and recommendations for future research.
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OBJECTIVE: To explore assisted reproductive technology (ART) programs' beliefs about and practices for screening program candidates for the use of ART services. DESIGN: An anonymous, self-administered, mailed questionnaire. SETTING: U.S. ART programs. PARTICIPANT(S): Directors of U.S. ART programs. MAIN OUTCOME MEASURE(S): Screening practices and beliefs, agreement with statements about screening rights and responsibility, information collected about candidates, and likelihood of turning away hypothetical candidates. RESULT(S): The majority of programs do not have a formal policy for screening candidates. The majority of program directors agree that they have a right and responsibility to screen candidates. On average, programs turn away 4% of candidates each year. The majority of programs report being very to extremely likely to deny treatment to the couples described in various scenarios, such as physical abuse, positive HIV status, and single parenthood. Significant variation was seen across programs in their likelihood of turning away various hypothetical candidates. CONCLUSION(S): There is substantial variation in ART programs' screening practices. These results highlight the need for increased debate over what constitutes inappropriate denial of access to services, and what are prudent, social, ethical, and medical judgments.
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In December 2002, a conference was held in Philadelphia to discuss public concerns about living organ transplantation with the goal of reaching a consensus about new strategies for such transplants. The conference was hosted by the Hospital of the University of Pennsylvania and the Center for Bioethics. A multidisciplinary group of leading experts and stakeholders was called to assess the current status of living donation and suggest productive changes to ensure safer and more ethically sound procedures for both donors and recipients. Prior to the meeting, the research team from the University of Pennsylvania, Center for Bioethics, conducted literature reviews and extensive background research on living organ transplantation. Summary briefs were prepared for all conference participants. Issues were divided into four subcategories; two or three experts led the discussion on each topic. At the conclusion of the conference, the points raised were summarized and discussed, and additional comments were offered before general agreement was reached on each subject. Transcribed minutes and summary statements were reviewed and circulated among participants to allow for additional comments and clarification. All feedback was incorporated into the statement, and a draft of the article was recirculated. Participants who have endorsed the following statements have agreed that these points represent the intent and spirit of the discussion, yet each participant reserves the right to disclaim the document in its entirety. The views represented in the consensus points are held by members of the consensus group and do not necessarily represent the views of the sponsor. A consensus was reached to propose new strategies and make improvements on existing practices and protocols. Specific attention was paid to the widely accepted needs of consistent and responsible communication with the public and press, standardization in donor assessment, a national living donor registry and new research focusing on larger sample numbers and long-term donor follow-up. These consensus points support the work carried out by other advisory transplant organizations and should assist in advocating for living organ donors, the live donor transplant process and the concerns of the public.
Improvement in policy for the management of scientific misconduct has been slow. While assurance of due process at the ORI level is now in place, similar protections at the institutional level and institutional responsibility for further oversight and a workplace where the responsible conduct of research can be practiced have not yet been addressed. In contrast, policy regarding human subject protection has evolved rapidly to reflect firmer norms, with decisive priority given to subject protection over scientific or social needs. Perhaps because scientific misconduct policy has the potential to harm the careers of individual scientists and harms to individual subjects are thought to be indirect, the scientific community has been successful in blocking every move toward testing more rigorous regulation. The mantras that scientists can discipline their own, and the price of competitive science is some level of scientific misconduct are not persuasive. The standards by which science is judged should not be an exception to those governing others who deal with the public's money and have a duty to the public interest.
While the Holocaust is often placed at the genesis of bioethics, this relatively young field has not yet seriously explored the conduct of German scientists and physicians involved in the human subjects experiments of the Holocaust. We comfort ourselves with the beliefs that the individuals involved in the events of the Holocaust were mad or evil and unlike other scientists and physicians. Yet the evidence is that these professionals were educated and capable members of a technologically sophisticated society who believed they were somehow behaving morally within the context of their social-political situation. The first defendants at Nuremberg were physicians and public health officials. An examination of the trial transcripts provides data about what motivated these medical scientists to engage in human experimentation and mass murder and the extent to which ethics rationales were given for unparalleled moral wrong-doing in biomedicine. Bioethics must still address these beliefs and subject them to close scrutiny.
BACKGROUND: The moral status of the human embryo is particularly controversial in the United States, where one debate has centered on embryos created in excess at in vitro fertilization (IVF) clinics. Little has been known about the disposal of these embryos. METHODS: We mailed anonymous, self-administered questionnaires to directors of 341 American IVF clinics. RESULTS: 217 of 341 clinics (64 percent) responded. Nearly all (97 percent) were willing to create and cryopreserve extra embryos. Fewer, but still a majority (59 percent), were explicitly willing to avoid creating extras. When embryos did remain in excess, clinics offered various options: continual cryopreservation for a charge (96 percent) or for no charge (4 percent), donation for reproductive use by other couples (76 percent), disposal prior to (60 percent) or following (54 percent) cryopreservation, and donation for research (60 percent) or embryologist training (19 percent). Qualifications varied widely among those personnel responsible for securing couples' consent for disposal and for conducting disposal itself. Some clinics performed a religious or quasi-religious disposal ceremony. Some clinics required a couple's participation in disposal; some allowed but did not require it; some others discouraged or disallowed it. CONCLUSIONS: The disposal of human embryos created in excess at American IVF clinics varies in ways suggesting both moral sensitivity and ethical divergence.
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Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated.
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