Consent for long-term storage of blood samples by Indigenous Australian research participants: the DRUID Study experience.

Abstract

Background: Little is known about the characteristics of people who do and do not agree to the long-term storage and use of their biological materials, or about potential biases that may be introduced as a result of differential consent. More specifically, concerns about tissue storage and use are especially relevant among population groups for whom blood and other biological materials are culturally significant, such as Indigenous Australians. Using data from a 2003-2005 study of 1,004 Indigenous Australians, we examined participants' choices regarding long-term storage of excess blood for possible use in future studies.

Results: Overall, 55% of participants agreed to long-term storage. Among 854 participants with a fasting blood sample and completed questionnaire, consent for storage was more likely among those aged 45+ years than those 15-44 (odds ratio (OR) = 1.55, 95% confidence interval (CI): 1.14, 2.11), and was similar for males and females. After adjustment for age and other covariates using logistic regression, consent was more likely for never smokers than current smokers (OR = 1.48, 95% CI: 1.04, 2.10), those reporting any non-Indigenous grandparent(s) (OR = 2.07, 95% CI: 1.50, 2.85), and those whose consent form was administered/witnessed by an Indigenous staff member (OR 1.43, 95% CI: 1.05, 1.94). Consent for long-term storage was associated with only small differences (generally less than +/- 5%) in the results of assays performed on all participants' blood samples as part of the baseline health examination.

Conclusion: These data show that consent for blood storage among these research participants was neither rare nor universal. It was associated with some socio-demographic/cultural factors but not with blood biochemistry. Decisions about requesting or giving consent for storage and later use of tissue samples must recognize a number of important, and potentially competing, ethical and logistical considerations.