Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com.
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...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2017-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC5590958?pdf=render |
| _version_ | 1819172651768217600 |
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| author | Derek So Bartha M Knoppers |
| author_facet | Derek So Bartha M Knoppers |
| author_sort | Derek So |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-22T20:10:35Z |
| format | Article |
| id | doaj.art-9fb300d2cb0d478982a0cf5302628f76 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-22T20:10:35Z |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-9fb300d2cb0d478982a0cf5302628f762022-12-21T18:14:03ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01129e018449110.1371/journal.pone.0184491Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com.Derek SoBartha M KnoppersAlthough 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.http://europepmc.org/articles/PMC5590958?pdf=render |
| spellingShingle | Derek So Bartha M Knoppers Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com. PLoS ONE |
| title | Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com. |
| title_full | Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com. |
| title_fullStr | Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com. |
| title_full_unstemmed | Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com. |
| title_short | Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com. |
| title_sort | ethics approval in applications for open access clinical trial data an analysis of researcher statements to clinicalstudydatarequest com |
| url | http://europepmc.org/articles/PMC5590958?pdf=render |
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