TAG ARCHIVES FOR biospecimens

6
May2013

Digging into the HIPAA/HITECH Act Omnibus Final Rule

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6 May
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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

16
Mar2013

Start by asking “Is it research?”

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16 Mar
Comments: 1

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

8
Mar2013

Research Ethics Roundup: Consent to research buried in a doctor’s form, details on how and why research is conducted on animals, and much more!

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8 Mar
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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!


Herbalife cozies up [...] Read more