by László M. Szabó, Esq., Director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey
TAG ARCHIVES FOR biospecimens
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
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
On this day in 1817, the New York Stock exchange was founded. In recognition of this historic milestone, this week’s installment features articles on various aspects of the research industry, from relationships with corporate financiers, to maintaining positive public opinion. With so much to learn, we hope that you will invest some time in this week’s Research Ethics Roundup!
by Andrea Johnson, JD, CIP, Regulatory Specialist in the Research Integrity Office at Oregon Health and Science University