IRB Advisor
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Tips for Simplifying Informed Consent Language
Using plain language in informed consent forms means exchanging medical and statistical jargon for words that people with low health literacy and low health numeracy would understand.
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Give People What They Need in Informed Consent: Plain Language
Most research informed consent forms are written at a high school reading level when many people who are being recruited for studies might need language nearer to a fifth-grade level, according to a new study.
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Dissenting Opinion: New Common Rule Penalizes the Compliant
Many see the single IRB requirement in the revised Common Rule as a necessary sword to sever the Gordian knot of regulatory overlap and unnecessary delay of multisite review. Suzanne M. Rivera, PhD, is not one of them.
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Deadline Extended for Common Rule Compliance
With finalization of the revised Common Rule postponed for at least six months — and possibly one year — IRBs should continue preparing to comply with the regulation as they await additional clarification and guidance.
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Study: Pain Research Can Harm Participants
Researchers must pay greater attention to the rights of study participants in pain research, concludes a recent paper by the Ethics Committee of the Pain-Omics Group.
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Is It Safe? NIH Ends Moratorium on Enhancing Pandemic Pathogens
"Gain-of-function” research designed to make pathogens deadlier or more transmissible in order to develop treatments and countermeasures has been given a green light by the National Institutes of Health.
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Improve Staff Efficiency, Productivity With These Tips
Staff training that includes a thorough focus on each employee’s job description and expectations, along with staff engagement, can be crucial to improving an IRB office’s workflow and efficiency. Consistency also is key.
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IRBs, Researchers Gain Much by Adding Statistical Reviewer
After an incident involving a protocol modification, the Northwell Health IRB of New Hyde Park, NY, found that the board needed certain expertise that it had been lacking.
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Identifying Key Personality Traits Affected by Parkinson’s Disease, Deep Brain Stimulation
Parkinson’s disease and deep brain stimulation procedures sometimes used to treat it can alter personality, including key traits that make a person, in essence, who they are. While many patients and families report positive changes, there is a need to better identify exactly what personality characteristics may be affected and to what degree personality is altered.
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Preparing for the Transition to a Single IRB Policy
One of the more sweeping changes in the revised Common Rule is the single IRB policy. However, there will be exceptions to this requirement when the regulations become effective, and there has been some confusion about the difference between a single and a “common” IRB.