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What is the impact of open data policies on participation in clinical trials?

There are obvious benefits associated with open data policies for the scientific community. As a consequence, research organisations are increasingly adopting open data policies as a requisite for publication. However, the discussion has yet to include the needs and concerns of participants whose data are being openly shared. In particular, could open data policies affect participants’ willingness to participate in research?

This question was investigated in a study that was published in PLOS ONE this week. Reassuringly, the authors state: “No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent.”.

However, the authors also state: “follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants’ considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity”.

In an associated blog on this paper, Viviane Callier (a contractor at the National Cancer Institute) states: “The results… suggest that the current consent process is flawed. Research participants, who do not always understand what they are consenting to, have legitimate concerns about how their data will be used…Policy discussions about open data policies, data security, and privacy should not be restricted to scientists. Study participants are key stakeholders in this process and their voices must be brought into open data policymaking discussions.”.

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