NIH Human Genomic Data Sharing Policy FAQs:
1. When does the policy go into effect? January 25, 2015.
2. What is the purpose of the policy? To ensure the broad and responsible sharing of genomic
research data generated from NIH-funded research.
3. What research is covered by the policy? NIH-funded research that generates large-scale
(defined as >100 individuals) human genomic data as well as the use of that data for subsequent
research. This includes genome-wide association studies, genome sequence, single nucleotide
polymorphisms arrays, transcriptonic, metagenetic, epigenomic and gene expression data. This
policy applies to grants, contract and cooperative agreements funded by NIH. Non-human
genomic data is also covered by the policy, but is subject to different requirements (see Section
IV.B of the policy and supplemental information; links at end of FAQs)
4. What are the investigator responsibilities when preparing a proposal for NIH funding and
before award?
(a) NIH application:
 Investigators seeking NIH funding should contact their NIH Institute or Center (IC)
Program Official or Project Officer to discuss the project, data sharing plan and data
certification process.
 Basic plans for following this policy should be included in the “Genomic Data Sharing
Plan” located in the Resources Sharing Plan section of the grant application. Data
sharing plans should describe how the expectations of the policy will be met, including
how data will be de-identified, how consent will be obtained and how the consent
language will be written to specify broad data sharing.
 Resources needed to support the Genomic Data Sharing Plan should be included in the
budget.
(b) Just-in-Time:
 A more detailed Genomic Data Sharing Plan must be provided to the funding IC prior to
award.
 The Institutional Certification for sharing human data must be provided to the funding
IC prior to award. The Institutional Certification will include IRB approval, limitations or
restrictions to data sharing, and state that data are being submitted to a controlledaccess database.
5. When is an IRB application required?
 If the study has not already been submitted to and approved by the JHM IRB, an eIRB2
application should be submitted when the investigator has received a score that is in
the fundable range.
 A planning phase application is acceptable if the complete study documents and details
have not been developed; a Genomic Data Sharing IRB Form should be uploaded with
the application (link at end of FAQs).
6. When must human data be submitted to an NIH repository?
 Investigators should register in dbGaP all studies that will include human genomic data
that fall within the scope of this policy by the time data cleaning and quality control
checking begin. After registration, investigators should submit the data to the relevant
NIH repository
 Large-scale human genomic data should be submitted to a NIH-designated genomic
data repository in a timely manner, as described in the Supplemental Information to the
NIH Genomic Data Sharing Policy.
 Data should be de-identified according to standards set forth by DHHS in 45 CFR
46.102(f) and the HIPAA Privacy Rule.
7. What information regarding repository submission must be included in the consent form?
 For studies initiated after January 25, 2015, the consent form should include a provision
for genomic and phenotypic data to be used for future research and shared broadly, and
a statement that a participant’s individual level data will be shared through a controlledaccess NIH-designated genomic data repository. Although NIH maintains both
unrestricted and controlled- access repositories, the JHSPH IRB will certify for
submission only to a controlled-access repository, as opposed to an unrestricted access
repository.
 For studies using genomic data from cell lines or clinical specimens that were created or
collected after January 25, 2015, informed consent for future research and broad data
sharing must be obtained, even if the cell lines or clinical specimens are de-identified.
 For studies conducted prior to January 25, 2015, the IRB will determine whether data
submission is not inconsistent with the informed consent provided by the participant.
8. What is an Institutional Certification?
 The Institutional Official is required to provide a certification to the IC prior to award
consistent with the genomic data sharing plan submitted with the funding request. The
IRB will obtain this certification from the Institutional Official after completing its review
of the proposed submission.
 A request for Institutional Certification must be submitted to the JHSPH IRB (either
through a Planning Phase Application in PHIRST for new projects, or through an
Amendment Application for ongoing projects).
 The IRB must review the data submission proposal and assure: that collection of
genomic and phenotypic data is consistent with 45 CFR 46; data submission and sharing
are consistent with the informed consent; risks of data sharing to participants and their
families were considered; risks of data sharing to groups or populations associated with
the data were considered; and that the investigator’s plan for de-identification meets
HIPAA and DHHS standards.
9.
What are the steps for study registration and submission of data?
 The NIH Institute or Center registers the study in the dbGaP registration system and the
PI will then receive an email with instructions to complete registration.
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The PI enters basic study information: target delivery and release dates, number of
participants, data type, secondary contact information, consent group.
The PI uploads a signed Institutional Certification.
The PI uploads the required data to dbGaP submission portal, or the portal of another
targeted NIH-designated genomic data repository.
The PI receives a study accession number to review study genomic and phenotype data
prior to release.
10. Are there any exceptions to this policy? There are limited exceptions, as described in the
policy.
Links:
NIH Genomic Data Sharing Policy and Supplemental Information
http://gds.nih.gov/03policy2.html
NIH Steps for dbGaP Genomic Study Registration and Submission of Data
http://gds.nih.gov/pdf/Steps_for_dbGaP_Genomic_Study_Registration_and_Submission_of_Data.pdf
Genomic Data Sharing IRB Form
http://www.jhsph.edu/offices-and-services/institutional-review-board/applications-and-relatedtasks/genomic-data-sharing-forms/index.html
GWAS Consent Form Template
http://www.jhsph.edu/offices-and-services/institutional-review-board/applications-and-relatedtasks/genomic-data-sharing-forms/index.html