Ethics approval in applications for openaccess clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com

摘要

Although there are a number of online platforms for patient-level clinical trial data sharingfrom industry sponsors, they are not very harmonized regarding the role of local ethicsapproval in the research proposal review process. The first and largest of these platforms isClinicalStudyDataRequest.com (CSDR), which includes over three thousand trials from thirteensponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asksapplicants to state whether they have received ethics approval for their research proposal,but in most cases does not require that they submit evidence of approval. However, thewebsite does require that applicants without ethical approval state the reason it was notrequired. In order to examine the perspectives of researchers on this topic, we coded everyresponse to that question received by CSDR between June 2014 and February 2017. Of111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification,57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations,and 20% referred to the approvals obtained by the original study. We conclude byexamining the experience of CSDR within the broader context of the access mechanismsand policies currently being used by other data sharing platforms, and discuss how our findingsmight be used to help clinical trial data providers design clear and informative accessdocuments.