Executive Summary
Governance and Business Models
The NBN governance and business models must include strategies that permit the NBN to
rapidly establish a firm foundation and facilitate its growth into a self-sustaining organization.
The NBN structure must be highly flexible and capable of expansion as the science progresses.
The management strategies must be sufficiently defined to attain the organization’s goals, yet
flexible to meet the likely evolution of research opportunities and needs.
The Design Team recognized that a sound business plan is needed to effectively operationalize
the NBN and partnerships with existing institutions.
Recommendation 8. The NBN Operations Center should be a not-for-profit organization.
The Design Team suggested that a non-for-profit organization provide stewardship of the NBN
because it will collect detailed clinical and genetic information about biospecimen donors. In
addition to enhancing credibility and maximizing public trust, a not-for-profit model would
allow substantial flexibility in accepting funds from public and private sources. The Foundation
for the NIH, or another not-for-profit organization, could serve as an incubator for the NBN until
the resource could become self-sustaining.
Recommendation 10. The NBN governance should be organized at three levels, to include a
Board of Governors, the NBN Operations Center, and its business units. The proposed
business units would include the following: Research Administration and Support,
Specimen and Data Acquisition, Storage and Distribution/Basic Analysis, Advanced
Analysis, Bioinformatics and Data Management, and Patient Relations.
Quality Assurance, Bioinformatics and Data Management, and Communications are core efforts
that would be prominent at the NBN operations level. Bioinformatics and Data Management and
Communications will also be represented in the business units. Business unit work (their own
governance structures permitting) can be carried out by any private or public entity—including
existing businesses or research consortia—through a competitive process.
Access to biospecimens should be administered by a neutral, streamlined, peer review system
facilitated by a Biospecimen Utilization Review Committee that provides timely review of
requests and distribution of samples with minimal administrative burden. Data and samples
should be distributed in a clearly articulated and equitable fashion based primarily upon the
quality of the proposed research. The Biospecimen Utilization Review Committee would
represent a component of the Research Administration and Support Business Unit, but would be
monitored at the Operations Center level as part of the quality assurance process.
|
