IRB Advisor – April 1, 2019
April 1, 2019
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HEAL: An NIH Moonshot Against Addiction and Pain
The National Institutes of Health is taking up this formidable research challenge with $850 million in federal funding, leveraging expertise from a wide variety of centers and institutes for the HEAL (Helping to End Addiction Long-term) initiative.
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Gene Therapy Studies on the Rise Due to Market Demands
The market’s growth raises the prospect of IRBs overseeing gene therapy clinical trials. It also means that research organizations, both large and small, should be prepared for such trials and develop or have access to an institutional biosafety committee.
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Central and Local IRBs: Can This Marriage Be Saved?
As the new normal becomes single IRB review for multisite studies, some researchers are wary that this system may undermine the vital role of local IRBs to protect research subjects in their community.
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Remember IRB Review Criteria When Updating Application Design
A revised application served as an educational tool for researchers, and it helped reviewers focus on the 111 criteria and avoid bringing extraneous questions into their review.
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Expedited Review Worksheet Includes 111-Criteria Checklist
The IRB at Central Michigan University revised its IRB application to make it more efficient and more closely aligned with federal regulations under 45 CFR § 46.111.
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Study Investigates Reasons Why People Do Not Enroll in Clinical Trials
The study found that a main reason why so few people participate is because there is no trial for more than half of cancer patients for their particular type and stage of cancer.
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Complex Research Ethics Question? Consultants Offer Their Expertise
A research ethics consultation serves as a resource to help answer investigators’ ethical questions.