BC Ethics Harmonization Initiative: Brief overview & update

BC Ethics Harmonization Initiative: Brief overview & update

Model Review: Harmony in Research Ethics AE. provincial collaboration working towardResearch harmonizing ethical Sarah Bennett, BA, Island Health, Ethics andreviews Compliance Manager, Victoria, BC

for multi-jurisdictional research in BC Jean Ruiz, MA, Senior Research Ethics Analyst, University of British Columbia, Vancouver, BC Talk Objectives o Why working together is better o REBC Ethics Case o

Tangible resources and models o Tips for getting there o Challenges and celebrations Why Work Together? o o

o o Funding organizations are increasingly expecting it e.g. NIH, one board of record ethics review Research teams constructed across institutions for expertise and resources Institutions following the same guidelines: o TCPS2 (2014) Canada o Belmont Report, 45 CFR 46, 21 CFR 50, 56 etc - US o Declaration of Helsinki, ICH GCP - International o There are many more More interesting Fun!

Benefits o Building Relationships Collaboration across institutions o Consistency o True Facilitation versus Bureaucracy (Administrivia) o

Better Resources o Increase Access to Expertise http://www.urbandictionary.com/define.php?term=administrivia Our Case A provincial collaboration working toward harmonizing ethical reviews for multi-jurisdictional research in BC Research Ethics BC includes academic and health sector stakeholders from across the province. REBC is open to new partners joining.

o University of Victoria Current Institutions: o Simon Fraser University o Fraser Health o Interior Health Interest Institutions: o Island Health o First Nations Health Authority o Northern Health o Emily Carr University of Art + Design o Children and Womens Hospital o British Columbia Institute of Technology o BC Cancer o Thompson Rivers University o Providence Health Care

o Kwantlen Polytechnic University o University of British Columbia (including o Langara College BREB, CREB, and UBC-O) o University of Northern BC History 2007 2010 Initial Planning & Consultation with stakeholders 2010 2011 Phase I SFU, UBC, UVIC proposal for collaborative ethics review process, MSFHR funding

2011 2015 Phase II Reciprocity agreement, REB relationships, working committees, advisory committee 2015 2017 Models for Minimal Risk and Above Minimal Risk studies are in place including Joint Certificate of Approval and Harmonized Post Approval Activities 2017-2018 Launch of the Provincial Research Ethics Platform (PREP)

Funding o MSFHR had provided key project management coordination support with funding of $1M 2011-2015 o Sustainability Grant has been provided until Feb. 2018 o Project management and coordination provided by SFU o Funding for the platform development at UBC REBC Setup from 2014 Senior Leaders o VP or designate with decision making authority for each partner institution o Senior Leaders Team is responsible for high level decisions regarding model adoption, technology solutions and sustainability Advisory Committee o Key people on the ground that deal with the day to day, e.g. REB

administrators and REB chairs Advisory Committee members represent: o Partner organizations o Geographical regions: North, Interior, Vancouver Island, Lower Mainland o Institutional perspectives: health authority, academic and research

o Roles: REB Chair, REB Administrator o Key areas of expertise: behavioural, clinical, minimal risk, above minimal risk Minimal Risk Model Researcher contacts their local REB BoR conducts review and provides draft provisos to other REBs

Other REBs provide provisos based on local requirements PREP algorithm determines Board of Record (BoR) BoR works with researcher to address provisos Local REB engages other REBs to decide BoR &

level of risk BoR approves & provides docs to other REBs & researcher Above Minimal Risk Researcher contacts their local REB BoR coordinates a Full Board review, including at least one rep from each other REB involved

Other REBs participate in Full Board or provide provisos based on local requirements PREP algorithm determines Board of Record (BoR) BoR works with researcher to address provisos Local REB engages other REBs to decide BoR &

level of risk BoR approves & provides docs to other REBs & researcher www.researchethics.ca Platform oCommon Interface oMaintain

REB Autonomy oCommon application forms (Clinical and Behavioural) oIncrease oTracking, efficiencies Reports, and Metrics Vision o

A continued collaborative BC Ethics Process o Maximal reciprocity o Expanding use of the models outside of partner institutions to smaller institutions o Capacity building

o Network of expertise Where to start [text] A provincial collaboration working toward harmonizing ethical reviews for multi-jurisdictional research in BC Institutional Warriors Really where to start o

With a problem o Our problem: Multiple ethical review hoops that BC researchers were having to jump through to do research o Our solution: o A single system for review for all of BCs health authorities and major academic institutions

Workshop Slide Activity! What is your problem? Think about an issue in your work that might benefit from a harmonized approach What are the pinch points? What is your solution? Who are your institutional warriors? How to build relationships across an institution or institutions? Start line o Be realistic about where each institution is

o Not everyone will be at the same starting point and that needs to be ok o Identify key players o Commitment from individuals members o

Institutional support o Technology Vulnerability? Key Principles o o o o Collaborative governance

Trust and respect High standards of ethical review Sustainability Objectives o o o Facilitate reciprocity between BC institutions Improve timeliness and efficiency of ethical review

processes Improve system effectiveness Build a community Measure your progress o Determine what is success and how you will measure it o Consider administrative and end users time o

Dont collect things that you dont need o Use qualitative and quantitative measures o Consider having an expert do this piece Dont shy away from differences o Academic versus health authority perspectives and

expertise o Differing policies & administrative processes across REBs o Separation of operational approvals & grants from research ethics process o Technology platform learning curve

Must haves o Patience! o Good people o Time to build relationships o

Willingness to be flexible o Listen to feedback from all stakeholders o Standardize language and processes o Communication! Conclusions

o Fail early, fail often o What doesnt work, let it go o Vulnerabilities (roles, institutions, reason for project e.g. everyone losing their jobs) o

Find common ground in policies, guidelines, and stories from the administrative trenches Compared to previous applications that I have made involving multiple jurisdictions, this has been extremely smooth. - A happy researcher Impromptu Rock Choir, Aint No Mountain High Enough: https://www.youtube.com/watch?v=3sw7R4gj1hQ Sarah Bennett, Chair - REBC Manager, Research Ethics & Compliance Island Health

250.519.6706 [email protected] Jean Ruiz, Unit Director - REBC Senior Research Ethics Analyst UBC 604.827.5310 [email protected]

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