Mark Yarborough

Interprofessional education in ethics at an academic health sciences center

The authors relate their experiences with interprofessional teaching of ethics at the University of Colorado Health Sciences Center, describing the history, planning, content, and structure of a required ethics course and discussing its role in the institutions plan to create more interprofessional education opportunities. The authors describe both the benefits of teaching ethics on an inter-professional basis and the challenges they encountered in launching the course. Challenges included responding to diverse and divergent faculty and student reactions, controlling a curriculum across schools, and learning how to think about education in interprofessional rather than profession-specific ways. Included in the discussion are the results obtained with various evaluation tools designed and assessed by the Office of Education on the campus, to which students and faculty responded the first time the course was offered.

Transforming the Culture of Biomedical Research From Compliance to Trustworthiness: Insights From Nonmedical Sectors

To discover ways that the biomedical research community can foster the publics trust essential to sustain the research enterprise, in 2005 the authors and their colleagues convened a group of national leaders from sectors outside of academic science and health care that are also dependent on the publics trust. These leaders provided information about what their sectors do to earn the publics trust that is applicable to academic biomedical research institutions, as well as insights into ways academic research institutions should respond to crises that have the potential to diminish the publics trust. The major strategies they identified for promoting the publics trust were the importance of fostering multiple types of relationships and developing accountability practices that exceed those required by external regulators. In this article, the authors compare these strategies with reports in the literature regarding efforts under way in health care to adapt strategies employed in other sectors to improve the safety of health care. On the basis of what the authors learned from both the national leaders outside of biomedical research and health care and the health care safety literature review, they present a set of recommendations for building and restoring trust, as well as a list of benchmarks for assessing the adequacy of efforts by research institutions to promote the publics trust in biomedical research.

Public trust and research a decade later: What have we learned since Jesse Gelsinger’s death?

Almost a decade has passed since the untimely death of Jesse Gelsinger. The reflections of Dr. Wilson and efforts made on a national scale to address various ethical issues in biomedical research provide an opportunity to consider what progress has been made in efforts to build and restore the publics trust in biomedical research. The restoration of public trust is especially critical in the aftermath of tragic events like Mr. Gelsingers death and the authors note the need for greater emphasis on building public trust than has occurred to date in the broader biomedical research community.

Newborn Screening and Cascade Testing for FMR1 Mutations

We describe an ongoing pilot project in which newborn screening (NBS) for FMR1 mutations and subsequent cascade testing are performed by the MIND Institute at the University of California, Davis Medical Center (UCDMC). To date, out of 3,042 newborns initially screened, 44 extended family members have been screened by cascade testing of extended family members once a newborn is identified. Fourteen newborns (7 males and 7 females) and 27 extended family members (5 males and 22 females) have been identified with FMR1 mutations. Three family histories are discussed in detail, each demonstrating some benefits and risks of NBS and cascade testing for FMR1 mutations in extended family members. While we acknowledge inherent risks, we propose that with genetic counseling, clinical follow‐up of identified individuals and cascade testing, NBS has significant benefits. Treatment for individuals in the extended family who would otherwise not have received treatment can be beneficial. In addition, knowledge of carrier status can lead to lifestyle changes and prophylactic interventions that are likely to reduce the risk of late onset neurological or psychiatric problems in carriers. Also with identification of carrier family members through NBS, reproductive choices become available to those who would not have known that they were at risk to have offspring with fragile X syndrome.

“Editing” Genes: A Case Study About How Language Matters in Bioethics

Metaphors used to describe new technologies mediate public understanding of the innovations. Analyzing the linguistic, rhetorical, and affective aspects of these metaphors opens the range of issues available for bioethical scrutiny and increases public accountability. This article shows how such a multidisciplinary approach can be useful by looking at a set of texts about one issue, the use of a newly developed technique for genetic modification, CRISPRcas9.

Continued Treatment of the Fatally Ill for the Benefit of Others

This paper examines the moral and professional issues present in cases involving continued treatment of fatally ill patients in order to benefit a third party. It is argued that such treatment can be justified in some cases from a moral point of view. Practical considerations make such cases difficult to identify at times. It is also argued on the other hand that professional concerns should rule out the permissibility of continuing such treatment. Thus, even though it may be morally permissible at times to continue treatment, it is not good medical practice to do so.

