To Help Society Vs. Distrust of Data Access: Participants' Opinions of Providing Consent for DNA Data Archiving

Introduction. The NIH Genomic Data Sharing Policy (NOT-OD-14-124) requires investigators to “submit large-scale human genomic data as well as relevant associated data (e.g., phenotype and exposure data) to an NIH-designated data repository in a timely manner.” No consensus exists about when researchers need additional participant consent to submit existing data to a federal database. Genomic data were collected as part of two on-going longitudinal studies, Seattle Social Development Project and the Raising Healthy Children Program. The present study examined participant attitudes towards the archiving of genetic data and factors that influenced consent.

Methods. In earlier assessments 604 SSDP and 681 RHC participants had provided DNA samples. These participants were reapproached and asked if they would agree to have their genetic and other study information archived in a national databank. Respondents were offered web or paper consent.  Regardless of their response, web participants were then asked to complete a 29 item anonymous survey to understand what was important to them in making the decision. Quantitative and qualitative consent data were available for 673 respondents.

Mixed methods were used to analyze the data. For the quantitative analysis, chi-square, logistic regression and ordered logistic regression models were run to examine the association between consent, demographics and the survey questionnaire. For the qualitative analysis, open-ended questions from the survey were coded, classified, and tabulated by the themes that emerged from the data.

Results.  Race and ethnicity did not significantly influence consent. However, trust in the institution and the research project were found to be significantly associated with consent. Of those who did not consent to archiving their data, 80% of the participants were concerned with risks arising from genomic research. Among those who consented, that number was 7%.  Qualitative results suggest that the value of the research to the participant, to society, the value of the study itself were the main factors influencing their decision.  Concerns included uncertainly about who would have access to the archive, potential unethical practices and government control of data.

Discussion.  While most study participants agree to release genomic data, a small but significant number do not. Additionally, survey information from non-consenters enable us to understand what information was important to participants as they came to a decision about whether or not to allow their genetic information to be archived and shared. Whatever their consent response, over 90% reported it was important that we asked their consent prior to archiving.