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Terms of Reference

Governance Structure for the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

Terms of Reference (2001 to 2011, as revised 2002, 2005, 2008 and 2009)

A partnership between three federal research Agencies (CIHR, NSERC and SSHRC)

1. Context
2. Role and Constitution of the New Governance Structure
3. General Comments
4. Interagency Advisory Panel on Research Ethics
   1. Mandate
   2. Membership
   3. Reporting Structure
   4. Meetings
5. Interagency Secretariat on Research Ethics
   1. Mandate
   2. Reporting Structure
6. Activities of the Panel and Secretariat on Research Ethics
7. Relationships With Other National Organizations
8. Objectives and Expected Outcomes

I. CONTEXT

The Presidents of the three federal research agencies (the Agencies) -- Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council (NSERC) and Social Sciences and Humanities Research Council (SSHRC) -- requested the creation of a new governance structure to support the continued development, evolution, interpretation and implementation of the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS). The objective is to ensure stewardship by the Agencies for the governance of the research ethics policies and practices of the institutions receiving Agency funding. The Agencies agreed that a new system of governance was required to address this need.

II. ROLE AND CONSTITUTION OF THE NEW GOVERNANCE STRUCTURE

The Interagency Advisory Panel on Research Ethics (the Panel) and the Interagency Secretariat on Research Ethics (the Secretariat) together provide the governance structure for the TCPS.

The Panel, supported by the Secretariat, ensures a coherent response to the needs and expectations of the researchers, research institutions and research ethics boards (REBs). It recognizes the diversity of approaches used in research involving humans; and helps promote the protection of human participants.

The Panel and the Secretariat advise the Presidents of the Agencies on the development, evolution, interpretation and implementation of the TCPS; they do not function as an appeal body regarding individual research ethics board (REB) decisions nor as an accreditation organization. None of them acts as an overseeing body of the actual implementation of the TCPS by institutions.

III. GENERAL COMMENTS

The Panel and the Secretariat facilitate and coordinate the evolution of the TCPS as well as its use in all research institutions receiving Agency funding. Recognizing the breadth of research activities and environments, the Panel and the Secretariat consult and collaborate with other organizations, such as governmental and non-governmental organizations and professional associations.

In carrying out their mandate, the Panel and the Secretariat are committed to openness and transparency.

IV. INTERAGENCY ADVISORY PANEL ON RESEARCH ETHICS

As a new structure to address evolving interagency needs in the ethics of research involving humans, the Panel functions as an interdisciplinary and pluralistic advisory body. It is to provide the Agencies with independent reflection and advice on research ethics policy of the TCPS.

A) Mandate

The mandate of the Panel is to:

• promote high ethical standards of conduct in research involving humans;
• advise the Agencies on the ongoing development and evolution of the TCPS;
• establish or commission ad hoc expert groups to address specific issues;
• provide interpretations of the TCPS for its implementation and use;
• learn from and respond to evolutions in research ethics issues and practices in a national and international context;
• promote and support the implementation of the TCPS;
• identify educational activities and mandate the Secretariat to promote and coordinate them;
• participate in the ongoing national discussion regarding the development of an oversight system for the ethics review processes;
• recognize the diversity of approaches used in research involving humans;
• report annually on its activities to the Presidents of the Agencies.

B) Membership

In addition to representing the regions of Canada, as well as gender, the Panel's membership provides:

• a balanced representation of researchers in biomedical and health sciences, social sciences and humanities, and those in the natural science and engineering fields undertaking research involving humans;
• expertise or experience in ethics, law, REB operations and research administration at an institutional level;
• representation from the community and/or research participants.

The Panel could include members of the Agencies' governing councils or standing committees.

The Panel has 12 members, in addition to the Executive Director of the Secretariat, who is an ex officio member (without voting rights). Observers may also be invited to participate in the meetings.

All members are volunteers. They do not receive honoraria in compensation for their contribution of expertise and time, though the Secretariat covers their expenses (such as travel and accommodation).

The Presidents of the three Agencies appoint the Panel members. Initial appointments are for a period of three years, with the possibility of extension for one to three years for a total six-year term. The appointments are staggered to provide flexibility and continuity.

The Chair of the Panel is also appointed by the three Presidents. The initial term of appointment is for two years with the possibility of one or more extensions.

C) Reporting Structure

The Panel reports to the Presidents of the Agencies, providing recommendations regarding the TCPS. The Presidents then determine the appropriate action to be taken.

D) Meetings

The Panel will usually meet at least twice each year, communicating further in person or by teleconference as required. The Executive Director and staff of the Secretariat participate in the meetings.

V. INTERAGENCY SECRETARIAT ON RESEARCH ETHICS

As an integral part of the governance structure for the TCPS and to address evolving interagency needs in the ethics of research involving humans, the Secretariat functions as an administrative and supporting body to both the Agencies and the Panel.

The roles and functions of the Secretariat towards the Panel and the Agencies, respectively, are the following:

A) Mandate

The mandate of the Secretariat with respect to both the Panel and Agencies is to:

• promote high ethical standards of conduct in research involving humans;
• learn from and respond to evolutions in research ethics issues and practices, in a national and international context;
• provide interpretations, as requested, of the existing TCPS for its implementation and use;
• recognize the diversity of approaches used in research involving humans;
• foster awareness and understanding of research ethics issues among researchers, research institutions, members of REBs, and the public;
• participate in the ongoing national discussion regarding the development of an oversight system for ethics review practices;
• promote and coordinate educational activities related to the implementation of the TCPS; identify concerns or issues that may arise as part of these activities and inform the Interagency Advisory Panel on Research Ethics should these issues warrant any modification or clarification of the TCPS;
• establish and sustain collaborative relationships with other organizations.

