On Monday, March 4, PRIM&R hosted a webinar titled PRIM&R’s Primer on the HIPAA/HITECH Act Omnibus Final Rule. Emily Chi Fogler, JD, senior legal counsel in the Office of General Counsel at Partners HealthCare System, and Jennifer Geetter, JD, partner in the law firm of McDermott Will & Emery LLP, participated as speakers, with P. Pearl O’Rourke, MD, as moderator. Following the webinar, we connected with Emily Chi Fogler, and she kindly answered a few more questions that came in from webinar participants, for <[...] Read more
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On March 12, 2013, PRIM&R hosted a webinar titled Online Research, Social Media, and the IRB: Assessing Ethics, Norms, and Risks. The presenters, Elizabeth Buchanan, PhD, and Joseph Konstan, PhD, answered many questions from the attendees during the lively question and answer period following this program. After the conclusion of the webinar, we asked Elizabeth and Joe to consider the remaining questions, and I’m pleased to share their answers with you today.
On February 28, 2013, PRIM&R hosted a webinar titled Key Decision Points: Is it Research Involving Human Subjects? It is Exempt? Is IRB Review Required? Following the webinar, I had a chance to connect with the presenters, Karen Hale, RPh, MPH, CIP, and Daniel Nelson, MSc, CIP, to discuss some of the questions that came in that they were unable to cover during the allotted time. Below, they share their perspectives on a few of the questions.
Q: Why can't I determine if a study involves "human subjects" before I determine if it is "research"?
A: From a regulatory standpoint, the definition of a “human [...] Read more
by Mindy Reeter, BS, CIP, Associate Director of the Office for Human Research Oversight at the University of Illinois College of Medicine at Peoria
As a human subjects protections professional, my children have always been exposed to medical research, and as consumers who utilize teaching hospitals and clinics for healthcare, my family has received our fair share of consent/assent forms inviting us to participate in research.
I [...] Read more
by Kaye Edwards, Associate Professor of Independent College Programs at Haverford College
On September 27, I attended the PRIM&R webinar titled Community Engagement in International Research: Considerations for Ethics Review with Jim Lavery, MSc, PhD, and Katherine King, PhD. As a new member of PRIM&R and a former institutional review board (IRB) member at my institution, Haverford College, I found the webinar to be relevant and thought-provoking.
In their role of protecting human subjects in research, institutional review boards (IRBs) tend to focus on informed consent of individual participants, but Lavery and King encouraged us to consider not just individuals who [...] Read more