Guidance on NIH Genomic Data Sharing (GDS) Policy


Who does this policy apply to?

All NIH-funded research that generates and uses large scale human or non-human genomic data, as well as the use of these data for subsequent research including:

  1. Genome-wide association studies (GWAS);
  2. Single nucleotide polymorphisms (SNP) arrays; and
  3. Genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data.

Examples are available in the Supplemental Information to the NIH GDS Policy.

When does this policy NOT apply?

Examples of NIH-funded research or research-related activities that are outside the Policy’s scope include:

  1. Instrument calibration exercises;
  2. Statistical or technical methods development; or
  3. The use of genomic data for control purposes, such as for assay development.

If you are unsure, contact your Program Official.

In addition, the following types of funding generally do not fall under the GDS Policy: Institutional Training Grants, K12 Career Awards, Individual Fellowships (Fs) such as the Ruth L. Kirschstein National Research Service Award, Resource Grants and Contracts (Ss), or facilities and coordinating centers funded to provide genotyping, sequencing, or other core services in support of GDS.

Creating a Genomic Data Sharing Plan

NIH expects investigators and their institutions to provide basic plans for following this Policy in the “Genomic Data Sharing Plan” located in the Resource Sharing Plan section of funding applications and proposals. The required elements for the data sharing are described below.


The data sharing plan should describe:

  1. How the expectations of the NIH GDS Policy will be met;
  2. Denote the type(s) of data to be submitted;
  3. Which data repository(s) data will be submitted to;
  4. The appropriate uses of the data (i.e. Data Use Limitation); and
  5. The data sharing timeline.

Any request for an exception to submission should also be included. The NIH Guidance for Investigators in Developing Genomic Data Sharing Plans provides expectations and examples of genomic data sharing plans for human and non-human research.

Institutional Certification

An Institutional Certification stipulating the appropriate secondary uses of data submitted to an NIH-designated repository should be provided by the Institutional Signing Official(s) of the submitting institution during the Just-in-Time pre-award process (or the start of research for NIH intramural investigators) when genomic data generation is proposed.

Informed Consent

If samples have not yet been collected: The informed consent document should include information regarding the data sharing.  The informed consent must be clear that DNA/samples will undergo genomic analysis and that genotype and phenotype will be shared for research purposes with investigators who submit proposals to the NIH Designated Data Repository.  Suggested language is available from COUHES and from the NIH National Human Genome Research Institute.

If samples have already been collected: COUHES must review the informed consent documents which were signed by participants to confirm whether or not the initial consent under which genetic materials were obtained is consistent with the submission of data to the NIH Designated Data Repository and the GDS Policy 

  1. For data from specimens collected before 1/25/2015, COUHES will assess whether the data submission is consistent with the informed consent given by the participant.  NIH will accept data derived from de-identified cell lines or clinical specimens lacking consent for research that were created or collected before 1/25/15.
  2. For studies initiated after 1/25/15, NIH expects researchers to obtain participants’ consent for their data to be shared broadly for future research.

COUHES may determine that the original consent is not consistent with the submission of data to the NIH Designated Data Repository. In this instance:

  1. COUHES may request re-consent of subjects. For example, if a study prohibited sharing by using statements such as “Your data will never be shared outside of MIT,” re-consenting may be appropriate if it is practicable. Any plan to re-consent should be submitted to COUHES as a modification to the protocol along with the modified consent form and must receive COUHES approval prior to implementation.
  2. COUHES may determine that the original consent is not consistent with submission of data to the NIH Designated Data Repository and determine that it cannot verify that the criteria outlined in the NIH Designated Data Repository have been met for submission of data. If so, investigators should consult their Program Official on exceptions.

The criteria for a waiver of consent under 45 CFR part 46 are not applicable to the IRB's determinations (45 CFR 46 does not apply to this use). The criteria the IRB must apply in making its determinations are those set forth in the GDS policy.

Checklist for COUHES Submission

If you are submitting data to an NIH-designated repository, please review the COUHES requirements below:

  1. Submit a Genomic Data Sharing Submission Certification Request Form to the COUHES Office at
  2. For prospective data collection, if you do not already have COUHES approval to receive/collect the data /specimens, submit a Comprehensive Application for review through COUHES Connect.
  3. For secondary research using samples that were not collected specifically for this research, complete an exempt evaluation to determine whether your research is non-human subjects research, exempt or requires the submission of a comprehensive review application. 
  4. All applications must include the following:
    1. A blank copy of each consent form used to collect samples from which data were/will be generated. If the dataset includes data from samples obtained at another institution, including commercial vendors such as ATCC, COUHES must review each of those consents as well.
      1. Submit each consent version across studies, and across time. This would be each IRB-approved consent document used to collect samples represented in the dataset.
      2. If no consent is available, consult with COUHES to determine whether the data may be submitted to an NIH designated repository.
    2. A copy of the IRB approval letter, if not approved by COUHES. MIT is considered engaged in humans subjects research if MIT receives a direct HHS award to conduct human subjects research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. When MIT is engaged in human subjects research COUHES review is required. The appropriate level of review will be determined at the time of submission.
    3. A completed Extramural Institutional Certification form that correlates with the dates samples were collected from participants.
      1. The Institutional Certification must state whether the data will be submitted to an unrestricted or controlled access database. Consult with COUHES on what, if any, data use limitations are needed.
    4. The genomic data sharing plan.