Policy

Effective January 25, 2023

The new National Institutes of Health (NIH) Data Management & Sharing (DMS) Policy supersedes the 2003 requirements and will become effective on January 25, 2023. This NIH policy aims to make scientific data management and sharing a norm while maximizing the availability and reusability of scientific data to foster trust and transparency in science. 

The DMS policy applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. Specifically, the policy applies to:

  • Competing grant applications that are submitted to NIH for January 25, 2023 and subsequent receipt dates.
  • Proposals for contracts that are submitted to NIH on or after January 25, 2023.
  • NIH Intramural Research Projects conducted on or after January 25, 2023.
  • Other funding agreements (e.g., Other Transactions) that are executed on or after January 25, 2023, unless otherwise stipulated by NIH.

This webpage is limited to considerations related to the sharing and management of human participant data. Please visit the UCSB Library’s NIH Data Sharing website to learn more about this new NIH policy.

DMS Plan

According to the policy, a DMS Plan should include the following sections:

  • Data Type: describe the scientific data to be managed, preserved, and shared.
  • Related Tools, Software and/or Code: indicate whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse and the names of the required tools and software. 
  • Standards: provide what standards will be applied to the scientific data and associated metadata (i.e., data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation). 
  • Data Preservation, Access, and Associated Timelines: outline plans and timelines for data preservation and access.
  • Access, Distribution, or Reuse Considerations: indicate plans to maximize the appropriate sharing of scientific data generated from NIH-funded or conducted research, consistent with privacy, security, informed consent, and proprietary issues.
  • Oversight of Data Management and Sharing: demonstrate how compliance with the plan will be monitored and managed, with what frequency, and by whom (e.g., titles, roles, responsibilities).

Considerations to protect participant data

While NIH expects that researchers will take steps to maximize scientific data sharing, researchers are expected to proactively address any risks associated with the sharing of human participant data. 

Researchers should:

  • 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 ICO(s).

ORahs instructions for researchers

  1. Indicate on the One Tab if your study is NIH funded. If NIH funding is added after your IRB protocol is approved, you must update your protocol via a modification and address the following items.
  2. Specific risks and safeguards associated with sharing & storing participant data should be included in the relevant section(s) of the Risk Tab in ORahs.
  3. Your Data Management & Sharing Plan should be included as an attachment to your submitted protocol.
  4. The informed consent process must communicate your plans for storing, future sharing, and use of participant data. More information can be found in the consent form templates.