Facilitating Efficient and Compliant Data Access Management Through DUOS

The Data Use Oversight System (DUOS) is a semi-automated study registration and DAR management service which enables the secondary use of human genomics and other controlled-access data in compliance with the informed consent of a study’s participants.

DUOS.org Website

The National Institutes of Health (NIH) Data Access Committees (DACs) play an important role in ensuring that controlled-access datasets (that contain potentially identifiable data and require approval prior to access) are used in a manner that is consistent with the informed consent of the study’s participants. The growing demand for controlled-access datasets has spurred the development of new semi-automated systems that retains oversight by the NIH DACs while enabling efficient review and approval of data access requests (DARs).

The Data Use Oversight System (DUOS) is a semi-automated study registration and DAR management service informed by the GA4GH DUO standard, which enables the secondary use of human genomics and other controlled-access data in compliance with the informed consent of a study’s participants. Four NIH DACs have tested DUOS to various extents and have provided feedback on the potential of the system to support NIH’s needs. The goal of the pilot was to assess whether DUOS can enhance current methods for overseeing and granting data access in ways that improve the user experience of the DACs, researchers, and institutional signing officials.

DUOS enables pre-authorization of researchers by their institutions to apply for controlled-access data. It is hoped that this initiative, conceptualized as “the Library Card,” will reduce the administrative burden on signing officials and the decrease the review and approval times of researcher DARs.

Contributing NIH Data Access Committees (DACs)

National Human Genome Research Institute (NHGRI)

National Institute for Allergy and Infectious Disease (NIAID)

National Heart, Lung, and Blood Institute (NHLBI)

Joint Addiction, Aging, and Mental Health (JAAMH) DAC

Joint DAC for the National Institute of Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and National Institute of Mental Health

Milestones

Phase I

The NHLBI and NHGRI DACs tested DUOS with DARs that were previously reviewed by each respective DAC. There was a high level of fidelity between DUOS’s proposed outcome based on semi-automated matching of the research use to data use limitations and the fully human review, with clear opportunities to improve and increase the level of fidelity. These outcomes guided improvements to DUOS that aimed to streamline processes and make the interface more user-friendly.

Phase II

NHGRI and NIAID DACs tested DUOS with new requests for controlled-access datasets hosted by NIH data repositories (submission and formal approval of the request occurred in parallel in dbGaP). NHLBI and JAAMH also tested the system and provided additional feedback to inform further improvement of DUOS for NIH.

The fidelity between DUOS semi-automated representation of the DAC process and the fully human review remained high (95%), and new features were implemented in DUOS to improve efficiency and the user experience for DACs. For example, DACs will only need to vote once to indicate a decision on multiple datasets with the same DULs, and DUOS was updated to the latest version of the DUO standard.

Phase III

The NHGRI DAC invited requestors seeking access to the GTEx dataset (phs000424) to submit the same request in DUOS. Over 70 researchers made a request in DUOS. Researchers were invited to provide feedback on DUOS and were generally comfortable with the system and found it relatively easy to use. Also, the Library Card Agreement was finalized during this phase of the pilot, enabling institutions to pre-authorize researchers to make a DAR (i.e., “Issue a Library Card”).

Launch in AnVIL

Researchers can now use DUOS to request access to NHGRI’s AnVIL controlled-access datasets. A list of available datasets can be found in the DUOS Data Library.

Additional Information

More information on DUOS for:

Learn More

GA4GH 11th Plenary Meeting – AnVIL

Lawson, Jonathan et al. “Aligning NIH's existing data use restrictions to the GA4GH DUO standard.” Cell genomics vol. 3,9 100381. 18 Aug. 2023, doi:10.1016/j.xgen.2023.100381

Rahimzadeh, Vasiliki et al. “Leveraging Algorithms to Improve Decision-Making Workflows for Genomic Data Access and Management.” Biopreservation and biobanking vol. 20,5 (2022): 429-435. doi:10.1089/bio.2022.0042

Lawson, Jonathan et al. “Achieving Procedural Parity in Managing Access to Genomic and Related Health Data: A Global Survey of Data Access Committee Members.” Biopreservation and biobanking, 10.1089/bio.2022.0205. 16 May. 2023, doi:10.1089/bio.2022.0205

GA4GH Data Use Ontology (GitHub)

GA4GH 8th Plenary Meeting - DUOS Project (16:32 - 19:13)
Elena Ghanaim, Health Science Policy Analyst, NHGRI

NHGRI Policy Panel: Genomic Data Sharing Policies: Challenges and Innovative Solutions for Sharing Human Genomic Data
Jonathan Lawson, Senior Software Product Manager, Broad Institute

Last updated: December 13, 2023