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 de-identified individual participant data becomes the norm.1 In response to our request for feedback we received many comments from individuals and groups. Some applauded the proposals, while others expressed disappointment they 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.
Link to access full article: www.ncbi.nlm.nih.gov/pubmed/28596041