Internal Review Boards
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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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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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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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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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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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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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Consortium Pushes for Evidence-Based Research Oversight
Rather than careful forethought of action, many of the principles of human research protections are essentially reactionary, formed in the aftermath of a succession of horrific episodes of unethical experimentation, experts say.
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Social Media Use By Participants Can Undermine Trials
The rapid communication enabled by various devices and platforms could undermine clinical trials, allowing research subjects to share notes and possibly manipulate the study.
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Does Federal Right to Try Law Imperil State RTT Laws?
Adding to the considerable confusion on Right to Try laws, by which dying patients may seek access to experimental drugs, a legal expert tells IRB Advisor that the 41 RTT state laws may be found unconstitutional if they conflict with the federal law passed last year.
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Working Group Created Common Rule 'To-Do' List
An IRB working group in Texas created a new Common Rule to-do list through collaboration between the University of Texas at Arlington IRB and other area IRBs.