Ethics Review of Biomedical Research in Uzbekistan: Policy and Program Gaps.

We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research centers even though they conduct CDTs (clinical drug trials).

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.

An analysis of online courses in research ethics in the Fogarty-sponsored bioethics training programs.

Several training programs sponsored by the NIH/Fogarty International Center's International Research Ethics Education and Curriculum Development Program offer online graduate-level courses in research ethics to participants in lowand middle-income countries. This paper describes the evaluation of four of these online courses and recommendations for improvements to achieve the highest-quality design and delivery. We used an evaluation matrix consisting of 95 criteria based on recommended best practices in eLearning.

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.

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.

Twenty years of human research ethics committees in the Baltic States.

Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. Legally and institutionally much has changed. In this paper we provide an historical and structural overview of ethical review of human research and identify some problems related to the role of ethical review in establishing quality research environment in these countries.

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.