Showing papers in "AJOB empirical bioethics in 2018"
TL;DR: This model offers a conceptual basis for the design of tailored interventions that target specific groups to promote trust of individual researchers and research institutions as well as to facilitate broader research participation.
Abstract: Background: To promote justice in research practice and rectify health disparities, greater diversity in research participation is needed. Lack of trust in medical research is one of the most signi...
84 citations
TL;DR: It is found that media portrayals of SEF pivot away from the ethical principle of nonmaleficence centered in the ASRM decision to discourage SEF, and highlight an issue of justice that can be remedied through the offer ofSEF as a workplace benefit.
Abstract: In 2012, the American Society for Reproductive Medicine (ASRM) lifted the experimental label on oocyte preservation, but cautioned against women using it to avoid age-related infertility, known as social egg freezing (SEF) In 2014, Facebook and Apple announced that they would offer SEF as a workplace benefit Within the context of a rapidly growing market for SEF, we were interested in how these two decisions affected media discussions, given that such discourse can strongly influence public perceptions and behaviors We used a content analysis methodology to code 138 articles published in US newspapers and magazines between 2012 and 2015 Focusing on a financial concern over the cost of SEF and the lack of insurance for SEF, we found that media portrayals of SEF pivot away from the ethical principle of nonmaleficence centered in the ASRM decision to discourage SEF Instead, they highlight an issue of justice that can be remedied through the offer of SEF as a workplace benefit Overall, media portrayals of SEF paint a simplistic and rosy picture that more options, especially more reproductive and economic options, automatically enhance women's autonomy
25 citations
TL;DR: Findings indicate that full transparency of financial pCoI should become a standard practice among the authors of biomedical educational materials and this information is not disclosed to readers.
Abstract: Background: Textbooks are a formative resource for health care providers during their education and are also an enduring reference for pathophysiology and treatment. Unlike the primary literature a...
23 citations
TL;DR: The motivations and interests shaping secondary findings reporting policies for clinical exome sequencing are investigated and offer a compelling example of standardization as a complex process that rarely leads simply to uniformity of practice.
Abstract: Background: Increasingly used for clinical purposes, genome and exome sequencing can generate clinically relevant information that is not directly related to the reason for testing (incidental or s...
22 citations
TL;DR: In this paper, the authors study the relation between contemporary normative Muslim ideas on assisted suicide and voluntary euthanasia and real-world views and attitudes of Muslims living in Belgium on the other hand.
Abstract: In the context of the Belgian debates on end-of-life care, the views of Muslims remain understudied. The aim of this article is twofold. First, we seek to document the relation between contemporary normative Muslim ideas on assisted suicide and voluntary euthanasia on the one hand and real-world views and attitudes of Muslims living in Belgium on the other hand. Second, we aim to identify whether a shift is observable in the views and attitudes regarding active termination of life between first- and second-generation Muslims. We have observed that when dealing with these bioethical issues, both first- and second-generation Muslims adopt a theological line of reasoning similar to the one that can be found in normative Islamic views. We have found an absolute rejection of every act that deliberately terminates life, based upon the unconditional belief in an afterlife and in God's sovereign power over life and death.
20 citations
TL;DR: It is argued for nuanced considerations of both race and genetic ancestry across research and care settings as genomics is translated into the practice of precision medicine and as learning health care systems offer continued improvements in care through integrated research.
Abstract: Over the past decade, the proliferation of genetic studies on human health and disease has reinvigorated debates about the appropriate role of race and ancestry in research and clinical care. Here ...
20 citations
TL;DR: This systematic review provides a synthesis of the empirical data reporting the ethical issues surrounding decisions made by research proxies, and the development of a conceptual framework of proxy decision-making for research.
Abstract: Background: Research involving adults lacking mental capacity relies on the involvement of a proxy or surrogate, although this raises a number of ethical concerns Empirical studies have examined attitudes towards proxy decision-making, proxies’ authority as decision-makers, decision accuracy, and other relevant factors However, a comprehensive evidence-based account of proxy decision-making is lacking This systematic review provides a synthesis of the empirical data reporting the ethical issues surrounding decisions made by research proxies, and the development of a conceptual framework of proxy decision-making for research Methods: A systematic review was conducted according to PRISMA guidelines Databases including MEDLINE, EMBASE, and CINAHL were searched using a combination of search terms, and empirical data from eligible studies were retrieved The review followed the framework synthesis approach to refine and develop a conceptual framework Results: Thirty-four studies were included in the review Two dimensions of proxy decision-making emerged The ethical framing criteria of decision-making used by proxies: use of a substituted judgement, use of a best interests approach, combination of substituted judgement and best interests, and ‘something else’, and the active elements of proxy decision-making: ‘knowing the person’, patient-proxy relationship, accuracy of the decision, and balancing risks, benefits and burdens, and attitudes towards proxy decision-making Interactions between the framing criteria and the elements of decision-making are complex and contextually-situated Conclusions: The findings from this systematic review challenge the accepted reductionist account of proxy decision-making Decision-making by research proxies is highly contextualized and multifactorial in nature The choice of proxy and the relational features of decision-making play a fundamental role: both in providing the proxy’s authority as decision-maker, and guiding the decision-making process The conceptual framework describes the relationship between the framing criteria used by the proxy, and the active elements of decision-making Further work to develop, and empirically test the proposed framework is needed
19 citations
TL;DR: The experiences of children participating in research at a site that integrates research and clinical care are described, including aspects of the research process and particular experiences as benefits and others as burdens.
