Building a Governance Strategy for CER: The Patient Outcomes Research To Advance
Learning (PORTAL) Network Experience
Authors: Paolino Andrea R. , McGlynn Elizabeth A. , Lieu Tracy , Nelson Andrew F. , Prausnitz Stephanie , Horberg Michael A. , Arterburn David E. , Gould Michael K. , Laws Reesa L. , Steiner John 
Published: March 2016

IntroductionThe Patient Outcomes Research to Advance Learning (PORTAL) Network was
established with funding from the Patient-Centered Outcomes Research Institute (PCORI)
in 2014. The PORTAL team adapted governance structures and processes from past research
network collaborations. We will review and outline the structures and processes of the
PORTAL governance approach and describe how proactively focusing on priority areas
helped us to facilitate an ambitious research agenda.BackgroundFor years a variety of
funders have supported large-scale infrastructure grants to promote the use of clinical
datasets to answer important comparative effectiveness research (CER) questions. These
awards have provided the impetus for health care systems to join forces in creating
clinical data research networks. Often, these scientific networks do not develop
governance processes proactively or systematically, and address issues only as problems
arise. Even if network leaders and collaborators foresee the need to develop governance
approaches, they may underestimate the time and effort required to develop sound
processes. The resulting delays can impede research progress.InnovationBecause the
PORTAL sites had built trust and a foundation of collaboration by participating with one
another in past research networks, essential elements of effective governance such as
guiding principles, decision making processes, project governance, data governance, and
stakeholders in governance were familiar to PORTAL investigators. This trust and
familiarity enabled the network to rapidly prioritize areas that required sound
governance approaches: responding to new research opportunities, creating a culture of
trust and collaboration, conducting individual studies, within the broader network,
assigning responsibility and credit to scientific investigators, sharing data while
protecting privacy/security, and allocating resources. The PORTAL Governance Document,
complete with a Toolkit of Appendices is included for reference and for adaptation by
other networks.CredibilityAs a result of identifying project-based governance priorities
(IRB approval, subcontracting, selection of new research including lead PI and
participating sites, and authorship) and data governance priorities (reciprocal data use
agreement, analytic plan procedures, and other tools for data governance), PORTAL
established most of its governance structure by Month 6 of the 18 month project. This
allowed science to progress and collaborators to experience first-hand how the
structures and procedures functioned in the remaining 12 months of the project, leaving
ample time to refine them and to develop new structures or processes as
necessary.DiscussionThe use of procedures and processes with which participating
investigators and their home institutions were already familiar allowed project and
regulatory requirements to be established quickly to protect patients, their data, and
the health care systems that act as stewards for both. As the project progressed, PORTAL
was able to test and adjust the structures it put place, and to make substantive
revisions by Month 17. As a result, priority processes have been predictable,
transparent and effective.Conclusion/Next stepsStrong governance practices are a
stewardship responsibility of research networks to justify the trust of patients, health
plan members, health care delivery organizations, and other stakeholders. Well-planned
governance can reduce the time necessary to initiate the scientific activities of a
network, a particular concern when the time frame to complete research is short.
Effective network and data governance structures protect patient and institutional data
as well as the interests of investigators and their institutions, and assures that the
network has built an environment to meet the goals of the research.