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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.
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.
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.
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.
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.
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.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball is a consultant for Ethicon USA and Mobile Instrument Service and Repair.
