I’m intrigued, on multiple levels, by the ethical, regulatory, and operational challenges of The Precision Medicine Initiative® (PMI) Cohort Program, now called the All of UsSM Research Program. This program—should it move forward—will be the largest health and medical research program on precision medicine in US history, and proposes to enroll one million or more volunteers in the next few years.
The PMI was introduced to the American public by former President Obama in his 2015 State of the Union address. It was summarized on the White House PMI website1 at the time as “a bold [...] Read more
Just before entering the Arena to participate in Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist moderated by Christine Grady, RN, PhD, and panelists Michelle H. Biros, MD; Neal Dickert Jr., MD, PhD; and Robert Silbergleit, MD, I recalled the three questions that I formulated upon registering for the AER16 conference. 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