Access, Distribution, or Reuse Considerations

NIH Expectations

Describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data related to:

  • Informed consent
  • Privacy and confidentiality protections consistent with applicable federal, Tribal, state, and local laws, regulations, and policies
  • Whether access to scientific data derived from humans will be controlled 
  • Any restrictions imposed by federal, Tribal, or state laws, regulations, or policies, or existing or anticipated agreements
  • Any other considerations that may limit the extent of data sharing. Any potential limitations on subsequent data use should be communicated to the individuals or entities (for example, data repository managers) that will preserve and share the scientific data. The NIH ICO will assess whether an applicant’s DMS plan appropriately considers and describes these factors. 

Adapted from: Writing a Data Management & Sharing Plan

Why is this being asked?

It is very important, the reason a DMSP is required, that you specify how you will share your data with non-group members after the project is completed. If the data is of a sensitive nature, privacy concerns, for instance, and public access is inappropriate, this is where that gets addressed. It is your opportunity to provide justification for not sharing or restricting access to your data. The NIH DMS Policy allows for limits on data sharing and reuse, but it needs to be explicitly specified in this section.

What to Include

Restrictions to Data Access

  • Indicate any restrictions to data and provide rationale and justification for your decision. This can include any of the following:
    • Not sharing the data because it conflicts with the Institutional Review Board approval or informed consent process, both of which take precedent over the NIH DMS Policy
    • Restricting the sharing of data because the dataset contains protected health information (PHI) and the data can't be de-identified without losing scientific utility
    • The data being contigent on a 'Data Usage Agreement' which does not provision for data sharing

Sample Responses 

  • This study does not contain any protected health information and there are no restrictions affecting access to this data. 
  • As this study uses a publically available dataset with no access restrictions, there will ultimately be no restrictions affecting access to this data. However, since the study will be continuing past the close of the performance period, we are requesting an embargo of one year from the close of the performance period be placed on making all data publically available. Data used to generate publications will still be made available at the time of publication. 
  • This study is approved by the Weill Cornell Medicine Institutional Review Board (Protocol 98734768), and the approved informed consent form does not allow for sharing of data collected during the study. As a result, data will not be shared at the conclusion of the study. However, per the WCM Data Retention Policy, all data and supporting documentation will be archived in the WCM Institutional Data Repository for Research at publication or at the end of the grant performance period.