Management Control Framework for Research Ethics Activities

June 2009

Table of Contents

Executive Summary

Introduction

The Internal Audit of the Management Control Framework for Research Ethics Activities is part of the Risk-Based Annual Internal Audit Plan 2008-2009 approved by the Canadian Institutes of Health Research (CIHR) Governing Council (GC).

CIHR's Overall Mandate and Organization
The mandate of CIHR is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products, and a strengthened Canadian health-care system. To accomplish this, CIHR provides a range of programs and activities designed to support outstanding research - both open research (investigator-initiated) and strategic - to build health research capacity and to promote knowledge translation. CIHR funds more than 11,000 health researchers and trainees in universities, teaching hospitals, and other health organizations and research centres across the country.

CIHR integrates research through an interdisciplinary structure composed of 13 "virtual" Institutes. The Institutes are not buildings or research centres, but networks of researchers brought together to focus on important health problems. Each Institute is led by a Scientific Director (SD), who is aided in turn by an Advisory Board. SDs and Advisory Boards work under the guidance of GC. Chaired by the CIHR President, GC is responsible for the management of CIHR, including developing its strategic directions, goals, and policies; evaluating its overall performance, including the achievement of its objective; and approving its budget.

Mandate for Research Ethics
According to the CIHR Act, CIHR's mandate includes the following responsibilities related to research ethics:

  • Promoting, assisting, and undertaking research that meets the highest international scientific standards of excellence and ethics and that pertains to all aspects of health, including bio-medical research, clinical research and research respecting health systems, health services, health of populations, societal and cultural dimensions of health, and environmental influences on health;
  • Fostering the discussion of ethical issues and the application of ethical principles to health research; and
  • Monitoring, analyzing, and evaluating issues, including ethical issues, pertaining to health or health research.

Governance for Research Ethics
There are two Standing Committees that assist GC in the ethics-related aspects of CIHR's mandate. The Standing Committee on Ethics (SCE)1 has a mandate to identify for GC emerging ethical issues of strategic relevance with respect to health and health research, and to provide GC with strategic advice on the ethical, legal, and socio-cultural dimensions of CIHR's mandate, at its own initiative or at the request of GC or the President, with specific regard to:

  • the exercise of ethics leadership;
  • the development of ethically sound policies in health research;
  • the development of the highest standards of ethics for CIHR and CIHR-funded research;
  • the advancement of ethics research and training; and
  • the linking and benchmarking of CIHR's ethics activities to community standards and national and international organizations, standards, and developments, to ensure that CIHR is at the forefront of excellence in these areas.

The Stem Cell Oversight Committee's (SCOC) role is to review research funding applications dealing with human pluripotent stem cells and other ethically sensitive human stem cell research to ensure that they are in accordance with CIHR's Stem Cell Guidelines.2 SCOC also reviews the Guidelines and updates them as the science and related public discourse evolve.

The Ethics Office (EO)
The Ethics Office (EO) is the focal point for realizing the ethics mandate at CIHR. EO plays an especially important role in the following areas:

  • Ethics in Research: EO is responsible for developing and implementing policies and guidelines to fulfill the ethical and legal responsibilities that CIHR holds as a research sponsor. EO works with SDs; Institute Advisory Board Ethics Designates (IABEDs), who advise the Institutes on ethical matters; SCE; and other key partners in order to ensure the highest ethical standards are met across the organization. EO also coordinates working groups and task forces, holds public consultations, and leads new policy initiatives in priority areas.
  • Funding Opportunities in Ethics: EO works with the Research and Knowledge Translation and Major Initiatives portfolios to build capacity in ethics; support the development and coordination of strategic initiatives; and fund research on ethics.
  • Ethics Advice on Public Policy and Legislation Development: EO coordinates CIHR's involvement in developing or influencing public policy and legislation in priority areas.

