title: Diverse perceptions of the informed consent process: implications for the recruitment and participation of diverse communities in the National Children's Study.
abstract: We examined the experiences, perceptions, and values that are brought to bear when individuals from different ethnic and cultural backgrounds consider participating in health research. Fifty-three women from Latino, Asian American, Middle Eastern, or Non-Latino, White backgrounds participated in seven English or Spanish focus groups facilitated by trained investigators using a standard protocol. Investigators described the National Children's Study (NCS) and then asked questions to elicit potential concerns, expectations, and informational needs. Group sessions were audio-recorded, transcribed verbatim, and analyzed using qualitative thematic methods. A major theme that emerged during focus groups was participant self-identification as a member of a cultural group or community when raising issues that would influence their decision to participate in research. A related theme was the belief by some that communities may differ in the ease of participation in the NCS. Identified themes related to the informed consent process included perceived risks, anticipated burden, perceived benefits, informational needs, and decision-making strategies. Although themes were shared across groups, there were cultural differences within themes. Findings indicated that individuals from diverse backgrounds may have different perspectives on and expectations for the research process. To effectively recruit representative samples, it will be important to address a range of issues relevant for informed consent and to consider the impact of participation on both individuals and communities.
authors.affiliation: Department of Pediatrics, University of California, Irvine, 101 Academy Way, Suite 150, Irvine, CA 92617, USA. klakes@uci.edu
authors.forename: Kimberley D
authors.initials: KD
authors.lastname: Lakes
authors.forename: Elaine
authors.initials: E
authors.lastname: Vaughan
authors.forename: Marissa
authors.initials: M
authors.lastname: Jones
authors.forename: Wylie
authors.initials: W
authors.lastname: Burke
authors.forename: Dean
authors.initials: D
authors.lastname: Baker
authors.forename: James M
authors.initials: JM
authors.lastname: Swanson
mesh_terms: D000293:Adolescent; D000328:Adult; D001213:Asian / Q000523:psychology; D003219:Confidentiality / Q000523:psychology; D018864:Cultural Diversity; D003469:Culture; D003657:Decision Making; D005006:Ethnicity / Q000523:psychology*; D005260:Female; D017144:Focus Groups; D006630:Hispanic or Latino / Q000523:psychology; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008875:Middle Aged; D018579:Patient Selection; D012933:Social Identification; D044465:White People / Q000523:psychology