REB Submission Requirements and Administrative Review

REB Submission Requirements and Administrative Review
DepartmentApplied Educational Research
Creation DateJanuary 4, 2011
Approval DateJanuary 4, 2011
Effective DateJanuary 4, 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.


The purpose of this policy is to describe the requirements for submission to the Research Ethics Board (REB) and the administrative processes carried out by the Research Office pertaining to REB submissions include but not limited to: new research projects submitted for initial review; amendments, modifications and change requests; updated safety information; approval renewal; unanticipated or Adverse Event reporting; and, protocol deviations.


REB members require documentation to review research submissions. This documentation must provide sufficient information to allow reviewer(s) to make a comprehensive assessment.

The Research Office provides the administrative support necessary, via its administrative processes, to ensure REB members have adequate and appropriate resources at their disposal for thoughtful review of REB submissions.


This policy applies to The Chair, members of the Research Office and/or administration.


The Research Office is responsible for maintaining the submission requirements, and for assuring their accessibility for investigators. Instructions to investigators regarding submissions, deadlines, forms, etc., can be found on the website or by contacting the Research Office directly.

2.1         Submission Requirements

2.1.1      The required documents, forms and checklists include but are not limited to:

  • REB Submission Form
    • Toronto Academic Health Science Network (TAHSN) 2010 form for trials that meet the World Health Organization’s definition of a Clinical Trial- “Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effect on health outcomes.”
    • FORM 1 for all other Social Science/Humanities submissions
  • REB Submission Checklist
    • Current Research Protocol
      • Summary or Abstract
      • Background
      • Purpose
      • Hypothesis/Null Hypothesis
      • Justification
      • Objectives
      • Methodology
        • Sample size
        • Statistical Analysis
        • Placebos (justification)
      • Inclusion/Exclusion Criteria
      • Procedures
      • Risks/Benefits/Safety plan
      • Ethical Considerations
      • Dissemination
    • Investigator’s Current Curriculum Vitae
    • Approval of Division/Chair Head
    • Other
      • Data Collection Forms
      • Questionnaires
      • Information Sheets
      • Interview Scripts
      • Participant’s Diaries
      • Data Safety Monitoring Board Charter
  • Informed Consent Form (ICF) Template (FORM 6)
  • ICF Checklist
  • REB Amendment Form (FORM 7)
  • REB Approval Renewal Form (FORM 3)
  • REB End-of-Study Report Form (FORM 9)
  • REB Protocol Deviation Form (FORM 8)
  • REB Serious Adverse Event Form (FORM 4)
  • REB Expedited Review Report Form (FORM2)
  • Focus Group Consent Form (FORM 10)

2.2         Administrative Review:

2.2.1      Upon receipt of submission, the coordinator or designate will log the date of submission, create a project file (if not previously created), add the submission to an existing file (if a file exists) and assess the submission for overall completeness using the Submission Checklist as a guide;

2.2.2      If the submission is incomplete the coordinator or designate will request the missing components from the investigator;

2.2.3      Once the submission is complete the coordinator or designate will assign the submission a unique project identification number (if not previously assigned) and will enter it into the REB database;

2.2.4      A determination of review type (full board or delegated) is made and packages are prepared and distributed to reviewer(s);

2.2.5      All original submission materials are retained in the Research Office.


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

  1. ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996. Section 3.

  1. World Health Organization (WHO). International Clinical Trials Registration Platform (ICTRP).
  2. World Health Organization (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011.
  3. Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT)