In order to function effectively and promote network progress, the following policies have been developed to align activities, duties, and responsibilities:
- Governance Policies for PCORnet, the National Patient-Centered Clinical Research Network
- PCORnet Policy for Affiliate Network Status
- PCORnet Front Door Policy
Historical Foundation of PCORnet Governance
During its Phase I development stage, PCORnet’s decision-making and policy-making activities were overseen by a governance structure that included PCORI senior leadership and representatives of PCORnet’s various stakeholder communities. That initial structure consisted of a Steering Committee, Executive Committee, and Patient Council. These groups quickly began working to refine the governance structure based on stakeholder feedback and an assessment of the various operational challenges and opportunities that the initiative presented.
The result was a draft document developed by the Executive Committee, Patient Council, a Governance Task Force, individual principal investigators (PIs) from the CDRNs and PPRNs, and individual members of the Steering Committee. The draft was reviewed by the Steering Committee, Patient Council, and PCORI. A working group made up of a senior PCORI representative, a CDRN PI and a PPRN PI then integrated feedback. The Executive Committee and then full Steering Committee approved the document in August 2015.
The resulting Governance Policies created a series of new PCORnet Committees overseeing decision-making and leadership, patient engagement, PCORnet’s data network, participation in PCORnet, and requirements for what constitutes research that may be designated as a “PCORnet Study.” The policies also created a new set of oversight bodies, replacing the previously established Steering Committee, Patient Council, and Task Forces, and reconstituted the Executive Committee.
Certain elements of these policies, and related processes and procedures, remain under development. The overall policies themselves can be amended on an ongoing basis to meet the developing needs of the initiative, with the PCORnet Council, formerly the Steering Committee, undertaking a formal review of all PCORnet policies at least annually.