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Epidemiology and Genomics Research Program

Informed Consents for Data Sharing

What Investigators Need to Know about Updating Informed Consents for the NIH Genomic Data Sharing Policy

Depending on when specimens were collected, investigators may need to update their informed consent documents and processes in order to use these specimens for NIH-funded research falling under the GDS Policy.

What consent is required?

NIH's Genomic Data Sharing (GDS) Policy requires that participants be informed that their specimens and data may be used in future research and that the data will be shared broadly. This consent requirement applies to both research and clinical specimens collected, or cell lines created, after the implementation date of the GDS Policy--January 25, 2015--even if the specimens are de-identified. For specimens collected or cell lines created before January 25, 2015, the requirement is different: consent does not have to explicitly address broad data sharing, although an IRB, privacy board, or equivalent body needs to determine that data sharing is not excluded by the participant's consent.

For projects expected to submit their data to an NIH repository under the GDS Policy, institutions must assure NIH and document through the Institution Certification that participants provided the appropriate consent based on when the samples to be used were collected or created. Additional information about Institutional Certification and official templates are available on the NIH website, along with GDS Policy guidance on required consent [PDF]. General information on required elements of informed consent, including how to address data sharing through repositories, is also available. Recently, NIH published points to consider and sample language for future use and/or sharing of data and biospecimens.

What are the consequences for not complying with the consent requirement?

In general, if the project falls under the NIH GDS Policy and the investigators do not have the appropriate GDS Policy consent for specimens collected after January 25, 2015, they will be unable to use these specimens for the project. In addition, genomic data generated from samples lacking this consent cannot be deposited into NIH controlled-access repositories, regardless of whether the project falls under the GDS Policy. Therefore, investigators should ensure that that their informed consent documents and processes are updated to comply with GDS Policy requirements.

While NCI leadership may, in rare cases, consider an exception to the NIH GDS Policy consent requirement if there is a "compelling scientific justification," investigators must provide an alternative data sharing plan outlining how they will still be able to make the data available to the scientific community. An exception requires the support of program leadership and the approval of the NCI Director.

Summary of GDS Policy Consent Expectations

When specimens were collected Consent expectation under GDS Policy Consequence if GDS consent requirement is not met
On or after January 25, 2015 "NIH expects that informed consent for future research use and broad data sharing will have been obtained even if the cell lines or clinical specimens are de-identified."
  • These specimens cannot be used for the proposed research without "compelling scientific reasons"
  • Data generated using these specimens cannot be shared in NIH-designated repositories; criteria of the NIH Institutional Certification cannot be met
  • An exception to the GDS Policy is required in order to use the specimens for the proposed research; since the individual-level data cannot be submitted to an NIH-designated repository, the investigator is expected to develop an alternative plan to share the data through other mechanisms
Before January 25, 2015 "[A]n assessment by an IRB, privacy board, or equivalent body is needed to ensure that data submission is not inconsistent with the informed consent provided by the research participant. NIH will accept data derived from de-identified cell lines or clinical specimens lacking consent for research use." N/A

What are the policies for sharing non-genomic data?

Some projects that don't generate genomic data may still be expected to share data broadly because of other NIH data sharing policies and requirements. Any project sharing data through an NIH-designated data repository will still need to affirm that participants provided appropriate consent for sharing their data broadly.

For further questions about the NIH GDS Policy, please contact EGRP Program Director Charlisse Caga-anan, J.D.

View more about NIH Data Sharing Policies