REB Suspensions/Terminations of REB Approval

AC-AER-025
REB Suspensions/Terminations of REB Approval
DepartmentApplied Educational Research
Creation DateMay 18, 2011
Approval DateMay 18, 2011
Effective DateMay 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 actions associated with suspension or termination of research that has been previously approved by the REB.

Definitions

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

Termination: The research activity is permanently stopped.

Policy

The Michener REB or delegated board of record (see Policy: Use of another REB as the board of record) has the authority to suspend or terminate REB approval of any research being carried out in part or in full that is not being conducted in accordance with current scientific, regulatory and ethical standards for the protection of human research participants, and/or has been associated with and/or runs the risk of causing serious harm to participants, and/or where there is investigator misconduct and/or the investigator is non-compliant with prescribed REB requirements.

 Responsibility

This policy applies to the Chair, investigators, 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 all information received by the REB during the course of the project meets the accepted standards of the REB or requires further consideration resulting in suspension and/or termination of the project in part or in full.

Procedures

2.1         Investigator/Sponsor Initiated Suspension

2.1.1      An investigator or sponsor may voluntarily suspend or terminate a study;

2.1.2      The REB will be notified immediately if the investigator or sponsor suspends or terminates a study and the rationale for suspension or termination;

2.1.3      The REB will be notified when voluntarily suspended studies are restarted;

2.1.4      The REB reserves the right to suspend or terminate a study that has been voluntarily suspended by an investigator or sponsor.

2.2         Institutional Suspension

2.2.1      The REB may suspend or terminate a research project at any time for the following reasons including but not limited to;

  1. i) The research project is not being carried out in accordance with the approved protocol;
  2. ii) The research project is not being carried out in accordance with REB requirements;

iii)          The research is not being conducted in accordance with current scientific, regulatory and ethical standards for the protection of human research participants;

  1. iv) The research has been associated with and/or runs the risk of causing serious harm to participants;
  2. v) Repeated or deliberate failure to properly obtain and document informed consent;
  3. vi) Repeated or deliberate failure to maintain accurate study records;

vii)         Investigator misconduct (see Research Code of Conduct) and/or investigator non-compliance with prescribed REB requirements;

2.2.2      The REB Chair has the authority to suspend REB approval;

2.2.3      The REB Chair must inform the members of the REB of his/her decision to suspend a previously approved project by the next convened REB meeting;

2.2.4      Only a fully convened REB can collectively decide to terminate a previously approved project;

2.2.5      The investigator will be officially notified by the REB (see Policy: REB Communication with Investigators) of any decisions to suspend or terminate a previously approved project and the rationale for this decision will be documented appropriately (see Policies: REB Documentation; and, REB Decision Determinations);

2.2.6      Suspended or terminated notifications will include:

  1. i) The requirement(s) to suspend or terminate the study;
  2. ii) The rationale for the suspension or termination;

iii)          Any additional requirements mandated by the REB;

2.2.7      The REB will take any appropriate actions required to protect the rights and welfare of research participants enrolled in a suspended or terminated project;

2.2.8      Where appropriate, the REB will inform research participants enrolled in a suspended or terminated project of the suspension or termination, reasons for the suspension or termination and any actions that must be taken to assure the safety of the participants;

2.2.9      REB approval may be reinstated if corrective actions have been taken and the conditions for reinstatement have been satisfactorily met.

 2.3         Reporting Suspensions/Terminations

2.3.1      The REB Chair will report all suspensions or terminations of previously approved projects and the rationale for the suspension or termination to the appropriate Institutional Official and/or any relevant regulatory authorities.

 References

  1. Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Article 6.15, 6.16, 11.9

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 4.12.

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) 4.4.5, 4.4.6.