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Collect samples and formalize an ultimate subject consent form for brain imaging studies

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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 subjects 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 subjects' 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.

Overall approach

We would like to facilitate neuroimaging data sharing by providing an "out of the box" solution addressing aforementioned human subjects 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

Consent form

Goal minimum

To address this problem we decided to collect :ref:`chap_consent_samples` 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.

Ultimate goal

Analysis of those might allow us to distill an :ref:`chap_consent_ultimate` (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.

Anonymization

Data must be de-identified before distribution. We will collect information on :ref:`existing <chap_anonymization_tools>` and possibly establishing an ultimate easy to use pipeline to standardize anonymization of neuroimaging data to simplify data sharing.

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