Decision Tree for GDS/DMC Policy Harmonization for NHLBI-funded Research

Chart Description

• Are NIH funds used to generate data for your proposed project?
  • If no, neither the DMS nor the GDS policy apply, except when your study is an ancillary study of an NIH funded parent study, where parent study’s data sharing policies apply .
  • If yes, proceed to Question 2.
• Question 2: Are you generating genomic data for your proposed project(s)?
  • If no, proceed to Question 3.
  • If yes, proceed to Question 4.

• Question 3: Are you generating or collecting scientific data (non-genomic) for your proposed project(s) with specific activity codes ?

  • If no, your projects do not generate scientific data. Neither the DMS nor the GDS Policy apply.
  • If yes, follow the DMS policy defined by your NOFOs/ICO policy/ program. The GDS policy does not apply.
  • The GDS Policy does not apply.
• Question 4: Are your genomic data generated from human specimens?
  • If no, proceed to Question 5.
  • If yes, proceed to Question 6.

• Question 5: Does the data meet the NIH threshold for genomic data sharing for non-human specimens, which NHLBI employs?

  • If no, follow the DMS Policy expectations as defined by your NOFOs/ICO policy/program.

  • If yes, follow the GDS Policy expectations :

    • No Institutional Certification is required.
    • Full sequence data is expected.
    • Your data do not have to be submitted to NIH/NHLBI repositories.

• Question 6: Does the dataset meet the NIH threshold for either genomic data sharing (which NHLBI employs) or NHLBI’s special population and rare diseases ?

  • If no, follow DMS Policy expectations* as defined by your NOFOs/program/NHLBI policy.
  • If yes, follow the GDS Policy:
    • Provide your institutional certification by Just In Time.
    • Submit your data to NIH-supported repositories.
    • Observe the data submission/sharing timelines.
• Note: If your genomic data are smaller than the NHLBI’s small data threshold and meet the scientific data standards, the DMS Policy may still apply. Seek guidance from your program officer regarding data protection if submission is expected.

( back to Genomic Data Sharing )

Grants and Training