Research Integrity Committee (RIC)
EO serves as the secretariat to CIHR's Research Integrity Committee (RIC), which includes a Chair who is external to CIHR and is appointed under the authority of the President. RIC is mandated to receive and consider allegations of non-compliance with CIHR research policies; and recommend action consistent with the CIHR Procedure for Addressing Allegations of Non-Compliance with Research Policies, including taking steps, if appropriate, to effect a resolution or remediation.

Risk Addressed by the Audit

The audit addresses the risk that the management control framework does not support the achievement of CIHR's mandate for research ethics. This risk is related to the Governance and Strategic Directions, Policy and Programs, and Accountability elements of the Treasury Board Secretariat's (TBS) Management Accountability Framework.3

Objective

The audit objective is to assess the adequacy of CIHR's management control framework for its research ethics activities.

Scope

The audit encompasses governance; planning and organization; management; and accountability reporting related to CIHR's mandate for research ethics.

Overall Audit Opinion

The audit has concluded that the management control framework for research ethics activities has moderate issues: there are control weaknesses, but overall risk exposure is limited because either the likelihood or the impact of the risk is not high.

Statementof Assurance

In my professional judgement as Chief Audit Executive, sufficient and appropriate audit procedures have been conducted and evidence gathered to support the accuracy of the opinion provided in this report. The audit of the management control framework for research ethics activities was conducted in accordance with the Federal Government Policy on Internal Audit and related professional standards. The audit opinion is based on a comparison of conditions that existed at the time of the audit against established audit criteria that were agreed upon with management. The evidence is sufficient to provide senior management with proof of the opinion.

Summary of Internal Control Strengths

CIHR has implemented the following key elements of the management control framework for research ethics:

  • CIHR has appointed the Director, Ethics Office as a full-time, executive-level position reporting functionally to the CIHR President and administratively to the Executive Vice-President (EVP), Corporate Affairs. The Director is responsible for leading and developing a team that undertakes and advises on CIHR activities aimed at promoting ethics in research, research in ethics, and integrity in health research, as well as contributing to the development of health and health research-related public policy from an ethics perspective.
  • EO provides training and information to staff and other stakeholders to ensure that research ethics responsibilities are understood and followed and that necessary skills are learned and employed. EO organizes Brown Bag lunches on a regular basis, at which experts present research ethics-related topics to CIHR staff and interested external partners. EO participates in the monthly University Delegates teleconference and provides the group with important updates related to ethics. Members of EO, in collaboration with the Program Planning and Process branch of the Research Portfolio, deliver semi-annual training sessions to CIHR staff on research ethics-related aspects of CIHR funding policies.
  • CIHR communicates its mandate for research ethics through its internet site: About Ethics at CIHR, The Ethics Office, Grants and Awards Guide (GAG), and the Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards (MOU). The GAG contains funding policies for research, including ethics-related requirements. The MOU is drawn between CIHR and the institution administering the funds given by CIHR to grants and awards holders. It spells out the responsibilities of CIHR, grants and awards holders, and the host institution. The institution's responsibility includes compliance with ethical standards, specifically for Research Involving Humans, Research Involving Animals, Integrity in Research and Scholarship, Conflicts of Interest, and Investigation and Resolution of Breaches of Agency Policies.
  • EO regularly communicates with key stakeholders (SCE, Scientific Council (SC), researchers, SDs, IABEDs, and staff) regarding new and emerging ethics issues as identified through the Preliminary Review on Bio-Ethics (PROBE) process, which is used to identify strategic priorities. SC is mandated by GC to develop, implement, and report on CIHR's research and knowledge translation strategy, in accordance with the CIHR Act and GC's overarching strategic directions. Ethics is a regular item on the SC agenda. EO also launches Requests for Applications (RFAs) and Priority Announcements related to emerging issues. Once strategic directions are identified and policy development is underway, EO liaises with its partners and the broader ethics community to obtain feedback through consultations, meetings, workshops, pre-conferences, conferences [ PDF (715 KB) | Help ], surveys, and the web. EO also presents ideas and action plans to a variety of committees, such as SC, University Delegates, and CIHR's Executive Management Committee (EMC). EO communicates its policies and guidelines to the research community through a variety of avenues, such as CIHR E-Alerts, presentations and displays at annual ethics conferences, EO website, and tools such as Frequently Asked Questions and newsletters [ PDF (242 KB) | Help ].
  • CIHR monitors the effectiveness of its EO's research ethics activities.

