REB Decision Determination

AC-AER-012
REB Decision Determination
DepartmentApplied Educational Research
Creation DateFebruary 18, 2011
Approval DateFebruary 18, 2011
Effective DateFebruary 18, 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 types of decisions that the REB may make when reviewing research proposals, amendments and studies subject to continuing review.

Definitions

Delegated Review: The level of REB review assigned to minimal risk research projects.

Delegated reviewers are selected from among the REB membership. (see: TCPS 2-Glossary)

Policy

The REB has the right to approve, reject/disapprove, monitor, propose modifications to, suspend or terminate any research involving human subjects conducted within or by faculty, staff or students of the Institute.

The REB will provide proportionate review for all research protocols and as such, reviews may be delegated or full-board.  For protocols that do not qualify for delegated review, decisions will be made via collective discussion/consensus.  In the absence of achieving consensus, decisions will be made by a majority vote of the members of the REB.

REB members who are in conflict of interest will declare their conflict to the Chair and will leave the room during presentation and deliberation and will recuse themselves from voting.

Responsibility:

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

The members of the REB are responsible for reviewing and approving all research studies carried out at the Michener Institute and assuring they meet current scientific, regulatory and ethical standards for the protection of human research participants.

The REB Chair or designate is responsible for ensuring that the decisions being made by the REB have been appropriately applied and are consistent and clear.

2.0  Procedures

2.1         REB Decisions Categorization

2.1.1      Approval

  1. Acceptable risk/benefit ratio;
  2. Meets current scientific, regulatory and ethical standards;
  • No modifications required.

2.1.2      Approval with modifications

  1. Acceptable risk/benefit ratio;
  2. Meets current scientific, regulatory and ethical standard;,
  • Modifications needed to satisfy approval (modifications may be minor or substantial).
  • Deferral
  • REB defers decision to subsequent meeting for further consideration;
  • Delegated reviewers may defer decision to the Full Board for review;
  • The investigator and/or knowledgeable individual may be asked to attend the meeting and clarify or elaborate upon issues in question.
  • Rejection/Disapproval

i         No acceptable risk/benefit ratio;

  1. Does not meet current scientific, regulatory and ethical standards;
  1. Modification is unlikely to satisfy REB.

2.1.5      Suspend or terminate ethics approval (See Policy:  Suspensions Terminations of REB Approval)

  1. There no longer exists acceptable risk/benefit ratio;
  2. No longer meets current scientific, regulatory and ethical standards;

iii.     Modification is unlikely to satisfy REB;

  1. Unacceptable or unmanageable non-compliance.

2.2         Documentation of REB decisions

2.2.1      Information pertaining to each REB decision for each study submission will be documented (see Policy: REB Documentation) including but not limited to:

  1. Attendance of REB members and others;
  2. Date, time, place of meeting;
  • Decision;
  1. Disputed issues and outcome of any vote;
  2. Basis for disapproving or requiring modifications;
  3. Recusals and/or conflicts of interest;
  • Required modifications;
  • Additional requests for information;
  1. Procedures for reviewing additional information.
  • The REB will notify the investigator in writing (see Policy: REB Communication with Investigators) of its decision to approve, approve with modifications, defer or reject submissions including but not limited to;
  1. New submissions;
  2. Amended submissions;
  • Submissions subject to continuing review;
    • In the case of deferred reviews, the REB will clearly define the reasons for deferring a review to the investigator and any additional information that will be required to review the study submission appropriately;
    • Investigators have the right to request reconsideration of any decision and/or appeal the decision of the REB (see Policy: REB Reconsideration and Appeals).
    • Approval letters will be signed by the Chair of the REB or designate and clearly define the conditions that must be met for continued approval (see Policy: REB Communication with Investigators and Policy: REB Signing Authority).

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

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. http://www.who.int/ethics/publications/research_standards_9789241502948/en/index.html

4. Canadian General Standards Board.  Research ethics oversight of biomedical trials 2010. (DRAFT)

Associated Documentation

Policy: Suspensions/Terminations of REB approval

Policy:  REB Documentation

Policy:  REB Communication with Investigators

Policy:  REB Reconsideration and Appeals

Policy:  REB Signing Authority