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
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Welcome to Research Ethics Reading List, a new feature from Ampersand where we feature books in or adjacent to the field of research ethics that we think you’ll find interesting, motivating, inspiring, challenging, or some combination of the four! In this edition we look at books about tech industry bias and blind spots; the powers, perversions, and potential of heredity; animal Infections and the next human pandemic; and more! Read more
On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of the revised Common Rule. [Update] On July 25, OHRP issued a Federal Register Notice and the community and public has until August 24, 2018 to Read more
This week’s Research Ethics Roundup reviews researchers’ efforts to learn about how traumatic brain injury affects women’s brains, the first CRISPR gene-editing human subjects trial, why patient groups object to changing FDA rules on off-label promotion, and scientists’ arguments for why living conditions for lab mice need to change.
Wanted: Women’s Brains — to Jump-Start Lagging Research on Female Concussions: In this STAT News article, Usha Lee McFarling examines new efforts to collect data on the effects of traumatic injury on women’s [...] Read more
Meet PRIM&R member Sharon Nelson, MSN, RN, CNS, CIP, executive director of consulting and compliance services at Schulman IRB. Read more