Extract of recommendations from report of Task Force on Ethics Reform

Notice

An extract of the Task Force report is being made available in both official languages with minor changes for ease of readership, for example formatting, numbering and statements referring to other parts of the report. A full copy of the Task Force report is available upon request, please contact ethics-ethique@cihr-irsc.gc.ca.

Ethics must be at the core of CIHR

[…]Ethics must be entrenched at the core of CIHR. Making ethics core at CIHR requires that ethics is understood as a source of knowledge, that it is valued at all levels of the organization as a forward looking enterprise, and that clear mandates and lines of accountability are established. To begin, making ethics core means that everyone at CIHR from top to bottom must recognize that CIHR’s ethics mandate is legislated. In other words, a strong ethics programme at CIHR is not optional; it is essential to the role CIHR plays in Canada’s democratic society.

The Task Force draws upon CIHR’s Health Research Roadmap, which has the following goal for ethics (part of its three-year implementation plan): Be nationally respected and internationally acknowledged for its role in the creation and continuous translation of health ethics knowledge to advance the highest standards of ethics and integrity in health research, policy and practice.

The following recommendations take this goal as their starting point, and are centred on how to make ethics core at CIHR. Our recommendations are aimed at strengthening the existing ethics framework at CIHR. No one – either in our submissions received or the Task Force itself – suggests a radical departure from the current framework. In fact, everything we heard and reflected on suggests that had the original vision been fully implemented, adequately resourced, and carefully and consistently managed, it would be much closer to fulfilling its legislated mandate. Indeed, CIHR had a leadership role in ethics identified by the 2006 International Review Panel (IRP); though by the 2011 IRP this leadership was largely absent. However, the underlying foundations and leadership potential for CIHR to once again be at the forefront of ethics internationally still remain strong. Thus, our recommendations have one goal in mind: restoring, strengthening, and refreshing the original vision for ethics at CIHR.

The Task Force’s recommendations: making ethics core at CIHR

We have one key recommendation from which all others flow: provide ethics leadership to CIHR. Fulfilling its legislated mandate in ethics requires both a vision for ethics and responsible ethics leadership at every level of the CIHR corporate structure (including Governing Council and the executive leadership) across all Institutes and programs. Leadership goes beyond any particular person and targets how the ethics mandate is implemented by all entities and even all persons at CIHR. Nonetheless, leadership also requires an individual who can lead and champion the effort.

Recommendation #1 A first (and this is only the first) step is to create a position of Vice President of Ethics (VP Ethics) or a position of equivalent stature, and then hiring a strong individual to fill that role.

In order to properly reflect the prominence of ethics within the CIHR mandate, this person must have earned a standing within the research ethics community that is at least analogous to that of the Institute Scientific Directors. He or she must have the knowledge, skills and experience to elevate the status of ethics to a position within the organization that more fairly reflects the prominence of ethics in the CIHR mandate, and to develop and execute innovative, world-class programming in research ethics and related research policy. The person in this position should be recognized nationally and internationally as a leading scholar and researcher in ethics familiar with interdisciplinary approaches to research in and application of ethics. The establishment of such a position would require appropriate support and recognition with other entities within CIHR and outside.

It must be stressed again that the appointment of an outstanding individual as VP Ethics is only a starting point for ethics leadership. Additional steps, taken simultaneously to hiring a VP Ethics, are required. Effective ethics leadership at CIHR can only be achieved by ensuring independence, integration, and interrelationships.

While we call this person the VP Ethics, the crucial issue is the functionality of the leadership position and not the actual title of the position. We are concerned with leadership, reporting relations, and recourses. Whatever title is chosen, it should reflect the importance of the position and carry with it the powers to implement the recommendations attached to the position outlined below.

Independence

Recommendation #2 CIHR must recognize its statutory mandate in ethics and give a clear corporate commitment to the VP Ethics

The highest levels at CIHR – the President and Governing Council (GC) – must give their full support to the VP Ethics in fulfilling its ethics mandate. A resolution coming directly from GC to this effect is necessary.

Recommendation #3 The VP Ethics must have a strong mandate based upon the CIHR Act

The Ethics VP’s mandate must be taken directly from CIHR’s founding statute. It should include specific reference to all sections of the CIHR Act addressing ethics and any antecedent powers necessary to fulfill that role.

Recommendation #4 The VP Ethics’ mandate should include knowledge generation and knowledge translation

As mentioned above, ethics is also an activity that generates new knowledge to inform heath research and is not just an institutional or quasi-regulatory requirement. The VP Ethics’ mandate must thus include the development of new ethics knowledge to move the field forward as a substantive area of research.

Recommendation #5 The VP Ethics must have decision-making autonomy within its mandate

The VP Ethics must be able to make decisions and effect change within the scope of the statutory ethics mandate without seeking approval from higher ups. This reflects the status of the VP Ethics as a member of senior management and the centrality of CIHR’s ethics mandate.

Recommendation #6 The VP Ethics must report directly to Governing Council

In recognition of the importance of the ethics mandate, the VP Ethics must be reporting to the highest level at CIHR.

Recommendation #7 The VP Ethics must have a seat on Science Council and Governing Council

The VP Ethics must be on a level equivalent to the Scientific Directors. This recognizes both the importance of CIHR’s ethics mandate and the calibre of the person who should be selected to fill the role. Additionally, a seat on the Science Council ensures that the VP Ethics is plugged into the work of the Institutes and is able to hear concerns and emerging issues directly from the Scientific Directors. The Chair of the Standing Committee on Ethics (SCE) who currently sits on Governing Council, would be replaced by the VP Ethics. This is because the SCE should become a new Ethics Advisory Board (see below) and hence would no longer be a standing committee of GC.  However, to reflect the central role that ethics must play at CIHR, an ethics representative (i.e. the VP Ethics) must remain on GC.

