On September 2, the Office of the Federal Register made available a pre-publication version of a much-anticipated Notice of Proposed Rulemaking (NPRM) that proposes changes to the Federal Policy for the Protection of Human Subjects, or the “Common Rule.”
The release of the NPRM comes four years after the publication of an Advance Notice of Proposed Rulemaking (ANPRM), which first put forward proposals to modernize the regulations governing human subjects research in the United States. The NPRM, which was issued by the Department of Health and Human Services (DHHS), [...] Read more
On July 10, 2015, the US House of Representatives passed H.R. 6, the 21st Century Cures Act, with a vote of 344-77. The passage of the bill, which many have hailed as a noteworthy example of bipartisan collaboration, is the result of more than a year of congressional hearings, roundtable discussions, whitepapers, and political debate. First introduced in April 2014 by Fred Upton (R-MI), chairman of the US House of Representatives’ Energy and Commerce Committee, and Representative Diana DeGette (D-CO), the 21st Century Cures initiative seeks to "accelerate the pace of cures in America."
The legislative phase of the 21st [...] Read more
By Anne Meade, senior manager for website and social media
The process of developing federal regulations may be unfamiliar to those whose jobs require adherence. In this excerpt from People and Perspectives, Richard Klein, director of the Food and Drug Administration’s Patient Liaison Program in the Office of Health and Constituent Affairs, talks about being involved in the process of writing the Common Rule. As this was his first foray into writing regulations, at the beginning, Mr. Klein did not anticipate too much difficulty. He quickly realized that assembling [...] Read more
by Dr. Toby Schonfeld, Human Subjects Research Review Official, Environmental Protection Agency
Dr. Toby Schonfeld, Human Subjects Research Review Official at the Environmental Protection Agency (EPA), recently shared her experience at PRIM&R’s 2014 Advancing Ethical Research Conference on the EPA's official science blog, "It All Starts with Science." We are pleased to share her thoughts and observations with our community, and thank Dr. Schonfeld and the EPA for allowing us to do so.
by Rebecca S. Ohnemus, MAA, CRA, Research Officer at University of the Incarnate Word
PRIM&R is pleased to introduce Rebecca Ohnemus, MAA, CRA, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what happened December 4-7 in Baltimore, MD.
I love listening in on [...] Read more