Informed trust and the financing of biomedical research.

manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health.1 Consequently, when medical institutions forge research collaborations with industry they should be mindful of the potential for these relationships to erode public confidence in the integrity of clinical research.2 Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers,3 scandals at the nation’s largest funder of biomedical research,4 and evidence of fabricated research findings in prominent medical journals.5 These unfortunate events have prompted many to reexamine strategies for managing industry relationships and the financial conflicts of interest they may create.6 In these discussions, three theses have emerged as integral elements of what we might call “the received view” regarding the management of financial conflicts of interest in clinical research. The first is that industry relationships are best managed through internal institutional policies, such as requiring investigators to disclose financial relationships to administrative officials, limiting investigator involvement in patient enrollment and other research activities, and imposing stiff sanctions on researchers who fail to reveal industry ties.7 The second is that institutional administrators or university compliance officials are best able to assess whether financial relationships may create conflicting interests that require management.8 The last is that successfully managing financial conflicts of interest is essential for preserving public confidence in the integrity of clinical research.9 Although the received view has gained wide acceptance and has rarely been challenged,10 we wish to suggest that these strategies for responding to public concern about the financing of clinical research are insufficient. We have argued elsewhere that the starting point for all institutional oversight policies pertaining to clinical research should be the promotion of informed trust between research institutions and the constituencies they purport to serve.11 Using this goal as our guide, we present a partnership-centered approach to managing financial conflicts of interest in clinical research. Unlike conventional strategies, the framework we develop places far less emphasis on regulatory compliance and disclosures of competing interests to administrative officials. Proceeding instead with the assumption that institutional policies on industry relationships should promote informed trust between clinical investigators and research volunteers, we argue that medical institutions must be far more transparent regarding the financing of biomedical research. Informed Trust and the Financing of Biomedical Research

Increasing Enrollment in Drug Trials: The Need for Greater Transparency About the Social Value of Research in Recruitment Efforts

“Clinical trials and the consequent benefits to society are in jeopardy in the United States because of a decline in the ability to recruit patients in a timely manner to trials addressing key clinical issues.”1 So states a recent commentary in a leading medical journal, reflecting widespread concern in the research community about recruiting sufficient numbers of people into clinical trials. Anyone who cares about medical progress should share this concern. What, then, is to be done about it? The authors, reflecting discussions at a US National Institutes of Health sponsored workshop convened to address recruitment challenges, call for, among other things, a “national campaign to increase public awareness and participation in clinical trials” in hopes that it will establish research participation “as a valued contribution to the general public.”1 Bolstering their call is scholarship contending that people have an obligation to participate in clinical research.2–4

Relationships hold the key to trustworthy and productive translational science: recommendations for expanding community engagement in biomedical research.

Good relationships between research institutions and communities are an essential, but often neglected, part of the infrastructure of translational science. In an effort to create greater interest among translational science researchers in cultivating relationships with community members, we report the results of a workshop we convened to learn how relationships vital to research are best created and sustained. We highlight common barriers and challenges that hinder relationships. We also provide recommendations that individual research institutions and teams can use to expand and strengthen their relationships with community members. The improved relationships between universities and communities that could result from their implementation should build greater public trust in biomedical research, lead to a stronger commitment to see it succeed, and engender shared values and commitments that will give rise to new rewards, recognition and admonishment to sustain those values and commitments over time, all of which would facilitate translational science.

On the dearth of philosophical contributions to medicine

A recent editorial in this journal calls for more philosophical work in the areas of philosophy of medical science and research methodology [1]. The purpose of the present paper is to bring to light and discuss some obstacles and opportunities for development in these areas. In section I, barriers to increased philosophical work in medicine outside ethics are discussed. In sections II and III, additional areas in medicine ripe for philosophical work are identified and discussed: (a) improving the epistemic fitness of much current clinical reasoning, (b) defining the conditions under which greater epistemic fitness can be achieved, and (c) technology assessment.