How does the NIH manage the GDS policy?
NIH has developed a governance structure for the oversight of the GDS Policy (see Governance Structure ). The NIH Director oversees the GDS Policy and its implementation. In carrying out this responsibility, the NIH Director is informed by a Senior Oversight Committee composed of Institute and Center (IC) Directors and senior leadership from within the Office of the Director. The Senior Oversight Committee (SOC) is responsible for the ongoing management and stewardship of the GDS Policy and operating procedures implemented across NIH ICs. The SOC Issues Group advises and makes recommendations to the SOC on issues related to the development, implementation, management, and evaluation of policies to promote the sharing of genomic research data.
Two steering committees report to the SOC, and are charged with the implementation, communication, and development of specific procedures related to the submission and data access practices for NIH-supported genomic research. The Technical Standards and Data Submission Steering Committee (TSDS), is composed of Genomic Program Administrators (GPAs), and staff from the National Center for Biotechnology Information. The TSDS advises the SOC of the programmatic and policy needs related to ensuring robust policies and rigorous standards for NIH-designated genomic data repositories, such as the database for Genotypes and Phenotypes (dbGaP), and the data contained therein. The Participant Protection and Data Management Steering Committee (PPDM), is composed of Data Access Committees (DAC) Chairs at NIH, as well as senior staff from NIH policy and oversight offices. The PPDM advises the SOC of the policy and programmatic needs and opportunities related to the protection of the interests of genomic research participants and appropriate management and oversight of their data in dbGaP or other NIH-designated genomic data repositories.
Each NIH Institute and Center (IC) has a GPA who serves as a point of contact for GDS Policy implementation within the IC. The GPAs serve as the senior staff lead and point of information for investigators, the Data Access Committee(s) in the GPA’s IC, the GDS governance committees, and the National Center for Biotechnology Information (NCBI), which manages dbGaP.
In order to maintain the relevance of the GDS Policy with evolving technological and ethical considerations, the NIH Director solicits recommendations on the Policy from external experts representing public and scientific stakeholders through the Advisory Committee to the Director as appropriate.