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BCEHI Phase II Strategic Plan: 2011‐2015 version: Sept 12/12 Page 1

BCEHI PHASE II Strategic Plan: 2011‐2015

SECTION A ‐ LEADERSHIP 2

A.1 BCEHI OVERVIEW 2 FIGURE 1. ORGANIZATIONAL CHART 2 A.2 KEY LEADERSHIP ROLES 2 A.3 GOVERNANCE AND ACCOUNTABILITY STRUCTURES AND PROCESSES 3

SECTION B – THE BC ETHICS HARMONIZATION INITIATIVE (BCEHI) STRATEGIC PLAN 4

B.1 CONTEXT 4 FIGURE 2. ETHICS HARMONIZATION IN BC: TIMELINE 4 B2: NEXT STEPS: THE PLAN FOR PHASE TWO (AUGUST 2011 – 2015) 6 COMPONENT #1 – STRENGTHENING THE INITIATIVE THROUGH NETWORKING AND LEADERSHIP 7 COMPONENT #2 – CONTINUED AND ENHANCED TESTING & EVALUATION TO DEVELOP EFFECTIVE AND SUSTAINABLE COLLABORATIVE REVIEW MODELS AND RESOURCES 8 COMPONENT #3 – CAPACITY BUILDING AND EDUCATION TO IMPLEMENT AND SUSTAIN THE INITIATIVE 10

SECTION C – BCEHI RETURN ON INVESTMENT 11

SECTION D – EVALUATION 13

FIGURE 3. LOGIC MODEL 14

APPENDIX A – STEERING COMMITTEE PARTNERS 15

DESCRIPTION OF ETHICAL REVIEW ACTIVITIES 15

APPENDIX B – GLOSSARY 17

SUMMARY OF ABBREVIATIONS 17 GLOSSARY OF KEY TERMS 17�

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directing research ethics boards, and executive functioning in academia, health services delivery, and government. Terms of reference for the Steering Committee were approved in March 2012. Director: The Director, housed at one of the Consortium organizations, is supported by funding from MSFHR and in‐kind contributions from one of the Consortium organizations. The Director reports to the Steering Committee, and is responsible for the overall management of the BCEHI which includes the following activities: implements and oversees the work plan for the BCEHI; supports the work and decision‐making of the Steering Committee and subsequent working groups; liaises with project consultants (legal, communications, technical) and senior leaders in research and research ethics; manages communications, knowledge transfer & exchange activities; manages BCEHI budget including liaison with UBC Finance regarding the receiving and distribution of funding and related reporting requirements of MSFHR; and oversees the evaluation of BCEHI and ensures feedback is incorporated into strategic planning and operations. Working Groups: Working Groups are comprised of representatives from the Consortium organizations and interested members of the health research ethics community. These groups are created for specific purposes to achieve the goals and objectives of the Initiative via the work plan. The Director will support the working groups.

A.3 Governance and Accountability Structures and Processes

UBC serves as the host institution for the MSFHR grant and provides financial accountability through standard institutional polices for financial management of contract research initiatives. Ongoing consultations with BC stakeholders reinforce that the organizing principle for the Initiative – a partnership based on collaborative governance allowing voluntary, phased‐in participation – is a pre‐requisite for any BC ethics harmonization initiative. The governance model for Phase Two attempts to parallel the concept of proportionate approach to research ethics review (i.e. the level of review is determined by the level of risk presented by the research) by aiming to harmonize the academic and health authority REBs tasked with the largest responsibility for overseeing health research taking place in the province. • During the first half of Phase Two (2011/12 – 2012/13), BCEHI’s focus will remain on

reinforcing trust and developing common processes and agreements between the current Consortium members. It is envisioned that additional organizations will be involved via the iterative model‐building process and working groups. Formal signatories to and supporters of the BCEHI may increase at any point during the four‐year funding period.

• During the second half of Phase Two (2013/14 – 2014/15), we hope that BCEHI participation in terms of formal signatories and support will have expanded to include the majority of BC institutions involved in multi‐jurisdictional health research (for example, Trinity Western University, BCIT, Selkirk College). As additional institutions join the BCEHI, a representative from their institution will be entitled to join the Steering Committee, with the expectation each new signatory will provide in‐kind support through their participation and in keeping with the terms of reference of the Steering Committee.

