REB SOP Development and Maintenance

AC-AER-019
REB SOP Development and Maintenance
DepartmentApplied Educational Research
Creation DateMay 10, 2011
Approval DateMay 10, 2011
Effective DateMay 10, 2011

Organizational Scope

This policy pertains to all staff, faculty, students or external persons intending to participate in or carry out research at and/or in collaboration with the Michener Institute.

Purpose

The purpose of this policy is to describe the processes associated with the development and maintenance of REB Standard Operating Procedures (SOPs).

Definitions

Policy:  a statement outlining specific decision-making directions that must be taken for a given circumstance in accordance with applicable laws, rules, regulations, and/or guidance.  (Authoritatively directive in nature using words like “will” or “must”)

Procedure: a statement that outlines specific steps for a certain task related activity.

SOP: Standard Operating Procedures-processes established for everyday operation, including a written set of instructions for a particular task.*

Terms of Reference: Rules or mandate under which the REB conducts its functions.

*Michener uses a Policy and Procedure framework; SOPs are standard in the Research Ethics Industry.  For Michener research purposes, SOPs and Policies and Procedures will be considered one in the same.

IRRC: The Institutional Research Review Committee is a multi-disciplinary committee that provides guidance for research and data related activities managed by the department of Applied Educational Research.

AER Document Catalogue: list of all proposed, draft, approved documents affiliated with the department of Applied Educational Research (AER)

Policy

The REB is committed to promoting participant protection and ethical conduct for all research endeavours carried out at The Michener Institute.  SOPs provide the necessary structural framework that defines process in line with all applicable guidance and regulations for all research carried out at Michener.  SOPs are written in a consistent uniform format for ease of comprehension and application.

Responsibility:

This policy applies to members of the REB, Research Office and/or administration, Institutional Research Review Committee and Academic Approval Committee.

2.0  Procedures

2.1        Development, Review, Revision and Approval of SOPs

2.1.1      In accordance with maintaining compliance with all relevant regulations and guidelines existing SOPs will be reviewed for completeness (at least every 3 years) and/or new SOPs will be created;

2.1.2      Amended/Revised/Created SOPs may occur due to:

  1. Changes in regulation/guidance;
  2. In order to line up with organisational directives;

iii.   Change of administrative practices;

  1. To address errors;
  2. To fill a need not previously addressed;

2.1.3      The most qualified AER member or designate will make the required adjustments to the SOP(s) in question and/or create the required SOP(s) necessary;

2.1.4      The most qualified AER member or designate will assign the SOP(s) an appropriate version code and log the SOP(s) in the AER Document Catalogue;

2.1.5      Version codes will follow the following format:

  1. All draft versions will start with a “1” after the “.”and will increase in succession for each draft version (i.e. 2.1, 2.2, 2.4,……)
  2. Final approved versions will be denoted by a “0” after the “.” (For instance, a final version code for the draft versions listed in 7.1.4i would be “2.0”)

iii.   The official SOP at any time will be the highest valued number ending in “0”.  (i.e. For SOP’s with versions 1.0, 2.0, 3.0, 4.0, 5.5-verison 4.0 would be the official SOP even though it is clear  that the SOP is currently under revision with version 5.5);

2.1.6      SOPs that have been amended and/or created will be circulated and reviewed by the IRRC for review and comment;

2.1.7      The most qualified AER member or designate will answer any questions pertaining to the SOP(s) that IRRC may pose;

2.1.8      The most qualified AER member or designate will make any necessary changes to the SOP(s) required by IRRC;

2.1.9      Once the SOP(s) has been approved by the IRRC it will be dated and its version code adjusted;

2.1.10   For major revisions (content revisions not errors of grammar or type), a revision summary will be completed and added to the appendix of the SOP;

2.1.11   SOPs will be appropriately labeled in accordance with Michener Policy;

2.1.12   Current and past SOPs will be archived and available for review if required.

2.2         Distribution and Dissemination of New and Amended SOP’s

2.2.1    The most qualified AER member or designate will disseminate information regarding new or majorly revised SOPs as soon as they are approved;

2.2.2      All staff, faculty, students or external persons intending to participate in or carry out research at and/or in collaboration with the Michener Institute will have access to SOPs and will be informed about relevant changes;

2.2.3      REB members and AER staff will be educated on AER SOPs;

2.2.4      AER will maintain records of SOP training;

2.2.5      Approved SOPs will be uploaded to www.michener.ca and my.michener.ca in a timely fashion.

2.3         Forms, Checklists, Templates and Worksheets

2.3.1      Official forms, checklists, templates and worksheets will be evaluated every 3 years;

2.3.2      Major content amendments or newly created forms will be approved via the same process as SOPs through the IRRC;

2.3.3      Official forms checklists, templates and worksheets will be version coded, distributed and disseminated in the same way as SOPs;

2.3.4      Unofficial forms, checklists, templates and worksheets will be evaluated on an as needed basis, amended accordingly and need not be vetted through IRRC.

 

3.0  References

  1. Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Chapter 6.

http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

  1. ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996. Section 3.2, 3.3, 3.4.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

  1. World Health Organization (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011. Standards 6, 9 http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf
  1. Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT)   4.1.

Associated Documentation

Policy:  Training and Education of REB members and Research Office Staff