Data Use Request (DUR) Process

Data Use Request

A Data Use Request (DUR) is an online application submitted by the researcher within the N3C Data Enclave that describes the scope and nature of the project and justifies the requested data access tier. Approval of the DUR by the Data Access Committee (DAC) is required before a researcher can access data within the enclave. (Approved DURs are valid for 1 year.) The following steps outline the process for a researcher to either submit a DUR for a new project or join an existing project.

You can also view tutorials for submitting a DUR on the N3C Tutorials page: https://covid.cd2h.org/tutorials/

N3C Data Enclave Introduction & Data Use Request (DUR) Process (recorded 11.17.2020) N3C Data Use Request (DUR) Process & Request for Appeal (recorded 10.06.2020)

Overview:

READ the checklist before starting the Data Use Request (DUR) process.

IMPORTANT CHECKLIST HIGHLIGHTS:

• You must also have completed the designated section of theNIH Information and Security Management Training
• Each individual data user must complete only the first course on the list titled: 2022 Information Security consisting of these 5 modules: Information Security, Counterintelligence & Insider Threat, Privacy, Records Management, and Emergency Preparedness. (Allow 60-90 minutes to complete all 5 modules inside the first course only.)
• After completing the 5th module of the 2022 Information Security course (only), a button will appear on the top bar that says, "Print Certificate". (Recommended to keep in case it is requested.)

1. Lead Investigator submits a Data Use Request online within the N3C Data Enclave
2. Data Access Committee (DAC) reviews and approves the research project.
3. Researchers are given access to the N3C data.

Data User Request (DUR) Process:

First Time User Prerequisites

Step 1: Institutional DUA

• Confirm your institution has an executed Data Use Agreement (DUA) (See DUA Signatory list)
• If your institution does not have a signed DUA, obtain a copy of the DUA to be signed by your institution.
• Submit the signed DUA to NCATS by emailing it to NCATSPartnerships@mail.nih.gov (link sends e-mail).
• Acquire an ORCID ID (account creation is free and quick). This is required both for registration and contributor attribution.
• If you are not affiliated with an institution, you fall under the term of citizen scientist and may only request access to the synthetic dataset for your research. It is required that you use the same email address to establish your DUA and you use to register for your N3C Data Enclave account.

Step 2: Additional Training Requirement for Human Subjects Protection (LDS and de-identified access only)

• If you intend to access a limited dataset (LDS) or a de-identified dataset, you must have proof of current (within the last 3 years) Human Subjects Protection training (ex. through CITI Program or NIH).

Step 3: Register for Access & Set-up Two-Factor Authentication -Register with N3C and request an N3C Data Enclave account. (Allow 2-5 business days for this to be set up.)

• Remember: If you are a citizen scientist, it is required that you use the same email address to register for your N3C Data Enclave account as you used to establish your DUA.
• NCATS requires two-factor authentication for access to the N3C Data Enclave. Before you apply for a DUR, download a two-factor authentication app on your smartphone or tablet: DUO, Free OTP, Google Authenticator, or Microsoft Authenticator.

Submit/Join a Project

Step 4: Submit the Electronic Data Use Request (DUR) Form

Log into the N3C Data Enclave to complete and submit the electronic Data Use Request form. The online Enclave-based form will prompt for description of the scope and nature of the work and justification for the level of data access being requested.

• During this online process, all users will review and attest to the Community Guiding Principles and the Attribution and Publication principles.
• Researchers will also read and attest to the N3C Data Use Agreement (DUA) and theN3C Data User Code of Conduct.
• The institution’s IRB determination letter is required when requesting access to the limited dataset. Upload a PDF of the determination letter documenting approval of the research protocol.
• Search for a specific Domain Team's DUR on the Enclave Projects webpage if you intend to affiliate your research project with it.

The electronic DUR form requires the following information about your research project:

1. Title of research project
2. Project description
3. Project rationale: used by the Data Access Committee (DAC) to assess the level of data (tier) being requested. Users should describe the minimum necessary level of data needed to conduct the research.

Step 5: Await Data Access Committee (DAC) Review Approval (allow 2-5 business days)

If approved, the user will receive an email with instructions for accessing the N3C Data Enclave. Researchers are then given access to the secure platform, which includes both training and ongoing support. (DUR approvals are valid for 1 year.)

Step 6: Workspace is Built (allow another 2-5 business days post DUR approval)

Step 7: Begin data analyses!