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‘Serious Noncompliance’ the Leading Incident Reported to OHRP
IRBs and research institutions may be concerned that reporting incidents of noncompliance to the HHS Office for Human Research Protections could be a red flag to prompt an investigation, but the reverse is actually true.
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The Ethical Question of Denying Children Antibiotics
As IRB members are no doubt aware, public health officials are warning that the overuse and misuse of antibiotics has selected out resistant strains of bacteria all over the globe. As a result, the short-lived miracle of the antibiotic era is at risk of coming to an end.
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‘Reimagining’ the IRB Model for the 21st Century
The IRB model created to protect human research subjects more than a half-century ago is in danger of being outstripped by technology-driven research and other forces. It must be “reimagined” for the 21st century to provide safe and ethical oversight of rapidly expanding research agenda, the authors of a recently published report argue.
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VCU IRB’s Member Handbook Covers What They Need to Know
The Virginia Commonwealth University IRB office created the IRB Member Handbook for training new members and to serve as a resource to all members.
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IRB’s New Member Handbook Improves IRB Training
Like many IRBs, the Virginia Commonwealth University IRB has been on a mission recently to streamline its processes, decrease approval time, and improve IRB member training.
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Here’s a List of Vulnerable Populations Historically Exploited in U.S. Research Studies
People who are part of vulnerable populations were exploited in the name of research over the years leading up to our current institutional review board and human research protections.
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Vulnerable Populations are a Cornerstone of Human Research Protections
Historical accounts of the biggest human research scandals of the past two centuries primarily involved vulnerable populations. The list is long and includes orphans, minorities, the disabled, prisoners, and others.
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The 21st Century Cures Act Easily Passed, But is it Good for Research Protection?
The 21st Century Cures Act's broad popularity and its $4.8 billion in spending for new research at the National Institutes of Health might not offset some of the bill’s problems tied to research protection, some critics say.
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People with Mental Illness Often Excluded from Clinical Trials
If a medication for major depression has a dangerous adverse interaction with a different medication that’s being studied in a clinical trial, will it be discovered by researchers and reported in the literature? Not likely, if no one enrolled in the study has major depression.
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IRB Designs Process to Separate QI from HSR
The most commonly asked question of the Intermountain Healthcare IRB in Salt Lake City has been: “Is this quality improvement or is it research?”