IRB Advisor – July 1, 2009
July 1, 2009
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IRB seals fate by approving fake protocol in federal sting
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 wondering whether the due diligence they exercise is diligent enough. -
HHS also faulted in GAO investigation
The General Accounting Office (GAO) report on the IRB system's vulnerabilities doesn't just criticize the individual IRBs targeted by the investigation. -
Get to know GINA: What it does â" and doesn't do
The Genetic Information Nondiscrimination Act (GINA) of 2008 protects Americans against discrimination in employment and health insurance coverage based on genetic information. -
Crafting informed consent under GINA
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). -
Save hours on minutes: How to hone the process
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. -
Tips for improving writing of IRB meeting minutes
IRB staff can greatly improve how the IRB meeting minutes are written by following a few helpful hints, experts say. -
Sample questions from IRB presenter guidelines
The office of protocol research at the University of Texas M.D. Anderson Cancer Center in Houston, TX, has created comprehensive guidelines that IRB members can use as they present their findings and opinions of protocols. -
Finding ethical balance on protocol violations
There isn't a black and white answer when an IRB discovers that a human subjects research site has collected some data that is tainted by a protocol violation.