Informed consent research on subjects' understanding needed "desperately," HHS' Ellis says.
This article was originally published in The Gray Sheet
Executive Summary
INFORMED CONSENT PROCESS RESEARCH "DESPERATELY NEEDED" to determine the degree to which research participants understand the consent forms they sign, Gary Ellis, director of the HHS Office of Protection from Research Risks, said Oct. 19 in Boston. Speaking at a Tufts University School of Medicine-sponsored Public Responsibility in Medicine & Research conference, Ellis stated: "The specificity of the federal regulatory language that has endured through many years and the enthusiasm with which we all adhere to it all belie the fact that little empirical work exists to document the degree of understanding achieved by research participants."
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.