The proposed governance model enables each institution fair representation in the efforts to meet the goals of harmonizing ethical reviews for multi‐jurisdictional health research in BC. This model

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population, and health services research, with the following key deliverables: (1) establish a Health Research Reciprocity Pilot Project working group; (2) conduct at least two pilot projects involving collaborative review processes to evaluate their effectiveness; and (3) ascertain obstacles and challenges to implementation of a “one‐board‐of‐record agreement” among all key health research stakeholder institutions, and propose options for overcoming these challenges. The broader objectives described in the original Phase One RFP were deferred until significant progress was made towards these three deliverables. The BC ethics harmonization effort is unique among efforts in other provinces in that activities such as shared educational resources, in addition to reciprocity and efficiency, are important elements of the concept of a provincial model.

Key Accomplishments and Lessons Learned From Phase One

A number of important steps were taken in pursuit of the agreed‐upon deliverables during Phase One. Key achievements in Phase One of the BC Ethics Harmonization Initiative (BCEHI), which ran from October 2010 to mid‐2011, include the completion of three collaborative review pilot projects, utilizing different review processes and technologies, an Open House in February 2011 to engage the BC research community, and a focus group with representatives from BC Pharma, held jointly with BC CRIN (BC Clinical Research Infrastructure Network) in May 2011. These accomplishments were reported to MSFHR in the Phase One Report and Recommendations for Moving Forward. In addition, a number of lessons were identified to inform future phases of the Initiative.

How Phase One Informs Phase Two

• Participation in these projects has and will continue to build trust between REBs and institutions conducting health research in the province.

• The two technology systems utilized (RISe and Share Point) were found to be generally acceptable.

• Recruiting suitable research projects to match the specific learning objectives of the pilot in the short timeframe was a challenge.

• Recommendations for Phase Two include: 1) Shift from a pilot project framework to an iterative model‐building testing and

evaluation process. 2) Fine‐tune the criteria for each model to be more specific as to what needs to be

learned and how they build from one another. 3) Allow more time to select the ‘correct’ studies for model testing. 4) The collaborative model‐building process is labour‐intensive and requires a project

manager / coordinator. 5) BCEHI resources should be allocated to the participating REBs to offset a portion of the

costs inherent in harmonization so that participation can be accomplished without negatively impacting upon the day‐to‐day activities of participating REBs. One long‐term solution would be a separate BCEHI administration and process path for multi‐centre studies that would be separately resourced.


B2: Next Steps: The Plan for Phase Two (August 2011 – 2015)

Emerging Reciprocity in BC ‐ Reciprocity agreements are needed to support harmonization. One of the major achievements to date is the input and endorsement of many REB Chairs, members and administrators. Coordinated and collaborative reviews have been conducted without formal agreements in place. In order to increase efficiencies, however, a higher level of reciprocity needs to be achieved. BCEHI will explicitly define and outline a vision of reciprocity during Phase Two and obtain formalized expression of support from senior leadership of key stakeholders. The long‐term goal is to make BC an attractive environment in which to do health research that involves multiple sites, regions, and populations. Key principles

• Collaborative governance allowing voluntary, phased‐in participation • Recognize the independence of BC’s research ethics boards and the autonomy of their

supporting institutions • Build on existing technology where possible to enable our objectives • Continue our high standard of ensuring ethical conduct of research involving humans • Strive for evolution and sustainability of harmonization processes

Priority objectives

• To improve timeliness and efficiency of ethical review processes • To improve the system effectiveness for health research ethics • To facilitate maximal reciprocity arrangements between BC institutions for the ethical

review of health research conducted within BC In keeping with BCEHI’s phased‐in iterative planning principle, the proposed work plan for the coming four years is divided into halves, with the focus of this proposal on 2011‐2013 activities: • During the first half of Phase Two (2011/12 – 2012/13), BCEHI’s focus will be on enhanced

testing and evaluation of collaborative review models and agreements. Deliverables for the second half will be developed and refined and such progress towards this strategic planning will be explained in MSFHR Annual Reports.

• During the second half of Phase Two (2013/14 – 2014/15), BCEHI’s focus will shift to implementing the Made‐for‐BC collaborative review model for multi‐jurisdictional health research, ensuring sustainability of the model, and evaluation of the Initiative as a whole.

We propose to build on Phase One accomplishments by mapping out the activities through the following three components and driven by a series of inter‐connected working groups:

1. strengthening the Initiative through networking and leadership 2. continued and enhanced testing and evaluation to develop effective and sustainable

collaborative review models and resources, and 3. capacity building and education to implement and sustain the Initiative.

