Consent for genetics studies among clinical trial participants: findings from Action for Health in Diabetes (Look AHEAD).
BACKGROUND
Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions.


OBJECTIVE
and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research.


RESULTS
IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic.


CONCLUSIONS
The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial.


CONCLUSIONS
Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.
Espeland
M A
MA
Department of Biostatistical Sciences, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA. mespelan@wfubmc.edu
Dotson
K
K
Jaramillo
S A
SA
Kahn
S E
SE
Harrison
B
B
Montez
M
M
Foreyt
J P
JP
Montgomery
B
B
Knowler
W C
WC
D000368:Aged; D002986:Clinical Trials as Topic; D003924:Diabetes Mellitus, Type 2 / Q000235:genetics; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005260:Female; D036281:Genetic Research / Q000941:ethics; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010353:Patient Education as Topic; D012107:Research Design; D040242:Risk Reduction Behavior