Secondary Biobanking Consent in an Underrepresented Population

One of the commonly raised questions in biobanking research relates to future specimen use. Consequently, there are regulations in place for biospecimen donors consenting to unspecified future research to safeguard their vulnerability to disclosure of protected health information, loss of control and risk of exploitation. While we have some understanding of participant attitudes to secondary biobanking, there are gaps in our understanding of attitudes between socioeconomic groups, as well as in the context of cancer. To address this, Drake et al. (2016) have approached a particularly underrepresented sample, African American men, to gain insight into their willingness to participate in secondary biobanking.¹

The investigators used an existing consent form relating to participation in a prostate cancer biopsy study. The study included 1,931 men, primarily Caucasian (87.1%) and African American (12.3%), with a small number of participants (0.6%) not identifying with either of these groups.

Drake et al. used the following three questions to determine participant attitudes to future research using their biospecimens:

1. May we use the materials collected in this study to analyze other factors? Other factors may include analyses, other than genetic, of markers derived from stored serum which were not part of the original research question.
2. May we share your information with other investigators at our institution without any protected health information?
3. May we share your information with other investigators at our institution with protected health information?

Almost all of the respondents (99%) provided consent for their biospecimen to be used to analyze other factors. Similarly, 88.2% consented to their specimens being shared with other investigators without protected health information; of this group, only 10.2% consented to their specimens being shared with protected health information included.

Based on their responses to the aforementioned questions, the researchers categorized participants as “yes always,” “yes conditional” or “never” to further analyze their responses.

Interestingly, when Drake et al. stratified responses according to particular participant characteristics, such as race, family history, stage of cancer and grade of cancer, they found a significant association with consent for future use. For example, participants with a family history of prostate cancer were 1.69 times more likely to “always” consent to their specimen being used in the future. They also found that African American participants were 3.49 times more likely to “always” consent to future use compared to Caucasian participants. Further, respondents with clinical stage T2 cancer (tumor present) were less likely to “always” consent to future use compared to men with clinical stage T1 cancer (not detectable by imaging).

Drake et al. highlight that their study is one of very few that has exclusively focused on male attitudes. Additionally, they surveyed actual consent, as opposed to willingness alone. This is the first study investigating willingness and participation extent in secondary biospecimen research in African American men, an underrepresented group. The authors suggest that it may inform future consent protocols for enrolling male patients in biobanking studies.

Reference
1. Drake, B.F., et al. (2016) “Secondary consent to biospecimen use in a prostate cancer biorepository,” BMC Research Notes, 9(346) doi: 10.1186/s13104-016-2159-3.