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. 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 Agencies - Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council (NSERC), and Social Sciences and Humanities Research Council (SSHRC) (the Agencies) - 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 agree that a new system of governance is 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 Secretariat on Research Ethics (the Secretariat) together provide the new 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); 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.

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.
  

• 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.

• 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;
• provide administrative, substantive and communication support to the Panel by:
  1. managing incoming requests for interpretation of the TCPS;
  2. arranging for expert advice on substantive questions of interpretation, as needed, for the Panel;
  3. issuing and disseminating official interpretations that the Panel develops of the existing TCPS; developing a publicly accessible bank of precedents;
  4. monitoring requests for interpretation over time to identify trends, gaps or difficulties in the TCPS and communicating these to the Panel for action;
  5. communicating the Panel's decisions, as well as highlights of their meetings, to the broader community in an open and transparent manner;
• establish and sustain collaborative relationships with other organizations.

• policy (for example, the scope of included/excluded research, research with Aboriginal communities, qualitative research, and naturalistic observation);
• 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.