Research With Vulnerable Participants: Safeguards for Vulnerable Clinical Trial Participants Part 3

i'm happy to say that as far as i can tell if any of the thousands of people who watch this online have other examples i'd be very interested in hearing about them as far as i can tell the clinical center was one of the very first institutions in the u.s and probably in the world to develop a

policy on research with adults who can't give informed consent we call it 87 for it's what it started in 1987 for that's the the number for it and that policy has been revised a number of times and basically what that policy aims to do it aims to implement four important safeguards for research with

individuals like miss p adults who can't give informed consent first is what you might call the compelling reason or the necessity requirement and here the idea is that if you can do your research just as well with people who can give informed consent then don't enroll people who can't give informed consent if those

investigators could have done their research equally well if people consent they shouldn't enroll miss p only enroll miss p only enroll a three-year-old only enroll somebody who's unconscious when you have to enroll people from that population in order to answer an important scientific question the way our policy puts that is the irb has to document that there's a

compelling reason to enroll individuals who can't give informed consent adults in this case who can't give informed consent surrogate decision maker if you're going to have somebody enroll them you have a compelling reason to enroll them for an important scientific reason and they can't make their own decisions about whether or not to be in research