STANDARD OPERATING PROCEDURES
Research Quality Management
SOP TITLE:
Site Visit for Research Involving Human
Pluripotent Stem Cells
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EFFECTIVE DATE:
May 7, 2013
SUPERSEDES:
July 5, 2011
FILE NUMBER:
RQM SOP #5
APPROVAL SIGNATURE
G. Glavin, Ph.D.
Associate Vice-President (Research & International)
Chair, Human Ethics Resource Committee
Date: ___________________________________
PURPOSE:
To describe the procedures to be followed with respect to site visits/inspections by the RQM
Office for research projects involving the use of human pluripotent stem cells.
GENERAL DESCRIPTION:
The Bannatyne Campus REBs and researcher records are subject to inspection by the RQM
Office to ensure compliance with the Canadian Institutes of Health Research (CIHR)
Guidelines for Human Pluripotent Stem Cell Research.
The internal site visit procedures in place are to be in accordance with, as applicable, Tri-Council
Policy Statement Ethical Conduct for Research Involving Humans 2nd Edition (TCPS 2) the
University of Manitoba policy the Ethics of Research involving Humans and the University of
Manitoba RQM Standard Operating Procedures (SOPs), specifically SOP # 1 for an REB
Administrative Site Visit.
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PROCEDURES:
Communicate with the Researcher by electronic report. Copy Associate Vice-President
(Research), if appropriate.
The RQM Office will schedule a site visit and request evidence that the researcher(s) has
complied with TCPS 2 and CIHR. Such evidence will include, but is not limited to:
1.
evidence that the researcher has applied to and received approval from the CIHR Stem
Cell Oversight Committee (SCOC);
2.
a copy of the appropriate Research Ethics Board (REB) approval;
3.
a copy of the Material Transfer Agreement(s) (MTA); and
4.
evidence of registration with the National Registry of human embryonic stem cell lines.
All recording and reporting by the RQM Office for site visits for research involving human
pluripotent stem cells will follow the RQM SOP # 1 for an REB Administrative Site Visit.
5.
SOP History
SOP
Number
RQM
SOP #5
Effective
Date
05 July
2011
Date
Reviewed
07 May
2013
Revision Summary
Change to Admin/signatory requirements and SOP format,
clarification of the RQM program throughout, update of
resources/links, addition of the SOP history section.
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