RES-0700 Research Ethics: Regulatory approval

Description	Consists of all records required for compliance with Canadian and international laws and regulations regarding research involving human subjects.  Some research projects involve U.S. research funding bodies and are subject to U.S. Federal Regulations regarding research involving human subjects. Records include assurances submitted to Health and Human Services, evaluations and approvals of assurances, certifications of research projects under approved assurances, related correspondence, and registration of Internal Review Board.  Records of Internal Review Board as required by the Regulation include Research Ethics Board records series: RES-0600 Research Ethics Board: Meetings and Decisions, RES-0610 Research Ethics Board: Membership and Training, RES-0620 Research Ethics Board: Review, Approval and Ongoing Monitoring, RES-0630 Research Ethics Board: Adverse Events and Non-compliance.
Retention Trigger	End of REB oversight of project and completion of project
Retention	Trigger + 7 years
Responsible Unit(s)	Research Services
Source
Records System	Romeo; paper
Citations	45 CFR part 46 HHS Regulations for the Protection of Human Subjects s. 46.115 21 CFR part 50 FDA Regulations for the Protection of Human Subjects
Record Authority	VP Research Innovation and International
Disposition	Secure destruction
Records Arising from Activity
Retention Rationale	U.S. Federal Regulation requires records to be retained for at least 3 years, or 3 years following the completion of the research.
Personal Information	No
Vital Record	No
Protection	Medium