BCEHI activities will be developed by the steering committee and working groups that are formed to focus on key areas, and resourced by MSFHR funding and in‐kind contributions by partner


organizations and others. The Director will serve as the coordinating liaison, to ensure that the working groups capitalize on important synergy between the groups by linking to and informing the other components of the Initiative (Figure 1 on Page 2 depicts these interactions). The steering committee and working groups will work with the Evaluation Consultant on collecting data and evaluating the effectiveness of their committee and/or group and its activities, as per the Evaluation Plan (see Section D).

Component #1 – Strengthening the Initiative through Networking and Leadership

Networking and leadership are critical to build trust between people and institutions. In the absence of mechanisms such as a national system of accrediting research ethics boards, the model building strategy and other collaborative processes are intended to continue aligning policies, procedures, practices, and vision as we move toward maximal reciprocity. Networking and leadership activities will be led through the Steering Committee.

Key Steering Committee areas of responsibility (as a whole and/or subcommittees) include the following: Terms of Reference (ToR), Strategic and Operational Planning, Evaluation and Reporting Fiscal Responsibility and Oversight, and Communications ‐ Engagement of Research Community. As well, the steering committee will provide leadership on the development of reciprocity agreements across the partners, and the overall development of a collaborative review model.

Reciprocity Agreements The objective of maximal reciprocity is to facilitate an efficient and timely review process supported by reciprocity agreements that reduce the need for duplicate review wherever possible. Stakeholders agree that full or partial reciprocity is feasible. The trend toward enhanced reciprocity is growing – including an agreement between UBC and other western province universities, and similar developments between some institutions in BC. The phased approach favoured by BC stakeholders is to recognize the independence of BC’s research ethics boards and the autonomy of their supporting institutions, and to implement full reciprocity agreements for multi‐centre studies where possible. Where full reciprocity is not feasible, partial reciprocity arrangements would be implemented. These would encompass a combination of models, including sharing ethical reviews and associated documents or conducting collaborative reviews with partner institutions employing BCEHI technology tools to store and share reviews in a secure manner. Key activities may include:

• Define “reciprocity” and identify mechanisms to facilitate reciprocity agreements • Develop a survey to determine existing reciprocity agreements and collaborative review

arrangements in BC and the needs of the BC REB community • Work with consortium partners (including legal consultants if necessary) to negotiate letters of

agreement • Post library of agreements in a shared document repository


Component #2 – Continued and Enhanced Testing & Evaluation to develop Effective and Sustainable Collaborative Review Models and Resources A number of activities will take place as part of an iterative model‐building testing and evaluation process. Three key areas are envisioned for working groups to develop distinct but linked streams of this process.

(1) Collaborative Model Development (oversight and development by steering committee)

Key activities may include:

• Develop model development plan with specific criteria for each model iteration • Develop collaborative, iterative model strategy; test models; produce a detailed plan (including

legal and financial agreements and technology requirements) to circulate to BC REB community for review and possible implementation

• Implement and evaluate “Made‐for‐BC” collaborative review model(s), and focus on sustainability planning

(2) Technology Tools One of BCEHI’s key principles is to build on existing technology and infrastructure where possible, to enable our objectives. Technology tools are critical in order to facilitate an effective, coordinated, value‐added approach to research ethics review harmonization. Two potential technological platforms for harmonized ethical reviews in BC under evaluation are an Ethics Exchange Portal and an IT Platform.

Ethics Exchange Portal (EEP) An Ethics Exchange Portal (EEP) is a secure on‐line site that would be fully accessible by BC’s REB community. The Share Point site developed during Phase One serves as a (temporary) document repository. An EEP would be a more sophisticated tool to provide a secure document repository allowing REBs to view other REB documentation, including certificates of approval. It would also act as an e‐library for REBs to access educational and training materials, as well as to share policies, procedures and best practices. The EEP could have an administrative role, for example: maintain and manage a province‐wide list of REBs, institutions, peer reviewers, areas of specialization, and contact information; and generate statistics such as number of multi‐jurisdictional studies, participating REBs. IT Platform Although a universal solution such as creating a shared system on a common IT platform such as Click Commerce (e.g. UBC RISe) with identical workflow across REBs offers advantages with respect to reciprocity, the Phase One learning reinforces the need to be sensitive to study context and differing institutional ethics review cultures. As the development and maintenance costs of a single IT platform are high, without substantial government support or alternate funding, achieving the objective of maximal reciprocity using a single IT platform is not feasible.


