Just by reading this title you probably have guessed that I am a big Star Wars Fan. We are a special breed, one that grew up with the movies and who like to complain about changes to the original saga. I will save you from my opinion on whether Han truly shot first or not, but as the last movie of the Star Wars franchise was released, I cannot help but notice some parallels between the journey of a Jedi and the work of an IRB professional working with single IRB studies.
A Jedi in these movies is a reluctant student, one forced to learn the ways of the Force due to the [...] Read more
The research world, and inevitably PRIM&R’s 2015 Advancing Ethical Research Conference (AER15), is abuzz with the proposed changes to the common rule. As most people are wondering what exactly these potential changes could mean for their research organizations, the question becomes "Are we ready?"
There is much to be said about single IRB review, but as P. Pearl O'Rourke, MD, pointed out during the pre-conference presentation "Single IRBs Are Here: Are You Ready?", up to this point it has been voluntary to participate in a reliance agreement with another institution or organization. What the new rule will force is a relationship that many institutions lack the infrastructure [...] 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 Stephanie Pyle, MFA, Manager of Community and Communications, Schulman Associates IRB
The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership established “to identify and promote practices that will increase the quality and efficiency of clinical trials.” While CTTI has several ongoing improvement initiatives, which you can learn more about on their website, a workshop at the <[...] Read more
by Avery Avrakotos, Education and Policy Manager, and Meryn Robinson, Educational Program and Membership Services
Technological advances, the growing need for comparative effectiveness research, an increasing demand for data transparency, and the continued globalization of the research enterprise were among some of the issues that human subjects protections professionals grappled with in 2013. For those involved in animal care and use, the year marked a continuation of efforts to educate the public about the value of animal research. As we reflect on 2013, and look ahead to what 2014 will bring, we are pleased to share with you a collection of Ampersand posts that reflect some of the year's major events, both for PRIM&R and [...] Read more