TAG ARCHIVES FOR standard of care

31
Jan2019

Standard of Care, Research, or “Innovative Treatment”: Which Is It?

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31 Jan
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Innovations in medical practice are critical to the advancement of medicine, but the question of “innovative treatment” versus “medical or surgical research” can often become clouded.  It was with great interest that I attended the breakout session led by Stephanie Cargill, PhD, and Jeremy Corsmo, MPH. When does a doctor’s innovative treatment of a patient become surgical or medical research? This question comes up frequently and is also posed when research takes place outside the surgical theater. I was relieved to find out I was not the only person on the planet to have dealt with this issue. As the co-chair of an independent IRB, Read more

30
Jan2015

Research Ethics Roundup: Priorities for Research Funding, Sharing Clinical Trial Data, and More

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30 Jan
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It has been a busy few weeks in the research oversight field with the release of a much anticipated Institute of Medicine report on data sharing and a new bill that seeks to overhaul drug and device development. Explore these and other stories below. HHS, Research Community Debate Informed Consent Policy: This piece from Kaiser Health News explores some of the various viewpoints surrounding the changes proposed by the Office for Human Research Protections in their “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care." Read more

22
Jan2015

PRIM&R’s Response to OHRP’s Draft Guidance on Research Evaluating Standards of Care

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22 Jan
Comments: 1

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

Research on the comparative effectiveness of commonly used interventions is becoming increasingly common as clinicians, researchers, and healthcare funders seek to improve the efficiency and effectiveness of health care by developing a strong evidence base about medical interventions. With the growth of such efforts, questions have emerged about how oversight rules and mechanisms for the protection of human subjects should apply to such endeavors. In October, following more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the [...] Read more

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