IRB Advisor – November 1, 2017
November 1, 2017
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Bypassing an IRB Review, Researchers Held Herpes Vaccine Trial on an Island
The human research protection community recently learned of a troubling clinical trial that involved private funding, a U.S. medical college researcher who died this summer, and a study held on a Caribbean island. The clinical trial was for a live attenuated herpes simplex virus-2 vaccine injected in human participants, and it was never reviewed by an IRB.
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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.
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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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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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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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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.