What should be the retention period for how long PCORI research awardees must retain the full data package for sharing?
Indefinitely
What restrictions on use of PCORI research awardee data are important to include in the data use agreement executed by third parties requesting access to the data (e.g., data will not be re-identified, data will be used only for research and not commercial purposes, data will be used only for research in the same therapeutic area as the original research project through which the data were collected)?
No restrictions on use, but PCORI awardees should be given ample time to publish their data first or be allowed to "claim" the topics of their publications, such that others would be restricted to publishing novel analyses (or metaanalyses) using the data (their own intellectual ideas). It would be unfair for awardees to conduct the project and then have a different team publish the results while their submission was under review.
What qualifications/credentials should be required for a third party requesting access to PCORI research awardee data (e.g., education level, specific scientific expertise)?
None. I think the American people are funding it, so should have open access to utilize the data for their own intellectual ideas.
What documentation should a third party requester be required to provide when applying to access PCORI research awardee data (e.g., research question and lay protocol summary, full protocol and statistical analysis plan, institutional review board approval)?
Research question and Aims. Less regulation is better as it would allow folks to use the data for meta-analyses.
Should PCORI establish data repository standards (e.g. security, curation standards)? If so, what should the minimum standards be for a repository to qualify as a PCORI suggested repository for PCORI research awardee data?
I feel like formatting for a particular repository structure would be an undue administrative burden on investigators. Perhaps a repository of links to the PIs data repository.
What is the appropriate model for informed consent that should be included in the policy?
Not sure, but sample IRB language or anything that could lighten administrative burden on investigators would be much appreciated.
Do you have any other comments? Specifically, we seek comment about any of the following sections: (I) Purpose, (II) Applicability, (III) Definitions, and (IV) Policy.
Indefinitely
What restrictions on use of PCORI research awardee data are important to include in the data use agreement executed by third parties requesting access to the data (e.g., data will not be re-identified, data will be used only for research and not commercial purposes, data will be used only for research in the same therapeutic area as the original research project through which the data were collected)?
No restrictions on use, but PCORI awardees should be given ample time to publish their data first or be allowed to "claim" the topics of their publications, such that others would be restricted to publishing novel analyses (or metaanalyses) using the data (their own intellectual ideas). It would be unfair for awardees to conduct the project and then have a different team publish the results while their submission was under review.
What qualifications/credentials should be required for a third party requesting access to PCORI research awardee data (e.g., education level, specific scientific expertise)?
None. I think the American people are funding it, so should have open access to utilize the data for their own intellectual ideas.
What documentation should a third party requester be required to provide when applying to access PCORI research awardee data (e.g., research question and lay protocol summary, full protocol and statistical analysis plan, institutional review board approval)?
Research question and Aims. Less regulation is better as it would allow folks to use the data for meta-analyses.
Should PCORI establish data repository standards (e.g. security, curation standards)? If so, what should the minimum standards be for a repository to qualify as a PCORI suggested repository for PCORI research awardee data?
I feel like formatting for a particular repository structure would be an undue administrative burden on investigators. Perhaps a repository of links to the PIs data repository.
What is the appropriate model for informed consent that should be included in the policy?
Not sure, but sample IRB language or anything that could lighten administrative burden on investigators would be much appreciated.
Do you have any other comments? Specifically, we seek comment about any of the following sections: (I) Purpose, (II) Applicability, (III) Definitions, and (IV) Policy.