There is little information about the content of ethics consultations in pediatrics. We sought to describe the reasons for consultation and ethical principles addressed during EC in pediatrics through retrospective review and directed content analysis of EC records at St. Jude Children's Research Hospital. Patient-based EC were highly complex and often involved evaluation of parental decision making, particularly consideration of the risks and benefits of a proposed medical intervention, and the physician's fiduciary responsibility to the patient. Nonpatient consultations provided guidance (...) in the development of institutional policies that would broadly affect patients and families. This is one of the few existing reviews of the content of pediatric EC and indicates that the distribution of ethical issues and reasons for moral distress are different than with adults. Pediatric EC often facilitates complex decision making among multiple stakeholders, and further prospective research is need.. (shrink)

This case is about a study of burn patients that included a request to the IRB for a waiver of consent for perianal specimen collection–a request which ultimately was not approved by a reviewing IR...

Genomic sequencing is becoming more common both in clinical practice and as a routine aspect of much research. Over the last 15 years there has been ongoing discussion about the implications of gen...

The rapid development of COVID-19 vaccines in 2020 involved an unprecedented clinical research initiative. The case here involves a Phase I clinical trial of “second-generation” COVID-19 vaccines d...

Volume 20, Issue 4, May 2020, Page 102-103.

Volume 19, Issue 10, October 2019, Page 97-98.

As medicine and science advance, new ethical questions emerge. Over time, deliberation and analysis result in a somewhat settled approach to a problem. Often the settled approach is based on group...

As part of the regulatory review process, both the Food and Drug Administration and Office for Human Research Protections (U.S. Department of Health and Human Services [HHS]...

Volume 20, Issue 10, October 2020, Page 82-83.

Volume 20, Issue 4, May 2020, Page 111-113.

Volume 20, Issue 4, May 2020, Page 106-108.

Volume 20, Issue 10, October 2020, Page 90-91.

The authors of this article are previous or current members of the Clinical Ethics Consultation Affairs (CECA) Committee, a standing committee of the American Society for Bioethics and Humanities (ASBH). The committee is composed of seasoned healthcare ethics consultants (HCECs), and it is charged with developing and disseminating education materials for HCECs and ethics committees. The purpose of this article is to describe the educational research and development processes behind our teaching materials, which culminated in a case studies book called (...) A Case-Based Study Guide for Addressing Patient-Centered Ethical Issues in Health Care (hereafter, the Study Guide). In this article, we also enumerate how the Study Guide could be used in teaching and learning, and we identify areas that are ripe for future work. (shrink)

For many rare diseases, the availability of effective interventions is limited or non-existent. In this context, clinical research evaluating emerging interventions may be the only potentially “the...

Volume 19, Issue 11, November 2019, Page 39-41.

Informed Consent: What Must Be Disclosed and What Must Be Understood seeks to challenge the “standard view” of consent. It seeks to do so by segregating the “disclosure function” from the “understa...

Volume 20, Issue 4, May 2020, Page 8-10.

Volume 20, Issue 8, August 2020, Page 46-49.

The American Journal of Bioethics, Volume 12, Issue 10, Page 18-20, October 2012.

While we agree with Fiester and Yuan (2023) that ethicists should not execute behavioral agreements in their role as clinical consultants along with many of the authors’ criticisms of such contract...

This research calls for attention to complexity theory and the integration of complexity methodologies in policy research. A complexity approach in research practice requires a systems worldview and recognition of non-linearity, networks, self-organization, emergence, and feedback in policy. Simply, if a phenomenon is complex and can be explored from varied contexts and scales, the conceptual frame, and the methodical approach should be able to address the complexity. Complexity science has the capacity to account for complexity in varied contexts, on varied (...) scales, and with an interrelated and interdependent environment. Further, if policy systems are at times simple, complicated, complex, and chaotic, then complexity mythologies combined with traditional qualitative and quantitative methods can bring to light the workings of the elusive black box. Complexity allows for triangulation of both linear and non-linear methodologies integrating qualitative, quantitative, network analysis, and agent-based models, as well as other methodologies. Complexity science is not the panacea to solve all policy problems with perfection. But if you do not acknowledge the complexity you will be missing out on the opportunity to shape patterns of sustainability, to effectively manage complex policy problems to someday solve them. (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)

Currently, there is consensus that community engagement and partnerships are essential to inclusive patient-centered clinical research. Yet there is variation about what it means to do this well an...