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 the federal regulations, such as 45 Code of Federal Regulations Part 46 in US.
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 is 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 do 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) nowadays require public data sharing, but do not provide explicit instructions on how.
We would like to facilitate neuroimaging data sharing by providing an “out of the box” solution addressing aforementioned human research participants concerns and consisting of
- widely acceptable consent form allowing deposition of anonymized data to public data archives
- collection of tools/pipelines to help anonymization of neuroimaging data making it ready for sharing
To address this problem we decided to collect Sample consent forms which have been previously approved by ethic committees in different institutions. Such samples could serve a basis for introducing similar ad-hoc consent forms at other institutions so they fulfill the desires of any particular committee, while allowing public sharing of collected data.
Analysis of those might allow us to distill an Ultimate consent form (or a set of those for different use-cases and jurisdictions, and/or guidelines) which would be compliant with all regulatory statues, while allowing for open sharing and access to the neuroimaging data.
If regulated by the same 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.
- Sample consent forms
- Ultimate consent form
- Anonymization tools
- Contact information