REB Initial Review

AC-AER-028
REB Initial Review
DepartmentApplied Educational Research
Creation DateJanuary 5, 2011
Approval DateJanuary 5, 2011
Effective DateJanuary 5, 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 minimum requirements for Research Ethics Board (REB) approval to carry out a research project at the Michener Institute.

Policy

Initial REB approval begins with a complete submission package to the Research Office (see Policy: REB Submission Requirements and Administrative Review). Before REB approval is granted, research involving human participants must meet specific criteria.

Responsibility:

This policy applies to the Chair 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 REB members are adequately educated and trained and/or have the expertise to review submissions appropriately. (see Policy: Training and Education of REB members and Research Office Staff)

2.0 Procedures

2.1         Minimal Criteria for Approval of Research

The REB will review research submissions for scientific and ethical merit.  These elements must exist for a REB approval:

2.1.1      The research being proposed is likely to generate knowledge that is generalizable and lead to improvements in the field of study;

2.1.2      The methodology is rigorous and likely to answer the research question(s);

2.1.3      For interventional studies, a state of clinical equipoise exists;

2.1.4      Risks to participants are minimized (participants are not exposed to unnecessary risk) and reasonable in relation to the anticipated benefits;

2.1.5      Participant selection is equitable;

2.1.6      Additional safeguards are included for the protection of vulnerable populations;

2.1.7      If applicable, community considerations are appropriate;

2.1.8      Recruitment methods are appropriate and respect the privacy of individual participants;

2.1.9      There exist no undue inducements to participation;

2.1.10   Informed Consent will be obtained and appropriately documented;

2.1.11   The Informed Consent Form (ICF) appropriately and adequately explains the research being proposed;

2.1.12   The Informed Consent process is clearly outlined and explained in the submission;

2.1.13   If applicable, there exists a Data Safety Monitoring Plan;

2.1.14   If applicable and to ensure safety, appropriate provisions have been made for routine monitoring of data;

2.1.15   Appropriate provisions have been made for protecting the privacy of participants and the confidentiality of their data;

2.1.16   Timely publication and dissemination of research results is not restricted;

2.1.17   Appropriate provisions have been made for the dissemination of research results;

2.1.18   Resources have committed for the successful completion of the study;

2.1.19   Any potential conflicts of interest have been managed appropriately;

2.1.20   The investigator has the appropriate credentials and qualifications to carry out the research being proposed;

2.1.21   The application has been signed by the principal investigator and supported by his/her Chair/Division Head;

2.1.22   All required regulatory requirements have been met.

2.2         Length of Approval:

2.2.1      Studies will be reviewed at least once per year;

2.2.2      The REB will review research submissions as frequently as required based on the degree of risk attributable to study participation.  Studies of the following type may be reviewed more frequently:

  • Procedures/treatments/agents that have not been previously used in humans;
  • Research where the risks are unknown;
  • There exists more than minimal risk for vulnerable populations with no prospect of direct benefit;
  • The presence of SAE’s;
  • There exist previously confirmed instances of investigator non-compliance;
  • At the discretion of the REB.

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 3, 4.1, 4.8.

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:  REB Submission Requirements and Administrative Review

Policy:  Training and Education of REB members and Research Office Staff