In Case You Missed It (ICYMI): From time-to-time, Ampersand will feature particularly well-received posts from the recent past. These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, part of a series of posts working through the Notice of Proposed Rulemaking for revisions to the Federal Policy for the Protection of Human Subjects, PRIM&R Executive Director Elisa Hurley explains the impetus for [...] Read more
TAG ARCHIVES FOR human subjects research
On August 2, 2016, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more
This week’s Research Ethics Roundup explores ClinicalTrials.gov transparency issues, a potentially controversial citywide study of a new procedure for gunshot and stabbing victims in Philadelphia, charges against an Indian drug developer accused of fraudulent research, and a rebuttal to researchers who have resisted including female mice and rats in pain research. Read more
How was it listening to Dr. Massie’s plenary session at the 2015 AER Conference (AER15)? It was like sitting in a cozy room, warmed by a glowing fire, catching up with a too-long-out-of-touch dear friend. Bob Massie is a magical storyteller. Describing in measured tones, touched with a tinge of irony a life challenged by health issues both genetic (hemophilia) and manmade (infection with HIV and Hepatitis C from a tainted blood supply), he painted dozens of tender, amusing, frightening pictures of a life lived, delayed [...] Read more
From a study that explores the regulatory burden researchers face to the development of a device that applies a biodegradable adhesive to internal organs, this week's Research Ethics Roundup delves into how advances in technology and changes in regulations are impacting the course of research.