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Schedule Number
RA5550
Primary Title
Human Research Ethics Management
Office of Primary Responsibility
UBCV: VP Research & Innovation, Office of Research Ethics; Researchers
UBCO: Office of Research Services
Description
The University requires all research involving human participants conducted by its students, staff, and faculty, on or off-campus, to undergo prior ethics review and clearance through the Office of Research Ethics.
The records include the agendas, minutes, and working papers of the Research Ethics Board, research ethics application files and associated attachments, modifications to the research, results of ethics review, documentation regarding formal and informal appeals of ethics review decisions, reports on adverse events, annual progress reports, and associated correspondence.
Vital: No
PIB: Yes
Authority:
BoG Policy LR2: Research Policy
BoG Policy LR9: Human Research Policy
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2 2018)
Health Canada. Guidance for Records Related to Clinical Trials Guide 0068
Office of Research Ethics, SOP #304: Documentation and Document Management, 2018
Date Approved: 20220729
Retention Schedule Secondaries
| Secondary No. | Secondary Title, Scope & Content | Retention, Destruction & Disposition |
|
01 |
Policies and Procedures |
EV+5Y, FR EV=Date superseded or obsolete FR=UA will fully retain records from this series |
|
05 |
General |
EV+5Y, D EV=Date superseded or obsolete |
|
15 |
Ethics Review Agreements (With other institutions or organizations) |
EV+10Y, FR EV=Date agreement is no longer in force FR=UA will fully retain records from this series |
|
25 |
Research Projects Submission Materials including approved acknowledged or disapproved. |
CY+15Y, SR (Clinical trials) CY+10Y, SR (All other Human Research) SR=UA will selectively retain research projects |
|
Research Ethics Boards (REB) Includes process and management documents such as terms of reference, governance structure, annual reports, process flowchart as well as board proceedings. |
AY+10Y, FR FR=UA will fully retain records of the Research Ethics Board |
Acronym Key: AY = Academic Year; CY = Calendar Year; D = Destroy; EV = Event; FY = Fiscal Year; FR = Full Retention by University Archives unless otherwise noted; OPR = Office or Department responsible for source of truth records; SO = when superseded or obsolete; SR = Selective Retention by University Archives; UA = University Archives; Y = Year