Family and transplant professionals' views of organ recovery before circulatory death for imminently dying patients: A qualitative study using semistructured interviews and focus groups.

Donation before circulatory death for imminently dying patients has been proposed to address organ scarcity and harms of nondonation. To characterize stakeholder attitudes about organ recovery before circulatory death we conducted semistructured interviews with family members (N = 15) who had experienced a loved one's unsuccessful donation after circulatory death and focus groups with professional stakeholders (surgeons, anesthesiologists, critical care specialists, palliative care specialists, organ procurement personnel, and policymakers, N = 46). We then used qualitative content analysis to characterize these perspectives. Professional stakeholders believed that donation of all organs before circulatory death was unacceptable, morally repulsive, and equivalent to murder; consent for such a procedure would be impermissible. Respondents feared the social costs related to recovery before death were too high. Although beliefs about recovery of all organs were widely shared, some professional stakeholders could accommodate removal of a single kidney before circulatory death. In contrast, family members were typically accepting of donation before circulatory death for a single kidney, and many believed recovery of all organs was permissible because they believed the cause of death was the donor's injury, not organ procurement. These findings suggest that definitions of death and precise rules around organ donation are critical for professional stakeholders, whereas donor families find less relevance in these constructs for determining the acceptability of organ donation. Donation of a single kidney before circulatory death warrants future exploration.

Potential yield of imminent death kidney donation.

About 99 000 people are waiting for a kidney in the United States, and many will die waiting. The concept of "imminent death" donation, a type of living donation, has been gaining attention among physicians, patients, and ethicists. We estimated the number of potential imminent death kidney donors at the University of Wisconsin Hospital and Clinics by assessing the number of annual deaths in individuals with normal kidney function. Based on a previous survey suggesting that one-third of patients might be willing to donate at imminent death, we estimate that between 76 and 396 people in the state of Wisconsin would be medically eligible and willing to donate each year at the time of imminent death. We extrapolated these numbers to all transplant centers in the United States, estimating that between 5925 and 31 097 people might be eligible and willing to donate each year. Our results suggest that allowing donation at imminent death and including discussions about organ donation in end-of-life planning could substantially reduce the nation's kidney waiting list while providing many more donors the opportunity to give this gift.

Harms of unsuccessful donation after circulatory death: An exploratory study.

While donation after circulatory death (DCD) has expanded options for organ donation, many who wish to donate are still unable to do so. We conducted face-to-face interviews with family members (N = 15) who had direct experience with unsuccessful DCD and 5 focus groups with professionals involved in the donation process. We used qualitative content analysis to characterize the harms of nondonation as perceived by participants. Participants reported a broad spectrum of harms affecting organ recipients, donors, and donor families. Harms included waste of precious life-giving organs and hospital resources, inability to honor the donor's memory and character, and impaired ability for families to make sense of tragedy and cope with loss. Donor families empathized with the initial hope and ultimate despair of potential recipients who must continue their wait on the transplant list. Focus group members reinforced these findings and highlighted the struggle of families to navigate the uncertainty regarding the timing of death during the donation process. While families reported significant harm, many appreciated the donation attempt. These findings highlight the importance of organ donation to donor families and the difficult experiences associated with current processes that could inform development of alternative donation strategies.

Study newsletters, community and ethics advisory boards, and focus group discussions provide ongoing feedback for a large biobank.

The Personalized Medicine Research Project (PMRP) is a population-based biobank with more than 20,000 adult participants in central Wisconsin. A Community Advisory Group (CAG) and Ethics and Security Advisory Board (ESAB) provide ongoing feedback. In addition, the study newsletter is used as a two-way communication tool with study participants. The aim of this study was to assess and compare feedback received from these communication/consultation strategies with results from focus group discussions in relation to protocol changes. In summer 2009, enrollee focus groups were held addressing these topics: newsletter format, readability, and content of three articles written to solicit PMRP subject feedback. The CAG and ESAB jointly reviewed focus group results, discussed protocol changes to access residual blood samples, and made recommendations about the general communication approach. Nearly everyone in three focus groups stated that they wanted more information about PMRP. No focus group participant said that accessing stored samples would have changed their enrollment decision. Most said they wanted to be informed directly about changes affecting their original consent. For minimal-risk PMRP protocol changes, the community, CAG, and ESAB were comfortable with an opt-out model because of the initial broad consent. The planned duration of the biobank extends for decades; therefore regular, ongoing communication to enrollees is necessary to maintain awareness and trust, especially relating to protocol changes reflecting evolving science. The multi-faceted approach to communication including newsletters, external advisory boards, and focus group discussions has been successful for the PMRP biobank and may be a model for others to consider.

Ashley revisited: a response to the critics.

