TAG ARCHIVES FOR regulatory

9
Dec2014

OHRP Discusses Draft Guidance on Appropriate Disclosure of Risks in Research about Standards of Care at AER14

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9 Dec
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In October, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance “discusses whether risks are considered risks of research when one of the purposes of the research is the evaluation or comparison of risks associated with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Following up on the release of the draft guidance, PRIM&R held a session at the 2014 Advancing [...]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

Unpacking OHRP’s Draft Guidance on Research Evaluating Standards of Care

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On Friday, October 24, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance follows more than a year of deliberation and public consultation prompted by the controversy surrounding the Surfactant, Positive Pressure, and Oxygenation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

18
Sep2014

Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

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18 Sep
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by Holly Fernandez Lynch, JD, MBioethics, Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the US Public Health Service Syphilis Study at Tuskegee, conducted by US government researchers from 1932 to 1972. This [...] Read more

29
Jul2014

Getting ahead of the wave: MOOC’s and human subjects research

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29 Jul
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by Rebecca D. Armstrong, DVM, PhD, director of research subject protection, at the University of California, Berkeley and a member of PRIM&R’s Education Committee

In early June, I was invited to attend a multiday convention, The Asilomar Convention for Learning Research in Higher Education, co-hosted by Stanford University and the Massachusetts Institute of Technology to share [...] Read more

25
Jun2014

Learn to be a professional: An interview with Brenda Ruotolo

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25 Jun
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by Megan Frame, membership coordinator 

 Welcome to another installment of our featured member interviews where we introduce you to our members—individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

 Today we’d like to introduce you to Brenda Ruotolo, who recently began [...] Read more