Summary of Internal Control Weaknesses

The following aspects of the management control framework require management's attention:

  • The Director, EO's formal mandate does not include the overall accountability, responsibility, and authority required for the effective and efficient coordination of research ethics activities across CIHR.
  • As a result, there is no effective mechanism for monitoring the overall effectiveness of research ethics activities across CIHR.
  • EO has received GC support for its Strategic Priorities and is in the process of developing a Strategic Plan for June 2009. To assist GC in its governance role, this Plan will need to incorporate research ethics activities and priorities across CIHR and include measurable goals and objectives.
  • To ensure that the Strategic Plan addresses appropriate research ethics issues in a timely manner, EO needs to develop a comprehensive, CIHR-wide risk profile of research ethics issues; use the risk profile to validate and modify as needed the Strategic Priorities that have been identified so far; prioritize the issues for mitigating action; and plan the mitigation strategy (for example, develop and implement additional policies and, or, guidelines).
  • The EO Operational Plan 2008-2009 identifies research ethics priorities, along with their resource needs. In future years, these priorities need to be reviewed in the context of the Strategic Plan so that workload, roles and responsibilities, and related resourcing issues can be analyzed over the longer-term; un-resourced or under-resourced priorities identified; and risks associated with delaying or deferring priorities assessed and presented through SCE for GC decision.
  • In addition to semi-annual initiative updates, the Director, EO needs to deliver an annual performance report through SCE to GC on the status of all research ethics activities across CIHR.

Internal Audit thanks management and staff for their excellent cooperation in this audit.

Dev Loyola-Nazareth
Chief Audit Executive
Canadian Institutes of Health Research

Detailed Report

Methodology and Criteria

The assessment of the management control framework for research ethics activities was performed through interviews with management and staff at the Ethics Office and discussion with the Executive Vice-President of Corporate Affairs; review of documentation; and analysis of controls against audit criteria. Controls were deemed adequate if they were sufficient to minimize the risks that threatened the achievement of objectives.

The audit uses criteria derived from the Professional Practices Framework of the Institute of Internal Auditors (IIA) and the TBS Management Accountability Framework (MAF). Detailed criteria and conclusions are contained in Appendix A to this report.

The audit was conducted between December 2008 and February 2009.

Observations, Recommendations, and Management Action Plan

The following are audit observations, recommendations, and management action plan to address weaknesses in the management control framework for research ethics activities.

Observation Recommendation Management Action Plan

1. The Director, EO's formal mandate does not include the overall accountability, responsibility, and authority required for the effective and efficient coordination of research ethics activities across CIHR.4

Shared Responsibilities for Ethics
Ethics at CIHR is a responsibility shared by various groups.

CIHR's mandate in ethics is supported by the Standing Committee on Ethics (SCE), which identifies for GC emerging ethical issues of strategic relevance with respect to health and health research. SCE provides GC with high-level strategic advice on the ethical, legal and socio-cultural dimensions of CIHR's mandate as set out in The CIHR Act, at its own initiative or at the request of GC or the President.

Ethics at CIHR is also supported by:

CIHR's Ethics Office (EO) develops and implements research ethics policies, builds capacity, and supports research on ethics. It also provides advice to the research community on ethical issues and related public policy and legislative issues. In addition, EO is responsible for advising on and supporting development of the CIHR Stem Cell policy, including procedures employed by SCOC.

In its work, EO interacts with other portfolios and the Institutes. For example, EO regularly attends Institute Advisory Board meetings; is a member of the Knowledge Translation portfolio's Advisory Committee; and is a voting member on the Institute Roundtable. EO presents semi-annual updates to SCE on its specific activities and initiatives.

