This week’s Research Ethics Roundup looks at a top Food and Drug Administration (FDA) official’s speech on real world evidence, a National Academies report that highlights the lack of guidance for the research community on the security concerns around dual-use research, how and why the All of Us Research Program is working with traditionally marginalized communities, and the effectiveness of Animal and Plant Health Inspection Service (APHIS) inspections of Agricultural Research Service facilities. Read more
TAG ARCHIVES FOR precision medicine initiative
This week’s Research Ethics Roundup looks at why the elderly continue to be underrepresented in clinical research, how a massive government study is working on community engagement efforts, the Food and Drug Administration (FDA)’s plan for new patient-focused drug development guidance, and a European Union committee’s opinion that nonhuman primate research should continue in its member countries. Read more
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