One IT option to be explored further to enable collaborative ethics review of some multi‐jurisdictional health research studies involving the eight institutions represented currently on the BCEHI steering committee is to leverage UBC’s RISe (Researcher Information Service) system. During Phase One of the BCEHI, RISe was reconfigured to create a “guest reviewer” role that REB administrators and reviewers from outside the UBC system, could be granted access to participate in the review of specific multi‐centre studies. RISe is based upon the Click Commerce platform, which is also used in a large number of US institutions and an increasing number in Canada such as the Universities of Calgary and Alberta, Ontario Cancer Research Ethics Board and Alberta ethics harmonization initiative (in development).

The phased approach favoured by BC stakeholders, in which the long term goal is to implement maximal reciprocity agreements for multi‐centre health studies, is premised on employing technology – either a newly created or revised EEP and/or IT platform – to store and share health research ethics review documents in a secure and easily accessible manner. A working group, in conjunction with technical consultants, will fully investigate technology tools to meet the needs of BC’s ethics community, be feasible and capable of being developed within the Phase Two budget and sustained into the future. Key activities may include:

• Develop a needs assessment survey to confirm the need for a EEP and/or IT Platform, and define the parameters of the system

• Determine the costs and time‐lines for contractors to assist with the overall project management of BCEHI technology tools i.e. business analysis, project design, data warehouse design, software deployment, education and training, ongoing maintenance an hosting costs

• Propose an implementation work plan for the second half of Phase Two including the long term EEP and/or IT Platform implementation requirements including costs and the responsibilities of stakeholder commitment to fund on an ongoing basis

(3) Forms and Templates

Rationalization of Forms, Development of Common Templates Related to reciprocity is the collection of common data along with the development of agreements as to what information must be included in application and consent forms. Common requirements for specific data will contribute to the acceptance of extra‐institutional ethics reviews by assuring each institution that the appropriate data has been collected. The Phase One pilot projects demonstrated that adoption of identical forms by each participating institution is not a prerequisite for harmonized review, although it would benefit researchers conducting multi‐jurisdictional studies. Forms content can, however, be rationalized, and consensus reached on what information comprises a ‘complete’ application. It may be possible to develop certain consolidated forms, such as informed consent forms, specific to multi‐jurisdictional biomedical/clinical research on the one hand and social science/ humanities/behavioural health research on the other.



• Reach consensus on required content for application forms • Develop stakeholder support for the creation of a limited set of common forms used in health

research • Propose an implementation plan for the second half of Phase Two including the continuation

and development of forms and templates for multicentre research

Component #3 – Capacity Building and Education to Implement and Sustain the Initiative The day‐to‐day requirements of supporting an REB represent a significant investment for all institutions that establish them. Without adequate resources including staff with appropriate time and expertise, a weakening of compliance and oversight is inevitable. All REBs in BC would benefit from adopting continuous quality improvement measures to continue their high standard of protecting research participants, adapt to changing research and regulatory environments, build capacity in their research offices to maintain vibrant research ethics boards and engaged board members. In addition, part of research oversight is a responsibility by institutions and their REBs to ensure that REB members as well as investigators and research team members understand ethical obligations associated with the conduct of human research. Courses such as the new (2011) TCPS2 online tutorial are helpful and increasingly required in Canada, but continuing REB members and staff also require ongoing educational programs to remain current on best practices in a changing guidance and regulatory landscape. One of the challenges across Canada is that there is no accreditation (or similar process) for REB performance. The result is a lack of inter‐institutional trust, common training standards, and interchange between committees. Creating a provincial structure by which there are agreed‐upon best practices (or even established REB standards) and shared training on these best practices/standards will contribute to a more effective research ethics system. This would promote both the development of common approaches to important ethical issues and develop personal relationships at the membership level between REBs to enhance trust and the sharing of expertise. Technology tools can facilitate this process but face‐to‐face exchange between committees is also critical to build relationships.

Education & Best Practices


• Identify educational needs of the BC REB Community • Identify online and other educational tools for use and investigate the feasibility of developing

needed tools • Explore the development of a provincial structure that will support the shared training of

members from different REBs


Communications Tying together all BCEHI activities and included under capacity building is the Communications Plan. The purpose of the communications plan is to communicate the work and goals of BCEHI in a way that will: heighten the profile and public visibility of the Initiative; articulate and demonstrate the benefits of harmonized research ethics for BC stakeholders; create consistency in key messages; increase the flow of information amongst and between the partners and key stakeholder groups; and provide interested individuals/ groups with opportunities and reasons to get involved. Target groups include individuals already connected to BCEHI (e.g. – those on committees, working groups, attendees at 2011 Open House), individuals in BC not directly involved with/aware of BCEHI (researchers, REB members, research administrators, leaders in health and education), and external stakeholders including those from other jurisdictions.

