TAG ARCHIVES FOR public policy

13
Oct2015

By Elisa A. Hurley, PhD, and Avery Avrakotos

On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, or “Common Rule.” If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981. Over the next few weeks, we will be exploring the proposals put forward in the NPRM, including some of the questions that have already emerged about the potential impact of the [...] 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

27
Aug2015

If you were to reflect on important events that occurred in 1966, a legal decision handed down that year had such impact as to influence the conduct of our society every day thereafter. History buffs may think I’m referring to the Supreme Court decision in the case of Miranda v. Arizona which protected the rights of the accused, and introduced the Miranda warning. While this was undeniably monumental and provided necessary protections within the criminal justice system, it was not the only important safeguard measure enacted that year. For animals, the critically significant Read more

8
Jun2015

By Elisa A. Hurley, PhD, executive director

It has been nearly four years since the Department of Health and Human Services (DHHS) released for public comment an Advance Notice of Proposed Rulemaking (ANPRM), titled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. The ANPRM, which proposed the first changes to the "Common Rule" since it was published in 1991, catalyzed considerable debate and discussion about the appropriate regulation of human subjects research.

In the Read more

3
Feb2015

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager The biomedical research landscape has evolved dramatically since the publication of the federal regulations for the protection of human subjects in 1974. In particular, research with human subjects has become an increasingly complex endeavor in which multi-center rather than institution-based research is increasingly the norm. In light of this shift, it is sensible to consider whether an alternative structure for research review better safeguards the rights and welfare of research participants and lessens unnecessary administrative burdens. In December, the National Institutes of Health (NIH) took a step in this direction with the release of a draft policy aimed at reducing inefficiencies associated with [...] Read more