NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD)

OMB 0925-0670

Sharing of research data is an integral element of the mission of the National Institutes of Health (NIH), as it advances our understanding of factors that influence health and disease, while also providing opportunities to accelerate research through the power of combining large and information-rich datasets. To promote robust sharing of human and non-human genomic data from a wide range of large-scale genomic research, and to provide appropriate protections for research involving human data, the NIH issued the NIH Genomic Data Sharing Policy (GDS Policy). The GDS Policy, an extension of the 2008 NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (the GWAS Policy), applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research.

The latest form for NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD) expires 2022-11-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 2 Provisional Institutional Certification Institutional Official to Certify Form and Instruction
Form 2 Provisional Institutional Certification Investigator filling out Form and Instruction
Form 2 Institutional Certification Institutional Official to Certify Submission Form and Instruction
Form 1 Project Renewal or Project Close-out Official to Certify Request Form and Instruction
Form 1 Project Renewal or Project Close-out Requester Submitting Request Form and Instruction
Form 1 Requesting Access to Data Signing Official to Certify Request Form and Instruction
Form 1 Data Access Request Form and Instruction
Form 2 Institutional Certification Investigator filing out Form and Instruction
Form 1 Study Registration and Data Submission Form and Instruction
GDS PRA SSA 2022 v6 (3).docx Supporting Statement A
Attachment 3 - 06_1 HHS Privacy Impact Assessment-NIH NLM dbGaP Database of Genotype an.pdf Supplementary Document
Provisional Institutional Certification Institutional Official to Certify Form and Instruction
Provisional Institutional Certification Investigator filling out Form and Instruction
Institutional Certification Institutional Official to Certify Submission Form and Instruction
Project Renewal or Project Close-out Official to Certify Request Form and Instruction
Project Renewal or Project Close-out Requester Submitting Request Form and Instruction
Requesting Access to Data Signing Official to Certify Request Form and Instruction
Data Access Request Form and Instruction
Institutional Certification Investigator filing out Form and Instruction
Study Registration and Data Submission Form and Instruction

All Historical Document Collections

202211-0925-001 Approved with change	Revision of a currently approved collection	2022-11-28
201907-0925-004 Approved without change	Revision of a currently approved collection	2019-07-31
201602-0925-015 Approved with change	Revision of a currently approved collection	2016-03-16
201301-0925-003 Approved without change	New collection (Request for a new OMB Control Number)	2013-01-31

OMB Details

Study Registration and Data Submission

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form 1

Attachment 1 Documentation of the dbGaP Registration system

Fillable Fileable

Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.