SECTION C – BCEHI RETURN ON INVESTMENT

Research activity in BC has expanded dramatically over the last decade. Virtually all research related to humans requires ethics approval to proceed. Increasing collaboration by researchers – inter‐provincially, nationally and internationally – is the norm. BC is not alone in the ethics harmonization endeavour. As evidenced by recent changes internationally and in Alberta, Newfoundland, Nova Scotia and Ontario, many jurisdictions are striving to streamline their health research ethics processes. Observation of the progress in other jurisdictions reveals similar challenges in translating high‐level plans into procedures. Networking with other jurisdictions will provide important lessons that will contribute to our success. As part of the Evaluation Plan, BCEHI will track and articulate the benefits and costs of ethics harmonization to our stakeholders according to identified measures (see Section D). Without the MSFHR’s vision and funding to support the BCEHI, the current research ethics system would be slow to change. Though many of our institutions have collaborated to a certain degree, ethics harmonization requires a structure that enables, supports, and rewards sustainable and systematic collaboration on ethics review. Each institution has its own processes, systems, priorities, and cultures. Every aspect of the BCEHI is directed toward adding value by improving timeliness and efficiency of ethical review processes, improving system effectiveness for health research ethics, and facilitating maximal reciprocity arrangements between BC institutions for the ethical review of health research with human participants conducted within BC.

Linking BCEHI Priority Objectives to Return on Investment

Improved timeliness and efficiency of ethical review processes Timeliness and efficiency of the adjudication and approval process for multi‐centre research are two commonly cited indicators of how well the overall research ethics process is managed. Improved timeliness (e.g. turnaround time) and efficiency (e.g. fewer duplicate reviews) enhance investigator and REB productivity thereby creating a more competitive research environment. BCEHI is confident that timeliness and efficiency for multi‐centre studies will improve as a result of implementing the “Made‐for‐BC” collaborative review model(s) built on existing technology.


Rationalization of ethics application and consent forms will aid reciprocity as well as reducing the workload for those investigators having to apply at multiple centres.

Improved system effectiveness for health research ethics Capacity building – strengthening the REB community – in BC through collaborative endeavors ranging from new collaborative review models and IT to the identification and sharing of best practices, reviewer expertise, and educational tools, will provide support for improvement and system effectiveness. Important system effectiveness returns on investment include increased consistency of ethical review in compliance with TCPS2 across REBs, continuous quality improvement measures to adapt to changing research and regulatory environments, increased recruitment, retention, and expertise of REB members, a more evenly allocated burden on individual REBs, stronger links between the research, practice and research ethics communities, and improved access to research‐based health care throughout British Columbia.

Maximal reciprocity Achieving maximal reciprocity arrangements between BC institutions for the ethical review of health research conducted within BC is considered to be the largest lever to improve system efficiency and effectiveness. A research ethics system enabled by reciprocity between institutions would reflect a high degree of trust and common expertise that was nurtured and developed over the funded period of the BCEHI and sustained in the province post‐funding.

A More Competitive and Innovative Health Research Environment Long‐term, BC wins if our province is an attractive environment in which to conduct health research that involves multiple sites, regions, and populations. BCEHI predicts more multi‐centre health research will be initiated in BC, and this is perhaps the ultimately quantifiable return on investment of harmonizing ethical reviews. The research environment directly and indirectly benefits research participants, researchers, research ethics boards, research and health organizations, and citizens. With increasing reliance on evidence‐based medicine and health system research, a growing base of BC research institutions and biotech organizations, health research will continue to expand and increase in economic importance to BC. An attractive research environment that can compete for high quality health research and clinical trials is often cited as a primary reason to justify substantial investment in harmonization initiatives. An innovative health research environment appeals to world‐class researchers, trainees, educators and health providers who may consider relocating to BC. Closer links between research, education and practice can result in improved access to research‐based health care throughout the province, which is an important link to better health status. Indirect benefits from industry‐sponsored research benefit British Columbians by providing revenue to fund public research, and early access for patients/research participants to new drugs and therapies. Overall, the BCEHI will promote more multi‐centre health research and make BC a more competitive and innovative health research environment. This shift may also raise BC’s influence on national and international research issues. The contributions of the BCEHI will continue to pay off long after the Initiative is completed.


