Effect of ethnicity, gender and drug use history on achieving high rates of affirmative informed consent for genetics research: impact of sharing with a national repository.
OBJECTIVE
Genetic research representative of the population is crucial to understanding the underlying causes of many diseases. In a prospective evaluation of informed consent we assessed the willingness of individuals of different ethnicities, gender and drug dependence history to participate in genetic studies in which their genetic sample could be shared with a repository at the National Institutes of Health.


METHODS
Potential subjects were recruited from the general population through the use of flyers and referrals from previous participants and clinicians with knowledge of our study. They could consent to 11 separate choices so that they could specify how and with whom their genetic sample could be shared. Rates of affirmative consent were then analysed by gender, ethnicity and drug dependence history.


RESULTS
Of 1416 volunteers enrolled, 99.7% gave affirmative informed consent for studies of addiction conducted in our laboratory. No significant difference was found for participation in genetic studies conducted in our laboratory by gender, ethnicity or drug dependence history. Over all 11 questions, individuals with a history of drug use were more likely to agree to consent to participate in our study than were healthy volunteers.


CONCLUSIONS
A high percentage of each category of gender, ethnicity and drug history, gave affirmative consent at all levels. The level of detail in and the amount of time spent reviewing the informed consent, and a relationship of trust with the clinical investigator may contribute to this outcome.
The Laboratory of the Biology of Addictive Diseases, The Rockefeller University, 1230 York Avenue, New York, NY 10065, USA. bray@rockefeller.edu
Brenda
B
Ray
Colin
C
Jackson
Elizabeth
E
Ducat
Ann
A
Ho
Sara
S
Hamon
Mary Jeanne
MJ
Kreek
D005260:Female; D036281:Genetic Research; D006801:Humans; D007258:Informed Consent / Q000523:psychology* / Q000592:standards; D008297:Male; D018579:Patient Selection / Q000941:ethics; D044469:Racial Groups / Q000523:psychology*; D012107:Research Design / Q000592:standards*; D012737:Sex Factors; D019966:Substance-Related Disorders / Q000523:psychology*; D014481:United States
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