Effective Reparation for the Guatemala S.T.D. Experiments: A Victim-Centered Approach.

Discussion of reparations for U.S.-Guatemala STD experiments of the 1940s and 50s should be informed by a range of international and U.S. reparation experiences, so that features that impair the effectiveness of repair are avoided, and features that enhance effectiveness of repair are emulated. Two features have contributed to the effectiveness or ineffectiveness of repair elsewhere but have not been critically examined in relation to the Guatemalan experiments: Whether experimental subjects or their families have the opportunity to participate in reparations processes, and whether any group of experimental subjects is intentionally denied recognition. Three advantages of victim participation are explored, and a critique provided of one narrow delimitation of victims. Even if political and moral failings ultimately prevent reparations for Guatemalan experimental subjects, an emphasis on effectiveness and victim-centeredness should nonetheless shape reparations for other, future victims of human rights abuses in experimentation.

Growing an ethics consultation service: A longitudinal study examining two decades of practice.

BACKGROUND: Little is known about what factors may contribute to the growth of a consultation service or how a practice may change or evolve across time. METHODS: This study examines data collected from a busy ethics consultation service over a period of more than two decades. RESULTS: We report a number of longitudinal findings that represent significant growth in the volume of ethics consultation requests from 19 in 1990 to 551 in 2013, as well as important changes in the patient population for which ethics help is requested. The findings include (1) a steady growth in requests from primary care providers (e.g., physicians and nurses), as well as increases in ancillary services (e.g., social workers); (2) a decrease in length of stay (days) before ethics help is requested; (3) an increase in the reasons that individuals ask for help from ethics; (4) an upsurge in consults requests from areas outside the intensive care unit (ICU); (5) a decrease in patients that died during hospitalization (e.g., live discharges); and (6) growth in the numbers of patients lacking decision-making capacity. CONCLUSIONS: We believe the increases in consult requests reflect appropriate and necessary growth because recent consultations have also been associated with consultations requiring (7) additional interventions and (8) reasonably high time intensity scores.

Gender and Race in the Timing of Requests for Ethics Consultations: A Single-Center Study.

BACKGROUND: Clinical ethics consultants are expected to "reduce disparities, discrimination, and inequities when providing consultations," but few studies about inequities in ethics consultation exist.1 The objectives of this study were (1) to determine if there were racial or gender differences in the timing of requests for ethics consultations related to limiting treatment, and (2) if such differences were found, to identify factors associated with that difference and the role, if any, of ethics consultants in mitigating them. METHODS: The study was a mixed methods retrospective study of consultation summaries and hospital and ethics center data on 56 age-and gender-matched Caucasian and African American Medicare patients who received ethics consultations related to issues around limiting medical treatment in the period 2011 to 2014. The average age of patients was 70.9. RESULTS: Consultation requests for females were made significantly earlier in their stays in the hospital (6.57 days) than were consultation requests made for males (16.07 days). For African American patients, the differences in admission-to-request intervals for female patients (5.93 days) and male patients (18.64 days) were greater than for Caucasian male and female patients. Differences in the timing of a consultation were not significantly correlated with the presence of an advance directive, the specialty of the attending physician, or the reasons for the consult request. Ethics consultants may have mitigated problems that developed during the lag in request times for African American males by spending more time, on average, on those consultations (316 minutes), especially more time, on average, than on consultations with Caucasian females (195 minutes). Most consultations (40 of 56) did result in movement toward limiting treatment, but no statistically significant differences were found among the groups studied in the movement toward limiting treatment. The average number of days from consult to discharge or death were strongly correlated with the intervals between admission to the hospital and request for an ethics consultation. CONCLUSION: Our findings suggest race and gender disparities in the timing of ethics consultations that consultants may have partially mitigated.

What is the impact of ethics on clinical trials?

Ethics has often been ignored or evaded in clinical trials, and the conditions under which global clinical trials are conducted make this problem likely to persist. Ethics can, however, have an impact at any of several stages of a trial when the individuals involved are committed. This editorial provides historical examples of ignoring, evading or, alternatively, using ethical help to improve clinical trials, and suggests that the actual role of ethics depends on the individuals involved.

Case Complexity and Quality Attestation for Clinical Ethics Consultants.

A proposal by the American Society for Bioethics and Humanities (ASBH) to identify individuals who are qualified to perform ethics consultations neglects case complexity in candidates' portfolios. To protect patients and healthcare organizations, and to be fair to candidates, a minimum case complexity level must be clearly and publicly articulated. This proof-of-concept study supports the feasibility of assessing case complexity. Using text analytics, we developed a complexity scoring system, and retrospectively analyzed more than 500 ethics summaries of consults performed at an academic medical center during 2013. We demonstrate its use with seven case summaries that range in complexity from uncomplicated to very complicated. We encourage the ASBH to require a minimum level of case complexity, and recommend that attestation portfolios include several cases of moderate complexity and at least one very complex case.

Nonconsensual clinical trials: a foreseeable risk of offshoring under global corporatism.

This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.

Pushing the dead into the next reproductive frontier: post mortem gamete retrieval under the uniform anatomical gift act.

In re Matter of Daniel Thomas Christy authorized post mortem gamete retrieval under the most recent revision of the Uniform Anatomical Gift Act. This article recommends that the National Conference of Commissioners on Uniform State Laws explicitly address the issue of post mortem gamete retrieval for reproductive purposes; that legislators specify whether their states will follow the Christy ruling; and that ethics committees and consultants prepare for the questions about human identity and self determination that post mortem gamete retrieval raises.

Should consensus be 'the commission method' in the US? The perspective of the Federal Advisory Committee Act, regulations, and case law.

This paper examines the drive for consensus from the perspective of the good government framework for federal advisory commissions in the United States. Specifically, the paper examines the Federal Advisory Committee Act (FACA)--the statute, its regulations, and case law. It shows that the FACA was intended to be an antidote to abuses in consensus-making processes, including the failure to fully include competing views on commissions. The index of suspicion in the FACA scheme rises when a group work product--including a consensus report--is to be the basis of recommendations to federal officials. Once FACA's requirements regarding committee composition are satisfied, the index of suspicion drops and FACA is indifferent to consensus-making; but the conditions for informed, meaningful participation apply to members who dissent from, as well as those who participate in, consensus. In negotiated rulemaking, the push for consensus and closure creates unacceptable tension with the good government goals of openness and accountability. Proponents of consensus-only bioethics commissions can learn from FACA-related legislative, agency, and judicial insights that consensus-seeking is not always desired by government officials; is rarely cost free; and that diversity and dissent enhance openness, accountability, and fairness. The burden of proof is therefore on proponents of a consensus-only standard for bioethics commissions to demonstrate that a drive for consensus furthers sound decision-making by government officials more than it sets back openness and accountability to a diverse public.