Compliance
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Report Examines How Research on Donated Organs Can Be Ethically Performed
Almost 5,000 organs from deceased donors were discarded in 2015 because they were deemed unsuitable for transplantation. Some donated organs are used solely for research because they don’t meet the criteria for transplantation.
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Studies of Insects as Food Now Heading to IRBs
It is still unusual for IRBs to receive protocols involving insect-derived food, but it can and does occur, so they should be prepared.
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Final Common Rule Compliance Date Set
The revised Common Rule has been issued in final form, with IRBs allowed to use three “burden-reducing” provisions to prepare for a Jan. 21, 2019, compliance date.
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Unresolved Issues With 'Right to Try'
New York University School of Medicine Working Group on Compassionate Use and Pre-Approval Access recently issued a statement that cited unresolved issues on the federal Right to Try law.
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Right to Try Law in Regulatory Limbo
The new Right to Try law has been dogged by implementation questions and remains in regulatory limbo.
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Vaccinated Healthcare Worker Acquires Measles Amid Outbreak
A healthcare worker with a history of measles vaccination still acquired the disease when treating unsuspected cases in the early stages of a large measles outbreak in the Minneapolis area last year.
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FDA Proposes Including Children in Adult Cancer Trials
IRB members have until Aug. 3, 2018, to submit comments on FDA draft guidance that would open adult oncology clinical trials to children ages 12 to 17 years.
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IRBs Can Learn to Make the Most of Central IRB Partnerships
The IRB at Inova Health System of Falls Church, VA, began working with a central IRB 15 years ago — long before the new Common Rule encouraged IRBs to designate an IRB of record for multisite studies.
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IRBs and IBCs: Critical Partners in Gene Research
In addition to IRB oversight, the National Institutes of Health requires that research using “recombinant or synthetic nucleic acid molecules” for gene transfer into human research subjects be approved by institutional biosafety committees.
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FDA Explains IRB Written Procedures Policy
New federal guidance on IRB written procedures leave “meaningful content” open to interpretation.