Mandate of the Director, EO
CIHR has appointed the Director, Ethics Office as a full-time, executive-level position reporting functionally to the CIHR President and administratively to the Executive Vice-President (EVP), Corporate Affairs. The Director is responsible for leading and developing a team that undertakes and advises on CIHR activities aimed at promoting ethics in research, research in ethics, and integrity in health research, as well as contributing to the development of health and health research-related public policy from an ethics perspective.

According to the Role Profile, the Director, EO promotes Research in Ethics by, inter alia:

  • Working closely with appropriate advisory bodies, the Research Portfolio and the Scientific Council (SC), in the development of CIHR's research agenda for addressing ethical, legal and socio-cultural issues (ELSI) related to health and health research, and translating that agenda into programs and operational plans; and
  • Ensuring the implementation of the research agenda in collaboration with other CIHR portfolios, Institutes, and partners.

The Director promotes Ethics in Research by:

  • Implementing and updating CIHR policies and procedures for responding to alleged breaches of research ethics and integrity; and
  • Leading and/or supporting the development and maintenance of policies and assurance mechanisms, as relevant and appropriate to CIHR's ethics mandate.

The Director contributes to CIHR at the corporate level by, inter alia:

  • Providing input and support to GC, SCE, SC, EMC, Extended Executive Management Committee, (EEMC), and SCOC as required and appropriate.

Per the Role Profile, the Director is mandated to work "in close collaboration with CIHR senior management, staff, and external stakeholders to ensure the efficient and effective delivery" of the EO mandate. The Role Profile does not address the following:

  • The Director, EO's mandate to coordinate research ethics activities;
  • The accountabilities to the Director of other positions and functions responsible for research ethics across CIHR;
  • The Director's mandate to seek and receive plans of research ethics activities from other responsible positions and functions;
  • The Director's mandate to incorporate the plans from other units in EO's strategic and operational planning; and
  • The Director's mandate to submit performance reports through SCE to GC covering all research ethics activities at CIHR.
It is recommended that:
  1. The CIHR Executive Vice-President amend the role profile of the Director, EO to include overall accountability, responsibility and authority for the effective and efficient coordination of research ethics activities across CIHR; and
  2. The Director, EO submit the role profile to the CIHR President for approval.

Responsibility:

  1. CIHR Executive Vice-President (EVP) and Director, Human Resources
  2. Director, EO

Action:

  1. EVP to coordinate with HR the recommendations in the audit report to amend the role profile of the Director, EO referenced in CIHR Role Profile #027.

    Revised document should be forwarded to CIHR's Job Evaluation Committee if necessary.
  2. Director, EO to submit the amended role profile to CIHR's President for approval.
Timelines:
  1. April-May 2009
  2. May 2009

2. There is a need for an effective mechanism to monitor the overall effectiveness of research ethics activities across CIHR.

EO's research ethics activities are monitored for their effectiveness. Progress on the EO operational plan is monitored through:

  • Weekly one-on-one meetings with staff and the Director, EO;
  • Weekly all-staff meetings;
  • Bi-lateral meetings with the Director and EVP, Corporate Affairs; and
  • Quarterly and mid-year responsibility centre budgetary reviews.

In addition, EO project charters are reviewed and revised annually based on developments and outcomes from previous year. Staff meetings and one-one-one meetings are held regularly to determine appropriate action, if necessary, to address incomplete activities and priorities. EO's recommendations plan is informally presented to CIHR's EVP for approval during the Director's bilateral meetings. EO promotes fiscal responsibility by routinely assessing the deliverables of contractors it hires, prior to approving final pay-out.

There is no systematic process for overall monitoring of activities undertaken by the various other groups that share responsibility for ethics at CIHR.

 It is recommended the CIHR Executive Vice-President ensure that the role profile of the Director, EO includes the monitoring of the overall effectiveness of research ethics activities across CIHR.

