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Research Ethics Board Policy
Approved by Senate June 2005

Preamble

The St. Thomas University endorses the principles set out in the Tri-Council Policy Statement "Ethical Conduct for Research Involving Humans" and this document describes how STU will apply Tri-Council policy.

Research is an essential component of the mission of St. Thomas University and some of this research involves studying human participants. The University has a responsibility to engage in research advancing human knowledge. The use of human beings in the conduct of research confers responsibilities to the investigator(s). It is also the responsibility of the University to promote ethical research.

This policy is intended to ensure that the highest ethical standards in the conduct of research involving human participants are maintained at the St. Thomas University in compliance with the Tri-Council Policy Statement. These ethical standards include respect for human dignity, respect for free and informed consent, respect for vulnerable persons, provision for privacy and confidentiality (for both subjects and researchers themselves), respect for justice and inclusiveness, balancing harms and benefits, minimizing harm, and maximizing benefit.

Review is available normally only to members of the STU research community, researchers in formal collaboration with STU members, or for research conducted at STU by outsiders. For the purposes of this policy, the term "STU research" will be used to refer to all three categories of research. The term "Research" is understood as involving systematic investigation to establish facts, principles, or generalizable knowledge but not including quality assurance studies, performance reviews or testing within the normal educational requirements.

This policy requires that all research projects involving human participants undertaken by members of the university community -- including all faculty, staff and students, including students carrying out research as part of class assignments -- fall within the jurisdiction of the STU Research Ethics Board, irrespective of the source of financial support (if any) and irrespective of the location of the project, in the latter case so long as the investigator represents the work as STU research. Researchers from outside the community who access resources or participants at STU are also required to undergo review. Review by the Research Ethics Board is also necessary for human remains, cadavers, tissues, biological fluids, etc., taken in routine situations but which are later used for educational purposes.

1.0 Terms of Reference

1.1 Responsibilities:

St. Thomas University Research Ethics Board (REB) is responsible to the President through the Assistant Vice-President Research of St. Thomas University for:

  • developing policies regarding ethical issues relating to the use of human participants in research and experimental teaching protocols;
  • reviewing all protocols requiring the participation of human participants for ethical approval;
  • reviewing annually all policies regarding ethical issues relating to the use of human participants in research projects to ensure that policies remain current;
  • dealing with matters concerned with human-based research referred to the REB by the President of STU;
  • preparing an annual report for submission to the President;
  • participating in continuing education organized by STU research administrators for the University community in matters relating to ethics and the use of human participants

The policies and practices adopted by the STU REB will be consistent with the Tri-Council Policy Statement: "Ethical Conduct for Research Involving Humans" (current version).

1.2 Composition of REB

The REB shall be made up of no less than 6 members, including both men and women, and include:

  • at least one community representative with no formal affiliation with the University
  • a minimum of four university members with broad expertise in the methods or in areas of research covered by the REB in different disciplines.
  • at least one university member with broad knowledge in ethics or experience in the evaluation of ethical implications of research involving human participants.
  • at least one member should be capable of alerting the REB to legal issues and implications in relevant areas of research.
  • An ex officio member from the Senate Research Committee
  • Alternates may be appointed at the discretion of the President. Alternates can be called in to replace members unable to attend or to provide expertise in a specific area.

The balance and composition of the university members on the REB shall be the purview of the President of STU who shall seek advice from the Senate prior to making appointments to the Board.

The REB will have access to a legal expert (other than the University's legal counsel) knowledgeable in the applicable law.

The President shall appoint one member of the REB to serve as Chair for a maximum term of three years.

Board members shall serve for three-year terms, which normally may be renewed once. Appointments can range from one to four years to allow for continuity of membership.

Members will be selected in accordance with Tri-Council Policy.

1.3 Meetings

The REB shall meet regularly to review submissions. In the event of a tie vote, the matter under consideration will be considered not passed.

The REB shall require a quorum of at least the majority of its members (not including alternates) at all meetings concerned with the ethical approval of research proposals. In addition, it is necessary to have at least one community member present and it is necessary to have one member capable of alerting the board to the legal issues.

Meetings are not required in the case of expedited review.

An annual schedule of REB meetings will be published.

1.4 Authority

The University endorses the ethical principles cited in the Tri-Council Policy Statement and has mandated its Research Ethics Board (REB) to ensure that all research investigations involving human participants are in compliance with the Statement.

The STU REB will have jurisdiction over all research involving human participants. All STU research involving human participants will proceed after ethical approval has been granted by the REB or in the case of undergraduate research by the Department (see section 2.7).

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