Make open data sharing a no-brainer for ethics committees.¶
Statement of the problem¶
The ideology of open and reproducible science makes its ways into various fields of science. Neuroimaging is a driving force today behind many fields of brain sciences. Despite possibly terabytes of neuroimaging data collected for research daily, just a small fraction becomes publicly available. Partially it is because management of neuroimaging data requires to confirm to established legal norms, i.e. addressing the aspect of research participants privacy. Those norms are usually established by institutional review boards (IRB, or otherwise called ethics committees), which are in turn “governed” by national, federal and supra-national regulations.
Flexibility in interpretation of original regulations established in the past century, decentralization of those committees, and lack of a “community” influence over them created the problem: for neuroimaging studies there was no commonly accepted version of a Consent form template which would allow for collected imaging data to be shared as openly as possible while providing adequate guarantees for research participants’ privacy. In majority of the cases, used Consent forms simply did not include any provision for public sharing of the data to get a “speedy” IRB approval for a study. Situation is particularly tricky because major granting agencies (e.g. NIH, NSF, RCUK) nowadays require public data sharing, but do not provide explicit instructions on how.
To facilitate neuroimaging data sharing, we providing an “out of the box” solution addressing aforementioned human research participants concerns and consisting of
- widely acceptable consent form templates (with various translations) allowing deposition of de-identified data to public data archives
- a template data user agreement (if your repository allows DUA instead of a licence)
- collection of tools/pipelines to help de-identification of neuroimaging data making it ready for sharing
You can read a summary of this work in our post-print: The Open Brain Consent: Informing research participants and obtaining consent to share brain imaging data
Sample Consent Forms¶
To address this problem we collected Sample consent forms which have been previously approved by ethic committees in different institutions. Such samples can be used for similar ad-hoc consent forms at other institutions so they fulfill the desires of any particular committee, while allowing public sharing of collected data.
Ultimate Consent Forms¶
Ultimate consent form and GDPR Documents were created to provide suggested consent form(s) for different use-cases, jurisdictions, and/or guidelines.
If regulated by the same supra-national/federal/state laws, there is really no objective reason why there could be no consensus among IRB committees within the same jurisdiction. Although somewhat a utopian statement, we hope that with examples/precedent cases and possibly your enthusiastic involvement we cold achieve our goal.
Data must be de-identified before distribution. We will collect information on existing and possibly establishing an ultimate easy to use pipeline to standardize de-identification of neuroimaging data to simplify data sharing.
- Sample consent forms
- Ultimate consent form
- GDPR edition
- GDPR Documents
- Anonymization tools
- Contact information