SECTION D – EVALUATION

BCEHI’s Evaluation Plan is an important aspect of the overall activities. It will provide critical feedback regarding future strategic and operational plans that will allow BCEHI to reach its objectives. The Evaluation Plan will aim to gather quantitative and qualitative data in order to understand how effective the BCEHI has been in moving forward and carrying out the activities outlined in the proposal and subsequent annual work plans, determine what difference BCEHI made in relation to the priorities it was designed to address, and examine what BCEHI could have done differently to have a greater impact. Although the logic model attempts to address short, medium and long‐term evaluation objectives, it may not be possible to measure long term impacts in four years. The Evaluation Plan will be developed in the fall of 2012 and reviewed annually, in conjunction with the logic model, as part of the annual planning process.

Baseline Evaluation Measures Phase II activities have been mapped out through three components: networking & leadership, collaborative review models, and capacity building & education. In terms of evaluating the networking and leadership component, data collected will include number of representatives on steering/working groups, level of engagement, numbers of common policies and procedures, and an analysis of any signed reciprocity agreements. In terms of evaluating collaborative review models, data collected will include turn‐around time, number of total applications/forms for ethics review, number of multi‐centre reviews, number of duplicate reviews, numbers of multi‐centre health research projects in BC, and an analysis of the pilot projects. In terms of evaluating capacity building and education, data collected will include the number of educational/ training programs delivered in the year preceding start of the initiative, changes to consent forms and protocols, the evolution towards shared/common education/training resources, and the impact of BCEHI on multi‐centre research in non‐health areas.

Follow‐up Evaluation Measures At the end of each fiscal year, evaluation findings will be fed back to BCEHI leaders and members in order to support discussions and decisions on future activities. Given the phased‐in approach based on an iterative model develop strategy and an expanding stakeholder base; we fully expect modifications to the Initiative workplan and timeline. These findings and subsequent modifications of the Initiative plan will be presented in the annual report to MSFHR.

Specification of Milestones The milestones for Phase Two can be found in Section B and will be further developed with finalization of the Evaluation Plan and logic model.

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APPENDIX A – STEERING COMMITTEE PARTNERS Description of Ethical Review Activities The Consortium for this proposal is representative of health research ethics activity in British Columbia and is comprised of the four largest universities (Simon Fraser University, University of Northern BC, University of BC, University of Victoria) and the four health authorities not represented under the UBC‐affiliated REB agreement (Fraser Health, Interior Health, Northern Health, Vancouver Island Health Authority). All Research Ethics Boards (REBs) comply with the Tri‐Council Policy Statement on Ethical Conduct for Research Involving Humans 2 (TCPS2). The following description of the Consortium’s ethical review activities demonstrates that the Consortium collectively provides at least 80 percent of human participant ethics reviews in BC. (a) Universities Simon Fraser University (SFU) SFU has one REB. The research reviewed by the SFU REB covers almost all categories of research with the exception at this point in time of clinical trials. The SFU REB is fully compliant with the requirements of the major national and international regulations and guidelines pertaining to ethical review of research. The annual number of new applications for January to December 2010 was 486 – 481 of these were minimal risk studies, 5 designated non‐minimal. The SFU REB meets once a month. The Office of Research Ethics reports to the Vice President Research and consists of a Director and 3.5 full‐time staff. University of British Columbia (UBC) UBC’s has six REBs: BC Cancer Agency REB; Behavioural REB (2 panels); Children’s and Women’s REB; Clinical REB; UBC‐Okanagan REB; and Providence Health Care REB. UBC’s affiliated REBs are independent committees which are supported financially by the Office of the Vice‐President Research and by their respective institutions. UBC’s REBs meet all of the requisite criteria for an authorized REB, pursuant to the TCPS2 the International Conference on Harmonization Good Clinical Practice Guidelines (ICH‐GCP’s) and the requirements of the US Department of Health and Human Services and the US Food & Drug Administration, as set out in the applicable US regulations. UBC’s REBs meet monthly, with the exception of the Behavioural and the Clinical REBs which meet twice a month. As at March 31st, 2011, UBC’s affiliated REBs combined oversee a total of 6,543 active applications. UBC’s affiliated REBs received 2,441 new applications in fiscal 2010‐11. 576 of these were full board, 1,865 were minimal risk. Between the 6 boards and the compliance / monitoring function UBC Research Ethics Office has 17 staff. University of Victoria (UVic) The University of Victoria has one Human Research Ethics Board (HREB), which includes a Joint UVIC/VIHA (Vancouver Island Health Authority) Research Ethics Subcommittee that operates separately from the main board. The major areas of research covered are social science, humanities, behavioural and health research. The Joint UVIC/VIHA subcommittee reviews research that is conducted within the auspices of VIHA (e.g., research involving VIHA patients or staff, or research conducted on VIHA premises). The UVIC HREB reviews research involving human biological materials, but neither the UVIC HREB nor the Joint UVIC‐VIHA Research Ethics Subcommittee reviews clinical trials. The main UVIC HREB board meets bi‐monthly on average from September to May (excluding December). Approximately 30% of the total new applications are reviewed by the convened full board. The balance of 70% is reviewed by delegated review to staff and REB co‐chairs. In 2010, UVIC reviewed 789 ethics applications. The Joint UVIC/VIHA Subcommittee has 5 members (4 faculty members and 1 graduate student), which meets 3 times a year. The Human Research Ethics staff consists of 3 full‐time employees, which supports the activities of the boards. University of Northern BC (UNBC) The mandate of the UNBC Research Ethics Board (REB) is to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants which is conducted under the aegis of the University, using the Tri‐Council Policy as the minimum standard. The REB is a Sub‐Committee of the Senate Committee on


