REB Reconsiderations/Appeal

AC-AER-016
REB Reconsiderations/Appeal
DepartmentApplied Educational Research
Creation DateMay 19, 2011
Approval DateMay 19, 2011
Effective DateMay 19, 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 reconsiderations and appeals processes for projects suspended, terminated, disapproved/rejected or approved with revisions that investigators feel compromise the feasibility or integrity of the proposed research.

Definitions

Suspension:  The research activity is temporarily stopped for further REB consideration and review.

Termination:  The research activity is permanently stopped.

Disapproved/rejected: The research activity has not been given approval by the Michener REB.

Board of record: Research Ethics Board (REB) that is fully compliant with the TCPS 2 and has been given authority of ethics review and oversight for a particular research study.

Formal relationship: Agreement in writing between The Michener Institute and another REB that allows The Michener to delegate the alternative REB as Board of Record on a study by study basis.

Policy

REB members are responsible for reviewing and reconsidering projects that are suspended, terminated, disapproved/rejected or approved with revisions that investigators feel compromise the feasibility or integrity of the proposed research upon request of the investigator.

In instances where an REB decision is appealed the REB will delegate another REB (see Policy: Use of another REB as the board of record) as the Board of Record for the appeal review of the study.  Delegation will occur with a REB that has a formal relationship with The Michener Institute.

Responsibility:

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

2.0 Procedures

2.1         Reconsideration of REB Decisions

2.1.1      Investigators may request prompt reconsideration of decisions affecting their research projects;

2.1.2      The investigator shall have the opportunity to address the REB but shall not be present for deliberations;

2.1.3      Investigator must provide appropriate justification for reconsideration and address the concerns posed by the REB resulting in the initial decision;

2.1.4      The REB will make every effort to resolve disagreements with investigators through deliberation, consultation or advice;

2.1.5      The REB will reconsider its decision(s) based on all the information provided, concerns addressed and justification provided by the investigator (see Policy: REB Decision Determinations);

2.1.6      The REB will communicate its final decision(s) to investigator (see Policy: Communication with Investigators) within as practicably expeditious time as possible;

2.1.7      The Investigator will have the opportunity to appeal any final decision;

2.1.8      The REB will appropriately document its decisions (see Policy: REB Documentation).

2.2         Appeals of REB Decisions

2.2.1      When an agreement cannot be reached between the REB and the investigator through reconsideration, the investigator and the REB have fully exhausted the reconsideration process and the REB has issued a final decision, the investigator may appeal the REB decision(s);

2.2.2      Investigators wishing to appeal the decision(s) of the REB regarding their study in full or in part will contact the REB in writing and declare their intention to appeal;

2.2.3      The REB Chair will contact an alternative board, having a formal relationship with the Michener REB, and request delegation of that board as Board of Record for an appeal;

2.2.4      Acceptance from the alternate board as appeal board will be formally documented by both the Michener Chair and the alternative board’s Chair;

2.2.5      No member of the Michener REB whose decision is under appeal may sit on the appeal board (alternate board of record);

2.2.6      All official documentation pertaining to the delegation of the alternate board will be kept on file as part of the study file;

2.2.7                      The Michener Research Office will inform the investigator of the delegation and guide the investigator to meeting the necessary submission requirements for the appeal board (alternate board of record);

2.2.8      The Michener Research Office will collaborate with the appeal board (alternate board of record) regarding any study related issues or required documents;

2.2.9      The appeal board may approve, reject/disapprove, monitor, propose modifications to, suspend or terminate the research proposal;

2.2.10   Investigator must provide appropriate justification for requesting an appeal, address the concerns posed by the REB resulting in the initial decision and indicate any breaches to the research ethics review process not supported by current scientific, regulatory and ethical standards for the protection of human research participants;

2.2.11   The appeal board (alternate board of record) with provide fair, reasoned and impartial review that is appropriately documented;

2.2.12   Both the investigator and Michener REB representative shall have the opportunity to address the appeal board (alternate board of record) but shall not be present for deliberations;

2.2.13   Appeal board (alternate board of record) decisions on behalf of the Michener Institute will be final;

2.2.14   The Michener REB will be officially notified by the appeal board (alternate board of record) of the decision in writing;

2.2.15   REB approval does not guarantee agreement of the Michener Institute to allow any research project to be carried out in its facility or with its faculty, students or staff.

 

3.0  References

  1. Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010.  Article 6.18, 6.19, 6.20

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 3.1.2, 3.3.9.

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
  2. Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT)   4.4.7.

Associated Documentation

Policy:  Use of another REB as the board of record

Policy:  REB Decision Determinations

Policy:  REB Communication with Investigators

Policy:  REB Documentation