Data Use Request, DUR
- Maryam Abdallah
To access N3C data, researchers must submit an online Data Use Request (DUR) through the NCATS N3C Data Enclave for each project for review by the N3C Data Access Committee (DAC). DAC reviews DURs will approve these requests after reviewing the following criteria:
Ensure research pertains to COVID-19.
Justify the level of data access based on the project’s needs.
Verify attestation to human subjects training and NIH IT Security.
Confirm IRB approval for human subjects research, especially for sensitive data requests.
Submitting a DUR
Who Needs to Submit a Data Use Request (DUR)?
Investigators Starting a New Project: Must submit a DUR to establish a new project via the N3C Data Enclave. Approval from the N3C Data Access Committee (DAC) leads to creation of a dedicated project workspace and access for the investigator.
DURs Are Project-Specific: Each new project or collaborative effort requires a separate DUR, regardless of previous approvals.
Investigators Joining as Collaborators: Require a DUR submission to join an existing project as a collaborator in the N3C Data Enclave. Approval grants access to the project’s existing workspace.
Review Time for a DUR by the N3C DAC
Standard Review Time: Total review and approval process typically takes 15 business days, with the primary review by the DAC usually within 10 business days. This is a short time considering the scale of available data. It’s likely quicker than initiating a project based on a single EHR from your site, and much quicker than accessing EHRs from 70+ sites individually.
Potential Delays: Can occur due to lack of detail in the DUR or IRB documentation.
What Information Should Be Included in a DUR?
Information researchers need to provide in the DUR includes:
The project title
Names of project personnel
The requested data access level. Requirements for access vary by data tier
A non-confidential, publicly viewable research statement that clearly states the COVID-19 research questions.
A project proposal that explains the specific need for the requested data level to support the research aims and a generalized outline of anticipated analysis. This will be reviewed by N3C DAC.
Required Documentation
1. USC IRB Documentation (LDS - Level 3 Data)
A USC IRB review is required prior to submitting a DUR due to the following conditions set by the Human Research Protection Program at USC that a Data Use Agreement (DUA) is needed to access the data set (Not Human Subjects Research WorkSheet, p. 6).
Please pursue the following with USC IRB based on the listed conditions:
NHSR* self-determination
Indicated for non research purposes using NHSR data
(1) no intent for research; or intent for conference presentation dependent on reach of conference, AND
(2) Using the following NHSR Data:
All of Us tier 1, tier 2
N3C tier 1, tier 2
Requires NO ACTION on part of researcher.
NOTE: N3C Code of Conduct indicates that data can only be used for research purposes and should be publicly disseminated in some form
*NHSR: Not Human Subjects Research
NHSR Determination
Indicated for non-human subjects research
(1) Any intent for research on NHSR; or intent for conference presentation dependent on reach of conference , AND
(2) Using the following NHSR Data:
All of Us tier 1, tier 2
N3C tier 1, tier 2
ACTION: iStar item 1.1
NOTE: A journal may request proof of an NHSR determination upon reviewal of submission. In this circumstance, a researcher without an NHSR Determination cannot retroactively request one.
IBR Review, exempt category 4 Indicated for Secondary Research uses of Identifiable Private Information or Identifiable Biospecimens.
(1) Having any Research or Public dissemination intent, AND
(2) Conducting human subjects' research using the following data:
All of Us – tier 3 (genomic data) (identifiable biospecimen)
N3C – tier 3 limited data (zip code, treatment dates, identifiable private information, no genomic data)
ACTION:
(1) Submit an Exempt Review in sections 5.1 in iStar.
(2) Use Social Behavioral/Secondary Research protocol template
2. Completion of NIH Information Security and Information Management Training within the last year.
Before beginning their projects or submitting a Data user request, all researchers must complete only the first course on the list title: 2023 Information security, which can be accessed at NIH’s information security training website,
This course consists of 5 modules: the “Information Security, Counterintelligence, Privacy Awareness, Records Management Refresher, Emergency Preparedness Refresher” course.
It will take approximately 60-90 minutes to complete the entire course (first course only)
After completing the 5th module of the 2023 Information Security course (first course only), a button will appear on the top bar that says "Print Certificate".
Users should save evidence of completion for their records (a screenshot or copy of the certificate of completion).
3. Documentation of completion of Human Subjects Research Protection training within the last 3 years.
Training in alignment USC’s policies if you intend to access the de-identified or limited datasets. (This training requirement does not apply to investigators who will only access the synthetic dataset.)
Users will be asked to provide the date the training was completed, and retain evidence of completion to provide NCATS upon request.
NIH Required Education in the Protection of Human Research Participants or CITI Program courses may be used to complete your required training; consult USC Human Research Protection Program (HRPP) for your institution's specific requirements.
After you Submit a DUR:
Upon DUR Approval, Project Workspace will be created.
Once your DUR is approved, you'll receive an email notification about the creation of a project workspace within the Enclave and access to the approved datasets. This may take ~15 days to be created.
Project Workspaces:
Act like folders, containing all datasets, analysis files, and resources for a specific research project.
Serve as the main area for conducting analyses, creating datasets, visualizations, and reports.
Objects can be referenced to your project workspace for use in analysis.
How Long Does a DUR Last?
One Year Effective Period: Approved DUR access to a workspace lasts for one year from the date access is granted.
Renew DUR: Submit a renewal DUR before the one-year expiration date to continue accessing the workspace. You will retest that your required trainings are up-to date.
Update DUR: Request significant changes to an approved DUR if needed, such as upgrading the data access level. Accepted revisions will renew the one-year expiration date of a workspace.
Appeal Rejections: If a DUR is rejected by the DAC, project leads can appeal the decision by updating and resubmitting the DUR.
Related Applications
Submit a new project request with an abstract, title, and data level needed; the submitter becomes the project lead. Or submit a DUR request to join an existing project as a collaborator.  More on how to submit DURs, here. |
View statuses, manage projects, link to domain teams, review collaborator requests, appeal rejected DURs, and access the download request dashboard. | |
 List of all of your projects, w links to thier unique workspaces. |  Image of a newly created Project Workspace, including code workbooks with selected dataset inputs that link to common data locations. |
A list of all N3C research projects, with links for joining projects by submitting collaborator DURs, where allowed.  |
More Resources
Learn more about the process for accessing the N3C Data Enclave.
Video Tutorial: N3C Data Use Request Workflow, Projects Workspace - Reviews the Data Use Request process for gaining access to secure N3C data in the Enclave