Research and Graduate Studies, and holds 9 regular meetings per year. Between January and December 2010, 225 applications were received; 98% of these received full review, 2% expedited. The UNBC REB is supported by 2 part time staff. (b) Health Authorities Fraser Health (FH) Fraser Health has one REB that reviews clinical, health services and population health research conducted within the health authority, which includes all community programs/sites as well as 12 hospital sites (Abbotsford Regional Hospital and Cancer Care Centre, Burnaby Hospital, Chilliwack General Hospital, Delta Hospital, Eagle Ridge Hospital, Fraser Canyon Hospital, Langley Memorial Hospital, Peace Arch Hospital, Ridge Meadows Hospital, Royal Columbian Hospital and Surrey Memorial Hospital). The REB membership meets TCPS2, Health Canada and United States government requirements. The FHREB meets once per month. 104 new applications for ethical review were received between April 1, 2010 and March 31, 2011 – 33 were full board (32%) and 71 were delegated (68%). The Fraser Health Research Ethics Board (FHREB) has two co‐Chairs, and is supported by three staff, including the Department of Evaluation and Research Services Director and Administrative Assistant, and a 1.0 FTE Research Ethics Coordinator. Interior Health (IH) The Interior Health Authority REB is an independent multi‐disciplinary body for the review of all research involving human participants conducted under the auspices of IH, in IH facilities/ programs, or by IH staff. The IH REB meets 10‐11 times per year. In the fiscal year ended March 31, 2011, it received 44 new applications. Of these, 30% received full board review and 70% delegated review. The IH REB has an Affiliation Agreement with UBCO that allows researchers affiliated with either institution to conduct research in either institution using one application and receiving one certificate indicating approval using a harmonized review process. The IH REB currently has upwards of 90 Active Studies. The Human Research Ethics staff consists of 3 part time staff for a total of 1.2 FTEs (0.5 FTE Chair of the REB, 0.5 FTE Research Coordinator responsible for administrative functioning, and 0.2 FTE clerical support). Northern Health (NH) All research involving human participants that is conducted within NH, or by members of NH, must be reviewed and approved by the NH Research Review Committee in order to ensure that ethical principles and standards respecting the personal welfare and rights of research participants have been recognized and accommodated. The Committee is also directed to consider the impact of the research on the NH organization. The Committee adheres to the Freedom of Information and Protection of Privacy Act (FIPPA) and the TCPS2. The Committee meets 10 times per year (excluding the summer months). The Committee received 42 new applications between April 1, 2010 and March 31, 2011. Applications are delegated to two reviewers and are presented and discussed at monthly Committee meetings. Less than 10% of applications received require full board review. Applications involve primarily health services and population health research. Clerical and administrative support is provided by .2FTE Administrative Assistant time and .2FTE Research & Evaluation Manager time. Northern Health and UNBC have a coordinated research ethics review process for UNBC Faculty, staff and student research. Vancouver Island Health Authority (VIHA) The VIHA REB reviews all human research that is conducted by members of the VIHA or that involves VIHA facilities, patients, residents, clients, staff or resources. All reviews comply with the principles set out in the TCPS2 and clinical trial research must comply with ICH GCP. VIHA maintains two REBs to provide oversight of all human research conducted in VIHA. The Clinical REB meets 11 times per year to review applications for clinical trial research and other research that require review by medical specialists (approx 3 to 6 new applications/month). The Health REB meets 5 times per year (approx 2 to 4 new applications per month). In addition, the Joint UVic/VIHA Ethics Sub‐committee reviews applications for UVic faculty, staff and students who wish to conduct research in VIHA (approx 2 to 4 new Joint applications/month). Approximately 104 new applications were received last year, of these one‐third required full board review, two thirds delegated review. Two VIHA staff (a Research Ethics Assistant and a Research Ethics Coordinator) are dedicated to providing clerical and administrative and program support to the two REBs and the Joint Sub‐Committee.


