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.

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.

IRB of Record means a reviewing IRB that assumes IRB responsibilities and is designated to do so through an approved Federalwide assurance on file with the federal Office for Human Research Protections.

Examples of IRB of Record in a sentence

• The protocol, addendum, and/or IRB of Record application must describe the data to be disclosed to collaborators, the entities to which the data are to be disclosed, how the data are to be transmitted, and how the transmitted data will be stored, retained, destroyed, and/or further disclosed and to whom.

• The delegation of duties between lead and relying institution and the responsibilities of each party conducting research are outlined in the Reliance Agreement and the research application submitted to the IRB of Record.

• PHI obtained in research for which the IRB of Record has waived the requirements to obtain a HIPAA authorization and a signed informed consent document may not be disclosed outside VA unless the VA facility Privacy Officer ensures and documents VA’s authority to disclose the PHI to another institution.

• The IRB of Record could also be known as the Lead IRB or a single IRB of Record.

• A Single IRB of Record is a term adopted by the Clinical Trials Transformation Initiative (CTTI).

• For these projects, the Florida Department of Health IRB must be the IRB of Record.

• When the research is conducted or supported by any Federal department or agency, the Relying Organizations designate the IRB of Record on its Federalwide Assurance (FWA) with the Federal Office of Human Research Protection (OHRP).

• The borrower's actual principal 2 No commas(,) or dollar 11 balance at the beginning of the signs ($) processing cycle.

• The agreement documents the respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating site relying on the IRB of Record.

• IRB of Record is the lead IRB who will oversee the conduct of research related activities at all research locations.

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.

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).