Background: UNAIDS guidelines require that participants in HIV prevention trials are provided with “state-of-the-art” risk reduction measures. Published data showing that new HIV prevention strategies are highly, but not completely, effective problematize “standard of prevention” packages that provide access to condoms and counseling only. This qualitative study asks how principal investigators on HIV prevention studies determine appropriate standards of prevention. It builds on previous work mapping standards of care in HIV prevention trials by investigating how decisions were arrived at, in addition to reporting what was decided. Methods: Semistructured interviews were conducted with 14 principal investigators of biomedical HIV prevention trials. Interviews were transcribed, coded, and analyzed thematically using predetermined categories derived from the ethics literature and spontaneous coding. Results: A spectrum of views was given by informants as to how standard of prevention should be determined, ranging from an ethical requirement to include newly validated technologies as soon as feasible, to a perceived need to reduce the prevention package to make it more like real life, thus enabling subsequent trials to test interventions against basic prevention packages. Each informant argued her position with reference to keeping the size and cost of studies reasonable, the need for conclusive data on the effectiveness of preventive interventions, perceived duties to trial participants, and regulatory requirements. Some saw reconsent as the critical issue in ongoing trials when relevant data from other studies were released. Conclusions: There was no ethical consensus about the standard of prevention among principal investigators. Rational arguments were made to support disparate positions. These results suggest a need to examine and articulate the ways that the narrow aims and obligations of a research study sit within the broader context of disease burden and inequitable access to health care in the resource-poor world in order to address how future research should proceed.

Background: The role of front-line researchers, those whose responsibilities include face-to-face contact with participants, is critical to ensuring the responsible conduct of community-based drug use research. To date, there has been little empirical examination of how front-line researchers perceive the effectiveness of ethical procedures in their real-world application and the moral stress they may experience when adherence to scientific procedures appears to conflict with participant protections. Methods: This study represents a first step in applying psychological science to examine the work-related attitudes, ethics climate, and moral dilemmas experienced by a national sample of 275 front-line staff members whose responsibilities include face-to-face interaction with participants in community-based drug-use research. Using an anonymous Web-based survey we psychometrically evaluated and examined relationships among six new scales tapping moral stress (frustration in response to perceived barriers to conducting research in a morally appropriate manner); organizational ethics climate; staff support; moral practice dilemmas (perceived conflicts between scientific integrity and participant welfare); research commitment; and research mistrust. Results: As predicted, front-line researchers who evidence a strong commitment to their role in the research process and who perceive their organizations as committed to research ethics and staff support experienced lower levels of moral stress. Front-line researchers who were distrustful of the research enterprise and frequently grappled with moral practice dilemmas reported higher levels of moral stress. Conclusion: Applying psychometrically reliable scales to empirically examine research ethics challenges can illuminate specific threats to scientific integrity and human subjects protections encountered by front-line staff and suggest organizational strategies for reducing moral stress and enhancing the responsible conduct of research.

Background: Information-sharing practices, disposition of oocytes, and embryo management are at the discretion of the individual assisted reproductive technology (ART) program, donors, and recipients. Ideally, these practices and policies should reflect the information and decision-making needs of the people involved. The ART program that was the focus of this study has incorporated pre- and postdonation discussion of oocyte and embryo disposition into the screening and follow-up processes to improve overall satisfaction. To improve programmatic policy, we assessed how these discussions and the informed consent process were reflected in oocyte donors’ legal contracts. Methods: This retrospective chart review (n = 55) was designed to identify and assess discrepancies between donors’ consented preferences and their executed legal agreements with oocyte recipients. Results: Sixty-three percent of donors had legal contracts that were inconsistent with their medical informed consent. Of this group, 58% agreed with the intended parents’ desires for contact and disposition, resulting in a shift to a position that was more amenable than their signed consent. In contrast, 42% refused to change their desire as expressed in the signed consent, rejecting the intended parents’ request. Most of the differences were around embryo donation, disposition, or donation for research. Seventeen percent of donors were unwilling to allow disclosure of a medical–genetic issue if identified in an offspring. Conclusions: It is imperative for donor coordinators, agency managers, physicians, psychologists, and attorneys to recognize that such discrepancies may occur. These discrepancies may be a sign of duress, manipulation, or anxiety in donors. Alternatively, donors may become clear about their desires and advocate for them as they learn more about the personal implications of their donation through discussions with mental health and legal professionals. Effective communication for all parties is fundamental to create a circle of communication that connects physicians, attorneys, and psychologists and supports donor and recipient decision making.

