IRB of Record definition

IRB of Record. The IRB that is responsible for the ethical review of human research on behalf of an institution and/or site or individual investigator.
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IRB of Record. A reviewing IRB that assumes IRB responsibilities for another institution and is designated to do so through an approved Federalwide Assurance on file with the federal Office for Human Research Protections.
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IRB of Record. An IRB that assumes IRB responsibilities or oversight for another institution. Also referred to as the Reviewing IRB. Local Research Context: Knowledge of the institution and community environment in which human subjects’ research will be conducted. In order for an IRB to agree to serve as IRB of Record for another institution, it must have adequate knowledge of local context (e.g., state laws, understanding of cultural context).
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Examples of IRB of Record in a sentence

  • INSTRUCTIONS AND INFORMATION This Appendix provides guidance on how to convert the UVA IRB approved consent/assent form(s) into a consent form(s) that is specific to a relying site when the UVA IRB is serving as the IRB of Record for a multisite study.

  • Reviewing IRB may become the IRB of Record for Relying Institution for Covered Research as of the date that this LOI is fully executed.

  • Any data breach will also be reported to the IRB of Record if the report meets the criteria of an Unanticipated Problem.

  • The term IRB of Record is deemed to be synonymous with reviewing IRB.

  • All personnel working on this protocol will follow all Policies and Procedures of: the IRB of Record the METROHEALTH Human Research Protection Program (HRPP SOPS) Provide the Reviewing IRB with: The list of research personnel engaged in the conduct of research.

  • If an audit is performed at the request of the IRB of Record, the Relying Institution will provide a copy of the report of its findings to the IRB of Record.

  • If the HIPAA authorization language will be incorporated into the consent document, the Relying Institution will work with the IRB of Record to provide, as requested, any language specific to the Relying Institution.

  • Promptly (generally, within two (2) business days) notify the IRB of Record after receiving notice that a Relying Institution’s PI(s) or other research personnel involved in the research has been suspended or restricted, and/or after discovering serious or continuing non-compliance or an unanticipated problem that involves risks to subjects or others within the Research.

  • Until the IRB oversight is transferred the IRB of Record will continue to assume oversight responsibility.

  • In the event of termination, each party will continue its obligations as an IRB of Record for ongoing Research until such responsibility is transferred as agreed in writing by the parties.


More Definitions of IRB of Record

IRB of Record. The reviewing IRB that performs a review on behalf of one or more institutions. Relying IRB: The IRB or entity that agrees to rely upon the IRB of Record.
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