BALTIMORE, MD – The Johns Hopkins Berman Institute of Bioethics is a recipient of one of 50 pilot project awards by the Patient-Centered Outcomes Research Institute (PCORI) to study stakeholder views of streamlined informed consent options for comparative effectiveness research (CER) studies.
"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.
A full list of Pilot Project awardees can be found here: http://www.pcori.org/funding-opportunities/pilot-projects/funded/
PCORI is an independent, non-profit organization whose establishment was authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.
Berman Institute project abstract: http://www.pcori.org/assets/Faden-Ruth.pdf
Bingham project abstract:http://www.pcori.org/assets/Bingham-Clifton.pdf
About The Johns Hopkins Berman Institute of Bioethics
One of the largest centers of its kind in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, nongovernmental organizations and private sector organizations to address and resolve ethical issues. Institute faculty members represent such disciplines as medicine, nursing, law, philosophy, public health and the social sciences. Their work helps anticipate and inform debates on complex moral challenges, discern ethically acceptable alternatives in medical, scientific and public health policy and help to prepare the next generation of bioethicists. More information is available at http://www.bioethicsinstitute.org.
About PCORI
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org