The Secretariat provides administrative, substantive and communication support to the Panel by:

• managing incoming requests for interpretation of the TCPS;
• arranging for expert advice on substantive questions of interpretation, as needed, for the Panel;
• issuing and disseminating official interpretations that the Panel develops of the existing TCPS to develop a publicly accessible bank of precedents;
• monitoring requests for interpretation over time to identify trends, gaps or difficulties in the TCPS and communicating these to the Panel for action;
• coordinating and supporting the Panel's, and its committees', meetings, communicating the Panel's decisions and highlights of their meetings, to the broader community in an open and transparent manner.

The Secretariat provides technical assistance and advice to the Agencies by:

• coordinating the institutional research ethics policy review process in the context of the eligibility process defined under the Memorandum of Understanding on Roles and Responsibilities in the Management of Federal Grants and Awards ¹ (MOU);
• assessing adherence of written institutional research ethics policies submitted to the Agencies and reports exclusively to the Agencies on TCPS adherence; the Agencies alone determine the eligibility of institutions;
• working in a collaborative and formative manner with institutions to ensure that institutional written research ethics policies meet the Agencies' expectations;
• providing technical and policy advice to the Agencies related to the implementation and application of the TCPS in institutions or organizations eligible to receive or administer federal research funds;
• coordinating and supports the meetings of the Interagency Management Committee and the Steering Committee.

B) Reporting Structure

The Executive Director of the Secretariat reports to the Interagency Advisory Panel on Research Ethics through its Chair primarily on policy matters, and to an Interagency Management Committee (IMC) primarily on interagency administrative and operational matters. The Secretariat reports exclusively to the Agencies regarding adherence of written institutional research ethics policies to the TCPS and its activities not under the jurisdiction of the Panel.

The IMC is composed of the Vice-President of Corporate Affairs of CIHR, the Corporate Secretary of NSERC, and the Executive Vice-President of SSHRC. The membership of this committee could vary should the Presidents of the Agencies wish to designate other senior executives and agree on such a modification.

The IMC provides administrative oversight and facilitates the interagency operations of the Secretariat. The IMC reports to the Steering Committee, composed of the Agencies' Presidents, on issues and decisions, as appropriate and required.

VI. ACTIVITIES OF THE PANEL AND SECRETARIAT ON RESEARCH ETHICS

The new governance structure went into operation in 2001 to 2002. The activities of the Panel and the Secretariat ensure coherent and comprehensive interaction with researchers, research institutions, REBs, governmental organizations (GOs) and non-governmental organizations (NGOs), as well as with the public, when appropriate, signalling the Agencies' stewardship responsibility for the development, evolution, interpretation and implementation of the TCPS.

The activities of the Panel and the Secretariat follow priorities established in consultation with the Agencies. The list of priorities is updated as appropriate and required.

The Panel and Secretariat's activities are of two main types:

1. policy (for example, the scope of included/excluded research, research with Aboriginal communities, qualitative research, and naturalistic observation);
2. issues related to the use of the TCPS (for example, ongoing monitoring of research, education and support for the academic research community, the need for resources to carry out ethics functions in institutions, and the relationship between the academic and private sectors).

VII. RELATIONSHIPS WITH OTHER NATIONAL ORGANIZATIONS

The Secretariat collaborates with other national organizations, such as the National Council on Ethics in Human Research, the Canadian Association of Research Ethics Boards, the Canadian Association of University Research Administrators, and the Humanities and Social Sciences Federation of Canada, among others.

The Secretariat also has the option to engage in activities through outsourcing, which benefits the process by involving a larger expert constituency in the implementation, use and monitoring of the TCPS. The new governance structure nurtures a climate of mutual learning and ongoing interaction along with the dissemination of information.

VIII. OBJECTIVES AND EXPECTED OUTCOMES

In summary, through their new governance structure, the Agencies:

• manage, coherently and consistently, the development, evolution, interpretation and implementation of the TCPS;
• support and assist researchers, research institutions and REBs;
• rationalize and consolidate human resources, program expenses and operational costs devoted to all matters related to the TCPS.

The new structure serves as a central support for the implementation of the TCPS, as well as for its development, evolution and interpretation. The Panel and Secretariat initiative is intended to contribute to a better governance of research ethics policies and practices in Canada and to enhance public trust in research involving humans undertaken under the auspices of Canadian institutions receiving funding from the Agencies.

The Panel and the Secretariat represent an operational and financial rationalization of the support the Agencies invest in the governance of research ethics policies and practices. It responds to Treasury Board's requirements for result-oriented management of public monies, accountability to the Canadian public, and valuing of Canadian citizens.

The original five-year term of mandate of the Panel and the Secretariat (Nov. 2001 to Nov. 2006) has been extended twice, once by an additional three years (up to November 30, 2009) and again, following an evaluation, by an additional two years (up to November 30, 2011) by which time the structure will be reviewed and possibly revised.

Endnotes:
1. http://www.nserc.gc.ca/institution/mou_e.htm