IRB Advisor – December 1, 2004
December 1, 2004
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Antidepressants and children debate yields lessons for IRBs
The recent warnings that children using certain antidepressants may be at increased risk to become suicidal and charges that previous studies pointing out the problem were kept from public view have reverberated throughout the research community. -
Use visual aids, testing to improve informed consent
Using visual aids in the informed consent process can significantly improve comprehension of issues such as risks and confidentiality, according to a study of pregnant women in Pune, India. -
Willingness to participate in trials varies by race
Non-Caucasian cancer patients, while just as interested as Caucasian patients in learning about clinical trials, approach their decision to enroll in one differently, according to new study. -
Do PIs really understand the submission process?
Youre all on the same team right? At times it doesnt seem so. Sometimes, the way people look at the IRB process and its documentation is that its just one more hurdle they have to jump through in order to conduct their research, says Sarah Frankel, PhD, education specialist at the Human Studies Committee of Washington University School of Medicine in St. Louis. -
Public education program successful with PAD trial
The Public Access Defibrillation (PAD) trial experience offers clinical trial administrators a firsthand look at how to conduct extensive public education in the absence of individual informed consent. -
Hopkins studies effect of violence on children
In a popular music video, the star is shot in one scene, then in the next, a small plastic bandage covers the purported wound as he continues singing with an arrogant swagger into the next verse. Guns and images of violence are popular entertainment in this country featured in the plot lines of popular movies, music videos, TV shows, and video games. -
News Brief
The Office for Human Research Protections (OHRP) has released an updated set of Human Subject Regulations Decision Charts, which can help IRBs determine whether an activity amounts to human subjects research that falls within the realm of the IRBs review process.