Planning for posttrial access to antiretroviral treatment for research participants in developing countries.

Despite recognition of the importance of posttrial access to antiretroviral therapy (ART), the implementation process has not been studied. We examined whether the National Institutes of Health (NIH) guidance document was being implemented in NIH-funded ART trials conducted in developing countries between July 2005 and June 2007. All of the 18 studies we identified had posttrial access plans for trial participants. More than 70% had specific mechanisms for posttrial access, but none guaranteed long-term sponsor funding after the trials. The plans reflected variation in local contexts and the uncertainty of predicting local conditions in the long term. The strength of the NIH guidance document may be that it encourages investigators to formulate plans in advance and to work with other stakeholders to provide access to ART.

Meeting folks where they are: collecting data from ethnic groups in the community.

Since the Nazi medical experiments in Europe and the Tuskegee Syphilis Study in the United States, members of ethnic groups have been reluctant to participate in research. However, a National Institutes of Health policy mandates that researchers develop and implement strategies to insure the inclusion of women and minorities as subjects in clinical investigations. The purpose of this paper is to discuss methods found to be effective in recruiting and retaining members of ethnic groups as participants in three research projects. The three studies were: (a) Gambling Behaviors in African American Elders and Perceived Effects on Health, (b) Adolescent Risk Behavior, Self Esteem, and Social Influence: Comparison of Dominican Youth in Their Homeland and in the United States, and (c) A Multicultural Study of Support for Alzheimer's Caregivers.