It has been a busy few weeks in the research oversight field with the release of a much anticipated Institute of Medicine report on data sharing and a new bill that seeks to overhaul drug and device development. Explore these and other stories below.
HHS, Research Community Debate Informed Consent Policy: This piece from Kaiser Health News explores some of the various viewpoints surrounding the changes proposed by the Office for Human Research Protections in their “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.”
How the US Underfunds Research for Migraines, Asthma and Depression: Research funding in the United States is declining, and evidence suggests that the funding that is available does not reflect the burden of disease in the United States. In this article for The Washington Post, Jason Millman explores the issue of research funding and considers the factors that influence funding determinations.
Regulatory Explainer: The 21st Century Cures Act: On Tuesday, the Energy and Commerce Committee’s Subcommittee on Health released the 21st Century Cures Act, which proposes significant changes to the way drugs and devices are marketed and approved in the United States. This piece from Regulatory Focus provides an overview of the proposed changes.
Sharing Older Clinical Trial Data Should be Judicious: Earlier this month, the Institute of Medicine released a report titled Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks. In this piece for Pharmalot, Ed Silverman interviews Ida Sim, a member of the committee that developed the report, to explore the recommendations offered in the report.
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.