NIH Releases Guidance on Informed Consent Language for Data Sharing


NIH Releases Guidance on Informed Consent Language for Data Sharing

Last month we talked about the new NIH Policy for Data Management and Sharing. Yesterday, the NIH released related documentation which provides suggested language to include in informed consent documents regarding the storage and sharing of research data for future use. As we like to say here at CDABS, it’s best to plan for sharing your data from the very start of your research project. This is why it’s so important to have a data management and sharing plan.

Some notes about the guidance:

  • The use of the sample language in this document is recommended but voluntary.
  • The language is intended to be incorporated in to the main informed consent document, not to replace or serve as a separate document, and its use does not obviate the need for IRB review.
  • The sample language is generic, and other considerations/language may be necessary in cases where data is being collected from vulnerable populations and communities, from certain cultural groups and from Tribal Nations, and when collecting genomic data.
  • The guidance and sample language generally do not distinguish between the sharing of data and of biospecimens, but participants may feel differently about the storage and sharing of each, and you might consider allowing them to consent separately to each.

The guidance recommends addressing the following topics in consent documents:

  • Time frame for data and biospecimen storage
  • Who will manage control of and access to data and biospecimens, or if data will be made available without restrictions
  • If identifiers will be retained, and the likelihood of re-identification
  • Whether sharing data and biospecimens will be optional and what happens in cases of withdrawal of consent
  • Associated risks and benefits of data and biospecimens being stored and shared
  • Potential commercial uses or applications that may result from stored and shared data and biospecimens

Other resources:

Access the full guidance document here:

Questions? Contact: Jean-Paul Courneya, bioinformationist, and Amy Yarnell, data services librarian at

The Center for Data and Bioinformation Services (CDABS) is the University of Maryland Health Sciences and Human Services Library hub for data and bioinformation learning, services, resources, and communication

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