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2017 ; 12
(9
): e0184491
Nephropedia Template TP
gab.com Text
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English Wikipedia
Ethics approval in applications for open-access clinical trial data: An analysis
of researcher statements to clinicalstudydatarequest com
#MMPMID28886178
So D
; Knoppers BM
PLoS One
2017[]; 12
(9
): e0184491
PMID28886178
show ga
Although there are a number of online platforms for patient-level clinical trial
data sharing from industry sponsors, they are not very harmonized regarding the
role of local ethics approval in the research proposal review process. The first
and largest of these platforms is ClinicalStudyDataRequest.com (CSDR), which
includes over three thousand trials from thirteen sponsors including
GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants 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,
the website does require that applicants without ethical approval state the
reason it was not required. In order to examine the perspectives of researchers
on this topic, we coded every response to that question received by CSDR between
June 2014 and February 2017. Of 111 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 by
examining the experience of CSDR within the broader context of the access
mechanisms and policies currently being used by other data sharing platforms, and
discuss how our findings might be used to help clinical trial data providers
design clear and informative access documents.