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Crisis Centre

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