Response to the NIH “Request for Information on Developing Consent Language for Future Use of Data and Biospecimens”.

Utility and useability of this resource

Thanks for assembling this useful resource which will prove helpful for a wide range of investigators.

Gaps or additional components that should be included

The introduction should include more information about the importance of data and materials sharing for the robustness of scientific research and for the reduction of duplicated effort.

I am concerned that the sample language only envisions controlled access to data and that this example will retrench a conservative approach to restrictive data sharing in cases when broader, unrestricted sharing would yield greater benefits with minimal potential for harm. Even in cases where individual-level raw data must be kept controlled access, either individual-level processed data or group-level summary data might be able be shared unrestricted. You should mention this in the sample language.

The NHGRI data sharing resources provide much better sample language for broader sharing which should be included here for any relevant projects, not just genomics. Not including this language in the sample policy here creates a risk that investigators will inadvertently fail to comply with NHGRI and NIH-wide genomic data sharing policies.

Hurdles or barriers to wider use of this resource by the community

When participants change their mind about participation I agree their materials should not be shared further by the investigators. The promise of best efforts to track down already-shared materials, however, is impractical. Subsequent inevitable failures to stop further research for already-shared materials will lead to disappointment for participants that will erode confidence in patient participation in research.