Responsibility:
Director, EO for approval by EVP

Action:
Develop a systematic process for overall monitoring of research ethics across CIHR. This process consists of:

  1. Identifying all CIHR branches undertaking research ethics activities;
  2. Informing each branch of this new audit requirement;
  3. Discussing and agreeing with each branch on the implementation of audit requirement;
  4. Discussing the nature of the information needed, i.e., format and frequency;
  5. Creating a mechanism to ensure the EO receives relevant information at the appropriate time; and
  6. Implementing the mechanism. Note that implementation will only be possible after the revised logic model has been finalized.

Consideration: Dedicated human resources may be required to achieve this requirement.

Timelines:

  1. April-May 2009
  2. April-May 2009
  3. May-June 2009
  4. May-June 2009
  5. June 2009
  6. November 2009
3. EO has received GC support for its Strategic Priorities and is in the process of developing a Strategic Plan for June 2009. To assist GC in its governance role, the Plan will need to incorporate research ethics activities and priorities across CIHR and include measurable goals and objectives.

In the 2008-2009 Responsibility Centre Operational Plan, the Director, EO set out the following goals and objectives:

  • Develop a long-term strategic plan for CIHR's ethics mandate; and
  • Develop performance measures and targets to evaluate CIHR's performance related to its ethics mandate.

Partial progress has been made on the first of these goals and objectives. The Strategic Priorities for Ethics at CIHR – 2009-2014 was presented by the SCE Chair to GC in November 2008. It contained the following priorities:

  • Inclusion of diverse communities and populations in health research;
  • Governance of research;
  • Ethics of research in an increasingly globalized world; and
  • Capacity building in bio-ethics research and ethics research.

GC affirmed these priorities and also raised the need to ensure the quality and reliability of research ethics and the need for coordinated ethics reviews, especially for multi-site initiatives.

The Strategic Priorities need to be incorporated in a Strategic Plan. EO has developed a draft Logic Model that it expects to present to SCE for comment and approval in Spring 2009. The Logic Model anticipates the Strategic Plan. Following SCE approval, the Logic Model will be presented to Scientific Council. EO is planning to have a draft Strategic Plan ready in Summer 2009.

The draft Logic Model specifies medium and long-term impacts, outcomes, outputs, activities, and objectives linked to The CIHR Act's mandate for research ethics. It focuses, however, primarily on EO. It does not incorporate CIHR-wide research ethics activities. In addition, it needs to be substantiated by indicators and measures for use in monitoring the achievement of the outputs, outcomes, and impacts.

It is recommended that the Director, EO:

  1. Develop a Strategic Plan for Research Ethics that:
    1. Encompasses research ethics activities across CIHR; and
    2. Contains measurable goals and objectives; and
  2. Inform relevant committees of the Plan:
    1. Present the Plan to Scientific Council (SC); and
    2. Submit the Plan to SCE for its recommendation for GC approval.

Responsibility:
Director, EO

Action:

  1. i. Director, EO to develop a draft strategic plan, building off its draft logic model and present it to SCE in June 2009 for discussion and comment.
  1. ii. Director, EO to discuss with the Evaluation and Analysis branch the measurability of the goals and objectives as set out in the strategic plan.
  2. i. Director, EO to present the plan to SC for information.
  1. ii. Director, EO to submit final strategic plan and logic model to SCE for its recommendation for GC approval, in fall 2009.

Timelines:

  1. i. June 2009
    ii. May 2009
  2. i. October 2009
    ii. November 2009

4. To ensure that the Strategic Plan addresses appropriate research ethics issues in a timely manner, EO needs to develop a CIHR-wide risk profile of research ethics issues; use the risk profile to validate and modify as needed the Strategic Priorities that have been identified so far; prioritize the issues for mitigating action; and plan the mitigation strategy (i.e., develop and implement policies and, or, guidelines).

EO has implemented most, but not all, of the key elements of a process for ensuring that it addresses appropriate research ethics issues in a timely manner. The implemented elements include scanning the research environment; reviewing research on research ethics; networking with like organizations; consulting stakeholders and practitioners; and compiling information/complaints/issues reported. This part of the process has yielded the Strategic Priorities for Ethics at CIHR for 2009-2014.

