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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IRB members have until Aug. 3, 2018, to submit comments on FDA draft guidance that would open adult oncology clinical trials to children ages 12 to 17 years.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.
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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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Ethical Response Needed if Patient Revokes Consent Due to Complications
A new paper explores ethical considerations if patients consent to a treatment plan with the understanding that it carries risks of complications, then revoke consent when complications arise.
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Study: Older Adults Living Alone With Cognitive Impairment Lack Support
There is a dearth of programs to support older adults living alone with cognitive impairment, creating a need for novel programs and interventions, found a recent study.
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New Guidance Helps Clinicians Navigate Demands for Nonbeneficial Care
New guidance from the Canadian Critical Care Society aims to help clinicians respond to families’ demands for life-sustaining treatment.
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Preference for Aggressive Treatment Isn’t Linked to Inpatient or ED Care
Preferences for more aggressive medical treatment are not significantly associated with inpatient or ED treatment, according to a recent study.