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The Office for Human Research Protections' 2014 Edition of International Compilation of Human Research Standards is available with hundreds of updates and three additional nations, including Cameroon, Mozambique, and Zambia.
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In their search for ways to improve informed consent, IRBs and the research community have used illustrations, different sizes and styles of fonts, simple language, videos, interactive displays, and other innovative methods.
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A large health system IRB found that incomplete study submissions were clogging up the IRB review system, resulting in long waits up to three months for approval.
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Academic and medical research institutions and their IRBs often have to deal with study proposals that fall between research and quality improvement (QI).
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Translation of full informed consent forms into other languages can be a costly and time-consuming endeavor for researchers, particularly if there are few non-English speaking participants in a study.
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Federal regulations require IRBs to include at least one non-affiliated, non-scientist member on the boards, commonly known as the "community member."
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Human research protection programs (HRPPs) receive only general guidance on how they might fulfil their educational requirements, so programs range from simply requiring research staff to complete online courses to institutions that offer a broad smorgasbord of educational options.
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When an IRB redesigns its electronic submission system, it's the right time to consider redesigning the IRB's workflow as well, some experts say.