NIH Data Management and Sharing

Resources for managing clinical data and human subjects research data, relative to the NIH policy. Also, resources for sharing clinical and human subjects research data, where applicable and appropriate.

Informed Consent & Data Sharing

From the NIH website:

NIH expects that in drafting their DMS plans, researchers will attempt to maximize scientific data sharing, but may acknowledge that certain factors (i.e., ethical, legal, or technical) may necessitate limiting sharing to some extent. Foreseeable limitations should be described when drafting DMS plans.

Specifically, the DMS Policy encourages respect for participants by encouraging researchers and award recipients to:

  • Address data management and sharing plans during the informed consent process to ensure prospective participants understand how their data will be managed and shared;
  • Outline steps they will take for protecting the privacy, rights, and confidentiality of prospective participants (i.e., through de-identification, Certificates of Confidentiality, and other protective measures);
  • Assess limitations on subsequent use of data and communicate these limitations to the individuals or entities (e.g., repositories) preserving and sharing the data; and
  • Consider whether access to shared scientific data derived from humans should be controlled, even if de-identified and lacking explicit limitations on subsequent use. Sharing via controlled access may be specified by certain funding opportunity announcements (FOAs) or the funding NIH Institutes or Centers.

Data Sharing and Use Agreements

NIH recommends the use of scientific data sharing and/or use agreements, preferably standardized, when sharing data from participants with and from repositories.  These agreements should be considered even if scientific data are de-identified and should be negotiated among researchers, institutions, and repositories. Key elements that promote the privacy of research participants in such agreements include:

  • Oversight. Agreements should clearly include certification from an institutional official that, at a minimum, scientific data have been appropriately de-identified (and to which standard), that an institutional oversight body has reviewed and considered the risks of data sharing, and that sharing is consistent with informed consent (as applicable).
  • Responsibilities. Agreements should delineate responsibilities of all parties having access to the data and clearly inform parties on data use limitations as well as responsibilities regarding privacy and confidentiality, including those required by Certificates of Confidentiality, as applicable. Restrictions. Agreements should explicitly outline sharing limitations and explicitly prohibit attempts to re-ide
  • Restrictions. Agreements should explicitly outline sharing limitations and explicitly prohibit attempts to re-identify and/or recontact participants or their family members unless there is explicit agreement to do so. Such restrictions should travel with the data.

HSC Data Use Agreements

UNM Service Catalog

Help with protocol development, consenting processes, and secure data management is available from multiple research support services.

Drop in Q&A Sessions

Health Sciences Library and Informatics Center (HSLIC) is holding several Drop-In sessions where you can ask your specific questions about data management plans and/or the new policy. 

Please Scan this code to see when the next session will be available.