Traditional research methodologies are being used to address a number of longstanding challenges, including how to make health care more efficient and effective, and how to fight poverty. This week’s Research Ethics Roundup sheds light on the role of research in answering those questions, as well as other stories related to research ethics and oversight.
Don’t Weaken the FDA’s Drug Approval Process: The 21st Century Cures Act proposes significant changes to the approval process for many medical products. In this opinion piece for The New York Times, Gregg Gonsalves, Mark Harington, and David A. Kessler warn that “Congress should be wary of changing standards that paved the way for the development and approval of breakthrough drugs for AIDS and other diseases and that, importantly, have been proven to be effective and safe.”
EU Rejects Effort to Ban Animal Research: In this article for the Washington Post, Tania Rabesandratana reports on the European Commission’s decision to reject a proposal supported by 1.17 million signatories to “abolish animal research across the European Union.” To address some of the concerns that prompted the petition, the Commission plans to “speed up the development and adoption of alternative methods and to better monitor compliance with the directive in member states.”
How Institutional Review Boards Can Support Learning Health Systems While Providing Meaningful Oversight: Learning health systems can play an important role in improving healthcare quality, while cutting costs, however, IRBs need clearer guidance on how to evaluate whether data collection in this context constitutes research. In this post for the Health Affairs Blog, Mildred Solomon argues that IRBs need to strike a “delicate balance” between being too lax and too stringent when evaluating risks and the need for informed consent in learning health systems.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.