Articles Tagged With: irbs
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Second Phase of Pandemic Raises More Questions, Concerns for IRBs
Research organizations and IRBs continue to face challenges and make tough decisions based on the best available information about a pandemic that changes daily as it spreads across the world.
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FDA Guidance Offers Foundation for IRB, Researcher Flexibility
The Food and Drug Administration’s guidance on conducting clinical trials during the pandemic provides reassurance that IRBs and research organizations can employ flexibility as they make changes to accommodate a world in which many patient visits are conducted remotely. The guidance does not change or modify existing regulations, but synthesizes existing regulations and emphasizes the built-in flexibility.
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What Happens to Human Research in the New Pandemic Era?
The big question in the clinical research world is how things will look when the COVID-19 pandemic has ended. Will everything go back to the way it was? If not, what changes will remain?
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Study Reveals Preferences for Simpler Research Language
Boilerplate language for informed consent documents is simple, but not always easy for study participants to understand. The goal for IRBs is to help researchers simplify the words and scientific jargon they use to describe studies to participants, but it is unclear how this can be accomplished. One solution is the Consent Language Explicit And Reasonable Initiative.
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Real-Time IRB Process Reduces Turnaround by 71%
The IRB of the Medical College of Wisconsin in Milwaukee experienced a protocol review turnaround time of 70.6 days, despite using a robust pre-review system. A real-time review process decreased turnaround to 20 days, a 71% reduction through 2018.
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COVID-19’s Effects Hit Healthcare, Research Institutions
IRBs have learned that their disaster plans did not prepare them for the effects of a fast-moving virus, COVID-19, that has demonstrated its far-reaching ability to shut down normal business and social interactions.