The following are examples of EO activities related to the process:

  • The Ethics Office 2008 summer student was tasked with developing a list of criteria to be used in a future analysis of frequently discussed topics addressed on the National Council on Ethics in Human Research (NCEHR) listserv.
  • EO is currently working on developing a system for reviewing research in research ethics; in the meantime, EO maintains an active Research Funded by the Ethics Office list of all the grants, awards, and partners it funds.
  • EO continues to network closely with many different external stakeholders, for example, Health Canada, the Public Health Agency of Canada (PHAC), Genome Canada, Canadian General Standards Board, Canadian Research Integrity Committee (CRIC), and Table of Sponsors for Human Research Participation. EO is currently organizing a retreat with the Health Portfolio to inform it of its activities and look for potential areas for future collaboration.
  • EO consults various internal stakeholders, including SDs and IABEDs.
  • For EO initiatives, advisory committees are established to ensure input from key stakeholders (for example, Aboriginal Guidelines Development, Partnerships with the Private Sector Working Group, Stem Cell Oversight Committee, Privacy Advisory Committee, IABEDs, SCE, and RIC).
  • EO, as the Secretariat to RIC, receives allegations of non-compliance with research policies. It presents these allegations to RIC, in accordance with the CIHR Procedure for Addressing Allegations of Non-Compliance with Research Policies. EO is responsible for compiling statistics on the allegations it receives.
  • EO, in collaboration with the Program Delivery Services unit, has developed an Applicant Status Alert System which enables CIHR to flag individuals confirmed of research misconduct.
  • EO has developed a follow-up process with CIHR's Financial Monitoring Unit regarding ethics issues observed during institutional site visits.

EO now needs to develop and use a CIHR-wide risk profile of research ethics issues to validate and modify as needed the Strategic Priorities that have been identified so far; prioritize the issues for mitigating action; and plan the mitigation strategy.

It is recommended that the Director, EO base the CIHR Research Ethics Strategic Plan on a comprehensive risk analysis of the issues.

Responsibility:
Director, EO

Action:

  1. Develop a CIHR-wide risk profile on research ethics issues.
  2. Use the risk profile to validate the strategic plan.
  3. Prioritize issues for mitigating action.
  4. Plan the mitigation strategy.

Timeline:
Winter 2009

5. The EO Operational Plan 2008-2009 identifies research ethics priorities, along with their resource needs. In future years, these priorities need to be reviewed in the context of the Strategic Plan so that workload, roles and responsibilities, and related resourcing issues can be analyzed over the longer-term; un-resourced or under-resourced priorities identified; and risks associated with delaying or deferring priorities assessed and presented through SCE for GC decision.

EO has undertaken a number of initiatives for managing its workload more effectively and efficiently.

In March 2006, EO conducted a review of its workload for the purpose of developing a common understanding of related issues and taking steps to address them. The Workload Review Meeting Summary Report identified two tools that could help manage workload in the short-term. The first is a "Work Request Checklist" to help screen requests for work from outside EO. The second is a "Responsibility Matrix" that could be used to catalogue staff members' expertise, specific projects, and ongoing responsibilities.

In June 2008, EO developed the Responsibility Matrix - "EO Work Distribution" - based on the Office's reorganization. The document allocates responsibilities to all of EO, for project leads, project assistants/contributors, committee participation (as member, contributor, supporter, observer), and miscellany. Examples of committees include GC, SCE, EMC, SC, EEMC, CIHR Community Engagement Working Group, IABEDs, Community-Based Research Ethics, Interagency Bioethics Group, and UNESCO. Examples of miscellany include CIHR contact for ethics on the Tri-Agency MOU, GENOME Canada, Clinical Trials Action Coalition, European Research Agency, and International Education on Research Ethics.