Background: In Brazil, all studies involving human beings must be evaluated by an institutional review board (IRB) registered with the National Commission for Ethics in Research (CONEP), the entity responsible for coordinating all IRBs in the country. Methods: In 2007, a broad quantitative evaluation of Brazilian IRBs was carried out, followed by a qualitative component conducted using a semistructured interview technique during the last three months of 2008. Twenty IRBs situated in five geographical regions of the country and located within different social and institutional contexts were selected. Eighty interviews were conducted. Results: In general, the functioning of all the IRBs was similar. Problems were found related to the infrastructure provided for their work and noncompliance with the Resolution 196/96 recommendation that IRB members be given time off from their normal duties for their work with the IRB. The research protocols were usually evaluated by only one or two members. It was mentioned that investigators tended to be resistant to sending their projects for evaluation and to challenging the reports issued. In general, the IRBs did not follow up on the studies that they approved because they lacked the means to be able to do so. Conclusions: Although a large network of IRBs has been created in Brazil, many of these IRBs confront serious difficulties in attempting to comply with the regulations established by the National Health Council (NHC), which may affect the ability of some IRBs to fulfill their role.

The creation of savior siblings has been the subject of intense ethical debate over the past decade. While ethical concerns might provide clinicians with valid reasons for not providing these clinical services, we suggest that it is more difficult to make a case for physicians not disclosing to the parents of sick children under their care the option of creating a savior sibling. We “test” the ethical objections to savior siblings empirically and conclude that they rely heavily on unsound theoretical or speculative arguments and inappropriately scrutinize parental motives for having children. We contend that empirical evidence makes this moral frame increasingly tendentious, and that debate about savior siblings should be reframed as debate about the ethics of nondisclosure.

This article draws on a subset of data from an empirical study supported by the National Science Foundation. The study explored how institutional review boards (IRBs) fulfill their obligations to oversee research that involves human subjects. The subset of data is used to discuss two themes that shed light on how IRBs approach issues that may have a bearing on protection of human subjects but that are not well covered by federal regulatory guidance. The authors conducted 40 semistructured, key informant interviews, over a 1-year period, with members of various types of IRBs, including independent, academic/university, hospital, medical school, and community/tribal IRBs. Among the 40 participants, there were 16 chairs (president, administrator) and 24 members, and 17 males and 23 females; most had served as IRB members for more than 5 years. The data from this study indicate that fulfillment of the IRBs’ oversight responsibilities may be undermined by a lack of regulatory guidance as to how much information should be disclosed to the IRB and to research participants about: (a) the purpose of a study including commercial purposes and (b) researcher/institutional compensation. The data suggest that without adequate regulatory guidance, IRBs may be meeting the letter but not the spirit of the federal regulations. The lack of regulatory guidance with respect to these two issues limits the extent to which IRBs can assess the adequacy of the consent process, the effectiveness of the IRB in performing oversight responsibilities, and optimal protection of human subjects.

In the pantheon of potential medical cure-alls, stem-cell therapy has enjoyed a long and storied existence in the public imagination. Widely believed to be one of the most promising avenues for tre...

Little research has been carried out to determine the attitudes of palliative care professionals to euthanasia. This research aimed to find out how Flemish palliative care nurses and physicians think about euthanasia. An anonymous questionnaire was sent to all physicians (147) and nurses (589) employed in palliative care teams and institutions in Flanders (Belgium). The questionnaire contained a demographic part, and an attitudinal part, consisting of a long series of ethical statements using a 5-point Likert-scale. Four hundred fifteen nurses (response rate 70.5%) and 99 physicians (67.3%) responded. A cluster analysis of the euthanasia questions resulted in three clusters: (moderate) opponents of euthanasia (n = 105, 23%), moderate advocates of euthanasia (n = 161, 35.2%), and staunch advocates of euthanasia (n = 191, 41.8%). A majority in all clusters believe that as soon as a patient experiences the benefits of good palliative care, most requests for euthanasia disappear and that all palliative care alternatives must be tried before a euthanasia request can be considered. Being a member of the cluster of the (moderate) opponents of euthanasia is associated with being male (p = .01), being older (p = .05), increasing years of experience in palliative care (p = .02), and being a physician (p = .02). Since most Flemish palliative care nurses and physicians are not absolutely against voluntary euthanasia, their attitudes seem to differ from the attitudes of their palliative care colleagues elsewhere. However, the attitudes of the Flemish palliative care nurses and physicians are largely contextual. For a very large majority, euthanasia is an option of last resort only.