Protecting participants of clinical trials conducted in the intensive care unit.

Research in the intensive care unit (ICU) raises a number of scientific and ethical challenges. Potential participants in critical care studies are likely to be considered particularly vulnerable-they may lack sufficient capacity to make informed decisions about trial participation, their health care proxies may lack legal authority to enroll them in research trials or may not know their true intent, and the life-threatening nature of the illness may make them or their surrogates more susceptible to therapeutic misconception. Because of this, critical care investigators must exercise extreme caution when designing and conducting studies in the ICU. In this article, we review the key literature addressing the various scientific and ethical issues raised by critical care research, including questions of equipoise and the selection of control groups, informed consent, therapeutic misconception, conflict of interest, and quality improvement projects. We also describe the current status of key policy or regulatory initiatives designed to address these issues, particularly in light of recent controversies involving critical care studies like the ARDSNet trial.

Presumed consent and other predictors of cadaveric organ donation in Europe.

CONTEXT: Few studies on presumed consent and environmental predictors of cadaveric organ donation in Europe have been published. OBJECTIVE: To determine if a presumed consent policy and other variables can be used to predict the cadaveric organ donation rate per million population. DESIGN: Secondary analysis of published data. SETTING: Europe. PARTICIPANTS: The unit of analysis for this study is the individual country. MAIN OUTCOME MEASURE: Cadaveric organ donation rate per million population. RESULTS: Original and transformed data were subjected to ordinary least-squares regression. All 4 independent variables were significant predictors of cadaveric donation rate, including (1) having a presumed consent (opting-out) policy in practice, (2) number of transplant centers per million population, (3) percentage of the population enrolled in third-tier education, and (4) percentage of population that is Roman Catholic. CONCLUSION: Findings may be useful to academics and professionals responsible for organ procurement. Additional research is necessary for practical application of findings. Generalizing these findings beyond Europe may be problematic because of external validity constraints.

Research ethics review: identifying public policy and program gaps.

We present an analytical framework for use by fellows of the Fogarty International Center-sponsored Advanced Certificate Program in Research Ethics for Central and Eastern Europe to identify gaps in the public policies establishing research ethics review systems that impede them from doing their job of protecting human research subjects. The framework, illustrated by examples from post-Communist countries, employs a logic model based on the public policy and public management literature. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum program.

Building research ethics capacity in post-communist countries: experience of two Fogarty training programs.

The post-Communist countries of Central and Eastern Europe and Central Asia are at various stages of development with respect to their capacity to protect human research participants. We examined the impact of two Fogarty-funded programs in this region, the Union Graduate College-Vilnius University Advanced Certificate Program and the Case Western Reserve University Master's Degree Program, by surveying these programs' graduates and by examining alumni activities. Alumni have served in leadership roles on research ethics committees, developed and taught new courses in research ethics, and contributed to scholarship. However, political, social, and economic challenges impede the ability of graduates to maximize their effectiveness. Additional curricular attention is needed in research methodology, policy development and implementation, and the interplay between research ethics and human rights.