In the 2008-09 Operational Plan, the Director, EO identified on-going operational activities as well as individual projects for the function. For each project, the Director described the key deliverables, assigned lead staff, and estimated a non-salary budget. In addition, the Director identified two vacancies.

Furthermore, as noted earlier, EO has identified key Strategic Priorities, endorsed by SCE and affirmed by GC in November 2008. EO has also suggested activities that could be implemented to achieve the Priorities.

Operational priorities and activities and the resources required to implement them need to be reviewed in the context of the Strategic Plan.

It is recommended that the Director, EO:

  1. Align the Operational Plans in future years with the approved Strategic Plan; and
  2. Ensure that resource needs for delivering the Plan, along with the risks related to inadequate resourcing, are presented to SCE for approval and communicated to GC for information.

Responsibility:
Director, EO

Action:

  1. When developing annual operational plans, ensure plans align with approved strategic plan.
  2. i. Director, EO to analyze the amount of resources required to undertake specific operational activities as set out in the EO operational plan, and assess the risks to CIHR of not undertaking these activities.

    ii. Director, EO to submit operational plan, including resourcing needs and associated risks, to SCE for recommendation for GC approval.

    iii. Regular monitoring of alignment of operations and strategic plans through mid-year and year-end reviews.

Timelines:

  1. February 2010
  2. i. February 2010
    ii. February 2010
    iii. Mid-year and year-end (for fiscal years 2010/11-2013/14)

6. In addition to semi-annual initiative updates, the Director, EO needs to deliver an annual performance report through SCE to GC on the status of research ethics activities across CIHR.

The Ethics Office Report of Activities (September 2001 to February 2003) had been created to present the achievements of EO. The report was found to be extremely labour intensive, requiring significant resources to complete. As an alternative, EO now reports on a semi-annual basis, at each SCE meeting, on specific initiatives it has undertaken. Motions are put forward by SCE members and carried, resulting in Matters for Action for EO. EO reports on the status of the Action to SCE at the following meeting.

EO will be recommending to the SCE Chair in March 2009 that, in addition to the EO semi-annual initiative updates, EO also deliver an annual report to the Committee on all activities related to EO priorities. The first annual presentation is scheduled to take place at the next face-to-face meeting of SCE in May/June 2009. To support GC's governance role, the annual report needs to address research ethics across CIHR.

It is recommended that the Director, EO produce an annual performance report on the status of research ethics activities across CIHR for delivery through SCE to GC.

Responsibility:
Director, EO

Action:
Develop an annual report on research ethics activities across CIHR, through consultation with other CIHR branches.

Present this report to SCE on an annual basis.

Timeline:
June of every year for the previous fiscal year.

The first annual report to SCE will be presented in June 2009 for the 2008-09 fiscal year.

Appendices

A: Audit Criteria and Conclusions

The audit uses the following definitions to make its assessment of the management control framework.

Conclusion on Audit Criteria Definition of Opinion
Well controlled Well managed, no material weaknesses noted or only minor improvements are needed.
Moderate issues Control weaknesses, but exposure is limited because either the likelihood or the impact of the risk is not high.
Significant improvement required Requires significant improvements in the area of material financial adjustments or control deficiencies represent serious exposure.

Overall Conclusion
The audit has concluded that the management control framework for research ethics activities has moderate issues: There are control weaknesses, but overall risk exposure is limited because either the likelihood or the impact of the risk is not high.

