Institutional Review Board Clause Samples
The Institutional Review Board (IRB) clause establishes the requirement for research involving human subjects to be reviewed and approved by an independent ethics committee. This clause typically outlines the need for researchers to submit study protocols, consent forms, and other relevant materials to the IRB before commencing the study, ensuring that participant rights and welfare are protected. Its core function is to safeguard ethical standards in research, thereby minimizing risks to participants and ensuring compliance with legal and institutional guidelines.
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Institutional Review Board. (IRB): Responsible for review and approval of research protocols involving the participation of human subjects, and Not Human Subjects Research determinations (as needed) in ESTR Application. The IRB classifies the project as Sensitive or non-Sensitive as part of their review.
Institutional Review Board. This study (protocol, ICF and all addenda) will be reviewed and approved by Sterling IRB. The study will not be activated and subjects will not be consented, receive any study products, or participate in any study procedures until the IRB has approved the protocol and the ICF. In addition, the IRB will review the study before any significant change in the protocol is initiated. After each review, the IRB's approval will be documented in a letter to the Investigator and a copy of the IRB approval letter will be forwarded to the Sponsor.
Institutional Review Board. In the event any project or portion thereof funded under this agreement requires the use of human research subjects, the then current IRB project terms, which are available online at ▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇.▇▇▇.▇▇▇/osp/negotiate-agreements/industry-other/t-csra, shall apply and be incorporated herein by reference.
Institutional Review Board. In accordance with US Title 21 Code of Federal Regulations (CFR) 56, the protocol, advertisement, ICF, and other information provided to subjects will be reviewed and approved by the IRB. The Sponsor will supply relevant material for the Investigator (or designee) to submit to the IRB for the protocol’s review and approval. Verification of the IRB unconditional approval of the protocol and the written ICF statement will be transmitted to the Investigator (or designee). The IRB will be informed by the Investigator (or designee) of subsequent protocol amendments and of serious and unexpected AEs. Approval for protocol amendments will be transmitted in writing to the Investigator (or designee). If requested, the Investigator (or designee) will permit audits by the IRB and regulatory inspections by providing direct access to source data/documents. The Investigator (or designee) will provide the IRB with progress reports at appropriate intervals (not to exceed 1 year) and a Study Progress Report following the completion, termination, or discontinuation of the Investigator’s (or designee’s) participation in the study.
Institutional Review Board. [Insert if applicable. Applicable if Subcontract involves the use of human subjects]
Institutional Review Board. Institution represents that the authorized IRB of Institution is registered in accordance with Applicable Laws, and that such registration will be maintained as current throughout the term of this Agreement and each SOW. For each Study, the Institution shall provide to SPONSOR documentation verifying review and approval by the IRB of (i) the information to be provided to potential Subjects of the Study to secure their informed consent, including information about any compensation being provided to Subjects for participation in the Study (“Informed Consent Materials”), (ii) the Protocol, (iii) the Investigator’s Brochure, if any and (iv) amendments to any of the foregoing. The Institution shall ensure that the IRB continues to monitor and review the Study during the term of the applicable Study in accordance with Applicable Laws and in any event at least once per year during the term of the applicable SOW and shall provide to SPONSOR documentation of the IRB’s continuing review contemporaneously therewith. Institution and/or Principal Investigator must notify SPONSOR in writing immediately if IRB approval of a Study is withdrawn.
Institutional Review Board. [Applicable if Subcontract involves the use of human subjects] Institutional Review Board approval must be obtained before any contact with human subjects. All research involving human subjects, or data from or about human subjects, must be conducted in accordance with applicable federal regulations (45 CFR 46 and 21 CFR 50 and 56) and the protocol approved by the IRB. Research activities include contacting Human Subjects, conducting the survey and the collecting and storing of any Human Subject data resulting from this survey. Upon notice of IRB approval, RTI will provide notice to the Subcontractor to commence work. Once this notice is provided to Subcontractor, the Subcontractor may commence with the research activities.
Institutional Review Board. UC shall obtain the approval of its Institutional Review Board (“IRB”) prior to commencing the Research Program and shall ensure that the IRB oversees the conduct of the study. UC shall comply with the directives of the IRB with respect to the Research Program, and shall notify Sponsor to the extent any such directives vary from the Research Program. In the event UC is unable to obtain IRB approval of the Research Program, the parties may terminate this Agreement without further obligation.
Institutional Review Board. 1. All project teams must provide the MLDS Center with an approval from their Institution’s Institutional Review Board (IRB) or a justification why IRB approval is not required.
2. Approval may include a Non-Human Subjects Research exemption waiver.
Institutional Review Board. Institution represents that the authorized IRB of Institution is registered in accordance with Applicable Laws, and that such registration will be maintained as current throughout the term of this Agreement and each SOW. For each Study, the Institution shall provide to SPONSOR documentation verifying review and approval by the IRB of (i) the information to be provided to potential Subjects of the Study to secure their informed consent, including information about any compensation being provided to Subjects for participation in the Study (“Informed Consent Materials”), (ii) the Protocol, (iii) the Investigator’s Brochure and (iv) amendments to any of the foregoing. The Institution shall ensure that the IRB continues to monitor and review the Study during the term of the applicable Study in accordance with Applicable Laws and in any event at least once per year during the term, and shall provide to SPONSOR documentation of the IRB’s continuing review contemporaneously therewith. Institution and Principal Investigator must notify SPONSOR in writing immediately if IRB approval is withdrawn.