IRB Advisor
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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.
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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.
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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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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.
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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.
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Consent Library Is Consistent With Quick Access to Better Wording
Dedicated editors help a research program manage an informed consent library of terms that can be included in consent forms as a substitute for medical/scientific language.
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Protocol Activation Model Leads to Reduction in Time-to-IRB Approval
A large cancer research institution in New York City overhauled its protocol review process, devised a library of scientific terms commonly used in consent forms, and invested in more staff. Within a couple of years, the updated process resulted in a striking reduction in the median time for protocol and consent review by the IRB. Time-to-IRB approval decreased from 135 days in 2017 to 80 days in 2018.
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Consent Calendar for Continuing Reviews Can Save IRB Meeting Time
The consent calendar is a century-old tool, but it can work well in saving time during IRB meetings. Typically, IRBs review each study up for continuing review, discussing and voting for each, separately. But that might not be the most efficient way to handle these on the board meeting agenda.
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IRB Devises Efficient, Time-Saving Annual Review Process
Continuing review might have gone away for many studies, but a research protection program’s responsibilities have not. This is why many IRBs have devised an alternative annual review process that combines workflow efficiency with enhanced research protection. One model for this regular review is an annual status report. Minimum risk, expedited review, and some additional studies do not need to go through the annual continuing review by the IRB, but they can be monitored through this review.