Human Subject Research. The Provider shall comply with the requirements of CFOP 215-8 for any activity under this Contract involving human subject research within the scope of 45 Code of Federal Regulations (CFR), Part 46, and 00 Xxxxxx Xxxxxx Code (U.S.C.) §§ 289, et seq., and may not commence such activity until review and approval by the Department’s Human Protections Review Committee and a duly constituted Institutional Review Board.
Human Subject Research. The Network Services Provider shall comply with the requirements of CFOP 215-8 for any activity under this Contract involving human subject research within the scope of 45 CFR, Part 46 and 42 U.S.C. § 289, et seq., and may not commence such activity until review and approval by the Department’s Human Protections Review Committee and a duly constituted Institutional Review Board.
Human Subject Research. The Provider shall comply with the requirements of CFOP 215-8 for any activity under this Contract involving human subject research within the scope of 45 CFR, Part 46, and 42 U.S.C. section 289, et seq., and may not commence such activity until review and approval by the Department’s Human Protections Review Committee and a duly constituted Institutional Review Board. A1-17 Coordination of Contracted Services. Section 287.0575, F.S., mandates various duties and responsibilities for certain State agencies and their contracted service providers, and requires the following Florida health and human services agencies to coordinate their monitoring of contracted services: Department of Children and Families, Agency for Persons with Disabilities, Department of Health, Department of Elderly Affairs, and Department of Veterans Affairs, where applicable. In accordance with Section 287.0575(2), F.S., each contract service provider that has more than one contract with one or more of the five Florida health and human services agencies must provide a comprehensive list of their health and human services contracts to their respective Contract Manager(s). The list must include the following information: Name of each contracting State agency and the applicable office or program issuing the contract. Identifying name and number of the contract. Starting and ending date of each contract. Amount of each contract. A brief description of the purpose of the contract and the types of services provided under each contract. Name and contact information of each Contract Manager.
Human Subject Research. UCSF and the Principal Investigators understand that the research covered by the Research Agreement involving human subjects (“Human Subject Research”) requires appropriate documentation, review and approval by UCSF’s Institutional Review Board (the “IRB”) and compliance with all IRB recommendations and requirements. UCSF and the Principal Investigators acknowledge and agree that (a) a copy of each IRB approval relating to Human Subject Research covered by the Research Agreement will be provided to SVI, (b) all clinical studies will be conducted under the supervision of qualified and licensed physicians, (c) all FDA regulations for Human Subject Research will be strictly observed, and (d) no Human Subject Research will be commenced before IRB approval has been granted. UCSF and the Principal Investigators assume full responsibility for any clinical decisions made as a result of data, directly or indirectly, generated during any research covered by the Research Agreement.
Human Subject Research. The Principal Investigator must comply with all Applicable Law related to human subject research, including National Institutes of Health guidelines and obtain written approval from the Sponsoring Institution’s IRB before undertaking any form of human subject research.
Human Subject Research. (Part I, Section 31.0) Protection of Human Subjects Act, 45 CFR, Part 46, Subpart A, Sections 46.101-124 and HIPAA. The Member agrees that prior to the initiation of the research, the Member will submit institutional Review Board (IRB) application material for all research involving human subjects, which is conducted in programs sponsored by the Department or in programs which receive funding from or through the State of Michigan, to the Department’s IRB for review and approval, or the IRB application and approval materials for acceptance of the review of another IRB. All such research must be approved by a Federally assured IRB, but the Department’s IRB can only accept the review and approval of another institution’s IRB under a formally-approved interdepartmental agreement. The manner of the review will be agreed upon between the Department’s IRB Chairperson and the Contractor’s IRB Chairperson or Chief Executive Officer(s).
Human Subject Research. Activities that meet the United States Department of Health and Human Services (DHHS) definition of research set forth in 45 CFR § 46.102(d) and involve human subjects as set forth in 45 CFR § 46.102(f), or activities that meet the United States Food and Drug Administration (FDA) definitions of research/clinical investigation set forth at 21 CFR § 50.3(c) and § 56.102(c) that involve human subjects as set forth at 21 CFR § 50.3(g), § 103(e), § 312.3(b) and § 812.3(p).
Human Subject Research. The Recipient will safeguard the rights and welfare of human subjects participating in Human Subject Research and will ensure that all Human Subject Research is carried out in accordance with: (i) national and local laws and regulations applicable to Human Subject Research; and (ii) International HSR Standards. In the event of any conflict between applicable national laws and International HSR Standards, the Recipient will comply with whichever standard provides the greater protection for research subjects, provided that the Recipient will not be in breach of any applicable national laws. The Recipient will ensure that appropriate terms are included in its agreements with any subcontractors responsible for carrying out Human Subject Research to ensure that the Recipient is able to comply with this obligation. The Recipient will not commence any Human Subject Research prior to being informed by Xxxxxxx that WHO's Research Ethics Review Committee (“WHO ERC”) has either: (i) approved the research protocol or protocols for such Human Subject Research; or (ii) issued a decision waiving the requirement for its approval. Unitaid will bear the cost of any ERC filing fees. The Recipient will ensure that appropriate liability insurance coverage is obtained prior to the commencement of all Human Subject Research and is maintained at all relevant times. Such insurance will conform to all relevant standards and regulations and will be consistent with best practices applicable in the sponsor’s jurisdiction. It will be taken out with a reputable international insurance provider and will cover, as a minimum, claims brought against the sponsor and the principal investigator and will include WHO/Unitaid as an additional insured party. The Recipient will promptly provide Unitaid with written confirmation that such insurance has been taken out, together with a copy of the certificate and policy providing evidence of such insurance, if requested by Unitaid.
Human Subject Research. Yes No Does the project entail research* involving human subjects and/or use of identifiable data? If yes: Has the project been reviewed and approved by the appropriate Institutional Review Board?
Human Subject Research
