Record-Keeping and Data Security: Insights for IRB Administrators and Researchers

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25 Jun

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Since the National Archives in Washington were founded they have solved historical mysteries, provided key information, and unlocked a great deal of forgotten knowledge. The power of records and record keeping is influential at all levels of human existence, but also may be harmful to the least empowered individuals in society (such as refugees or the elderly). At PRIM&R's AER Conference, presenters offered insights into essential documentation and stressed the importance of good record keeping and data management for IRBs. Read more

25
Oct2017

OHRP and FDA Release Final Guidance on IRB Meeting Minutes

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25 Oct

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Last month, the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released final guidance on meeting minutes for IRBs who oversee human subjects research under FDA and/or HHS regulations. The final guidance includes a few small changes from the draft released in November 2015. This is the first time the two agencies have jointly issued guidance in this area; the guidance summarizes how the agencies believe IRBs and institutions should apply the federal regulations as they pertain to the creation of IRB meeting minutes. Read more