The recruitment of HIV-infected children into clinical research: An exploration of factors that influence decision makin

Based on ethical and scientific justifications, recent public policy measures have been implemented to address the under-representation of women, minorities and children in clinical research. It is unknown if proportional representation alone is an assurance of the equitable distribution of benefits and burdens of clinical research at the local level. This study was designed to explore the local distribution of benefits and burdens of enrollment in clinical research in the context of pediatric HIV disease.;The specific aims of this project were to: (1) describe the process that staff engage in to identify, approach, and enroll potential subjects for participation in a clinical research protocol, (2) explore what factors parents consider when making decisions about the enrollment of their HIV-infected children in clinical research, and (3) explore staff and parent attitudes and beliefs about clinical research. A qualitative empirical study was conducted at three pediatric HIV clinics and their affiliated Pediatric AIDS Clinical Trial Units (P-ACTU). The professional staff affiliated with the clinics and P-ACTUs and parents who brought their children to the clinics for medical appointments were interviewed. Highlights of the study findings are presented below.;First, the process by which staff identify, approach and enroll parents of HIV-infected children in clinical research is described. Of particular note is the elucidation of the assessment of social and medical factors unrelated to eligibility that staff conduct before they approach parents to consider enrollment in research as well as when in the recruitment process the results of this assessment are incorporated.;Second, the factors that parents incorporate into their decisions about enrollment are identified. Parents base their decisions on the impact they believe enrollment will have on their child's health status. The factors parents consider are: the positive opinion and/or trust they have in their child's medical provider, their attitudes and beliefs about research generally and factors specific to the protocol offered. A model of decision-making is proposed and five patterns of decision-making are identified.;Third, staff expressed a generally positive attitude towards research both in terms of its role in advancing medical science as well as the direct and in-direct medical benefits that may accrue to individual children who enroll. Parents with past research experience are almost twice as likely to report positive attitudes about research as compared to parents who have never been approached to consider enrollment.;Local recommendations are proposed to maximize the number of eligible children offered enrollment in clinical research; establish criteria for social factors assessed in advance of approaching a parent to consider enrollment; identify and address barriers to parent compliance; and explore ways to improve parent understanding of research. National recommendations are proposed to encourage and support local efforts.