Canadian Institutes of Health Research: Update Dr. Danika Goosney, Director of Science, Knowledge Translation and Ethics Presentation to the Canadian Association of Research Ethics Boards National Conference, May 1-2, 2015

Overview CIHR’s renewed Standing Committee on Ethics CIHR’s Ethics Action Plan Update on national work toward a pan- Canadian accreditation system for REBs Highlights of Big Data-related activities CIHR’s Reforms of the Open Suite of Programs

Renewed Standing Committee on Ethics (SCE) Mandate: To provide the Governing Council with high-level strategic ethics advice on the ethical, legal and socio-cultural dimensions of CIHR's mandate as set out in the CIHR Act, at its initiative or at the request of the Governing Council, Science Council, or the President. Membership drawn from external experts and staff (“integrated model”): Chair- Governing Council member. National and international experts in ethics, Health Journal editor, member(s) of the Public, Industry member, representatives of CIHR Institute Scientific Directors and Institute Advisory Board Ethics Designates Ex-officio members: CIHR senior management; Director and Manager, Science Knowledge Translation and Ethics Branch; Executive Director, Secretariat on Responsible Conduct of Research.

SCE Members (1) Voting Members Paul Garfinkel (SCE Chair) Governing Council Member Lisa Schwartz (Vice-Chair) Judy Illes Kathleen Oberle Raphael Saginur Canadian experts Jeffrey Botkin Glenn Cohen International experts Vardit Ravitsky CIHR Institute Advisory Board Ethics Designate Malcolm King Paul Lasko CIHR Institutes- Scientific Directors Jean Miller Member of the public Alan Leshner Health Journal Editor/Publisher (To be appointed) Industry

SCE Members (2) Non Voting Members Jane Aubin CIHR Executive Vice President, Chief Scientific Officer and Vice-President, Research, Knowledge Translation and Ethics Portfolio Thérèse Roy CIHR Chief Financial Officer and Vice President, Resource Planning and Management Portfolio Susan Zimmerman Executive Director Secretariat on Responsible Conduct of Research Danika Goosney CIHR Director Science, Knowledge Translation and Ethics Branch Geneviève Dubois-Flynn CIHR Manager Ethics Strategies/Office

Action Plan Objectives Ethics Action Plan Action Plan Objectives Strengthen ethics leadership at CIHR Ensure ethics considerations inform CIHR decisions Nurture and monitor research capacity in ethics Capture and assess the impact of CIHR’s ethics activities Develop a new CIHR ethics communications strategy. Review CIHR’s ethics leadership model and action plan after five years. CIHR’s Ethics Action Plan: Placing Ethics at the Core of CIHR’s Business: Standing Committee on Ethics members are engaged in working groups to advance the objectives of the Action Plan. Current priorities are the development of a performance measurement strategy for ethics, and a strategy for ongoing engagement with stakeholders.

Ethics Review Efficiencies The Canadian Clinical Trials Coordinating Centre (CCTCC) Accreditation Working Group is being established. Its mandate is to consider the design of a pan-Canadian accreditation system for REBs (scope to be determined at their first meeting). Membership consists of individuals with expertise in multidimensional aspects of REB operations. A report will be submitted to the Clinical Trial Summit’s sponsors (CIHR, Rx&D, HealthCareCAN) and Health Canada within 9 months.  

Highlight on Big Data: Council of Canadian Academies (CCA) Report What is the CCA? An independent, not-for-profit organization that began operation in 2005 with an endowment of $30 million from the Government of Canada. The CCA supports independent evidence-based expert assessments to inform public policy development in Canada. What is the issue? Canada has some of the best-developed data repositories for studying health and health care, yet the research community has long reported difficulties in accessing data. The Charge to CCA: CIHR sponsored an independent assessment by a CCA Expert Panel on “Timely access to health and social data for health research and health system innovation in Canada”. (Timely = 4 months from data request) The scope is confined to public interest research (i.e., conducted by public bodies and/or supported by public funds). The Report: The CCA Assessment was published March 31, 2015 at: http://www.scienceadvice.ca/en/assessments/completed/health-data.aspx

CCA Report: Findings (2) The CCA report draws attention to challenges and opportunities. Key Messages: Canada is a “complex environment of dissimilar entities” all with a role in access to data: data custodians, research ethics boards, researchers, health care providers, senior policy makers, etc. Canada needs to move: from a “Culture of Caution” to a “Culture of Trust”. This shift needs demonstration of trustworthiness through best practices and public engagement. from a “Data Custodianship” to a “Data Stewardship” model, in which enabling access to data is a core institutional objective and is balanced with protecting privacy. Technical and Methodological Challenges Substantial Potential Health Benefits Ethical and Legal Frameworks need Clarity, Consistency & Efficiencies Low but Tangible Risks to Privacy Governance Best Practices

Highlight on Big Data: eHealth Innovations Initiative Aims to develop, integrate, and evaluate eHealth innovations that will improve the cost-effectiveness of patient and population-centred care The first phase centres around developing partnerships between Canadian technology companies and ‘innovation communities’ (researchers, clinicians, decision makers, patients) to co-develop and integrate innovative e-health solutions that deliver real-world health care value Two priority areas: Early identification of, and intervention for youth and adolescents (11-25 years of age) with mental health conditions Support of seniors with complex care needs in their homes Ethical and social considerations: End users’ perception of the value and usability of the eHealth innovation as it pertains to their care is incorporated into an integrated science approach The evaluation of social impacts of new technologies at a community and health system level will consider equitably shared benefits so that certain groups are not disadvantaged and risks are proportional to benefits.

CIHR Reforms of the Open Suite of Programs The transition to the new Open Suite of Programs and peer review processes is occurring over a number of years. Piloting is an essential part of the transition plan to allow CIHR to adjust and refine processes and systems in order to best support applicants and reviewers. As each of the pilot studies is complete, findings are made available to contribute to the body of literature on peer review and program design. Fellowships – completed (www.cihr-irsc.gc.ca/e/47940.html) Knowledge Synthesis Pilot #1 – completed (www.cihr-irsc.gc.ca/e/48940.html); Pilot #2 – underway Partnerships for Health System Improvement (PHSI) – underway Knowledge to Action – underway Improvements have already been implemented as a result of early pilot results: Development of a new rating scale for peer reviewers with more gradation at the higher levels. Establishment of a virtual chair/moderator role to shepherd sets of applications and ensure that online discussions are being held for applications with discrepant reviews. More comprehensive training material for applicants. More comprehensive training material for peer reviewers. Technology enhancements to ResearchNet to improve usability. 10

CIHR Open Reforms (2) Foundation and Project Schemes The 2014 Foundation Scheme 1st live pilot notice of decisions for Stage 2 will be released on May 15, 2015. Funding opportunities for the next round of competitions have been published: 2015 Foundation Scheme 2nd live pilot 2016 Project Scheme 1st live pilot The information in these funding opportunities and supporting documents may change based on the analysis of the results from ongoing pilots. College of Reviewers CIHR will begin to enroll College members, using a phased-in approach. CIHR will be coordinating with institutions to identify potential College members later this year. Senior leaders will also be recruited from various research communities to act as expertise cluster leads in the College. An expression of interest process will be launched in the coming months. 11

Thanks!