IRB Advisor articles from July 2009

IRB Advisor archives from July 2009

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...

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....

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...

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...

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...

Tips for improving writing of IRB meeting minutes.
July 1, 2009... Tips for improving writing of IRB meeting minutes Use "action" verbs actively IRB staff can greatly improve how the IRB meeting minutes are written by following a few helpful hints, experts say. For one thing, IRB meeting...

Sample questions from IRB presenter guidelines.
July 1, 2009... Sample questions from IRB presenter guidelines Presenters touch on eight main points The office of protocol research at the University of Texas M.D. Anderson Cancer Center in Houston, TX, has created comprehensive guidelines that IRB...

Finding ethical balance on protocol violations.
July 1, 2009... Finding ethical balance on protocol violations A real world problem 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. ...

CNE/CME objectives/questions.
July 1, 2009... CNE/CME objectives The CNE/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...