Abstract: Background: Participation in research is associated with benefits and burdens for individual research participants. Children living with a chronic illness are considered particularly vulnerable as ...
17 citations
Cincinnati Children's Hospital Medical Center1, University of Cincinnati2, University of Louisville3, Northwestern University4, Marshfield Clinic5, University of Washington6, Seattle Children's7, Icahn School of Medicine at Mount Sinai8, National Institutes of Health9, Kaiser Permanente10, University of Minnesota11, Mayo Clinic12, Vanderbilt University13, Harvard University14
TL;DR: A large, experimental survey of patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups, and identified factors associated with willingness.
Abstract: Background: The factors influencing parents’ willingness to enroll their children in biobanks are poorly understood This study sought to assess parents’ willingness to enroll their children, and t
16 citations
TL;DR: Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming, and that federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.
Abstract: The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.
16 citations
TL;DR: This study shows that people who share their genetic data publicly online—far from being insensitive to privacy risks—have a complex understanding of the social, relational, and contextual nature of genetic privacy.
Abstract: This study reports on 13 semistructured in-depth interviews to qualitatively explore the experiences of individuals who publicly shared their direct-to-consumer genetic testing results on t...
TL;DR: A qualitative study to explore the perceptions, values, and preferences of pregnant women and their partners about NIPT and examine how these values and perceptions influence reproductive autonomy and decision making in relation to NipT in these two different cultural settings, Lebanon and Quebec.
Abstract: Noninvasive prenatal testing (NIPT), based on the detection of cell-free fetal DNA in maternal blood, has transformed the landscape of prenatal care by offering clinical benefits (noninvasive, high specificity and sensitivity, early detection of abnormalities) compared to existing prenatal screening tests. NIPT has expanded rapidly and is currently commercially available in most of the world. As NIPT spreads globally, culturally sensitive and ethically sound implementation will require policies that take into consideration the social and cultural context of prenatal testing decisions. In a Western context, the main ethical argument for providing access and public funding of prenatal tests is the promotion of reproductive autonomy (also referred to as "procreative liberty" and "reproductive freedom"), by enabling pregnant women and couples to access information about the fetus in order to choose a certain course of action for pregnancy management (continuation of pregnancy and preparation for birth or termination). So how is the framework of reproductive autonomy operationalized in non-Western cultural contexts? We used Quebec, Canada, and Beirut, Lebanon, for case studies to explore what ethical considerations related to reproductive autonomy should guide the implementation of the test in various cultural contexts. To answer this question, we conducted a qualitative study to (1) explore the perceptions, values, and preferences of pregnant women and their partners about NIPT and (2) examine how these values and perceptions influence reproductive autonomy and decision making in relation to NIPT in these two different cultural settings, Lebanon and Quebec. Our findings may guide health care professionals in providing counseling and in helping women and their partners make better informed prenatal testing decisions. Further, at a policy level, such understanding might inform the development of local guidelines and policies that are appropriate to each context.
TL;DR: The wider public appears to think that crossing the line from treatment to enhancement with tDCS would not be in a child's best interests, and an important alternative interpretation of the results is that lay people may be willing to use enhancers that matched their preference for “natural” enhancers.
Abstract: Background: Transcranial direct current stimulation (tDCS) is an experimental brain stimulation technology that may one day be used to enhance the cognitive capacities of children. Discussion about...
TL;DR: A desire among trainees for enhanced practical ethics training in preparation for the clerkship phase of medical education is found, and several strategies are recommended that can begin to address these findings.
Abstract: Background: It has been widely reported that medical trainees experience situations with profound ethical implications during their clinical rotations. To address this, most U.S. medical schools in...
TL;DR: An empirical study to explore clinician and lay opinions on the acceptability of physician paternalism found the doctor withholding surgery was more acceptable when prognosis was certain to be poor.
Abstract: We conducted an empirical study to explore clinician and lay opinions on the acceptability of physician paternalism. Respondents read a vignette describing a patient with brain hemorrhage facing urgent surgery that would be lifesaving but would result in long-term severe disability. Cases were randomized to show either low or high surrogate distress and certain or uncertain prognosis, with respondents rating the acceptability of not offering brain surgery. Clinicians (N = 169) were more likely than nonclinicians (N = 649) to find the doctor withholding surgery acceptable (30.2% vs. 11.4%, p ≤ 0.001). Among clinicians, the doctor withholding surgery was more acceptable when prognosis was certain to be poor (odds ratio [OR] 2.04, 95% confidence interval [CI] 1.04, 4.01). There was no effect of surrogate distress on clinician ratings. Responses among lay public were more variable. Given the differences in attitudes across clinicians and lay public, there is an ongoing need to engage stakeholders in the process of end-of-life decision making.
