RESUMEN
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.
Asunto(s)
Benchmarking/economía , Ensayos Clínicos como Asunto/economía , Reembolso de Incentivo/normas , Proyectos de Investigación , Sujetos de Investigación/economía , Benchmarking/ética , Ensayos Clínicos como Asunto/ética , Humanos , Motivación , Selección de PacienteRESUMEN
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. However, it is often difficult to recruit HIV-infected Hispanics and African Americans in 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 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 decision-making, are empowered, and function in a cohesive manner. Successful research teams build relationships with research participants to increase the probability that racial and ethnic minorities will enroll and participate fully in research.
Asunto(s)
Infecciones por VIH/etnología , Infecciones por VIH/enfermería , Grupos Minoritarios , Investigación en Enfermería/organización & administración , Población Negra , Servicios de Salud Comunitaria , Hispánicos o Latinos , Humanos , Comunicación Interdisciplinaria , Estados UnidosRESUMEN
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. A total of 35 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 included mostly male participants (n = 22), had a mean age of 45, had nearly equal representation of race/ethnicity, and were diagnosed 2 to 22 years earlier. 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 related to the decisions of participants to enroll in clinical trials emerged, which are as follows: 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.