TAG ARCHIVES FOR informed consent

10
Dec2014

by Jim Gearhart, BA, Member of the Board of Directors for Quorum Review IRB

PRIM&R is pleased to share a post from Jim Gearhart, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what happened December 4-7 in Baltimore, MD. 

PRIM&R’s 2014 AER Conference got off to an inspiring start on Friday with perceptive discussions [...] Read more

9
Dec2014

In October, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance “discusses whether risks are considered risks of research when one of the purposes of the research is the evaluation or comparison of risks associated with standards of care. It also discusses disclosing certain reasonably foreseeable risks to prospective subjects when seeking their informed consent to participate in such research activities.”

Following up on the release of the draft guidance, PRIM&R held a session at the 2014 Advancing [...] Read more

4
Nov2014

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

On Friday, October 24, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance follows more than a year of deliberation and public consultation prompted by the controversy surrounding the Surfactant, Positive Pressure, and Oxygenation Trial (SUPPORT).

SUPPORT was a multisite randomized trial that took place from 2005 to 2009 and sought to determine, in part, the optimal oxygen saturation for extremely premature infants. [...] Read more

22
Oct2014

Elizabeth_Buchananby Elizabeth Buchanan, PhD, Endowed Chair in Ethics, University of Wisconsin-Stout

On Thursday, October 30, PRIM&R will host a webinar, The Future of Internet Research: What We Can Learn from the Facebook Emotional Contagion Study, which will explore the Facebook emotional contagion study and some of the questions that it raised related to internet and social media research. In advance of that webinar, we are sharing different perspectives on the controversy. Last week, PRIM&R’s executive director, Elisa A. Hurley, PhD, <[...] Read more