Underrepresentation of HIV-infected Hispanics and African Americans in clinical trials seriously limits our understanding of the benefits and risks of treatment in these populations. This qualitative study examined factors that racial/ethnic minority patients consider when making decisions regarding research participation. Thirty-five HIV-infected Hispanic and African American patients enrolled in clinical research protocols at the National Institutes of Health were recruited to participate in focus groups and in-depth interviews. The sample of mostly men (n = 22), had a mean age of 45, nearly equal representation of race/ethnicity, and diagnosed 2 to 22 years ago. Baseline questionnaires included demographics and measures of social support and acculturation. Interviewers had similar racial/ethnic, cultural, and linguistic backgrounds as the participants. Four major themes around participants’ decisions to enroll in clinical trials emerged: Enhancers, Barriers, Beliefs, and Psychosocial Context. Results may help researchers develop strategies to facilitate inclusion of HIV-infected Hispanics and African Americans into clinical trials.
Slow or insufficient enrollment in clinical research and a high demand for research participants raises questions about the need for and use of incentives to participate, including payment. Much of the available literature on payment to research participants focuses on ethical concerns, and rarely addresses guidelines, benchmarks, or formulas to assist investigators to assign or evaluate appropriate payment for individuals who take part in clinical research trials and procedures. Using four years of data collected about the inconvenience units assigned by intramural investigators to selected clinical research procedures conducted at the National Institutes of Health (NIH) Clinical Center, this study provides payment benchmarks for commonly performed procedures. Results were obtained from data collected on 36,273 incidents of payment made for procedures to research participants from August 2004 to August 2008. Analysis of the inconvenience units value assigned to specific procedures suggests that despite a wide distribution and frequent outliers, a convergence in practice around the center of distribution for most procedures does exist. As one of the first published studies reporting data reflecting payment amount for specific clinical research procedures, these data can guide investigators and institutional review boards as they establish and review an appropriate amount of payment to offer research participants. Our data may be useful in promoting payment standards for procedures, thereby complementing proposals or guidelines that advise payment calculations according to time and procedures.
HIV infection occurs in disproportionately high rates among racial and ethnic minorities in the United States, making it imperative that individuals from these groups be included in research studies. Unfortunately, it is often difficult to recruit HIV-infected Hispanics and African Americans into clinical trials, but a skilled interdisciplinary team that includes researchers with racial and ethnic diversity can help. This article describes a successful approach for building an interdisciplinary team that values the participation of racial and ethnic minorities in clinical trials and that has the skills to work with these groups. The success of the Adelante (a Spanish word meaning forward) Team can be attributed to team members who actively participate in decisionmaking, are empowered, and function in a cohesive manner. Successful research teams build relationships with research participants in order to increase the probability that racial and ethnic minorities will enroll and participate fully in research. KeywordsAfrican American; clinical research; Hispanic; HIV; interdisciplinary; team building Building a strong interdisciplinary research team is an important step in addressing the challenges of conducting HIV research in racial and ethnic minority communities. As the science and delivery of health care becomes increasingly complex, there is a need to move from discipline-specific to collaborative research models (Loeb et al., 2008). This paper will describe a successful approach used to build a collaborative interdisciplinary research team to study the participation of HIV-infected Hispanics and African Americans in clinical trials. Aboelela and colleagues (2007) have recommended the following definition for interdisciplinary research:Interdisciplinary research is any study or group of studies undertaken by scholars from two or more distinct scientific disciplines. The research is based upon a conceptual model that links or integrates theoretical frameworks from those disciplines, uses study design and methodology that is not limited to any one field, and requires the use of perspectives and skills of the involved disciplines throughout multiple phases of the research process. (p. 341)The advantages of interdisciplinary research include reduction of fragmentation and duplication of efforts, representation of significant and varied perspectives, and development of culturally competent strategies (Garcia-Ramirez, Paloma, Suarez-Balcazar, & Balcazar, 2009;McGuire, 1999;Proenca, 2007). The members of our research team have combined skills and expertise in nursing, social work, bioethics, medicine, communications, research, linguistics, public relations, and patient recruitment. The Need for Research in Racial and Ethnic Minority CommunitiesAlthough African Americans are the largest group affected by HIV infection in the United States, they continue to be underrepresented in clinical trials (Branson, Davis, & Butler, 2007;Garber, Hanusa, Switzer, Mellors, & Arnold, 2007;Loftin, Barnett, Bunn, & Sullivan, ...
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