Reviewing IRB definition

Reviewing IRB. The “IRB of record” (including an IRB Organization) to which authority for IRB review and oversight has been ceded by another Participating Institution for an instance of Research under this Agreement.

Reviewing IRB means the IRB that provides the ethical and regulatory review of the research for the Relying Organization.

Reviewing IRB. The Reviewing IRB will review the continuing review/renewal request. Upon completion of the review and approval of the request, the Reviewing IRB will provide the Relying researcher with the approval letter and the approved consent document(s).

Examples of Reviewing IRB in a sentence

• Relying Institution is solely responsible for identifying all ancillary reviews required by applicable regulation or policy in the Reliance Application and must notify Reviewing IRB of the outcome of such reviews prior to final protocol approval.

• Participating Institutions agree that the Reviewing IRB Institution/IRB Organization need not be a HIPAA Covered Entity for purposes of the Reviewing IRB making a waiver or alteration of authorization determination so long as the Reviewing IRB meets the composition and qualification requirements of applicable regulation.

• Promptly notify the Overall PI, Site Investigator(s), and the Relying Institution(s) of its determinations (e.g., exemption) or review decisions regarding the Research (e.g., approval, disapproval, required modifications); of changes in the Research reviewed and approved by the Reviewing IRB after initial approval; and of lapses in IRB approval and any applicable corrective action plans.

• Promptly notify the Reviewing IRB of any specific local requirements and restrictions on use and disclosure of PHI that could prevent the Reviewing IRB from approving a request for waiver of HIPAA authorization with respect to the Relying Institution.

• For clarity, there may be Research for which more than one Reviewing IRB may be selected.

More Definitions of Reviewing IRB

Reviewing IRB. [Reviewing IRB name] Relying Institution: [Relying Institution name]

Reviewing IRB means an IRB that reviews multi-site research on behalf of another institution’s IRB engaged a research study.

Reviewing IRB. Select the IRB based on the primary affiliation of the faculty member supervising this research. Note: For projects that involve UCSD MRI facility, or Rady Children’s Hospital, the UCSD IRB must be the Reviewing IRB regardless of the primary institutional affiliation of the faculty mentor. Only research that does not exceed minimal risk and meets criteria for exempt or expedited review may be reviewed under this agreement.

Reviewing IRB. The selected IRB of record that conducts the ethical review for participating sites of the multi-site study, including initial reviews, modifications, continuing reviews, and reportable events. Lead PI: Responsible for the communication and overall conduct of the study and regulatory compliance. The Lead PI will be submitting the regulatory IRB submissions on behalf of all the sites relying on the reviewing IRB. (Note: The Lead PI may not always be associated with the reviewing IRB, but the Lead PI’s responsibilities nevertheless remain the same.) Relying PI: Responsible for providing the Lead PI with necessary information according to the reviewing IRB’s policies and procedures so the reviewing IRB can conduct an IRB review. The relying PI must know what is also required from their local relying IRB. Relying PI responsibilities Central IRB: IRB of record (also known as the Reviewing IRB) provides the ethical review for all sites participating in more than one multisite study. The sites are usually in a network, consortium or particular program, e.g. NCI’s CIRB. Commercial IRB: Commercial or independent IRBs are contracted agencies that are not affiliated with specific institutions and are paid to conduct reviews of research with human subjects, e.g., Quorum IRB, Ethical and Independent Review (E&I Review), Western IRB (WIRB).

Reviewing IRB. The IRB that conducts the IRB review. Single IRB (sIRB): The IRB of record that has been selected to carry out the IRB review requirements for a multi-site or cooperative research study. The IRB may also act as the Privacy Board for research involving HIPAA.

Reviewing IRB. In consultation as needed with the JPPE Program Director at CGU, the JPPE Program Director at SDSU will review all dissertation research plans of JPPE students and assign those involving human subjects for review, on an alternating basis, to the IRB of either SDSU or CGU.

Reviewing IRB. A term used in Reliance Agreements to identify the party to the agreement that acts as the sIRB in providing IRB review for all sites participating in the conduct of the same multi-site protocol.