IRB Advisor
RSSArticles
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Two eyes are better than one: Secondary reviews improve protocol review process
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Spotlight on Compliance: Off-label use differs from investigational use
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Have book, will study
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Adverse event reporting often creates confusion, conflicts over when and how
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On-line conference trains researchers
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Should IRBs standardize payments to subjects?
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Vaccine, drug development link IRBs and researchers
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Key finance question: Is relationship covered?
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Risk-benefit assessment: One size doesn’t fit all
Assessing risks and benefits is an evolving process in the human research protection world especially for IRBs that handle social-behavioral, as well as biomedical, studies. One size in risk-benefit assessment definitely does not fit all. For instance, IRBs sometimes over-emphasize risks in studies involving social-behavioral topics without considering protections that researchers have put in place, IRB experts say. -
For international consent, clarity is key
Creating clear, truly understandable informed consent documentation can sometimes be a challenge for IRB members and researchers, particularly in the area of international research. Making sure that details are not lost in translation and that the documentation meets U.S. federal and international regulations can also present some difficulty.