REB Authority and Purpose

AC-AER-032
REB Authority and Purpose
DepartmentApplied Educational Research
Creation DateAugust 15, 2011
Approval DateAugust 15, 2011
Effective DateAugust 15, 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: define the purpose of the REB; the institutional authority under which the REB may be established and given power; and, the principles under which REB decision-making will be guided.

Policy

3.1         Purpose of the REB

The REB is charged with protecting the rights and welfare of human subjects participating in research at The Michener Institute.  The REB will make sure that all research studies carried out at the Michener Institute meet current scientific, regulatory and ethical standards for the protection of human research participants including but not limited to:

  1. The Tri-Council Policy Statement (TCPS 2): Ethical Conduct for Research Involving Humans, 2010;
  2. The International Conference on Harmonization Good Clinical Practice: Consolidated Guidelines;
  • The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects;
  1. Health Canada Food and Drug Act; and,
  2. Where applicable, any other regulations or guidelines of relevance.

3.2         Institutional Authority

The Michener institute shall establish or appoint another REB empowered under the authority of the Board of Governors (see Policy:  Use of another REB as Board of Record) to review the ethical acceptability of all research involving human participants or human biological materials.

3.3         Core Principles

The REB is guided by the three core principles outlined in the TCPS2:

  1. Respect for persons
  2. Concern for Welfare
  • Justice

3.4         REB Authority

3.4.1      The REB has the authority to ensure that all research being conducted at the Michener Institute is done in such a way as to protect the rights and welfare of participants.  The REB has the authority to:

  1. Approve, reject/disapprove, monitor, propose modifications to, suspend or terminate any research involving human subjects conducted within or by faculty or students o the institution;
  2. Conduct continuing ethical review;
  • Delegate another REB as board of record for a given study (see Policy: Use of another REB as Board of Record).

Responsibility:

This Policy applies to the Chair, investigators, members of the Research Office and/or administration, and REB.

4.0 References

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

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.

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

  1. The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. http://www.wma.net/en/30publications/10policies/b3/index.html
  2. Health Canada (Division 5, Part C) Food and Drug Act 2001.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/consultation/clini-rev-exam/ctrf_dd_eccr_dt_2007-03-26-eng.php

Associated Documentation

Policy:  Use of another REB as Board of Record