"We are so pleased that questions of informed consent will be included in these PCORI pilot projects," says Nancy Kass, ScD, co-principal investigator on the project and Deputy Director for Public Health at the Johns Hopkins Berman Institute of Bioethics. "Traditional informed consent has been a barrier to routinely making patient-centered research part of clinical practice. Our project will capture the views of patients, doctors, researchers and other stakeholders about what types of information or formal consent make sense to them," Kass says.
The $653,344 award will support three daylong deliberative engagement sessions with diverse stakeholders, including patients, clinicians, institutional review board members, PCOR researchers and health care administrators. After obtaining and characterizing their viewpoints, the project aims to identify the least burdensome, ethically acceptable strategies for consent, disclosure and authorization for prospective PCOR studies, both observational and randomized clinical trials.
"It is a testament to the commitments of PCORI that awards to identify best practices for patient-centered research will now include a project examining best practices for informed consent," says Ruth Faden, PhD, MPH, co-principal investigator and Director of the Berman Institute.
Johns Hopkins University was honored by a second award, for a pilot project studying the integration of patient-centered outcomes in arthritis clinical care, led by Clifton O. Bingham, MD.
"The Pilot Projects will improve our understanding of how to conduct research and disseminate research findings in ways that are more responsive to the needs of patients and the health care community," said PCORI Executive Director Joe Selby, MD, MPH. "We are excited to be funding 50 projects nationwide, led by creative and innovative researchers. Their work will help us establish a foundation for patient-centered outcomes research that will give patients, caregivers and clinicians the tools they need every day."
PCORI is committing $30 million in funding over two years for the pilot projects, which were selected by PCORI's Board of Governors through a competitive, multi-stage review process. Proposals were evaluated for their scientific merit and rigor and fit within eight areas of interest outlined in the pilot projects announcement. Like all of the pilot projects, funding for the Berman Institute's project has been approved pending completion of a business review and a formal award agreement with PCORI.
Provided by Johns Hopkins University School of Medicine
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