April 1, 2020
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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.
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.
IRB’s Re-Engineered Program Makes It More Responsive
The revised Common Rule requires IRBs and research institutions to become more efficient and attentive. It also makes clear that an IRB cannot do all things for all stakeholders. The University of Texas Health San Antonio created a human research protection program office to handle institutional components of research protection work.
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.
Interactive Online Checklists Help Investigators With Informed Consent
A recent study revealed that an informed consent checklist of basic consent elements guides investigators on how to present key information required by the Common Rule.
New Working Group to Produce Guidance for Pediatric Gene Therapy
The NYU Grossman School of Medicine’s working group on Pediatric Gene Therapy and Medical Ethics formed in the fall of 2019 to address and propose recommendations to issues involving gene-based therapies in pediatric populations, including research activities.
IRBs Can Prepare for Cannabis Research
The cannabis industry is a booming economic force across the nation as states increasingly legalize the sale of medical and/or recreational marijuana. It remains on the national Schedule I list of drugs that are not acceptable for legal sale. But what do healthcare providers really understand about the drug’s safety, risks, and benefits? Not enough, human research protection professionals say.