HiREB Terms of Reference

General:

The Hamilton Integrated Research Ethics Board in Health Sciences (HiREB) is an independent committee acting on behalf of the Faculty of Health Sciences (McMaster University), Hamilton Health Sciences (HHS) and St. Joseph’s Healthcare Hamilton (SJHH). It may also act on behalf of other organizations with which there are appropriate, formalized inter-institutional agreements.

Resources:

To facilitate its activities, the HiREB will be provided with the necessary and sufficient ongoing financial and administrative resources to fulfill its duties.

Duties and Powers:

The Research Ethics Board shall:

  1. Have as its primary mandate the protection of the rights, safety and wellbeing of research participants in all health sciences research studies conducted under the auspices of McMaster University, Hamilton Health Sciences or St Joseph’s Healthcare Hamilton by any member of the staff (including supervised learners).
  1. Act on behalf of other organizations with which there are appropriate, formalized inter-institutional agreements.
  1. Have membership composition and function according to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, ICH Good Clinical Practice and other applicable laws and guidelines.
  1. Review its standing membership regularly to ensure that HiREB has the necessary expertise to carry out its responsibilities.
  1. Provide initial review of submitted research protocols according to established HiREB policies and procedures and in accordance with theTri-Council Policy Statement: Ethical Conduct for Research Involving Humans, ICH Good Clinical Practice, the Health Ethics Guide of the Catholic Health Association of Canada (SJHH only) and other applicable laws and guidelines.
  1. Establish formal agreements with other institutions or organizations to facilitate review and approval of multi-site research projects which have undergone review by another Research Ethics Board.
  1. Establish processes to review and approve minimal risk protocols as defined by the Tri-Council Policy Statement, in addition to minor amendments, progress reports, annual renewals, protocol violations and adverse event reports, as well as study completion reports; subject to confirmation of decisions by the full HiREB.
  1. Consider the missions and values of the organizations when recommending approvals for individual sites.
  1. Provide continuing review of approved research studies in accordance with the Tri-Council Policy Statement, ICH Good Clinical Practice and other applicable laws and guidelines.
  1. Withdraw approval of any research study which fails to meet acceptable ethical and scientific standards or which violates the terms and conditions of HiREB approval.
  1. Liaise with the Associate Dean Research, Faculty of Health Sciences, the Vice-President Research, Hamilton Health Sciences, the Vice-President Research and Academic/Executive Lead Research, St. Joseph’s Healthcare Hamilton, and the office of the Vice-President Research and International Affairs, McMaster University regarding policy initiatives, and with the purpose of achieving uniform standards among the Hospital and University affiliated research ethics boards.
  1. Provide ongoing education on research ethics issues for HiREB members and the research community served by the research ethics board.
  1. Meet at least 9 times a year.

Accountability:

  1. The HiREB recommends research protocols to the Medical Advisory Committees of SJHH and HHS. Approval of research protocols remains the responsibility of the Board of Directors of the HHS and the Board of Trustees of SJHH.
  1. HiREB will report regularly and as required to the individual Boards through the relevant Medical Advisory Committee on decisions and activities of the Integrated Research Ethics Board, and provide annual updates to the relevant governing bodies on substantive issues in terms of policy, process and compliance
  1. At the discretion of the Chair of the HiREB matters of concern and/or significance will be highlighted to the MACs and Boards of HHS and SJHH.

Membership:

  1. Members with expertise in relevant research disciplines, fields and methodologies covered by the board.
  1. Member(s) knowledgeable in ethics.
  2. Lay member(s) having no affiliation with the institutions.
  3. Member(s) knowledgeable in privacy issues.
  4. Member(s) knowledgeable in Canadian laws relevant to the research being reviewed.
  1. Ad hoc members as required (non-voting).
  2. Presidents or delegates of partner institutions (ex officio, non- voting).
  3. A member may abstain from voting in the event a research protocol is inconsistent with the mission and values of a participating organization or the personal values of the member.

December 8, 2011