IRB Advisor – April 1, 2008
April 1, 2008
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Fallout from controversial OHRP decision regarding IC may confuse PIs, IRBs
Whatever IRB members might think happened in the recent regulatory controversy over studying the use of infection control checklists in Michigan hospitals, the truth might be stranger. -
Here's how the Johns Hopkins and OHRP controversy unfolded
It all began when investigators published a study that had good news for the infection control industry. -
Survey helps evaluate IRB's efficiency, performance
How well is your IRB doing? It depends on who you ask. The subjectivity of any answer makes it a difficult question to measure. -
IOM committee finds Privacy Rule causing problems for research
An Institute of Medicine (IOM) committee studying the effects of the HIPAA Privacy Rule has painstakingly documented the strain it is putting on research. -
Assent process should focus on children's understanding of research
Giving children a chance to assent to their own participation in research is an important goal of the pediatric research community. Done properly, it can empower young patients, help them develop their decision-making skills, and prompt them to take their participation more seriously. -
Suicide rating scale can be valuable assessment tool in drug studies
The controversy of the past few years over possible suicidality associated with various drugs pointed out the importance of tracking suicidal thoughts or behavior in subjects involved in clinical trials.