7
Feb2017

Researchers should see this slide deck. At the end of Patricia Furlong’s keynote address at the 2016 Advancing Ethical Research Conference, I realized that this was the only note I had written during the session (though for the purposes of this post, I have gone back to the proceedings to quote other relevant thoughts). Read more

31
Jan2017

Mary L. Gray, PhD is a Senior Researcher at Microsoft Research and Fellow at Harvard University’s Berkman Center for Internet and Society. She maintains an appointment as Associate Professor of the Media School, with affiliations in American Studies, Anthropology, and Gender Studies at Indiana University. Dr. Gray’s research looks at how media access and everyday uses of technologies transform people's lives. She gave a keynote speech at PRIM&R’s 2016 Advancing Ethical Research titled ” When Human Subjects, Science, and Consumer Rights Collide.” Read more

30
Jan2017

On January 18, 2017, the final rule from the Department of Health and Human Services (HHS) and the National Institute of Health (NIH)’s corresponding policy on reporting to ClinicalTrials.gov will take effect. ClinicalTrials.gov, which is run by NIH, is a searchable registry of clinical trials. It is a federal requirement that sponsors of certain clinical studies that either have one American research site or are conducted under an investigational device exemption (IDE) or an investigational new drug (IND) application register and report the summary results on ClinicalTrials.gov. However, currently very few pharmaceutical companies, academic institutions, and government agencies are complying with the requirement. The regulatory changes taking effect will only have a meaningful impact if the incoming Administration chooses to enforce them. Read more

27
Jan2017

This week’s Research Ethics Roundup examines the case for sharing data from research with primates, what the new Common Rule looks like, successful Zika research enrollment numbers, and the debate over what the California Institute for Regenerative Medicine (CIRM) has achieved. Read more

25
Jan2017

I’m intrigued, on multiple levels, by the ethical, regulatory, and operational challenges of The Precision Medicine Initiative® (PMI) Cohort Program, now called the All of UsSM Research Program. This program—should it move forward—will be the largest health and medical research program on precision medicine in US history, and proposes to enroll one million or more volunteers in the next few years.

The PMI was introduced to the American public by former President Obama in his 2015 State of the Union address. It was summarized on the White House PMI website1 at the time as “a bold [...] Read more

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