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NIH Data Management and Sharing Policy

This guide supports researchers' efforts to comply with the NIH Data Management and Sharing Policy. It offers step-by-step guidance on how to plan for data sharing and write a data management and sharing plan to meet NIH requirements.

Consider How Participants Will Be Protected

NIH's DMS Policy requires that researchers follow the laws and regulations protecting research subjects and encourages researchers to:

  • Implement an informed consent process that ensures that research participants understand how their data will be managed and shared
  • Plan for the protection of participant privacy and confidentiality (e.g., through the use of de-identification)
  • Consider if the scientific data generated should be shared via a controlled-access data repository

See NIH's "Writing a Data Management & Sharing Plan" guidance and this FAQ on protecting research participants for more details.

Also see "Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data" for principles and best practices for protecting participant privacy.

Ask for Support from Johns Hopkins IRBs

An institutional review board (IRB), is responsible for reviewing and approving research to ensure that the rights and welfare of human participants are protected.

The following Johns Hopkins IRBs can offer guidance and support on meeting NIH requirements for data management and sharing.

Johns Hopkins Institutional Review Board Divisions Served
Homewood Institutional Review Board Carey Business School, Krieger School of Arts and Sciences, Nitze School of Advanced International Studies, Peabody Institute, School of Education, and Whiting School of Engineering
Johns Hopkins Medicine Institutional Review Boards Johns Hopkins Health Systems, Johns Hopkins Hospital, Kennedy Krieger Institute, School of Medicine, School of Nursing
Office of the Institutional Review Board, Johns Hopkins Bloomberg School of Public Health Johns Hopkins Bloomberg School of Public Health

Work with the JHU Data Trust if Using JHM Data

If your research proposes to use and share JHM data, the IRB approval process may include a review by the JHM Data Trust.

JHM data is patient- or member-related data stored by Johns Hopkins Medicine participating organizations in their clinical enterprise systems, including billing, finance, health plan, and clinical administrative records or systems. The data stored in these systems may include individual-level research results or data streams from patient monitoring devices.

Note that researchers do not need to initiate Data Trust reviews. If needed, these reviews are automatically initiated as part of the IRB process.

For more about JHM data and JHM participating organizations, see the JHM Data Trust Policy. For more about sharing JHM data, see the Data Trust's FAQs on "External Data Sharing" and "Review of Data Requests."

Ensure Data-Related Informed Consent

Researchers' intentions for scientific data management and sharing, as proactively described in data management and sharing (DMS) plans, is strongly encouraged to be part of the informed consent process.

While NIH expects that researchers will take steps to maximize scientific data sharing, it does not proscribe how sharing should be specified in the informed consent process.

NIH Guidance

While the NIH DMS Policy does not expect that informed consent given by participants will be obtained in any particular way, it has developed the following resources for developing consent language related to data sharing:

Note that NIH institutes and centers may have their own guidance for informed consent language (e.g., the National Institute on Alcohol Abuse and Alcoholism [NIAAA] and the National Institute of Mental Health [NIMH])

Guidance from Johns Hopkins Institutional Review Boards (IRBs)
Johns Hopkins Medicine IRBs

Note that additional consent forms for specific situations are on the JHM IRB Forms page.

For more information on the informed consent process as governed by the Johns Hopkins Medicine IRBs, see the Organizational Policies page, specifically policies 109.7, 109.8, 111.14, 116.1, 116.3, 116.4, 116.5, 117.1, D403.1, and PER1. 

Office of the IRB, Johns Hopkins Bloomberg School of Public Health
  • Consent Form Guidance - see section VI "Consent Process, Consent Forms, Recruitment and Other Participant Interaction Issues"
  • Adult Signed Consent Form RCR1 - see the sections, "What happens to data that are collected in the study?," "How will the confidentiality of your data be protected?," "What happens to data and biospecimens that are collected in the study?," and "Genomic Data Sharing."
  • Genomic Data Sharing Language

Note that additional consent forms for specific situations are on the Consent Forms page.

Guidance from Other Sources
  • Meyer MN. Practical Tips for Ethical Data Sharing. Advances in Methods and Practices in Psychological Science. 2018;1(1):131-144. doi:10.1177/2515245917747656 - Includes advice on data management and sharing language for consent forms

Reponsibly Manage AI/AN Participant Data

NIH Guidance
Guidance from Other Sources

Appropriately De-identify Participant Data

NIH Guidance

Supplemental information to the NIH Policy for Data Management and Sharing offers guidance on the de-identification of human subjects data. For the full guidance, go to "Protecting Privacy When Sharing Human Research Participant Data."

In general, data should be shared only in a de-identified format, while also maintaining the scientific utility of the data.

NIH directs researchers to the following standards, methods and tools.

Standards for Data Identifiability
Methods and Tools for De-identification
JHU Guidance and Support