The Government Accountability Office on Monday announced the appointment of seven new members to the Board of Governors of the Patient-Centered Outcomes Research Institute.
PCORI, an independent nonprofit organization established by Congress in 2010, funds research to provide patients, caregivers and clinicians with evidence-based information in order to make better-informed healthcare decisions.
PCORI’s new Board members, who are appointed for a six-year term and may be reappointed for one subsequent six-year term, include:
- Kara Ayers, Assistant Professor, Department of Pediatrics, University of Cincinnati
- Jennifer DeVoe, MD, Professor and Chair, Department of Family Medicine, Oregon Health and Science University
- Christopher Friese, the Elizabeth Tone Hosmer Professor of Nursing, University of Michigan
- Trent Haywood, MD, Senior Vice President, Office of Clinical Affairs and Chief Medical Officer, Blue Cross Blue Shield Association
- Michael Herndon, DO, Chief Medical Officer, Oklahoma Health Care Authority
- Michelle McMurry-Heath, MD, worldwide Vice President for Global Regulatory Affairs, International Clinical Evidence and Strategic Operations for Medical Device Companies, Johnson & Johnson
- Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, Food and Drug Administration
“These highly regarded professionals will assist the PCORI Governing Board as it continues to fund and evaluate patient-centered research aimed at helping patients make better health-care decisions,” says Gene Dodaro, comptroller general of the United States and head of the GAO. “Their diversity of experiences and perspectives
should prove very helpful as PCORI moves forward with its mission.”
The Affordable Care Act, which authorized the creation of PCORI, gave the Comptroller General of the United States responsibility for appointing the members of PCORI’s Board, which is comprised of up of 19 representatives of the patient, general consumer, clinical, insurance, research, employer, industry, policy and other healthcare sectors—as well as the directors of the National Institutes of Health and Agency for Healthcare Research and Quality.
To date, PCORI has invested $ 2.4 billion to fund more than 440 patient-centered comparative clinical effectiveness research studies and other projects.
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Earlier this month, PCORI’s Board of Governors approved a new policy calling for researchers using PCORI funds to share their data sets and documentation for reanalysis and reuse, with funding to be provided to research teams to prepare the data and other materials for sharing.
According to the organization, the new policy is among the most far-reaching adopted by publicly supported funders of health research.
“Through this data sharing policy, we’re taking a major step in advancing open science,” says Joe Selby, MD, executive director of PCORI. “By supporting how others may use information generated by the studies we’ve funded, we’re helping to enhance the quality and increase the quantity of evidence for healthcare decision making. We’re also reducing redundancy in collecting clinical data sets, which can speed research and the production of more useful evidence.”
As part of the policy, certain research teams that receive PCORI funding are expected to place the data generated during their studies—as well as the documentation for how the data were produced—into a repository designated by the organization. These data, including de-identified information collected from study participants, full protocols, meta-data and statistical analysis plans, will then be made available to other research teams for reanalysis and additional analyses.
In addition, the policy mandates that all personally-identifiable health information must be deidentified to comply with HIPAA regulations, while informed consent obtained from study participants must be sufficiently broad to permit future research by other researchers.