IRB Advisor
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PRIM&R Finds Itself Caught in State Travel Ban Controversy
The 2017 PRIM&R conference was scheduled for November in San Antonio, TX. All was well until the Texas legislature passed legislation in May 2017 that allows adoption providers to turn away potential parents, including lesbian, gay, bisexual, and transgender families and others, based on the adoption providers’ religious beliefs.
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Informed Consent Conundrum: Making the Complex Concise
New language regarding informed consent in the revised Common Rule seems benign enough at first reading, but actually accomplishing the directives in a scientifically valid manner is a formidable undertaking.
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Finding a Path to Informed Consent for the Addicted
As an opioid epidemic ravages the country, a cutting-edge question on the frontier of neuroscience is: Can addiction be blocked in the brain? Even if it could, the question for IRBs will immediately be: Can an addict give informed consent?
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De-identifying Data in Qualitative Research Is Complex, Time-consuming
One of the more complicated issues social, behavioral, and education research investigators and IRBs might consider involves how to de-identify data for use in qualitative studies.
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IRBs Must Prepare for Studies Involving Transgender Populations
The transgender population has situational vulnerability that should be taken into account when IRBs review studies enrolling these individuals.
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Brain Reanimation Investigator Reports Dramatic Results
Though the findings come with a considerable caveat — they have yet to be published in a peer-reviewed journal — the lead investigator of a controversial brain reanimation study using “living cadavers” is reporting some dramatic results.
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HHS to Take Action to Protect Research Whistleblowers
The Department of Health and Human Services is taking measures to protect whistleblowers who express concern about human research trials, agreeing with a government watchdog report that the current system has a chilling effect due to “fear of reprisal.”
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IRBs Could Address Ethical Issues Related to Tracking Devices
Some IRBs have begun to review studies that use medical devices with tracking technology. These types of mobile devices raise some ethical and regulatory questions.
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The Choice: A Decision to Decline a Clinical Trial
Ten years ago, Rebecca Dresser, MS, JD, faced a life-changing and, quite possibly, life-saving decision. As a bioethicist and IRB member, she was informed of a diagnosis of cancer and offered a difficult choice: She could enter a new clinical trial for treatment, or follow a specific regimen recommended by oncologists on a tumor board.
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IRB Collaborations With Tech Companies Could Mean What to the IRB?
Tech companies increasingly are partnering with research institutions. These partnerships include sharing data and project collaboration. What IRBs will want to know as this trend continues is what it means from a human research protection perspective.