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Its probably a good idea to expect more obstacles and delays than imagined when initiating a collaboration for conducting central IRB reviews across a region.
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IRBs should have both a minutes process and a minutes template, an expert says.
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IRBs should ask themselves: Are we gatekeepers? Or are we collaborators, navigators, and concierges?
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A late-August Office of Human Research Protections (OHRP) public meeting in Washington, D.C. brought debate from researchers, physicians, and patient advocates on the subject of standard of care research and how IRBs should assess risks in randomized trials.
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IRBs and researchers could improve the informed consent (IC) process by looking at research participants from a different perspective, an expert says.
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While private companies that conduct human subject research do not fall within the definition of regulated research, the decision whether to entirely forgo approval is not always clear.
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Seek help early and often
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The last 12 months have been packed for IRB members. Respondents to IRB Advisors annual salary survey report that their workloads and working hours are on the rise.
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The cliché about documentation should be a maxim at IRBs, an expert advises: If you dont document it, you didnt do it.
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As more research institutions develop collaborations to share IRB reviews, they may find that developing trust is one of the most important and most challenging first steps.