There has been a lot of anticipation and uncertainty in the research oversight community during the 16 months since the release of the Notice of Proposed Rulemaking to revise the Common Rule. We learned last week that the process is, in the final days of the Obama Administration, officially moving forward.
On January 4, a revised Common Rule was submitted to the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA). OIRA’s review is the [...] Read more
On December 13, 2016, President Obama signed into law the 21st Century Cures Act. Passed as the Cures Act, the sweeping law aims to foster innovation, reduce administrative burdens, and otherwise enhance the nation’s approach to healthcare, medicine, and research. Read more
This week’s Research Ethics Roundup reviews the complex issues surrounding clinical trials and infants, concerns about publications not including all of a study’s adverse events, and the vice president’s new “cancer moonshot” nonprofit. Read more
Before attending AER16, I was warned that it can be a bit overwhelming. Between the choices in sessions, the panels, the keynote speakers, and information provided , there is such a wealth of information it can be difficult to process it all. Since the Ethical Research Board (ERB) at Nashua Community College (which I chair) is quite new, the list of tasks we have to create, consider, and complete already feels endless; moreover, picking a starting place is difficult, given that everything seems essential. Two of my sessions on the second day of the conference, helped me refocus my ‘to do’ list— and provided me the title for this blog post. Read more
Each time a research protocol involving children comes to us for review, my committee members and I look to one another for help deciding how to balance obtaining potentially valuable information that might one day impact the lives of other children with the delicate exercise of approving a protocol involving children. Often, we don’t have the answer within our ranks, and do not know who to look to for assistance. We ask ourselves: "Who can help us now?" Read more
Much of my AER16 schedule focused on risks in vulnerable populations. For me, an important backdrop for these topics was presented in the Plenary Session A New Framework for Human Subjects Research? An Update from NAS, moderated by Alexander Capron. The presenters, Barbara Bierer, MD, Steven Joffe, MD, MPH, and Heather Pierce, JD, MPH, did not discuss research risks or vulnerable populations, but they discussed how the current regulatory and policy framework fits with current research practices. Read more