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Research Building Blocks: Retention of Research Data

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Data Retention Requirements & Responsibilities

All data and records related to research must be retained for a specific period of time after project completion. The timeframe requirements vary based upon Institutional, Governmental, and Publisher's policies. UHN approved research protocols will define the researcher's responsibilities with respect to the storage and retention of research data for this Institution. Data sharing is permitted provided the integrity and reliability of the data is maintained and that safeguards are established to protect the privacy and confidentiality of health information.   

Research Data, as defined in UHN Policy 40.50.004:

"is the factual records used as primary sources for research, and that are commonly accepted in the research community as necessary to validate research findings. Virtually all types of digital information or hardcopy media have the potential to be research data, if they are being used as a primary resource for research. Research data are not intellectual property, and thus cannot be patented or copyrighted. Research data include, but are not limited to, original documents, data, and records (e.g. hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial)."

UHN Retention Requirements

UHN's Data Ownership, Stewardship & Security of Health Information research policy indicates that UHN researchers are responsible for the storage and retention of research data for a minimum of 10 years after the research project ends. Extended timeframes may be required if stipulated by specific funding or regulatory agencies, publishing journals, the terms of a research agreement, intellectual property rights requirements, or as specified by UHN in the event of a research misconduct allegation. 

The policy also provides an itemized list of specific researcher responsibilities, including the requirement that researchers work with de-identified personal health or other confidential information, except when identifiable data is absolutely required. The privacy and confidentiality of personal information is mandated by the UHN Privacy Policy.      

At the end of the required retention period the research data should be destroyed in accordance with the Storage, Transport & Destruction of Confidential Information administrative policy.

Government of Canada Regulations

TCPS 2 (2018) is the latest edition of the Canadian Government's publication entitled TRI-Council Policy Statement: Ethical Conduct for Research Involving Humans. This document provides extensive details relating to research ethics and policies which must be followed when conducting human research. Informed Consent must be obtained from participants when conducting human research.  However, research that relies only on secondary use of non-identifiable information does not require consent (Chapter 5 - Privacy and Confidentiality).  

Safeguarding of Information: Researchers must clearly state to Research Ethics Board (REB) the details regarding their planned safeguarding of information throughout the entire life cycle of the research, including its retention and/or disposal.  TCPS 2 does not specify a data retention time period as it will vary depending on the research discipline, research purpose and the kind of data involved.  

Clinical Trials: With respect to Canadian clinical trials involving drug, device, or natural health product studies regulated by Health Canada, the current law indicates a duty to preserve data for up to 25 years (Refer to the "Records Section, C.05.012 Item 4" in Health Canada's “Regulations Amending the Food and Drug Regulations” (1024 - Clinical Trials).