1/ Pleased to share a new Open Access paper in Clinical Trials, led by Emily Largent, on the value of community consultation in clinical trials that request waivers of the requirement for informed consent (threadlet). journals.sagepub.com/doi/10.1177/...

The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research - Emily A Largent, Steven Joffe, Neal W Dickert, Stephanie R Morain, 2...

There is growing interest in using embedded research methods, particularly pragmatic clinical trials, to address well-known evidentiary shortcomings afflicting ...

2/ Federal regs allow informed consent waivers in 2 settings. The 1st is “investigations involv[ing] human subjects who have a life-threatening medical condition that necessitates urgent intervention …, and who, because of their condition…cannot provide informed consent.