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Unanswered Questions

  • personnel research - protocol review

    Jun 20, 2022 9:29 AM
    Posted in: IRB Forum

    . Here's a question for IRB chairs and direct administrators. How do you approach the review process for your own research protocols? Do you feel it is enough to recuse yourself from the decision process, or do you ask a different IRB to review your ...

  • 2018 Common Rule and FDA regulated studies

    Jun 17, 2022 12:44 PM
    Posted in: IRB Forum

    . Are other institutions reviewing HHS funded FDA regulated studies that meet the HHS definition of being research involving human subjects under the Pre 2018 Common Rule or the 2018 Common Rule?

  • HIPAA authorization for CE ceding to an external/central ...

    Jun 14, 2022 12:59 PM
    Posted in: IRB Forum

    . Hello, I'm curious what requirements other IRBs under a CE have in place regarding HIPAA authorizations when ceding to an external or central IRB, or even in relation to general sponsor template HIPAA language. We currently require a local combined ...

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