IRB of Record Sample Clauses
The "IRB of Record" clause designates a specific Institutional Review Board (IRB) as the primary authority responsible for reviewing and overseeing a research study involving human subjects. In practice, this means that all ethical review, approval, and ongoing monitoring for the study are centralized under one IRB, even if multiple institutions are involved. This arrangement streamlines the review process, reduces duplication of effort, and ensures consistent application of ethical standards across all participating sites, thereby facilitating compliance and protecting research participants.
IRB of Record. An IRB is considered the IRB of record when it assumes IRB responsibilities for another institution and is designated to do so through an approved Assurance with OHRP. A Memorandum of Understanding is required, designating the relationship, for The University of Alabama IRB to serve as the IRB of Record.
IRB of Record. Informed consent must be obtained before the subject takes part in any aspect of the research study unless the IRB has approved a waiver of the requirement to obtain consent. ☐ Principal Investigator ☐ Qualified member(s) of the study team IMPORTANT: Consent should NOT be solicited immediately before beginning an elective procedure or scheduled therapy because the subject will not have time to consider whether to participate or not. When using DocuSign for electronic consent the subject must has access to their own computer, tablet, or smart phone. For security reasons, subjects should not use public or shared devices for signing e-informed consents. ►IF consent must be obtained the same day that study procedures commence, explain why the subject cannot be given more time to decide to consent and what will be done to ensure the potential subject has enough time to make an informed decision. ☐ N/A ☐ IN PERSON WRITTEN Informed Consent (on-site wet ink signature)
IRB of Record. Select the following:
a. Sub‐section A. Yes, UCI will Rely on Another non‐UCI IRB
b. Sub‐section B. Identify the sIRB collaboration – Select “Single Study IRB Agreements” and indicate the Reviewing IRB.
IRB of Record. The IRB of Record will take minutes of its meetings in which an ISR for the Parties is reviewed. A notice of the IRB’s action will be provided to the Parties. • The IRB of Record will document all findings and actions regarding the Parties’ ISR taken outside of convened meetings, and will provide copies of such documentation to the Parties upon request. • The IRB of Record will report any suspension or termination of the Parties’ ISR immediately to the HSC-S, OLHS-NL, and/or Ochsner. • The IRB of Record will report to the Parties any request for audit, investigation or external review of the Parties’ ISR, including by a government regulatory agency. • The IRB of Record will report to the Parties any noncompliance with the federal regulations, as it relates to the Parties’ ISR. Notwithstanding the preceding, the Parties acknowledge and agree that HSC-S and HSC-S Faculty must follow its standard operating procedures (SOPs).
IRB of Record. The IRB responsible for review of research and determining that the research meets IRB regulatory requirements for approval.
IRB of Record. The Institutional Review Board (IRB) responsible for the initial and continuing review and approval of a given research project.