The case of Ashley X involved a young girl with profound and permanent developmental disability who underwent growth attenuation using high-dose estrogen, a hysterectomy, and surgical removal of her breast buds. Many individuals and groups have been critical of the decisions made by Ashley's parents, physicians, and the hospital ethics committee that supported the decision. While some of the opposition has been grounded in distorted facts and misunderstandings, others have raised important concerns. The purpose of this paper is to provide a brief review of the case and the issues it raised, then address 25 distinct substantive arguments that have been proposed as reasons that Ashley's treatment might be unethical. We conclude that while some important concerns have been raised, the weight of these concerns is not sufficient to consider the interventions used in Ashley's case to be contrary to her best interests, nor are they sufficient to preclude similar use of these interventions in the future for carefully selected patients who might also benefit from them.

"The Hopkins Mongol Case": The Dawn of the Bioethics Movement.

One of the earliest controversies in the modern history of bioethics was known at the time as "the Hopkins Mongol case," involving an infant with Trisomy 21 and duodenal atresia whose parents declined to consent to surgery. Fluids and feeding were withheld, and the infant died of dehydration after 15 days. The child's short life had a profound impact on the author's career and that of several others and ultimately led to changes in the care of children and adults with disabilities and the way difficult end-of-life decisions are made in US hospitals today. It also contributed to the growth of the modern bioethics movement and scholarship focused on pediatric bioethics issues.

Community consultation and communication for a population-based DNA biobank: the Marshfield clinic personalized medicine research project.

The purpose of this article is to describe community consultation and communication efforts for the Personalized Medicine Research Project (PMRP), a population-based biobank. A series of focus group discussions was held in the year preceding initial recruitment efforts with potentially eligible community residents and slightly less than a year after initial recruitment with eligible residents who had declined participation in PMRP. A Community Advisory Group, with 19 members reflecting the demographics of the eligible community, was formed and meets twice yearly to provide advice and feedback to the PMRP Principal Investigator and the local IRB. Ongoing communication with study subjects, who consent on the condition that personal genetic results will not be disclosed, takes place through a newsletter that is distributed twice yearly, community talks and media coverage. Most focus group participants were concerned about the confidentiality of both their medical and genetic data. Focus group discussions with eligible residents who elected not to participate in PMRP revealed that many knew very little about the project, but thought that too much information had been provided, leading them to believe that it would take too long for them to understand and enroll in the study. In conclusion, an engaged community advisory group can provide a sounding board to study investigators for many study issues and can provide guidance for broader communication activities. Researchers need to balance the provision of information for potential subjects to make informed decisions about study participation, with respect for individuals' time to read and interpret study materials.

Informed Consent Should Be a Required Element for Newborn Screening, Even for Disorders with High Benefit-Risk Ratios.

Over-enthusiastic newborn screening has often caused substantial harm and has been imposed on the public without adequate information on benefits and risks and without parental consent. This problem will become worse when genomic screening is implemented. For the past 40 years, there has been broad agreement about the criteria for ethically responsible screening, but the criteria have been systematically ignored by policy makers and practitioners. Claims of high benefit and low risk are common, but they require precise definition and documentation, which has often not occurred, undermining claims that involuntary testing is justified. Even when the benefits and risks are well established, it does not automatically follow that involuntary testing is justified, a position supported by the widespread tolerance for parental refusal of immunizations and newborn screening.

Reconsidering the dead donor rule: is it important that organ donors be dead?

The "dead donor rule" is increasingly under attack for several reasons. First, there has long been disagreement about whether there is a correct or coherent definition of "death." Second, it has long been clear that the concept and ascertainment of "brain death" is medically flawed. Third, the requirement stands in the way of improving organ supply by prohibiting organ removal from patients who have little to lose--e.g., infants with anencephaly--and from patients who ardently want to donate while still alive--e.g., patients in a permanent vegetative state. One argument against abandoning the dead donor rule has been that the rule is important to the general public. There is now data suggesting that this assumption also may be flawed. These findings add additional weight to proposals to abandon the dead donor rule so that organ supply can be expanded in a way that is consistent with traditional notions of ethics, law, public policy, and public opinion.

Genetic data and electronic health records: a discussion of ethical, logistical and technological considerations.

OBJECTIVE: The completion of sequencing the human genome in 2003 has spurred the production and collection of genetic data at ever increasing rates. Genetic data obtained for clinical purposes, as is true for all results of clinical tests, are expected to be included in patients' medical records. With this explosion of information, questions of what, when, where and how to incorporate genetic data into electronic health records (EHRs) have reached a critical point. In order to answer these questions fully, this paper addresses the ethical, logistical and technological issues involved in incorporating these data into EHRs. MATERIALS AND METHODS: This paper reviews journal articles, government documents and websites relevant to the ethics, genetics and informatics domains as they pertain to EHRs. RESULTS AND DISCUSSION: The authors explore concerns and tasks facing health information technology (HIT) developers at the intersection of ethics, genetics, and technology as applied to EHR development. CONCLUSIONS: By ensuring the efficient and effective incorporation of genetic data into EHRs, HIT developers will play a key role in facilitating the delivery of personalized medicine.