REB Signing Authority

AC-AER-018
REB Signing Authority
DepartmentApplied Educational Research
Creation DateMarch 14, 2011
Approval DateMarch 14, 2011
Effective DateMarch 14, 2011

Organizational Scope

This policy pertains to all staff, faculty, students or external persons intending to participate in research ethics review at and/or in collaboration with the Michener Institute.

Purpose

The purpose of this policy is to describe the nature of REB signing authority, the responsibilities attributed to such authority and the circumstances under which signing authority may be delegated.

Definitions

Authorized Signatory: Person(s) authorized to sign documents on behalf of the REB.

Policy

The REB is accountable for the REB review process and resulting decisions.  To maintain consistence and accountability the Chair of the REB or his/her designate functions as the authorized signatory and assumes all signatory responsibility for official REB related correspondence and documentation.

Responsibility:

This policy applies to the Chair, members of the Research Office and/or administration, and REB.

Answering to the highest body within the institution, the REB Chair will provide overall leadership and oversight for the REB, facilitate the REB review process and assume responsibility for signing all official documents related to REB review.  REB oversight is maintained by the Chair even in instances where he/she has delegated signing authority.

2.0 Procedures

2.1         REB Review, Approval and Official Correspondence

2.1.1      The REB Signing Authority (Chair or designate) will assume signing responsibility for:

  • Results of REB reviews;
  • Actions and decisions made by the REB;
  • Official correspondence with external agencies (regulatory, funding and/or sponsors);
  • Official correspondence with investigators and participants (see Policies: REB Communication with Investigators and REB Communication with Participants).

2.2         Delegation of REB Signing Authority

2.2.1      The REB Signing Authority (Chair) may delegate REB signing authority to a member of the REB or Research Office who has the capacity to assume the responsibilities associated with the role;

2.2.2      When delegating REB signing authority the Chair will clearly define the associated limitations;

2.2.3      Delegation of signing authority will be documented;

2.2.4      The REB Singing Authority (Chair) may not delegate signing authority to consultants or independent contractors;

2.2.5     The REB Signing Authority (Chair) may delegate signing authority for other correspondence such as letters, memos, and emails, between the REB, Research Office and/or Investigators that do not grant or imply the granting of approval to the appropriate Research Office staff member(s).

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

Policy: REB Communications-Research Staff

Policy: REB Communications with Participants