Governance Resources

The N3C is committed to providing a secure platform for COVID-19 data and reliable infrastructure to support research. This page outlines policy documents and other governance resources that help ensure that these goals are met.

On this page you can:

Institutions

Agreement for institutions to sign before transfering data to N3C

Data Transfer Agreement This legal document covers the terms of the transfer of data to N3C. It also covers the disclosure of a limited dataset from the contributing site and is signed by the transferring institution’s legal signatory and NCATS.

For questions about executing the DTA, contact NCATSPartnerships@mail.nih.gov.

Agreement for institutions to sign before participating researchers access data

Data Use Agreement This document is the required agreement signed by institutions participating in the usage of N3C data. A searchable roster of institutions that have already signed this agreement can be found here

N3C Data Use and Requests for Additional Data

Institutional Review Board (IRB) Documents This page contains the Central IRB Approval Letter for N3C and the N3C IRB Protocol.

Privacy-Preserving Record Linkage (PPRL) Governance Document This document describes N3C Privacy-Preserving Record Linakge, including options for participation, guiding principles and rules for participation, and the dataset ingestion process.

Publicly Available Data (PAD) Policy_ This document outlines the expectations and process for requesting and approving a publicly available dataset (PAD) to be included in the N3C Data Enclave. It also covers requesting the use of a PAD in a given data use request (DUR).

Users

Policies for downloading Enclave data

Results Download Policy This document describes a process to permit the download of quantitative artifacts used in analyses of data from the N3C Data Enclave that are necessary for sharing results, while at the same time ensuring protection and security of the data in the Enclave and compliance with the NCATS Data Transfer and Data Use Agreements.

Note: At the advice of the NIH Tribal Health Research Office (THRO), all individuals who self-identified as American Indian (AI) or Alaska Native (AN) in the EMR have had their race changed to “OTHER”. In addition, for these rows, we replace race_source_value with "Other" and race_source_concept_id with 0. Furthermore, all zip codes that represent a region where the majority of residents are American Indian (AI) or Alaska Native (AN) have been removed.

Policies for Publication

N3C Publication Intent Form The N3C Publication Intent Form (formerly known as the Manuscript Concept Form) is designed to inform the N3C Publication Committee, the N3C Leadership, and NCATS of all N3C publications and presentations.

Attribution and Publication Principles This document provides guidelines and approaches that all users within the N3C research community uphold, and it addresses attribution and publication principles with regard to N3C Community dissemination of research.

N3C Contributors Form This form enables individual N3C researchers to record what they have contributed to and how.

N3C Paper Status Update Form Use this form to update the N3C Publication committee about a manuscript you previously intended to publish.

How to access different types of N3C data

Data Access Requirements This table outlines the levels of access for N3C data, as well as the requirements for each.

Expectations for members of the N3C Community

N3C Community Guiding Principles The N3C community is committed to providing a welcoming and inspiring environment for all community members.

The Community Guiding Principles document outlines expectations of every N3C community member, which includes, institutions and individuals who use N3C resources, expertise, and data.

N3C Data User Code of Conduct Following the terms and conditions outlined in the Data Use Agreement, this document outlines permitted and prohibited activity within the N3C Data Enclave.