Criteria Conclusions
Governance
1. CIHR Governing Council sets clear (i.e., measurable or assessable) high-level, strategic direction and goals for CIHR research ethics activities, which are consistent with CIHR's mandate.		 Moderate issues Observation 3
Planning and Organization
2. The scope of CIHR's planned research ethics activities is consistent with the strategic direction and goals set by Governing Council. 		Moderate issues Observation 3, 4
3. CIHR clearly (i.e., with direct accountabilities and authorities) assigns roles and responsibilities for research ethics activities.
  1. CIHR has appointed a senior full-time position to provide independent and objective oversight and leadership in research ethics.
Well controlled
  1. For organizational consistency and efficiency, the senior full-time position providing independent and objective oversight and leadership in research ethics ensures the coordination of its activities with other units within CIHR.
Significant improvement required Observation 1
4. CIHR ensures the allocation of appropriate resources for its research ethics activities. Moderate issues Observation 5
5. CIHR provides training and conducts performance evaluations to ensure that research ethics responsibilities are understood and followed, and that necessary skills are learned and employed. Well controlled
Management
6. CIHR clearly articulates its accountability, authority, and responsibility for research ethics and the application of its research ethics policies and guidelines.		 Well controlled
7. CIHR ensures that it is addressing the appropriate research ethics issues in a timely manner. Moderate issues Observation 4
8. CIHR ensures that its stakeholders are kept up-to-date on the issues it has identified and on the policies and guidelines it has issued. Well controlled
9. CIHR assesses and manages research ethics issues-related risks as part of its enterprise risk management (ERM) process. Well controlled
10. CIHR monitors the effectiveness of its research ethics activities. Moderate issues Observation 2
Accountability
11. CIHR Governing Council reviews reports at least annually from management on the achievement of research ethics strategic direction and goals and directs management to take corrective action as required.		 Moderate issues Observation 6

B: 2002 December Report of the Auditor General of Canada5

Exhibit 9.1 – The Elements of Accountability

Accountability is a relationship based on obligations to demonstrate, review, and take responsibility for performance, both the results achieved in light of agreed expectations and the means used.

A relationship Accountability involves two (or more) parties in a relationship that features certain obligations.
Obligations All parties in an accountability relationship have obligations that imply responsibilities and consequences. In addition to the obligations inherent in the relationship (to demonstrate, review, and take responsibility), others can come from outside (such as legal, professional, contractual, and hierarchic obligations) and from an internalized sense of integrity.
Demonstrate Demonstrating performance involves proactively reporting what results have been achieved and the appropriateness of the means used; it requires honesty, openness, and transparency. In a hierarchic relationship, this obligation is on the subordinate party.
Review Review involves analyzing and reflecting on the reported results and the means used, and then taking appropriate action. Each party has an obligation to review. Those accounting should review to learn what is working and what is not, and should adjust their activities accordingly. Those holding to account should direct or call for any needed change. If performance is good, this could simply mean reconfirming current activities or could entail individual rewards. If performance is weak, corrective action would be expected. Review and adjustment of unacceptable performance might involve sanctions on individuals. Review can also result in revising expectations or adjusting other elements of the accountability relationship.
Take responsibility Taking responsibility emphasizes answering for and accepting responsibility for what has or has not been accomplished and for the means used in the effort.
Results A key focus in accountability is on the results (outputs and outcomes) accomplished or not accomplished.
Agreed expectations The agreed expectations stem from either a formal or informal agreement on what is to be accomplished. In a hierarchic situation, one would expect a degree of discussion between the two parties as to what is reasonable and feasible, placing an obligation on the superior party to be clear about what is expected.
In light of This emphasizes that performance is comparative. One is called on to compare what was accomplished with what was expected. Effective accountability requires disclosure: setting out beforehand what is expected and then reporting against those expectations. It also requires learning: looking in light of the expectations at what was accomplished or not, and what has been learned that will improve future performance.
The means used How one delivers public services, uses authority, and handles public money are more than means of achieving results: they are ends in themselves, important reflections of public sector values and ethics. It is expected that the means used treat people fairly, are undertaken with propriety, and reflect good stewardship—that is, provide best value for money and respect the environment.

Footnotes

Footnote 1

The Standing Committee on Ethics’ Terms of Reference

1

Footnote 2

The Stem Cell Oversight Committee’s Terms of Reference

2

Footnote 3

The Management Accountability Framework sets out the Treasury Board's expectations of senior public service managers for good public service management.

3

Footnote 4

As reference, Appendix B provides the Office of the Auditor General’s description of elements of accountability.

4

Footnote 5

Exhibit 9.1 – The elements of accountability

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