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(DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on institutional review board (IRB) written procedures.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
TAG ARCHIVES FOR human subjects research
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.
PRIM&R is pleased to welcome Boghuma Kabisen Titanji, MD, MSc, PhD, as one of the keynote speakers at the upcoming 2015 Advancing Ethical Research Conference to be hosted in Boston November 12-15, 2015. Dr. Titanji will lead off the conference program on November 13 with an address titled, Facts and Fiction: The Ethics of Healthcare Research in Developing Countries.
PRIM&R: How did you develop an interest in your field?
Boghuma Kabisen Titanji (BT): Very early on during my training as a physician in my home country Cameroon, I [...] Read more