David Magnus

Strangers at the benchside: research ethics consultation.

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program.

Protecting Subjects' Interests in Genetics Research

Biomedical researchers often assume that sponsors, subjects, families, and disease-associated advocacy groups contribute to research solely because of altruism. This view fails to capture the diverse interests of many participants in the emerging research enterprise. In the past two decades, patient groups have become increasingly active in the promotion and facilitation of genetics research. Simultaneously, a significant shift of academic biomedical science toward commercialization has occurred, spurred by U.S. federal policy changes. The concurrent rise in both the roles that subjects play and the commercial interests they have presents numerous ethical challenges. We examine the interests of different research participants, finding that these interests are not addressed by current policies and practices. We conclude that all participants should be given a voice in decisions affecting ownership, access to, and use of commercialized products and services, and that researchers and institutions should negotiate issues relating to control of research results and the sharing of benefits before the research is performed.

The OHRP and SUPPORT

A group of medical ethicists and pediatricians asks for reconsideration of the recent Office for Human Research Protections decision about informed consent in SUPPORT.

Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing.

The goal of this study is to provide an ethical framework for clinicians and companies providing noninvasive prenatal testing using cell‐free fetal DNA or whole fetal cells.

Accepting Brain Death

The cases of Jahi McMath and Marlise Munoz have reopened public debate about brain death. But the law and ethics have long recognized that deferring to medical expertise regarding the diagnosis of brain death is the most reasonable way to manage the process of dying.

Use of neurodevelopmental delay in pediatric solid organ transplant listing decisions: Inconsistencies in standards across major pediatric transplant centers

Abstract:  Children with NDD present for organ transplant evaluation, but the role of NDD as a listing criterion itself is poorly described. Therefore, we sought to investigate how major pediatric solid organ transplant programs use NDD as a criterion in their listing decisions. We developed a survey that was sent via post to active pediatric solid organ transplant programs across the United States investigating transplant listing decision‐making for neurodevelopmentally delayed children. Respondents were medical/surgical directors and transplant coordinators. Descriptive statistics summarize the findings. Programs inconsistently use NDD in listing decisions. Thirty‐nine percent of programs stated that they “rarely” or “never” consider NDD in their decisions, whereas 43% of programs “always” or “usually” do. Sixty‐two percent of programs report that informal processes guide their use of NDD, and no programs describe their process as “formal, explicit, and uniform.” The degree of delay is an additional source of discordance among programs, with 14% of programs reporting mild or moderate NDD as a relative contraindication to listing and 22% reporting that NDD was “irrelevant” to the listing decision. The use of NDD in pediatric solid organ transplant listing decisions is varied and inconsistent across active programs.

Direct-to-consumer genetic tests: beyond medical regulation?

The availability of personalized genomic tests, ordered directly by consumers, is rapidly growing. These tests are unlike other genetic or biochemical tests in the sheer amount of data they provide, but interpretation of these genome-wide analyses for health remains uncertain because of the lack of information about environmental and other factors, and because for the vast majority of genetic loci the associations with disease are weak. Although these tests could provide value to customers by offering tools for social networking or genealogy, there are questions about whether and how to regulate these tests and about the extent to which they provide medical information.

Toward clinical genomics in everyday medicine: perspectives and recommendations

ABSTRACT Precision or personalized medicine through clinical genome and exome sequencing has been described by some as a revolution that could transform healthcare delivery, yet it is currently used in only a small fraction of patients, principally for the diagnosis of suspected Mendelian conditions and for targeting cancer treatments. Given the burden of illness in our society, it is of interest to ask how clinical genome and exome sequencing can be constructively integrated more broadly into the routine practice of medicine for the betterment of public health. In November 2014, 46 experts from academia, industry, policy and patient advocacy gathered in a conference sponsored by Illumina, Inc. to discuss this question, share viewpoints and propose recommendations. This perspective summarizes that work and identifies some of the obstacles and opportunities that must be considered in translating advances in genomics more widely into the practice of medicine.

Wrongful Termination: Lessons From the Geron Clinical Trial

Geron Corporation is a publically traded company that launched a phase I clinical trial of a human embryonic stem cell‐based therapy for spinal cord injury. The company enrolled the first patient in October 2010 and stopped the trial 1 year later. The fifth patient had been enrolled but not transplanted when the company announced the trials end. After discussions with clinical staff and family, an agreement was reached to add her to the cohort and proceed with the transplant. Two and half years later, the research is still waiting to restart. With this background in mind, we discuss the major ethical and social questions raised by the Geron case. We offer recommendations for institutional review boards and clinical sites as they deliberate approvals of early‐phase trials in frontier medicine.

Quality of communication in interpreted versus noninterpreted PICU family meetings.

Objectives:To describe the quality of physician-family communication during interpreted and noninterpreted family meetings in the PICU. Design:Prospective, exploratory, descriptive observational study of noninterpreted English family meetings and interpreted Spanish family meetings in the pediatric intensive care setting. Setting:A single, university-based, tertiary children’s hospital. Subjects:Participants in PICU family meetings, including medical staff, family members, ancillary staff, and interpreters. Interventions:Thirty family meetings (21 English and nine Spanish) were audio-recorded, transcribed, de-identified, and analyzed using the qualitative method of directed content analysis. Measurements and Main Results:Quality of communication was analyzed in three ways: 1) presence of elements of shared decision-making, 2) balance between physician and family speech, and 3) complexity of physician speech. Of the 11 elements of shared decision-making, only four occurred in more than half of English meetings, and only three occurred in more than half of Spanish meetings. Physicians spoke for a mean of 20.7 minutes, while families spoke for 9.3 minutes during English meetings. During Spanish meetings, physicians spoke for a mean of 14.9 minutes versus just 3.7 minutes of family speech. Physician speech complexity received a mean grade level score of 8.2 in English meetings compared to 7.2 in Spanish meetings. Conclusions:The quality of physician-family communication during PICU family meetings is poor overall. Interpreted meetings had poorer communication quality as evidenced by fewer elements of shared decision-making and greater imbalance between physician and family speech. However, physician speech may be less complex during interpreted meetings. Our data suggest that physicians can improve communication in both interpreted and noninterpreted family meetings by increasing the use of elements of shared decision-making, improving the balance between physician and family speech, and decreasing the complexity of physician speech.