TAG ARCHIVES FOR public policy

22
Jan2015

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

Research on the comparative effectiveness of commonly used interventions is becoming increasingly common as clinicians, researchers, and healthcare funders seek to improve the efficiency and effectiveness of health care by developing a strong evidence base about medical interventions. With the growth of such efforts, questions have emerged about how oversight rules and mechanisms for the protection of human subjects should apply to such endeavors. In October, following more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the [...] Read more

13
Jan2015

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

On December 3, the National Institutes of Health (NIH) issued a request for comments on its "Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research," which "proposes that all NIH-funded multi-site studies carried out in the [United States], whether supported through grants, contracts, or the NIH intramural program, should use a single IRB."

Citing a changed research landscape, the background section of the policy suggests [...] Read more

2
Jan2015

U.S. Urged to Clarify Extent of Funding Moratorium on Risky Virus Research:

Researchers are pleading with the US government to clarify the details of a recent moratorium placed on funding projects that show potential risks due to the use of certain viruses. Concerns include confusion on the specific viruses and experiments covered by the new policy. A statement released by the National [...] Read more

4
Nov2014

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

On Friday, October 24, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance follows more than a year of deliberation and public consultation prompted by the controversy surrounding the Surfactant, Positive Pressure, and Oxygenation Trial (SUPPORT).

SUPPORT was a multisite randomized trial that took place from 2005 to 2009 and sought to determine, in part, the optimal oxygen saturation for extremely premature infants. [...] Read more

30
Oct2014

by Hugh Tilson, MD, MPH, DrPH, PRIM&R Board Member and Co-Chair of the PRIM&R Project on the Boundary Between Research and Practice

Please join the PRIM&R Project on the Boundary Between Research and Practice in celebrating the release of a white paper titled Health-Related Activities Along the Boundary Between [...] Read more