IRB Advisor
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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?”
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When it was Time to Standardize, IRB Went With a P&G Committee
Collaboration and consolidation of IRBs likely will be an ongoing trend that necessitates action to reduce problems and improve streamlining — in other words, best practices.
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Meeting Management ABCs From an Expert IRB Chair
After 32 years as an IRB member and 20 years as chair, one IRB expert says the key to IRB meeting success could be boiled down to one word: Respect.
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Research on Brain Scan Risk of Alzheimer’s an Ethical Challenge
While different than genetic signs for dementia, biomarker information found in research brain scans also can suggest heightened risk for developing Alzheimer’s disease, and thus the disclosure or withholding of results raises ethical questions for IRBs and investigators.
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Clinical Trial Addresses the Tricky Process of Revealing Genetic Risk Factors for Alzheimer’s
Genetic research that could prevent or treat Alzheimer’s are under study. The caveat is that the human subjects recruited into trials must be willing to know if they carry the DNA markers that may predispose them to subsequent dementia.
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Vandy-Duke Research Partnership to Put Clinical Trials on Fast Track
Two venerable research institutions are collaborating in a far-reaching partnership that aims to safely speed research, translating trial results to patient interventions in more expedited fashion.
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When IRBs Take a Walk on the Wild Side: The Dark Web
What many IRBs might not know is that researchers increasingly are turning to the “dark web” for data.