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IRBs might help board members improve their protocol review process through the use of a tool that guides them through questions to ask about each study.
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As often happens in research, new rules, policies, and guidelines often follow media reports of research integrity and ethical breaches.
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When attempting to activate a clinical trial, one of the biggest concerns an institution faces is turnaround time. At Cedars-Sinai Medical Center in Los Angeles, activation of a new clinical trial could sometimes take 118 days, including IRB review, study team response time, and non-IRB required reviews such as contract negotiations. But for some protocols, including early-stage oncology or therapeutic studies, the institution looked for other ways to bring those new therapies to patients as efficiently and safely as possible.
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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.
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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.
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IRB managers sometimes are daunted by the prospect of streamlining their program.
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Universities and colleges that once thought international research was beyond their reach increasingly are looking for and finding ways to conduct research overseas, some experts say.
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Experts offer strategies for international research
