IRB Advisor articles from April 2008

IRB Advisor archives from April 2008

Fallout from controversial OHRP decision regarding IC may confuse PIs, IRBs.
April 1, 2008... Fallout from controversial OHRP decision regarding IC may confuse PIs, IRBs Media attention highlights unclear guidance Whatever IRB members might think happened in the recent regulatory controversy over studying the use of infection...

Here's how the Johns Hopkins and OHRP controversy unfolded.
April 1, 2008... Here's how the Johns Hopkins and OHRP controversy unfolded One complaint set it in motion It all began when investigators published a study that had good news for the infection control industry. Investigators at Johns Hopkins...

Survey helps evaluate IRB's efficiency, performance.
April 1, 2008... Survey helps evaluate IRB's efficiency, performance Provides checks and balance How well is your IRB doing? It depends on who you ask. The subjectivity of any answer makes it a difficult question to measure. This is why an IRB...

IOM committee finds Privacy Rule causing problems for research.
April 1, 2008... IOM committee finds Privacy Rule causing problems for research Changes to regulations, HHS guidance urged An Institute of Medicine (IOM) committee studying the effects of the HIPAA Privacy Rule has painstakingly documented the strain it...

Assent process should focus on children's understanding of research.
April 1, 2008... Assent process should focus on children's understanding of research Focus on capacity to understand, not competence Giving children a chance to assent to their own participation in research is an important goal of the pediatric...

Suicide rating scale can be valuable assessment tool in drug studies.
April 1, 2008... Suicide rating scale can be valuable assessment tool in drug studies FDA requests use of Columbia scale in some trials The controversy of the past few years over possible suicidality associated with various drugs pointed out the...

CE/CME objectives/questions.
April 1, 2008... CE/CME objectives The CE/CME objectives for IRB Advisor are to help physicians and nurses be able to: *establish clinical trial programs using accepted ethical principles for human subject protection; *apply the mandated...