Participant Protection and Data Management Steering Committee (PPDM) Charge and Roster

Purpose

The Participant Protection and Data Management Steering Committee (PPDM) advises the Senior Oversight Committee (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 the NIH database of Genotypes and Phenotypes (dbGaP) or other NIH-designated genomic data repositories. In addition to genomic research participants, the PPDM is also concerned with the interests of data submitters and data accessors with regard to data access issues. The PPDM serves as the principal trans-NIH committee to promote communication across the NIH Institutes and Centers (ICs) about participant and data protection, and data access and distribution issues. The PPDM may initiate the development and ongoing review of specific policies and procedures related to issues of participant protection in genomic data management, data access, and data distribution.

Function

The PPDM charge is to stimulate dialog and promote common principles and procedures for requesting and receiving access to genomic data through the NIH Data Access Committees (DACs). Its work includes procedural standards for data access and principles for data security in the secondary use of genomic data. In particular, the PPDM will help ensure that DAC procedures and operating practices are consistent across ICs. The PPDM shall provide analyses and make recommendations to the SOC on policy or procedures related to activities within its purview as well as work directly with its membership to promote common practices across the NIH. As needed, PPDM special working groups may be appointed by the Co-Chairs for specific tasks and time periods. The Co-Chairs will generally appoint a working group chair from among the PPDM membership. Broad representation by IC staff on these working groups will be encouraged, as appropriate, in order to facilitate discussion from various perspectives and promote consensus in decision making.

Membership

The PPDM will be comprised of NIH DAC Chairs, representatives of relevant NIH data repositories, and experts in human subjects’ research and bioethics.

PPDM Co-Chairs will be appointed by the Co-Chairs of the SOC. One Co-Chair will be drawn from the PPDM membership and one from the GDS senior policy staff. Co-Chair terms are for one year; Co-Chairs may serve more than one term.

Meetings

Regular meetings of the PPDM will be held at least six times per year. The Co-Chairs may call additional meetings as necessary. Proceedings of the meetings will be summarized and disseminated to the members and reported to the SOC.

Administrative Support

Staff support for the PPDM is provided through the NIH Director. GWAS staff will be responsible for management of the PPDM, including maintaining its records, organizing meetings, and drafting meeting summaries for approval by the Co-Chairs.

Sunset Provisions

The PPDM charter will undergo periodic review at least every three years. Any major amendments to the charter of the PPDM require the approval of the SOC Co-Chairs. Termination of the PPDM requires the approval of the NIH Director.

PPDM Members:

Elizabeth Gillanders, Ph.D. (Co-Chair )
NCI

Laura Lyman Rodriguez, Ph.D. (Co-Chair )
NHGRI

Peggy Tucker, M.D.
NCI

Hemin Chin, Ph.D.
NEI

Valentina Di Francesco
NIAID

Emily Harris, Ph.D., M.P.H.
NIAMS/NIDCR

Vinay Pai, Ph.D.
NIBIB

John Ilekis, Ph.D.
NICHD

Joni Rutter, Ph.D.
NIDA

Rebekah Rasooly, M.D.
NIDDK

Donna Krasnewich, M.D., Ph.D.
NIGMS

Katrina Gwinn, Ph.D.
NINDS

Erin M. Ramos, Ph.D., M.P.H.
NHGRI

Vivian Ota Wang, Ph.D.
NHGRI

Holly Krull, Ph.D.
NHLBI

Ex-Officios

Sally Amero, Ph.D.
OD

Charlotte Holden, J.D.
OD

Hillary Leeds, J.D.
NHLBI

Valerie Bonham, J.D.
OGC, NIH Branch