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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.
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Social-behavioral IRBs Gear Up for Common Rule Changes
Social-behavioral IRBs will face new policy and procedure changes under the new Common Rule.
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Unique Informed Consent Challenges if Research Participant Is Incarcerated
Informed consent for research involving incarcerated people presents multiple unique ethical challenges for investigators.
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Report Examines How Research on Donated Organs Can Be Ethically Performed
Research on how to improve the quality and quantity of organs available for transplant poses multiple ethical challenges.
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Purdue IRB Shuts Down Youth Study
An IRB at Purdue University in West Lafayette, IN, has terminated a study of young people with high blood pressure after a youth camp last summer was plagued by multiple incidents of violence and sexual harassment.
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OHRP and FDA Issue Guidance on IRB Meeting Minutes
The Office for Human Research Protections and the FDA prepared guidance to inform IRBs about how best to prepare and maintain IRB meeting minutes under both agencies’ regulatory requirements.