Completing an Institutional Certification Form

Step 1: Download Institutional Certification Forms

NIH provides different versions of the Institutional Certification based on 1) source of NIH funding (e.g. NIH intramural vs NIH extramural programs), 2) whether samples were collected before or on/after the effective date of the GDS policy, and 3) consent status for samples collected before the effective date.

Please note that:

• The downloadable forms work best if completed in Adobe
• Use of electronic signatures is encouraged, but the downloadable forms cannot validate an image signature
• The Signing Official (SO) electronic signature will lock the form such that no other changes can be made

Extramural (Grants & Contracts)

NIH Intramural (NIH Staff Only)

Although Institutional Certifications are not expected until Just-in-Time, applicants are now being asked to anticipate genomic data sharing in their Data Management and Sharing Plan according to criteria in the Institutional Certification. For more information see Writing a Data Management & Sharing Plan.

Step 2: Study Information

The initial part of the Institutional Certification form asks for some basic information about the study and the performing institution(s).

• Name of the NIH Genomic Program Administrator (GPA)
  • The genomic program administrator (GPA) at the NIH IC funding the project, or at the IC most closely aligned with the project.
• Name of institution
  • The name of the institution submitting the certification.
• Original study name
  • The original institutional review board (IRB or equivalent body)-approved study under which the participants provided informed consent and the specimens were collected.
• Project title for data to be submitted
  • The name of the research project. It may or may not be the same as the original study.
• Collaborating sites
  • The collaborating sites that this Certification will cover (only applicable to multi-site studies).
    • Click “add to list” after entering each site. This will allow the form to generate a list of all the collaborating sites, which will automatically fill out the “list of collaborating sites” field.
    • If necessary, click “clear list” to delete all the collaborating sites and start over.

Step 3: Assurances

In this section, the institution, in consultation with its IRB or equivalent body, assures NIH that the study being submitted is consistent with the NIH GDS Policy, and with the informed consent of the original study participants. Learn more about assurances in the "What are Institutions Expected to Certify? Elements of an Institutional Certification" section of our About Institutional Certifications page.

Step 4: Controlled Vs. Unrestricted Access

In this and the following section of the Institutional Certification, submitters can specify any applicable limits on how the genomic and phenotypic data may be shared and who may access the data. The appropriate limitations are decided by the submitting investigator and their institution, in consultation with the IRB or equivalent body.

Access to Individual-Level Human Data

• The informed consent under which the data or samples were collected determines whether the submitted data should be available through an unrestricted or a controlled access repository.
  • Data in controlled access databases are available to investigators only after review of their proposed research use. Data in unrestricted access databases are publicly available to anyone.

Certificates of Confidentiality

Certificates of Confidentiality (CoC) protect the privacy of research participants by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the participant consents or in a few other specific situations. If your research involves generating identifiable, sensitive information (such as individual-level human genomic data) and is funded in whole or in part by NIH, your research is automatically deemed to be issued a Certificate of Confidentiality (CoC).

Access to Genomic Summary Results (GSR)

• Genomic summary results (GSR), which are sometimes called “aggregate genomic data” or “summary data,” are the result of analyses of genomic data across many individuals included within a specific study's dataset. NIH provides genomic summary results from most studies submitted to NIH-designated data repositories through unrestricted access.
• For more details on GSR and how to manage GSR, please consult NOT-OD-19-023.
• NIH realizes that it may not be appropriate to share GSR from some studies with unrestricted access. For instance, data from datasets considered to have particular “sensitivities” related to individual privacy or potential for group harm (e.g., those with populations from isolated geographic regions, or with rare or potentially stigmatizing traits). In those cases, investigators should designate the study as “sensitive,” which will make the GSR controlled access and prohibit public posting.
  • To learn about designating studies as “sensitive” for the purposes of GSR access, please consult Points to Consider for Institutions and Institutional Review Boards in the Submission and Secondary Use of Human Genomic Data under the NIH Genomic Data Sharing Policy.

    Need help developing informed consent documents for data sharing? We recommend that those writing and approving informed consent documents review community standards, such as:

    • National Human Genome Research Institute’s (NHGRI) Informed Consent for Secondary Research with Data and Biospecimens discusses the inclusion of disclosures about use and access to GSR during the informed consent process.
    • International standards on genomic data sharing, such as the E18 Genomic Sampling and Management of Genomic Data Guidance for Industry
    • The NIH Genomic Data Sharing Policy expectations related to informed consent

Step 5: Restrictions: Data Use Limitations (DULs)

Selected data use limitations and DUL modifiers should be based on language in the informed consent forms as well as any additional considerations deemed necessary by an IRB or equivalent review body committee. For more information, NIH provides relevant considerations for IRB and institutions to refer to in "Points to Consider in Developing Effective Data Use Limitation Statements".

Whenever possible, NIH strongly encourages investigators to use human genomic data generated from participants who gave consent for unrestricted access, or who gave consent for General Research Use (see table below) under controlled access. Similarly, NIH encourages consent language to avoid restrictions on the types of users who may access the data. This will maximize the potential for important research and public health impacts.

Standard Data Use Limitations

Data Use Limitation Modifiers (Optional)

• If appropriate, indicate any necessary modifiers to the standard DULs.

Step 6: Signatures

In the final section, the project investigator and their institutional signing official certify that this form has been reviewed by an IRB (or equivalent body) and/or other senior institutional officials, and that all parties agree that this submission meets the requirements of the form.

• Investigator name
  • The investigator at the certifying institution
• Title
  • The title of the signing investigator
• Institutional Signing Official (SO)
  • A senior official at an institution who is credentialed through the NIH eRA Commons and is authorized to enter the institution into a legally binding contract.
  • For intramural research projects, the SO is the IC's scientific director or their designee.

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