REB Continuing Review

AC-AER-011
REB Continuing Review
DepartmentApplied Educational Research
Creation DateJanuary 27, 2011
Approval DateJanuary 27, 2011
Effective DateJanuary 27, 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 process of obtaining continuation of REB approval for ongoing research being carried out at or in collaboration with the Michener Institute.

Definitions

Approval Period: The standard and maximum period of time of approval will be 1 year from date of initial approval.  (The REB reserves the right based on proportionate review, to adjust the approval period).

Ongoing research project: Any project of the following including but not limited to:

  1. Projects where data is still being collected from subjects (included follow-up data after recruitment period has ended);
  2. Projects where data is still being collected from secondary sources (medical records, linked data sets);
  • Projects utilizing human tissue samples where the samples are still being withdrawn from a tissue bank or made available from another research group.

Progress Reports: Written status reports of the research currently underway.

Policy

The REB will review any ongoing research projects at least once per year to determine if approval should be continued.  The criteria for initial approval (see Procedure section 2.1 of Policy: REB Initial Review) must be maintained for continuing approval.

The REB will consider all progress reports and new information in their deliberations for continuing review. 

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.

2.0  Procedures

2.1         REB member selection           

2.1.1      The REB shall be composed of a diverse membership representing both genders; varied cultures/ethnicities and professional competencies;

2.1.2      REB members will be selected based on the needs of the REB and individual qualifications;

2.1.3      REB members may fill a delegated and/or full-board role based on the research needs of The Michener at any given time.

2.2         REB Composition (Full Board)

2.2.1      The REB Chair will monitor the membership composition of the REB;

2.2.2      The REB will be composed primarily of Canadian citizens or permanent residents (as defined under the Immigration and Refugee Protection Act).  In accordance with Article 6.4 of the Tri-Council Policy Statement 2 (TCPS 2), the composition of the REB will consist of at least five (5) members including both men and women of whom:

  • At least two (2) members have broad expertise in research methodology covered by the REB;
  • At least one (1) member who is knowledgeable in ethics;
  • For biomedical research, at least one (1) member who is knowledgeable in the relevant law (advisable but not mandatory for other areas of research);
  • At least one (1) member with no affiliation with the institution will be recruited from the community served by the institution;

2.2.3      The overall membership of the REB will have the collective experience necessary to appropriately review research submissions at The Michener Institute;

2.2.4      The Michener Institute may choose to delegate review(s) to another REB as the board of record (see Policy: Use of another REB as the board of record) where a formal relationship exists between the two institutions.

2.3         REB Chair

2.3.1      The appointment of the REB Chair will be approved by the Board of Directors;

2.3.2      The term of the chair is three (3) years and is renewable;

2.3.3       The Chair of the REB may appoint a Vice-Chair who will assume the duty of the REB Chair in his/her absence;

2.3.4       The Chair appoints REB members.

2.4         REB Members

2.4.1      Board members will represent both Allied Health Care and non-Allied Health Care departments of the Institution, be actively involved in health related research and/or knowledgeable and interested in research ethics;

2.4.2      Board members will serve three (3) years unless agreed otherwise in advance or until the member resigns;

2.4.3      Student members may be appointed for briefer periods;

2.4.4      New members will be nominated by relevant Institutional leaders or selected from the institution and the community by the Chair of the REB.

2.5         Documentation and Publication of REB membership

2.5.1      The Research Office will maintain an updated list of all REB members;

2.5.2      All REB members will be made aware of confidentiality and conflict of interest issues associated with their duties.

2.6         Consultants

2.6.1      On occasion, the REB may seek the advice or invite individuals (ad hoc members) with a particular expertise beyond the combined scope of the group to consult on issues associated with specific studies;

2.6.2      The consultant’s input will be documented;

2.6.3      Consultants will not influence quorum, participate in deliberations of studies, vote or have any decision-making authority.

3.0   References

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

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.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

Associated Documentation

Policy:  Use of another REB as the board of record