We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...) In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

Bioethics, Volume 36, Issue 3, Page 313-317, March 2022.

It is unclear whether the regulatory distinction between non-identifiable and identifiable information—information used to determine informed consent practices for the use of clinically derived samples for genetic research—is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know (...) about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario. Curiosity-based reasons were the most common among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples. (shrink)

Background: The parent of a child with profound cognitive disability will have complex decisions to consider throughout the life of their child. An especially complex decision is whether to place a tracheotomy to support the child’s airway. The decision may involve the parent wanting a tracheotomy and the clinician advising against this intervention or the clinician recommending a tracheotomy while the parent is opposed to the intervention. This conflict over what is best for the child may lead to a bioethics (...) consult. Objective: The study explores the conflicts that may arise around tracheotomy placements. Research design: This study is a retrospective cohort study of pediatric patients for whom a tracheotomy decision required a bioethics consult. Participants and research context: Pediatric patients aged birth to 18 years old with a bioethics consult for a tracheotomy decision conflict between April 2010 and December 2016. A standardized data collection tool was used to review notes entered by the palliative care team, social workers, primary clinical team interim summaries, and the bioethics consult service. Ethical considerations: The study was reviewed and approved by the medical center’s institutional review board. Results: There were 248 clinical bioethics consults during the identified study period. There were 31 consults involving 21 children where the word tracheotomy was mentioned in the consult, and 13 of the 21 consults were for children with profound cognitive disability. Discussion and conclusion: Clinicians need to be aware of their own biases when discussing a child’s prognosis and treatment options while also understanding the parents’ values and what the parent might consider to be burdensome in the care of their child and the acceptable burden for the child to experience. (shrink)

Research ethics consultation is increasingly recognized as a potentially valuable mechanism for addressing the depth and breadth of ethical issues that arise in research related to human health and well-being. However, fundamental questions remain, including: What is “research ethics consultation”? And what is its justification beyond the purposes already served by existing entities? We examine how a research ethics consultation service may differ from or complement the role of an institutional review board by offering a definition of research ethics consultation (...) and by exploring the potential scope of a consultation service in terms of types of clients served, questions addressed, and advice provided at various stages of the research process. We then consider the relationship between research ethics consultation services and IRBs, as well as the issues that may arise between them, including possible conflicts of interest. (shrink)

We face significant challenges in the translation of basic biomedical research into meaningful improvements in patients' health, moving research from “bench to bedside.” The federal government's ne...

In this issue, Greer Donley, Sara Chandros Hull, and Benjamin E. Berkman explore the implications of using whole genome sequencing in the prenatal context. They focus on how whole genome sequencing may refine pregnancy expectations, impact child‐rearing decisions, and foreclose children's desire not to know more about their future. Their paper inspired me to reimagine the predominant worldviews of genomics prediction. One worldview is characterized by woe: the world as we know it will be forever changed unless we avoid the (...) perils of genomics. I found myself thinking of this as the Eeyore phenotype. The Tigger phenotype is a worldview characterized by confidence: the world as we know it is forever changed, and we should embrace our genomic future. Donley, Hull, and Berkman adopt a new phenotype, one that perhaps resembles Christopher Robin. This worldview is characterized by its commitment to moving forward, nurturing relationships, and deliberating thoughtfully: it applies the evidentiary model to whole genome sequencing. Like Christopher Robin, who accepted that growing up was inevitable, the authors appreciate that progress is inevitable. Their response is to offer recommendations for research that might help the Eeyores and Tiggers find common ground. (shrink)

Bioethicists teaching and writing about the uses of prenatal genetic testing sometimes use “difficult cases” in which people with a disability want to test and select for the presence of their disability. Such cases challenge our stereotypes but also play into them.

It is unclear whether the regulatory distinction between non-identifiable and identifiable information—information used to determine informed consent practices for the use of clinically derived samples for genetic research—is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know (...) about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario. Curiosity-based reasons were the most common among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples. (shrink)

Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in (...) substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies. (shrink)

The idea of patient advocacy as a function of clinical ethics consultation (CEC) has been debated in the bioethics literature. In particular, opinion is divided as to whether patient advocacy inherently is in conflict with the other duties of the ethics consultant, especially that of impartial mediator. The debate is complicated, however, because patient advocacy is not uniformly conceptualized. This article examines two literatures that are crucial to understanding patient advocacy in the context of bioethical deliberations: the CEC literature and (...) the literature on advocacy in the social work profession. A review of this literature identifies four distinct approaches to patient advocacy that are relevant to CEC: (1) the best interest approach, (2) the patient rights approach, (3) the representational approach, and (4) the empowerment approach. After providing a clearer understanding of the varied meanings of patient advocacy in the context of CEC, we assert that patient advocacy is not inherently inconsistent with the function of the ethics consultant and the CEC process. Finally, we provide a framework to help consultants determine if they should adopt an advocacy role. (shrink)