1. Sustainable Entity Update #2 Discussion Document

2. Background
PCORI held a sustainability focus group in Nashville, TN on 11/28/2016
During the meeting, a new Sustainable Entity Team was launched (Composition: Hernandez, Fleurence, Rothman, Margolis, Kaushal, Terry, and Forrest)
This document is the 2nd update of the team’s work

3. Sustainable Entity Team Work Groups
Organizational design, Legal and By-Laws (focus of this update)
Business Model and Plan
Membership
Engagement/Network Core
Strategy and Operations

4. Sustainable Organizational Design
3 Components
Networks
Coordinating Center(s) with service cores
NewCo with a Program Office
Consortium of Networks
Each network may be a collection of institutions and/or communities
Coordinating Center(s)/Service Cores
Coordinate and conduct common activities across the consortium and provide specialized services in a functional service model
NewCo/Program Office
New entity that will be a company and serve as the administrative unit of the sustainable entity

5. Consortium of Networks
PCORnet CDRNs and PPRNs will be encouraged to apply for membership in the sustainable entity’s network consortium
Forthcoming: Membership workgroup membership model
We will not carry forward the PPRN and CDRN labels

6. Support people-centric and people-driven research
All Networks
Support people-centric and people-driven research
Engage stakeholders
Develop people-informed research priorities
Do Research

7. Institutional Networks
Engage stakeholders in research
Data Network: maintain the PCORnet common data model (CDM) and run queries
Research: participate in one or all of the following: research using the CDM, prospective clinical studies/trials, health system analytics, implementation science
NewCo Support: willing to allow a portion of revenue to support the program office and its contracted service cores/coordinating centers
Scientific Resource: provide scientific leadership for studies and serve as a resource for studies that the networks do not lead
National Utility: willing to be part of a national evidence generation platform

8. Community Networks
Engagement: composed of activated and empowered communities of participants and clinicians
Research: initiate and participate in prospective clinical studies/trials, and observational research using registry data
Service Core Support: an engagement/network service core will provide tools and services (at a fee) to strengthen networks’ engagement, research capacity, and maturation

9. Benefits of Sustainable Entity for Community Networks
Business development 
Access to standards developed and maintained by NewCo (governance, policies, data, regulatory, administrative)
Access to institutions for network-generated research
Access to network design and development services via the Engagement/Network Core
Participation in the learning community of networks
Sharing of best practices using the Commons
Access to a technology platform that lowers the cost of maintaining the network’s registry (future state)

10. Community Network Benefits for the Sustainable Entity
People-generated research priorities
Research-ready communities strengthen business development
Greater research impact
Results will be immediately implemented by the community networks
Provide value to institutional leaders interested in impact and speed to impact
One of the distinguishing characteristics of the sustainable entity

11. Ways that Community Networks Generate Revenue
Front door generates business that requires involvement of Community Networks (CN) only
NewCo/Program Office “tax” revenue from this business
Front door generates business that involves collaboration between CN and Institutions
Some revenue supports Program Office/NewCo
Some revenue to institutions
Some revenue to CNs
Pricing determined by program office; front door leads may come via central front door or via the networks themselves

12. Coordinating Center(s) & Service Cores
NewCo will contract with Coordinating Center(s) and service cores
Functions or services may be across 1 or more institutions to allow functional and flexible service model
Common functions/services with standardized procedures may include:
Data and query fulfillment
Engagement/Network
Research/Clinical Trials Clinical Operations
Project Management
Specialized service cores may provide expert or concentrated activities

13. Collaborative Research Groups
Could be maintained in the Network Consortium as a strategy for organizing expertise, participants/clinicians/scientists, and research catalysts
How they are best integrated into the emerging design is an open area for discussion

14. NewCo/Program Office
Sustainable entity will include a new company, NewCo
NewCo will serve as the program office for the Network Consortium
Functions include:
Business development, including front door activities (most important)
Standards management
Governance support (of the Board and for the members)
Legal and Regulatory
Contracting
Management of the Network Consortium

15. NewCo - Continued 501(c)(3) not-for-profit entity
Founded with a small Board of Directors and a start-up staff, including an Executive Director
To set this up:
Choose a name for NewCo, name the founding Board of Directors (n=3 to 5; grow to over time)
Incorporate with a 2-page document called Articles of Incorporation
Apply to IRS for tax-exempt status (takes 9 months)
Board ratifies by-laws
Obtain start-up funds for staff
Set up a bank account

16. Governing Board – Initial Thoughts
Ensure activities are mission-aligned and supporting patient-centered national evidence generation platform
Reviews mix of industry / foundation / and federally funded studies
Composition: 3 – 13 members, target = 9 to 11; considering an initial BoD of n=5