TAG ARCHIVES FOR Common Rule

30
Sep2015

From its inception, one of PRIM&R's goals has been the education of research ethics and oversight professionals. To do this, we host conferences, short courses, webinars, and other offerings, such as PRIM&R’s online and member-only Knowledge Center, to assist our community in their daily work. The newest tool was brought about by our Knowledge Center Advisory Group. It's my pleasure to share PRIM&[...] Read more

22
Sep2015

The much-anticipated Notice of Proposed Rulemaking—offering the first changes to the Common Rule since its publication in 1991—has now been released. in the interest of providing PRIM&R’s community with as much exposure to the issues raised within it, and the writing and scholarship around the proposed rules changes, PRIM&R and other organizations are cross-posting their thoughts.  This post, from Dr. Celia B. Fisher at Fordham University, focuses on the proposed changes to minimal risk.  It originally appeared on Ethics & Society, the Fordham University Center for Ethics Education blog.

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3
Sep2015

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

28
Aug2015

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

29
May2015

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

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