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¶
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
Please first fill out this VERY brief survey about the consent forms for your studies: http://goo.gl/forms/2lsmYcOsAs . It only has a few questions and should take a few minutes to fill out. Even if your consent form doesn’t yet include any provision for data sharing, your contribution would be very valuable (although it would consist of simply saying “No”).
We’re always looking for new materials to add to this shared neuroimaging resource. In particular, we’re looking for:
- Samples of consent forms allowing re-distribution/deposit to public archives
- Relevant publications and discussions
- Changes/recommendations for the ultimate consent form formulation
To add to the materials on this site, please open an issue on our GitHub issues page or send a new pull request via GitHub pull requests. Whether or not you should open an issue or make a pull request depends on the type of contribution you are making.
For sample consent forms and links to relevant publications, please make submissions exclusively via the GitHub issues page. When submitting consent forms, please include a full URL to the form and the desired filename you’d like to see it represented as on the Sample consent forms page. Note that for the URL you submit, persistent URLs such as DOIs are ideal, since these will not require frequent updates to this site in the event that a link moves. If a consent form does not have a DOI associated with it, an Internet Archive Wayback Machine saved page also works well in practice.
Changes to the ultimate consent form should be made via GitHub pull requests.
IRB committee members¶
We would welcome your feedback very much, in particular:
- What concerns on public sharing of neuroimaging data you might have if all identifiable information is removed (e.g. skull stripped) and research participants agreed to those terms.
- What particular consent form composition and wording aspects would you recommend (e.g. “make it an explicit additional form requiring a separate signature”) and why?
Speaking multiple languages?¶
Please file an issue on GitHub Issues mentioning languages you would like to contribute or help maintain translations for, or simply propose a PR with the translation. We will be happy for you to join our Internationalization (i18n) teams.
All Open Brain Constent (OBC) documents now follow following versioning schema:
- MAJOR - boost when introducing major changes
- MINOR - any change which might already require translations review/update
- PATCH - language-specific minor fixes
Translations must use MAJOR.MINOR component from the corresponding English version of the document.
.PATCH is incremented in English version only if change does not require translations update (e.g., a typo).
.PATCH is incremented in translations upon any tune up of translation from its previous state for the same MAJOR.MINOR version.
TODO: more details
When using our template forms, you can mention that your ethics followed the OBC recommendations: Open Brain Consent working group (2021). The Open Brain Consent: Informing research participants and obtaining consent to share brain imaging data. Human Brain Mapping, 1-7 https://doi.org/10.1002/hbm.25351.
Tackling these challenges requires diverse types of contributions.
Every contribution is very welcomed and we try to acknowledge as many as we can.
For our repository, the allcontributors bot recognizes the contributors to this initiative - be this in the form of feedback, further content, in-person discussions, review, maintenance or many more contribution types.
You can find an overview of the wonderful people that contributed to this project in the associated GitHub repository.
Maintainers are encouraged to alert the allcontributors bot if they are aware of a yet unrecognized contribution by commenting on issues or PRs with a bot invocation that follows the structure
@all-contributors please add @jane for code feedback review.
||||||| parent of f5135b1 (ENH: prune probably stale email address, added basic info on versioning and instructions to file an issue if to join teams) .. _GitHub issues: https://github.com/datalad/open-brain-consent/issues .. _GitHub pull requests: https://github.com/datalad/open-brain-consent/pulls ======= .. _GitHub issues: https://github.com/datalad/open-brain-consent/issues .. _GitHub pull requests: https://github.com/datalad/open-brain-consent/pulls
>>>>>>> f5135b1 (ENH: prune probably stale email address, added basic info on versioning and instructions to file an issue if to join teams)