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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
| Reference and duplicate copies of records are considered transitory and should only be kept as long as necessary and never longer than the retention of the official record. |
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 2022)
Health Canada. Guidance document: Drugs for Clinical Trials Involving Human Subjects GUI-0100 (section 5.12)
Office of Research Ethics, SOP #304: Documentation and Document Management, 2018
UBC Directive: Financial Conflict of Interest (FCOI) in Public Health Service (PHS) Funded Research, 2020
UBC Information Security Standard U1
Date Approved: 20220729, 20250423
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EV+5Y, FR EV=Date superseded or obsolete FR=UA will fully retain records from this series |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EV+5Y, D EV=Date superseded or obsolete |
|
10 |
Financial Conflicts of Interest (FCOI)
Includes records relating to all Public Health Service (PHS) Investigator Disclosures of significant Financial Interest (SFI), responses and reviews of such Disclosures, and actions taken such as FCOI management plans.
|
EV+3Y, D
EV=Close of study and final expenditure report has been submitted |
|
12 |
Financial Conflicts of Interest Training
Includes records of training completion for researchers, such as completion records from the Collaborative Institutional Training Initiative (CITI Program).
|
P
P=Office of research Ethics will permanently retain training records |
|
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 review decisions. This secondary also includes compliance issues. |
CY+15Y, SR (Clinical trials) CY+10Y, SR (All other Human Research) SR=UA will selectively retain research projects |
|
27 |
Complaints
Includes complaints and related correspondence regarding research projects involving human participants.
|
EV=7Y, D
EV=Date complaint and/or inquiry is resolved
|
|
49 |
Research Ethics Boards (REB) Administration
Includes administrative documents such as appointment letters and correspondence related to service on the board, membership lists, and training for REB members.
|
AY+10Y, SR
SR=UA will filly retain membership lists. All other records can be destroyed |
|
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 |
|
|
51 |
Outreach
Outreach training given by the ORE to units, departments, communities, etc. For professional development, see HR4000-48.
|
EV+3Y, D
EV=Date superseded or obsolete
|
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