IRB Advisor articles

Recent articles from IRB Advisor

IRB seals fate by approving fake protocol in federal sting.
July 1, 2009... IRB seals fate by approving fake protocol in federal sting "To say this is just a problem of [some] IRBs is very naive." A federal undercover investigation into possible vulnerabilities in the IRB review system has led to the closure of one independent IRB, and has left other IRBs...

HHS also faulted in GAO investigation.
July 1, 2009... HHS also faulted in GAO investigation Questions raised after fake IRB registered The General Accounting Office (GAO) report on the IRB system's vulnerabilities doesn't just criticize the individual IRBs targeted by the investigation. It also faults the U.S. Department of Health...

Get to know GINA: What it does a[euro]" and doesn't do.
July 1, 2009... Get to know GINA: What it does -- and doesn't do Genetic nondiscrimination act shouldn't be oversold The Genetic Information Nondiscrimination Act (GINA) of 2008 protects Americans against discrimination in employment and health insurance coverage based on genetic information. It...

Crafting informed consent under GINA.
July 1, 2009... Crafting informed consent under GINA OHRP's suggested language is a good place to start The Office for Human Research Protections (OHRP) recently released guidance for IRBs and investigators on how to deal with the new Genetic Information Nondiscrimination Act (GINA). The...

Save hours on minutes: How to hone the process.
July 1, 2009... Save hours on minutes: How to hone the process No short-cuts, but efficiency possible There might not be any shortcuts to creating the most accurate and thorough IRB reviews and meeting minutes, but it is possible to make these consistent and accurate with a well-thought-out process....