IRB Advisor – October 1, 2012
October 1, 2012
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VOICE offers model for thorough, subjectfriendly consent process
The human subjects protection field continues to search for ways to improve the informed consent (IC) process. IRB professionals often express concern that potential research participants do not understand their rights or the true risks and benefits of a study, although they might sign the IC forms and say they have no questions. -
Tips on using teach-back in the IC process
Research institutions that plan to use the teach-back method as part of their informed consent process should make certain there is adequate training for clinical trial professionals. One research site has found that simulations work best for this purpose. -
Best Practices: Do the minutes reflect well-run meetings?
It's important that IRB meetings are run efficiently, keeping discussions brisk and on the important human subjects protection issues. But it's also important that these discussions are well-documented in the IRB meeting minutes. -
IRBs ease conflicts with investigators
Most IRB directors or chairs can recount stories about their tensions with investigators. All boards must balance the institution's need to protect subjects with investigators' concerns about unduly hampering their research. -
IRB officials share ideas for bridging the gap with PIs
Robert Klitzman's survey of IRB chairs, members and administrators revealed a number of ideas that can be adopted by other institutions that want to improve relations with their investigators. -
More active consent for newborn screenings?
Nearly every baby born in the United States undergoes a simple heel-stick in the first few days of life that has potentially profound health implications for his or her life. -
Trials don't ask cancer subjects about tobacco use
Despite evidence suggesting that tobacco use can hamper cancer treatments, patients with cancer who enter clinical trials are rarely asked about their use of tobacco, according to a recent study.