REB Member Duties

AC-AER-029
REB Member Duties
DepartmentApplied Educational Research
Creation DateJanuary 6, 2011
Approval DateJanuary 6, 2011
Effective DateJanuary 6, 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 duties of Michener Institute Research Ethics Board (REB) members.

Policy

REB members are required to do their due diligence in protecting the rights and welfare of the participants of research by reviewing potential research submissions for scientific and ethical merit. REB members are required to be knowledgeable in the current scientific, regulatory and ethical standards that govern research process (see Research Code of Conduct).

Responsibility:

This policy applies to the Chair, members of the REB and Research Office

2.0  Procedures

2.1         Attendance

2.1.1      REB members will attend scheduled full-board meetings (see Policy: REB Composition and Management) and any educational events (see Policy:  REB Training and Education of Related Staff);

2.1.2      REB members will attend the entire meeting not just a section of it.

2.2         Term of membership

2.2.1      REB members will commit to a renewable term of three years (see REB Terms of Reference and REB Composition and Management).

2.3         Duties

2.3.1      REB members are required to review all submission material and provide relevant input regarding the submission at the convened meeting;

2.3.2      Community and/or non-scientific Member(s): will provide input regarding community related issues and applications of the proposed research and reflect the perspectives of the participant;

2.3.3      Scientific Member(s): will provide input on the scholarly and scientific merits of the study particularly concerned with methodology;

2.3.5      Member(s) knowledgeable in Law: will provide input regarding legal issues and their implications;

2.3.6      Member(s) knowledgeable in Ethics: will provide input regarding ethical issues and their implications;

2.3.7      Consultants: may be called to provide enhanced understanding and assist in the review of issues that are beyond the scope of the regular REB membership.  Consultants are non-voting members;

2.3.8      REB Chair: In addition to reviewing submissions the Chair is required to:

  • Lead any Full Board meetings;
  • Perform or delegate to another a delegated review;
  • Review studies submitted for continuing review;
  • Suspend the conduct of research if necessary to protect participants or in the event that the Primary Investigator fails to meet the expectations of an investigator carrying out research at the Michener Institute (see Research Code of Conduct);
  • Delegate his/her responsibilities to another qualified individual.

2.3.9      Vice Chair: may be appointed by the Chair to assist or act on behalf of the Chair.

2.4         Primary Reviewer

2.4.1      Primary reviewers will asses submissions in greater detail than the rest of the REB and present their considerations to the rest of the REB during Full Board Meetings, lead the discussion, make recommendations and may be required to review additional materials (investigator responses);

2.4.2      Primary Reviewers who review delegated review will complete a Delegated Review Report and submit it to the Chair via the research office;

2.4.3      Primary reviewers who cannot attend a scheduled meeting will submit their reviews to the Chair via the research office in advance of the scheduled meeting.

2.5         Secondary Reviewer

2.5.1      Will assess submissions in detail, add to the discussion led by the primary reviewer and submit their comments to the primary reviewer and the Chair via the research office;

2.5.2      Secondary reviewers who cannot attend a scheduled meeting will submit their reviews to the Primary Reviewer and the Chair via the research office in advance of the scheduled meeting.

2.6         Continuing Education

2.6.1      All REB members will attend continuing education events and seek out educational opportunities related to research review to attend or participate in.

2.7         Conflicts of Interest

2.7.1      REB members will disclose their conflicts of interest regarding any research submission (see Policy: REB Member Conflict of Interest);

2.7.2      REB members in conflict of interest will recuse themselves of participating in review for the submission in question.

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.

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)

Associated Documentation

Research Code of Conduct

Policy:  REB Composition and Management

Policy:  REB Training and Education of Related Staff

REB Terms of Reference

Policy:  REB Member Conflict of Interest