TAG ARCHIVES FOR comparative effectiveness research

11
Sep2015

In the wake of the controversy over the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), a team of bioethicists set out to answer two main questions raised by the controversy: (1) “what do people think about the risks and benefits of research on medical practices?,” and (2) “what do people think about different approaches to informing patients that this type of research is being conducted?” Their research, the Research on Medical Practices Ethics Study, examined the views of the general population regarding research on medical practices through a series [...] Read more

22
Jan2015

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more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the [...]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

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On Friday, October 24, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance follows more than a year of deliberation and public consultation prompted by the controversy surrounding the Surfactant, Positive Pressure, and Oxygenation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

15
Oct2014

by Elisa A. Hurley, PhD, Executive Director

Much has been written in the past few months—pro and con—about the results of the Facebook emotional contagion study published in June in the Proceedings of the National Academy of Sciences. The study manipulated the News Feeds of 700,000 unknowing Facebook users for a week in January 2012 by adjusting Facebook’s existing algorithm to over-select for either more positive or more negative language in posts. At the end of the week, [...] Read more

18
Jan2014

by Avery Avrakotos, Education and Policy Manager, and Meryn Robinson, Educational Program and Membership Services

Technological advances, the growing need for comparative effectiveness research, an increasing demand for data transparency, and the continued globalization of the research enterprise were among some of the issues that human subjects protections professionals grappled with in 2013. For those involved in animal care and use, the year marked a continuation of efforts to educate the public about the value of animal research. As we reflect on 2013, and look ahead to what 2014 will bring, we are pleased to share with you a collection of Ampersand posts that reflect some of the year's major events, both for PRIM&R and [...] Read more

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