By Jason Gerson, PhD
The Patient-Centered Outcomes Research Institute (PCORI) supports research that provides high-integrity, evidence-based information to patients, clinicians, and the broader healthcare community. PCORI funds clinical comparative effectiveness research (CER) that engages patients and other stakeholders throughout the research process. The research we fund aspires to answer real-world questions about what works best for patients, based on their circumstances and concerns.
From PCORI’s start, supporting methodological research has been a priority; it is highlighted as such in our authorizing legislation. We think broadly about what [...] Read more
On June 29, the National Academies of Science, Medicine, and Engineering released Part 2 of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The report, written by the Committee on Federal Research Regulations and Reporting Requirements in response to a Congressional request, examines the impact of regulations and policies governing federally funded academic research in the United States. Part 1, released in September 2015, concluded that the continued expansion of federal regulations is “diminishing the effectiveness of the U.S. research enterprise, and lowering the return on federal investment in basic and applied research by diverting investigators’ time and institutional [...] Read more
At November’s 2015 Advancing Ethical Research Conference (AER15), PRIM&R recognized the substantial achievements and contributions of longtime PRIM&R member, Karen Hale, RPh, MPH, CIP.
Karen is the recipient of the 2015 Applied Research Ethics National Association (ARENA) Legacy Award (ALA). The ALA was developed to honor not only the chosen individual, but also to honor the living legacy created by ARENA, which was the membership division of PRIM&R [...] Read more
On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, or “Common Rule.” If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.
In earlier posts, we explored a new category of activities that would be excluded from oversight under the Common Rule and proposed changes to the category of <[...] Read more
We're two weeks away from the 2015 Social, Behavioral, and Educational Research Conference (SBER15) and the 2015 Advancing Ethical Research Conference (AER15), so we thought we'd take a look back at a compelling moment from a previous conference. Read on for this week's Time Capsule Tuesday.
Conference: The Evolution of Protecting Human Subjects: From Nuremburg to the Nineties, November 1991
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