|Department||Applied Educational Research|
|Creation Date||May 26, 2011|
|Approval Date||May 26, 2011|
|Effective Date||May 26, 2011|
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 affirm the Michener Institute’s commitment to acceptable standards of conduct (see: Research Code of Conduct), describe non-compliance and any actions that the REB may take.
Non-compliance: failure or refusal to comply with accepted standards
Serious non-compliance: non-compliance that adversely affects the rights and welfare of participants or increases participants’ risk of harm
Continuing non-compliance: ongoing pattern of non-compliance
The REB is committed to promoting participant protection and ethical conduct for all research endeavours carried out at The Michener Institute. Investigators are required to comply with current scientific, regulatory and ethical standards for the protection of human research participants and the Michener Research Code of Conduct.
This policy applies to the Chair, investigators, members of the REB, Research Office and/or administration.
2.1.1 Reports of non-compliance should be made to the REB and may come from any source;
2.1.2 Whenever possible, reports of non-compliance should be documented by the source in writing (see Policy: REB Documentation);
2.1.3 Verbal reports will be recorded and documented (see Policy: REB Documentation);
2.1.4 The REB Chair will review all reports and allegations of non-compliance;
2.1.5 The REB Chair reserves the right to convene the REB and/or seek guidance from external experts to review the allegations;
2.1.6 Investigators of non-compliance that is NOT serious and/or NOT continuing will receive guidance from the Research Office and/or the REB to achieve and maintain compliance for their projects;
2.1.7 Actions that may be considered by the REB in response to serious and/or ongoing non-compliance include but are not limited to:
- Modification of the protocol;
- Notification of current participants;
iii. Modification of the informed consent process and/or information given to participants and/or documentation;
- Re-consent of current participants;
- Monitor the consent process;
- More frequent continuing review;
vii. Require or increase monitoring of the study;
viii. Suspend the project;
- Terminate the project.
2.1.8 All correspondence regarding review, determinations and actions associated with non-compliance will be documented (see Policy: REB Documentation);
2.1.9 The REB Chair and/or board will determine what actions should be taken (see Policy: REB Decision Determinations) and communicate these actions to the investigator(s) and/or any applicable institutional and regulatory authority (see Policy: REB Communication with Investigators);
2.1.10 The Investigator(s) may request prompt reconsideration of decisions affecting their research projects (see Policy: REB Reconsideration and Appeals);
2.1.11 The Investigator will have the opportunity to appeal any final decision. (see Policy: REB Reconsideration and Appeals).
- Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010.
- ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996.
- World Health Organization (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011.
- Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT) 4.4.7.