TL;DR: In this article, phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants, and adverse events (AEs) are collected in part through pa...
Abstract: Background: Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through pa...
TL;DR: Differences are found between the academic literature and public comments among all themes, except for personal responsibility, which reveals some of the similarities and discrepancies in how philosophical issues associated with psychiatric treatments are discussed in professional circles and among the public.
Abstract: Background: Psychiatric interventions are a contested area in medicine, not only because of their history of abuses, but also because their therapeutic goal is to affect emotions, thoughts, beliefs...
TL;DR: It is argued that while building and maintaining trusting relationships in research is important—not least in developing countries—strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out.
Abstract: Background: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, howeve...
TL;DR: The majority of biospecimen donors stated they should not be paid for tissue bank participation, however, a minority believe they should bepaid for donating tissue if the tissue is used in revenue-generating projects, providing some support for the current biobanking practice of not providing compensation.
Abstract: Background: The purpose of this study was to determine whether biospecimen donors believe they should receive compensation. This is the first study to report biospecimen donors' views on compensati...
TL;DR: Examining why anonymity matters to stakeholders will be helpful in devising strategies to successfully implement identity-release options as gamete donation increasingly moves away from the practice of anonymity.
Abstract: Background: Anonymity remains the more common practice in gamete donations, but legislation prohibiting anonymity with a goal of protecting donor-conceived children’s right to know their genetic or...
TL;DR: Assessment of how New Zealand RECs weigh the potentially competing goals of enabling research and protecting patients’ rights found IRB/REC members have rich experience of moral reasoning regarding research ethics, especially in areas where the official guidance is underdeveloped.
Abstract: Purpose: Secondary use of clinical tissue and data is an increasingly important platform for health research. Many jurisdictions allow research ethics committees (RECs) or institutional review boar...
TL;DR: TheBioethics publishing community needs to develop robust policies for authors, peer reviewers, and editors and these should be made publicly available to enhance academic and public trust in bioethics scholarship.
Abstract: Background: In biomedical research, there have been numerous scandals highlighting conflicts of interest (COIs) leading to significant bias in judgment and questionable practices. Academic institut...
TL;DR: Medical students' willingness to approach or report a provider for a risky or unprofessional behavior is influenced by the type of health care provider in question.
Abstract: The bioethics literature lacks findings about medical students' attitudes toward reporting risky behaviors that can cause error or reduce the perceived quality of health care. A survey was administered to 159 medical students to assess their likelihood to directly approach and to report various providers-a physician, nurse, or medical student-for three behaviors (poor hand hygiene, intoxication, or disrespect of patients). For the same behavior, medical students were significantly more likely to approach a classmate, followed by a nurse and then a doctor (p < .0001), to ask for behavioral modification. Across all three health care provider types, medical students were most likely to report intoxication (p < .0001). Medical students' willingness to approach or report a provider for a risky or unprofessional behavior is influenced by the type of health care provider in question. Medical schools should implement patient safety curricula that alleviate fears about reporting superiors and create anonymous reporting systems to improve reporting rates.
TL;DR: Physicians were nearly evenly divided regarding whether they should help control societal costs when caring for individual patients, but a strong majority agreed that physicians should refuse costly interventions that have little chance of benefit.
Abstract: Background: Recent campaigns (e.g., the American Board of Internal Medicine Foundation’s Choosing Wisely) reflect the increasing role that physicians are expected to have in stewarding health care ...
TL;DR: This is one of the first studies to document short-term impacts of a theatrical performance on both attitudes and behavioral intentions toward research ethics and clinical research participation and there were significant declines for trust in medical researchers.
Abstract: OBJECTIVE This study assessed the short-term impact of the play "Informed Consent" by Deborah Zoe Laufer (a fictionalized look at the controversy over specimens collected from the Havasupai Tribe for diabetes research in 1989) on perceptions of trust, willingness to donate biospecimens, and attitudes toward harm and privacy among the medical and undergraduate students, faculty, and the public in the Intermountain West. METHODS Surveys were administered before and after a staged reading of the play by professional actors. Survey items included the short form Trust in Medical Researchers, and single-item questions about group identity, ethics of genetic testing in children, and willingness to donate biospecimens. In addition, respondents were given the option to answer open-ended questions through e-mail. RESULTS Out of the 481 who attended the play, 421 completed both the pre and post surveys, and 166 participants completed open-ended questions online approximately 1 week after the play. Across all participants, there were significant declines for trust in medical researchers and for the survey item "is it ethical for investigators to test children for adult onset diseases" (p < .001 for both) following the play. There was a significant increase in agreement to improve group identity protections (p < .001) and there were no differences on willingness to donate biospecimens to research (p = .777). Qualitative data provided extensive contextual data supporting these perspectives. DISCUSSION This is one of the first studies to document short-term impacts of a theatrical performance on both attitudes and behavioral intentions toward research ethics and clinical research participation. Future research should continue to explore the impact of theatrical performances among public and investigators on the ethical issues and complexities in clinical research.