Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral findings,? (...) or?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice. (shrink)

The National Institutes of Health and other federal health agencies are considering establishing a national biobank to study the roles of genes and environment in human health. A preliminary public engagement study was conducted to assess public attitudes and concerns about the proposed biobank, including the expectations for return of individual research results. A total of 141 adults of different ages, incomes, genders, ethnicities, and races participated in 16 focus groups in six locations across the country. Focus group participants voiced (...) a strong desire to be able to access individual research results. Recognizing the wide range of possible research results from a large cohort study, they repeatedly and spontaneously suggested that cohort study participants be given ongoing choices as to which results they received. (shrink)

When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their (...) report entirely on one individual faculty member and made no comment on the institution’s responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution’s critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability. (shrink)

Caring for critically ill and dying patients often triggers both professional and personal growth for physician trainees. In pediatrics, the neonatal intensive care unit is among the most distressing settings for trainees. We used longitudinal narrative writing to gain insight into how physician trainees are challenged by and make sense of repetitive, ongoing conflicts experienced as part of caring for very sick and dying babies. The study took place in a 45-bed, university-based NICU in an urban setting in the United (...) States. From November 2009 to June 2010 we enrolled pediatric residents and neonatology fellows at the beginning of their NICU rotations. Participants were asked to engage in individual, longitudinal narrative writing about their “experience in the NICU.” Thematic narrative analysis was performed. Thirty-seven physician trainees participated in the study. The mean number of narratives per trainee was 12; a total of 441 narratives were available for analysis. Conflict was the most pervasive theme in the narratives. Trainees experienced conflicts with families and conflicts with other clinicians. Trainees also described multiple conflicts of identity as members of the neonatology team, as members of the medical profession, as members of their own families, and as members of society. Physician trainees experience significant conflict and distress while learning to care for critically ill and dying infants. These conflicts often led them to question their own morals and their role in the medical profession. Physician trainees should be educated to expect various types of distress during intensive care rotations, encouraged to identify their own sources of distress, and supported in mitigating their effects. (shrink)