TAG ARCHIVES FOR OHRP

11
Oct2013

On Wednesday, September 18, PRIM&R hosted a webinar titled Doing More with Less: Best IRB Practices for Institutions with Small Research Programs. Scott Lipkin, DPM, CIP, chief of the Network Office of Research and Innovation at the Lehigh Valley Health Network, and Lori Roesch, CIM, CIP, manager or the research subject protection program at Aurora Health Care, Inc, participated as speakers, with Elisa A. Hurley, PhD, education director at PRIM&R, as moderator.

Read more

5
Sep2013

by Elisa A. Hurley, PhD, Education Director

As I shared in yesterday’s blog post, I had the privilege of attending the Department of Health and Human Service (DHHS) public meeting in Washington, DC, on “matters related to protection of human subjects and research considering standard of care interventions,” which was convened to address some of the issues raised by the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT).

Yesterday I mentioned the surprising areas of convergence among the 27 presenters who took their turn at the podium. Today I will focus on some of [...] Read more

4
Sep2013

by Elisa A. Hurley, PhD, Education Director

Last Wednesday, August 28, 2013, the Department of Health and Human Service (DHHS) held a public meeting in Washington, DC on “matters related to protection of human subjects and research considering standard of care interventions.” It was an unprecedented event on a historic day—the 50th anniversary of the March on Washington—and I was lucky enough to attend the event as a representative for PRIM&R. Over the course of two posts, I want to share some of my reflections from this remarkable day.

Those of you who have been following events for the past [...] Read more

15
Jul2013

by Elisa A. Hurley, PhD, Education Director

Those who have been following the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) controversy know that the story has continued to unfold over the past month. Here I review several of the latest developments, some of which may have wide implications for the human research protections [...] Read more

10
Jun2013

by Elisa Hurley, PRIM&R Education Director

Since our post last Thursday, there have been some additional, noteworthy developments around the SUPPORT trial and the Office for Human Research Protections’ (OHRPs’) latest actions that we thought were worth sharing. One day after the publication of OHRP’s letter stating it was putting on hold all compliance actions against the lead SUPPORT site, the New England Journal of Medicine (NEJM) posted a letter to the editor, signed by nearly 50 prominent bioethicists, calling for OHRP to retract [...] Read more