Recommendation #8 The office of the VP Ethics must have sufficient support and personnel to fulfill the VP’s mandate

Again, reflecting the importance of the role, the VP Ethics must have support and personnel just as the Scientific Directors do in heading the Institutes. The support should be sufficient to enable the VP Ethics to tackle larger reforms, launch CIHR-wide initiatives, engage in research and policy development, and partner with agencies external to CIHR, in the same manner as the Scientific Directors.

Integration

Recommendation #9 The VP Ethics should be the head of the Ethics Office

It is only logical for the VP Ethics to head the Ethics Office (EO). However, this implies that the EO must be taken out of the Research and Knowledge Translation Portfolio and placed directly under the VP Ethics. The VP Ethics can also provide the EO the stability and long-term management that has been lacking in recent years.

Recommendation #10 The SCE should become a new Ethics Advisory Board (EAB) for the Ethics VP

The current SCE, while enormously respected, must evolve into the EAB and act in an advisory capacity to the VP Ethics (and Institute Advisory Board Ethics Designates (IABEDs) upon request). This will clarify the role of the SCE/EAB, ensure that it has an appropriate outlet for its high-level and forward-thinking advice, and avoid duplication of roles. Since the Ethics VP will be reporting directly to GC and acting as the “voice” of ethics within CIHR, it is unnecessary for the EAB to report to GC.

Recommendation #11 The EO should have sufficient and trained personnel to support the VP Ethics, EAB, IABEDs, Institutes, and other ethics initiatives (e.g. Stem Cell Oversight Committee, Canadian Council on Animal Care)

The EO already possesses tremendous talent and skill in its staff. However, recent cutbacks have meant that they no longer have sufficient resources to support ethics at CIHR. The EO must have enough human resources to take on the coordinating role of its mandate if CIHR is to fulfill its statutory mandate in ethics.

Recommendation #12 The EO should have a dedicated financial envelope

Dedicated and stable funding is necessary for the EO to plan on a long-term basis. It is also required for the EO to take on its own initiatives under the auspices of the VP Ethics, be part of national and international partnerships, and enter into cost-sharing partnerships (for example, research funding opportunities with the Institutes).

Recommendation #13 The EO should be the point of contact for ethics at CIHR

The EO should be the point of first contact for any ethics-related initiatives or inquires across CIHR. This will ensure simplicity, help assure uniformity and avoid confusion as to who is the reference point for ethics at CIHR. It will further engrain the EO as the coordinating body for ethics at CIHR.

Recommendation #14 The selection process for IABEDs should be clarified and made transparent

Currently, there is no formal process for selecting IABEDs. A formal recruitment process should be implemented in order to recruit IABEDs with the necessary background to fulfill the role. This should be done in conjunction with the Scientific Directors.

Recommendation #15 The IABEDs should receive training in order to have the requisite skills to perform their function

There is great disparity in how IABEDs have been utilized at the Institutes. Much of this comes down to inadequate training in terms of what their role is and knowledge of the ethics programme at CIHR. A standardized training programme would improve this and ensure the Institutes utilize their IABED appropriately.

Recommendation #16 The IABEDs must have a mechanism for regular meetings with the VP Ethics and EO

Lack of communication was commonly cited as a problem area. To ensure both input from the Institutes (via the IABEDs) into the EO and VP Ethics’ activities and buy in, the IABEDs must meet regularly either in person or via teleconference. This would also provide opportunity to explore cooperation between the EO/VP Ethics and the Institutes, as well as between the Institutes.

Recommendation #17 The Chair of the IABEDs should have a seat on the EAB as ex officio

This will ensure a sufficient link exists between the IABEDs and the EAB. The Chair can bring to the EAB concerns from other IABEDs and offer the Institutes’ perspective.

Recommendation #18 The CIHR Ethics Strategic Plan 2009-2014 and Logic Model for the Function of the Ethics Portfolio at CIHR should be updated, approved, and implemented

Significant effort from the EO and other stakeholders went into developing these documents and to ensuring that they meshed with CIHR’s overarching Health Research Roadmap. Despite this, they were never formally approved. The VP Ethics should immediately review these key documents and update them as necessary in conjunction with appropriate stakeholders. They should form the basis of the VP Ethics’ agenda for the first few years. Governing Council and Science Council should then review them for approval.

Interrelationships

Recommendation #19 The Ethics VP and EO should partner with national and international groups on ethical issues of mutual concern

Most if not all of the ethical issues facing CIHR are also issues of national and international concern. Therefore, wherever appropriate, the VP Ethics and EO should enter into partnerships to address these issues on a national and global scale. CIHR can use Canada’s prominence in research ethics to once again become a leader in the field.

Recommendation #20 CIHR should dedicate at least 3% of its research budget to research in ethics, distributed by the EO or the Institutes

A hard funding target in terms of percentage of overall budget is required to properly reflect the prominence of CIHR’s ethics mandate. In this way, CIHR would be comparable to other health research funding bodies (for example, the National Institutes of Health) that have set a 3% target.

Other: Substantive issues

While outside our mandate, submissions we received during consultations identified several substantive issues in ethics: harmonization of ethics review for multi-site research; data sharing; commercialization; peer review of ethics-related research projects.

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