title: Why or why not? A qualitative analysis of low-income parents' reasons for accepting or rejecting simulated research enrollment for their children.
abstract: A simulation of enrollment in a high- or low-risk research study was conducted with low-income, mostly minority parents. Simulation participants were provided scenarios based on actual low-risk research involving premature babies or actual high-risk research involving devices designed as bridges to heart transplants when all other therapies had failed. Their understanding of the procedures, risks, and benefits was based only the information gained from consent materials for the high- or low-risk protocol. After reviewing the consent information, participants were asked to state their own decision as to whether to enroll their simulated child in the described study. The low-income sample of parents who participated in this simulation were overwhelmingly positive about enrolling a child in the two studies; 66% of those considering the high-risk study and 91% in the low-risk study indicated they would enroll a child. Parents in both conditions cited the value of learning ways to improve the health care of others as a primary reason for agreeing; they also valued knowledge for its own sake. Reasons for refusal varied according to the risk level. Many were unwilling to accept the risks involved in the high-risk study; parents considering the low-risk study of premature infants were concerned about possible discomforts for the infant. More of them also cited the length of the study and the need for repetitious follow-up visits. Information gained from the stated rationales gives insights into ways that researchers can enhance consent materials and the recruitment process.
authors.affiliation: a Frank Porter Graham Child Development Institute, University of North Carolina at Chapel Hill , Chapel Hill , North Carolina , USA.
authors.forename: Frances Alexander
authors.initials: FA
authors.lastname: Campbell
authors.forename: Barbara Davis
authors.initials: BD
authors.lastname: Goldman
mesh_terms: D000328:Adult; D003657:Decision Making; D005260:Female; D006330:Heart Defects, Congenital / Q000601:surgery*; D016027:Heart Transplantation; D006805:Human Experimentation; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D010290:Parents / Q000523:psychology*; D011203:Poverty; D036301:Qualitative Research; D012307:Risk Factors
keywords: Research enrollment of children; barriers to enrollment; low-income parents