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By Jill Drachenberg, Managing Editor, AHC Media
The Senate will not consider the 21st Century Cures Act – sweeping medical legislation the House passed in July 2015. Instead, the Senate Committee on Health, Education, Labor, and Pensions will consider several smaller pieces of legislation with similar goals, according to a news statement from committee Chairman Lamar Alexander (R-TN).
The new bills are slated for committee discussion in February, March, and April for final markup on the bills. The February meeting will include the following:
Later meetings will include markup on the following proposed legislation:
According to coverage from the September 2015 issue of IRB Advisor, the act was intended in part to speed new medical devices and life-saving treatments to market for those with serious illnesses such as cancer and traumatic brain injuries. It also called for $8 billion in additional NIH funding. The act raised concerns from researchers and IRB experts due to a section that would have made possible a broad expansion of informed consent waivers for studies that pose “no more than minimal risk” to research subjects.
“With the Cures Act, we think the waiver will expand beyond extraordinary circumstances and that’s inappropriate,” Michael A. Carome, MD, director of the health research group at Public Citizen in Washington, DC, told IRB Advisor. “Expanding the waiver to research that involves no more than minimal risk violates the universal principle for respect of persons, and there’s no reason to do this; we don’t believe existing law has inhibited clinical trials that promote new drugs, so we see no reason to expand the waiver.”
The Cures Act passed the House last summer with rare bipartisan support, but stalled in the Senate over funding disagreements.