Key Dates

Related Announcements

• August 27, 2014 - NIH Genomic Data Sharing Policy. See Notice NOT-OD-14-124.
• October 29, 2020 - Final NIH Policy for Data Management and Sharing. See Notice NOT-OD-21-013.
• July 05, 2019 - Notice of New NIH-Designated Data Repository: NHGRI’s Genomic Data Science Analysis, Visualization, and Informatics Lab-space (AnVIL). See Notice NOT-HG-19-024.
• September 7, 2017 - Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality. See Notice NOT-OD-17-109.

Issued by

National Human Genome Research Institute (NHGRI)

Purpose

The purpose of this Notice is to update and replace the current Notice of New NIH-Designated Data Repository: NHGRI’s Analysis, Visualization, and Informatics Lab-space (AnVIL) (NOT-HG-19-024).

AnVIL as an NIH-Designated Data Repository for Meeting NIH Data Sharing Policy Requirements

AnVIL is a secure, cloud-based platform where researchers can store, combine, share, and analyze unrestricted- and controlled-access datasets, particularly those generated with NHGRI funding or support. AnVIL serves as the primary NIH-designated data repository for NHGRI-funded data, metadata, and associated documentation. NHGRI-funded investigators may submit to AnVIL to fulfill the expectations of the NIH Genomic Data Sharing Policy (NOT-OD-14-124) and the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013).

Security Controls

The NHGRI AnVIL and the data it contains are secured in accordance with the industry best practices, the NIST 800-53 Moderate security controls following the FedRAMP standard.  AnVIL also supports sharing of clinical research data and HIPAA compliance, when required. As needed, relevant parties will execute Business Associate Agreements and must follow Good Clinical Practice guidelines to protect patient privacy.

Certificates of Confidentiality

Additionally, as an NIH-funded program, all “identifiable, sensitive information” as defined by the NIH Certificates of Confidentiality Policy (NOT-OD-17-109) that is made publicly available through AnVIL via unrestricted or controlled-access are covered by a Certificate of Confidentially. All persons who access or work with such data managed by AnVIL must abide by the NIH Certificates of Confidentiality Policy.

Study Registration and Access Management

As of the publication of this Guide Notice, the Data Use Oversight System (DUOS) will be used by NHGRI to register new studies and manage access to controlled-access datasets hosted by AnVIL. Researchers interested in accessing controlled-access human genomic data released on AnVIL can apply for data access through DUOS or the NIH dbGaP Authorized Access Portal. Requesting institutions must agree to the NIH Library Card Agreement to pre-authorize researchers to make Data Access Requests in DUOS.

Per the NIH Genomic Data Sharing (GDS) Policy (NOT-OD-14-124), NIH Data Access Committees (DACs) review data access requests to ensure the request is compliant with any limitations or restrictions on use. If the DAC approves the request, investigators will receive an email with instructions on accessing the data. Investigators and their institutions are responsible for adhering to the NIH Data Use Certification and any dataset-specific data use limitations or requirements, and the Genomic Data User Code of Conduct.

Use of AnVIL By NHGRI-Funded Consortia

Principal investigators and consortia investigators on NHGRI-funded projects may share pre-release data according to consortium-level data use agreements, and the Consortium Guidelines for AnVIL Data Access.

AnVIL Operations

NHGRI funds and manages AnVIL through cooperative agreements. Staff from AnVIL primary grantee institutions and their subcontractors with responsibility for maintaining and securing AnVIL data and software will have only operational access to the data in AnVIL, as described in the terms and conditions of the AnVIL cooperative agreements (RFA-HG-22-020; RFA-HG-22-021). No staff associated with AnVIL will have privileged access to the data beyond the scope of platform operations. No ownership rights of the datasets (including derived or derivative data) are granted to AnVIL primary grantee institutions or their subcontractors. 

Inquiries

Please direct all inquiries to:

NHGRI Data Sharing Contacts
National Human Genome Research Institute
Email: nhgridatasharing@mail.nih.gov