Today, PRIM&R submitted comments (PDF) to the White House Office of Science and Technology Policy (OSTP) in response to their Request for Public Comment on Draft Desirable Characteristics of Repositories for Managing and Sharing Data Resulting From Federally Funded Research. The request solicits information that it hopes will enable the department to reduce burden for researchers. OSTP is accepting comments on the draft characteristics until Friday, March 6, 2020, and we encourage those in our audience to join us in submitting comments (learn more on how to do this with the instructions at the end of this post). You can read our full comments here (PDF).
PRIM&R endorses the OSTP efforts to improve the consistency of guidelines for best practices in long-term storage of data from federally funded research. We especially appreciate the current step of developing a proposed, common set of desirable characteristics of data repositories, because this kind of forward thinking has the potential to improves standards for both government and non-governmental data repositories alike.
Furthermore, we agree that harmonization of federal policies around research can be an important and effective means of supporting the conduct of responsible research; it can reduce policy redundancies that do little to add to research oversight and drain limited research resources, and can foster the consistent adoption of best practices. As we have argued in comments to NIH in 2018 and 2020, harmonization of policies is clearly desirable in the data sharing and management space.
PRIM&R also appreciates that the draft acknowledges that there are important additional human subject protections considerations when the data repository involves human data, and that these considerations are relevant even if that data is deidentified. To that end, we support the draft’s general language on privacy, but urge that as the OSTP further develops its common set of characteristics and considerations, or provides further guidance in this area, it include language about the need for repositories to have in place mechanisms for preventing or discouraging reidentification of deidentified data, in addition to enforcing submitters’ data use restrictions.
The OSTP solicited comments on two categories: The first category is desirable characteristics for all data repositories; the second is additional considerations for repositories that contain human data.
PRIM&R believes that all data repositories should have a mechanism for ensuring credit for data generators, which will incentivize researchers to share their data in the spirit of open science.
Additionally, we agree that repositories that contain human data should have “plans for addressing violations of terms-of-use by users and data mismanagement by the repository,” and we argue that these plans should construe “terms-of-use” as broadly as possible (and explicitly include research service agreements).
We also call on the government to carefully consider what both penalties and culpability for the violation of subjects’ rights in the course of data sharing, since limiting penalties to merely a rescission of funding is likely to be an inadequate deterrent to future bad actors.
Finally, researchers have an obligation to use data in a manner consistent with original consent, and we believe the “Fidelity to Consent” consideration as written is likely to be provide insufficient guidance in this area. We therefore urge the OSTP to make clear that repositories that store human data themselves have a responsibility to establish mechanisms for attaching permissions granted in the original consent, as machine-readable metadata, to the data itself.
We encourage you to submit comment, and you are welcome to use some or all of our language or thinking in your response. The directions to submit comment are excerpted below; read them in full here.
Comments should be submitted online to: OpenScience@ostp.eop.gov. Email submissions should be machine-readable [pdf, word] and not copy-protected. Submissions should include “RFC Response: Desirable Repository Characteristics” in the subject line of the message.