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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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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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Seek help early and often
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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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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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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 should ask themselves: Are we gatekeepers? Or are we collaborators, navigators, and concierges?
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For about 30 years, the Indiana University School of Medicine in Indianapolis has had a research partnership with Moi University's Teaching and Referral Hospital in Eldoret, Kenya, including an exchange program for medical students. As the clinical collaboration grew, IU researchers partnered with researchers at Moi to conduct studies in Kenya and other parts of Africa.
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Not every clinical trial report sees the light of day. Some are abandoned when trial sponsors no longer actively seek publication, or when a study is misreported and no efforts are made to correct it.
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Research institutions nationwide continue to look for ways to improve quality while eliminating redundancy, regulatory creep, and inefficiencies. The key to success is flexibility and considering changes in any type of process that is not working as efficiently as possible, experts say.