APPENDIX B – GLOSSARY Summary of Abbreviations BCCRIN BC Clinical Research Infrastructure Network BCEHI British Columbia Ethics Harmonization Initiative EEP Ethics Exchange Portal FH Fraser Health Authority IH Interior Health Authority IT Information Technology MSFHR Michael Smith Foundation for Health Research NH Northern Health REB Research Ethics Board RISe Researcher Information Services System SFU Simon Fraser University TCPS2 Tri‐Council Policy Statement 2 UVic University of Victoria UBC University of British Columbia UNBC University of Northern BC VIHA Vancouver Island Health Authority WG Working Group Glossary of Key Terms

Consortium – The Consortium for this proposal is representative of health research ethics activity in British Columbia and is comprised of the four largest universities (Simon Fraser University, University of Northern BC, University of BC, University of Victoria) and the four health authorities not represented under the UBC‐affiliated REB agreement (Fraser Health, Interior Health, Northern Health, Vancouver Island Health Authority). Delegated (REB) review – Research Ethics Review conducted by one or more members of the REB as authorized by the REB; permitted for research that is not more than minimal risk, in the discretion of the REB. Full board (REB) review – Research Ethics Review conducted by the fully convened research ethics board; is the default requirement for research involving humans. Harmonization – an effective, coordinated, value‐added approach to multi‐jurisdictional ethics review Health Research – Creation of new knowledge and its translation into improved health for humans, more effective health services and products, and a strengthened health‐care system (adapted from CIHR mandate). Individual REBs determine what constitutes “health research” according to their institutional policies and procedures. Local organizational review – health authorities in BC have organizational resource and/or impact review and approval process(s). These are not ethics review processes, but occur simultaneously with REB review and are required before research can commence within a health authority. This is referred to in a variety of ways across organizations. Minimal risk research – Research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in the aspects of their everyday life that relate to the research. (TCPS2)


Multi‐jurisdictional research – Research requiring review by more than one BC institution’s REB in accordance with the provisions of the TCPS2 and the institutional policies of the BC institution. Note: may be referred to as multi‐centre, multi‐site, multi‐institutional, multi‐organizational Maximal Reciprocity – The highest level of reciprocity acceptable to an institution for its ethical review requirements, based upon the relationship of the institutions to each other, the perceived risks of the study(s), and institutional policies.

• Full/Straight Reciprocity – Institutions accept the research ethics reviews of each other’s REBs, without the need for a subsequent re‐review at a delegated or other level.

• Partial Reciprocity – Institutions enter into arrangements involving some combination of collaborative review, sharing of documents, and/or subsequent delegated review. Possible arrangements fall somewhere along a continuum ranging from full to none.

Reciprocal research ethics board (REB) review – A mutual arrangement between institutions that, subject to an agreed upon level of oversight, permits research being conducted under the auspices of one of the participating institutions to be reviewed and approved by one of the other participating institution’s REBs. Reciprocity agreement – The formal agreement/document between institutions, that validates and enables reciprocal review and/or other research ethics board collaborative review models. Research ethics board (REB) – A body of researchers, community members, and others with specific expertise (e.g. in ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all research involving humans conducted within the institution’s jurisdiction or under its auspices. (TCPS2) RISe System – UBC’s online research administration tool (Researcher Information Services) that aids researchers and administrators to manage applications online via a completely transparent process that can be tracked through to approval, certification or awarding of funds. The software platform for RISe is Click Commerce. Share Point – a Microsoft software product that provides a secure online environment for collaboration among multiple people and organizations

BC Et H arm onization Initia tive PHASE II S an...BCEHI Phase II Strategic Plan: 2011‐2015 version: Sept 12/12 Page 1 BCEHI PHASE II Strategic Plan: 2011‐2015 SECTION A ‐ LEADERSHIP

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