Study Registration and Data Submission to an NIH-Designated Controlled-Access Data Repository

When planning to register a study in the NIH database of Genotypes and Phenotypes (dbGaP) and submit human genomic and associated phenotypic data to an NIH-designated controlled-access data repository, please consider the following steps:

• Contact the appropriate NIH Institute or Center (IC) Genomic Program Administrator (GPA). This step is very important and should be first in the study registration and data submission process. It should occur as early in the process as possible, even during planning, as it helps the NIH IC to prepare for upcoming data submissions, facilitates communications with data repository staff, and identifies special situations that may need to be considered, such as studies with a complicated design or organizational structure.
• Complete the registration and data submission process electronically in the dbGaP authorized access portal which involves:
  • Providing basic study information (e.g., data types, number of participants).
  • Uploading the Institutional Certification, an assurance that plans for the submission of large-scale human genomic data to the NIH meet the expectations of the NIH GDS Policy.
  • Uploading the data to the dbGaP submission portal, once the registration is approved and complete.
  • Processing of the data by dbGaP staff.

Related Resources for dbGaP Study Registration and Data Submission

• Genomic Program Administrators Roster – Names and contact information of the NIH Institute or Center (IC) Genomic Program Administrators (GPAs) who are responsible for working with investigators to facilitate study registration in dbGaP and submission of data to NIH-designated data repositories. GPAs also serve as the lead NIH IC point of contact for the NIH GDS Policy.
• dbGaP “How-To Register a Study” Tutorial (YouTube) – Instructional video about how to register a study in dbGaP.
• dbGaP Genomic Study Registration and Submission of Data Flowchart – Flowchart that guides investigators and institutions through the processes for dbGaP study registration and submission.
• Institutional Certifications – Information about the Institutional Certification, through which institutions assure that plans for the submission of large-scale human genomic data to an NIH-designated data repository meet the expectations of the NIH GDS Policy (e.g. the data submission is consistent with any applicable laws and regulations as well as relevant institutional policies, any limitations on the research use of the data are delineated, the identities or research participants will not be disclosed to NIH-designated data repositories, an Institutional Review Board or equivalent has reviewed the proposal for data submission plans). Includes information for both extramural and intramural (NIH) investigators
• Guidance on Consent for Future Research Use and Broad Sharing of Human Genomic and Phenotypic Data Subject to the NIH Genomic Data Sharing Policy – Provides information to be tailored to individual studies and conveyed to prospective participants during the consent process in order to meet the NIH GDS Policy expectations.
• Points to Consider in Developing Effective Data Use Limitation Statements – Provides guidance to investigators and institutions developing limitations on the secondary research use of the datasets to be submitted to an NIH-designated controlled-access data repository, based on the informed consent of study participants. Institutions should use the Standard Data Use Limitations that have been developed, when delineating the appropriate use of the data they are submitting.
• Guidance for Institutions Submitting Data under the NIH GDS Policy – Guidance to institutions submitting grant applications or contract proposals for meeting the expectations outlined in the NIH GDS Policy. Institutions and organizations may find this document helpful when developing their own internal guidance or institutional policy documents.
• Non-NIH-Funded dbGaP Submission Requests:
  • Expectations for Non-NIH-Funded Submission Requests – Outlines the expectations and provides instructions for requests to submit data that were not generated from NIH-funded research.
  • Example of Basic Study Information for Non-NIH-Funded Studies – Example of the basic study information that investigators should provide to the appropriate GPA for consideration of a non-NIH funded data submission request.
• Examples of Journals Requiring Broad Sharing of Data – Resource that contains a sampling of journals that require or encourage submission of data associated with a publication to a public repository. Links to the relevant information provided by each listed journal are included.
• Examples of Genomic Data Standards Resources and Initiatives – The Supplemental Information to the NIH GDS Policy references a number of resources and initiatives with regard to genomic data standards. This document provides more information about these cited resources and initiatives.

Requesting Access to Controlled-Access Data Maintained in NIH-Designated Data Repositories (e.g., dbGaP)

Responsible stewardship of controlled-access data subject to the NIH GDS Policy is shared among the NIH, the investigators approved to access the data, and the investigators’ institutions. Investigators who are interested in obtaining controlled-access data from NIH-designated data repositories for secondary research use must:

• Submit a Data Access Request (DAR) through the dbGaP authorized-access portal, describing the proposed research use of the data.
  • Investigators should review the supplemental instructions for more information and helpful tips on how to prepare a successful DAR.
  • The investigator must be a tenure-track professor, senior scientist, or equivalent, to be able to submit a DAR.
  • For collaborations between multiple institutions, the investigator(s) at each institution must submit a separate DAR and receive approval before data may be accessed. Each institution is ultimately responsible for the oversight of its investigator’s management and use of the data.
  • Investigators wishing to access HeLa genome sequence data should review the Special Instructions.
  • Upon submitting a DAR, certify, along with the institution, adherence to:
    • The terms of access described in the Data Use Certification (DUC) Agreement and the Genomic Data User Code of Conduct.
    • The NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy.
  • Allow for Data Access Committees (DACs) review of the DAR. DACs, comprised of federal employees with the appropriate expertise, are established by NIH Institutes or Centers to review DARs based on whether the request conforms to the specifications within the NIH GDS Policy and program specific requirements or procedures (if any), and for consistency with any data use limitations. Based on their review, DACs approve or disapprove DARs, or return DARs for revision.

Once approved, investigators may download and access the data for one year. Prior to the expiration of the one-year access period, investigators must also submit a project renewal or close-out report, describing the progress made on the approved research project.

Related Resources for Requesting Access to dbGaP Data

• dbGaP How-to Tutorials (YouTube). Instruction videos that guide dbGaP users through the following processes:
  • Data Access Requests
  • Project Renewals
  • Project Close-Outs
• NIH Extramural Investigator Data Access Request Flowchart – Flowchart that outlines the process by which extramural investigators request access to datasets from dbGaP.
• NIH Intramural Investigator and Staff Data Access Request Process:
  • NIH Staff Data Access Request Flowchart – Flowchart that outlines the process by which NIH intramural investigators request access to datasets from dbGaP.
  • NIH Staff Request Form for Permission to Access Controlled-Access Data – This form outlines the requirements and process for eligible NIH employees to request permission from their NIH Institutes or Centers (ICs) to submit Data Access Requests. The permission form and contact information for the relevant IC officials are included.
• Tips for Preparing a Successful Data Access Request – Helpful information for investigators preparing a Data Access Request, including instructions on how to draft an appropriate Research Use Statement.
• Model Data Use Certification (DUC) Agreement – A sample agreement that delineates the terms of data access that investigators and their institutions agree to adhere to at the time of submission of a Data Access Request. DUCs are generated for each study in dbGaP and include any study or IC specific terms (e.g. data use limitations), suggested acknowledgement statement, and standard terms of access. Investigators are also expected to abide to the Genomic Data User Code of Conduct.
• NIH Position Statement on Use of Cloud Computing for Storage and Analysis of Controlled-Access Data under the NIH GDS Policy – This statement describes NIH’s position and expectations regarding the use of public or private cloud systems for the storage and analysis of data obtained from NIH-designated repositories under the auspices of the NIH GDS Policy.