Informed consent for genetic research.

BACKGROUND: Rapid technological advances in genetic research and public concern about genetic discrimination have led to anticipatory safeguards in the informed consent process in the absence of legal examples of proven discrimination. Despite federal and state regulations to restrict access to personal health information, including genetic information, institutional review boards have required the addition of language to informed consent documents that warns about the risks of discrimination with participation in genetic research.

OBJECTIVE: To determine the reasons that families refused consent for their infant's participation in a study evaluating a genetic cause of respiratory distress syndrome.

DESIGN: Survey conducted between February 1, 2002, and March 31, 2003.

SETTING: Academic, tertiary free-standing children's hospital.

PARTICIPANTS: A convenience sample of 465 families were approached for consent. The 135 families who refused consent were surveyed.

MAIN OUTCOME MEASURES: Reasons for refusal.

RESULTS: Of the nonconsenting families, 79% spontaneously and specifically identified institutionally required language in our consent form concerning the risk of denial of access to health insurance and employment as the primary reason for refusal; 97% indicated that their fears resulted directly from language in our consent form. Only 20% of families who refused consent cited inadequate time to consider the study.

CONCLUSIONS: The institutionally required description of risk of genetic discrimination due solely to participation in genetic research was the primary reason for refusal to consent in this cohort. Information about federally and institutionally mandated protections for confidentiality of participants in genetic research should be included in the informed consent document to balance the description of hypothetical risks and more accurately inform subjects.