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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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Dual Antiplatelet Therapy for Minor Ischemic Stroke or TIA
These investigators undertook this study to evaluate the effect of clopidogrel plus aspirin, vs. aspirin alone, in an international population of patients who had minor ischemic stroke or TIA — Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT).
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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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Tenecteplase vs. Alteplase for Ischemic Stroke
In a recent trial, treatment with tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase if administered to patients with ischemic stroke within 4.5 hours of symptom onset.
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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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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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Prodromal Symptoms Predict the Onset of α-Synucleinopathies
In this review of the common prodromal symptoms of α-synucleinopathies, such as Parkinson’s disease, dementia with Lewy bodies, and multiple system atrophy, the authors provided a potential framework for a timeline of the development of these conditions, starting with these prodromal symptoms.
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Chemotherapy-induced Neuropathy in Childhood Cancer Survivors
Long-term symptoms and disability from chemotherapy-induced peripheral neuropathy occur in more than half of childhood survivors of cancer, with vinca alkaloids and platinum agents implicated most often.
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Cannabidiol: Does It Help in Drug-resistant Epileptic Encephalopathies?
In this double-blind, placebo-controlled trial, the authors investigated the efficacy of adjunctive cannabidiol in a population of severe developmental epileptic encephalopathies and found some efficacy.