The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups. Some applauded the proposal while others expressed disappointment it did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers.
It is encouraging that data sharing is already occurring in some settings. Over the past year, however, we have learned that the challenges are substantial and the requisite mechanisms are not in place to mandate universal data sharing at this time. Although many issues must be addressed for data sharing to become the norm, we remain committed to this goal. full article
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