IRB Advisor – July 1, 2018
July 1, 2018
View Issues
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Right to Try Law Raises Questions About FDA, IRB Oversight
The FDA “remains committed” to reviewing and approving investigational drugs through its expanded access program, which will continue in conjunction with the recently enacted federal Right to Try law.
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Prepare Contingency Plans for Transferring Oversight
IRBs should create a contingency plan that would go into effect when a natural disaster or a major problem disrupts operations.
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FDA Explains IRB Written Procedures Policy
New federal guidance on IRB written procedures leave “meaningful content” open to interpretation.
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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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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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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IRB members have until Aug. 3, 2018, to submit comments on FDA draft guidance that would open adult oncology clinical trials to children ages 12 to 17 years.