It’s hard to grasp how little you know. Having worked as an IRB administrator at a research hospital for a little over a year, I think I’ve come far in understanding ethical review of medical research. The learning curve is steep, but my study of the regulations and supporting materials, as well as help from the professionals I work with, provided me with a base of knowledge about ethical research. I applied what I learned in my day-to-day work, and when unique events arose, I went back to source material or relied on my colleagues to find to a solution. Read more
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After participating for the second time in PRIM&R’s Advancing Ethical Research (AER) Conference (the first time being in Boston at AER15), I am reminded of a familiar phrase often spoken by my dear mother: "nothing new...but everything new.” With this I mean that although the topics addressed during each of the conferences I attended were not new to me, the conference sessions revealed new insights because of the exceptional way each of the speakers presented them. In particular, each session provided practical ways to continue my commitment to ethical research and respect for the research within my local context despite a lack of regulation for social, behavioral, and educational research (SBER). Read more
This year’s Advancing Ethical Research (AER) Conference provided me with the depth of knowledge I was expecting, but also with a new perspective that I had not anticipated. Full disclosure: I went to this conference assuming the pre-conference program would be most applicable and useful to my job. The pre-conference that I attended, IRB201, was, indeed, amazing. I walked away having memorized the 45 CFR 46.111 criteria for IRB review and approval and the ability to apply them to a protocol (or at least a practice protocol). Over the last few weeks, this new skill has carried me far; it has substantially refined my pre-review process, allowing me to more thoroughly and efficiently deliver an IRB protocol to my IRB administrator for her review. As one of just four IRB staff members at my institution, anything that streamlines the process and decreases burden is welcomed, and my newfound efficiency has not gone unnoticed or unappreciated. Read more
Researchers should see this slide deck. At the end of Patricia Furlong’s keynote address at the 2016 Advancing Ethical Research Conference, I realized that this was the only note I had written during the session (though for the purposes of this post, I have gone back to the proceedings to quote other relevant thoughts). 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