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Research Involving Human Subjects

Retention Rule Number: 
Specific Retention Rule 2011.01
Function/Activity: 
To document the methods, conduct, and/or results of research involving human subjects.
Description/Type of Records: 
Consent forms, protocol documents, risk assessments, applications for regulatory approval, approvals, funding applications, contracts, invoices, staff timesheets, research data, lab certification, procedure manuals, x-rays, electrocardiograms, and medical scans. NOTE: This retention rule DOES NOT apply to records created by the Research Ethics Boards.

Retention Rules

Office of Primary Responsibility (OPR)
Retention
Disposition
Office of Primary Responsibility (OPR): 

Principal Investigator

Office of Primary Responsibility (OPR): 

For research involving human subjects regulated by Health Canada:

Retention: 

25 years from date project is closed.

Disposition: 

Retain or destroy at the discretion of the principal investigator/University.

Office of Primary Responsibility (OPR): 

For all other research involving human subjects:

Retention: 

5 years from date project is closed or in accordance with the terms and conditions of the research agreement or funding agency.

Disposition: 

Retain or destroy at the discretion of the principal investigator/University or in accordance with the terms and conditions of the research agreement or funding agency.

NOTE:  A clinical study is considered to be closed when the principal investigator determines that the study has ended AND the Research Ethics Board has issued notice that the project has been closed.

NOTE:  The principal investigator must retain financial records for personal/professional accounting purposes.  The University maintains and retains the financial records necessary for institutional reporting/auditing purposes and to meet retention requirements under the Income Tax Act.