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Model Review: Harmony in Research Ethics

Model Review: Harmony in Research Ethics. E. Sarah Bennett, BA, Island Health, Research Ethics and Compliance Manager, Victoria, BC Jean Ruiz, MA, Senior Research Ethics Analyst, University of British Columbia, Vancouver, BC. Talk Objectives. Why working together is better REBC Ethics Case

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Model Review: Harmony in Research Ethics

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  1. Model Review: Harmony in Research Ethics E. Sarah Bennett, BA, Island Health, Research Ethics and Compliance Manager, Victoria, BC Jean Ruiz, MA, Senior Research Ethics Analyst, University of British Columbia, Vancouver, BC

  2. Talk Objectives • Why working together is better • REBC Ethics Case • Tangible resources and models • Tips for getting there • Challenges and celebrations

  3. Why Work Together? • 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: • TCPS2 (2014) – Canada • Belmont Report, 45 CFR 46, 21 CFR 50, 56 etc… - US • Declaration of Helsinki, ICH GCP - International • There are many more • More interesting  Fun!

  4. Benefits • Building Relationships – Collaboration across institutions • Consistency • True Facilitation versus Bureaucracy (‘Administrivia’) • Better Resources • Increase Access to Expertise

  5. http://www.urbandictionary.com/define.php?term=administrivia

  6. Our Case

  7. Research Ethics BC includes academic and health sector stakeholders from across the province. REBC is open to new partners joining. Current Institutions: Fraser Health Interior Health Island Health Northern Health Children and Women’s Hospital BC Cancer Providence Health Care University of British Columbia (including BREB, CREB, and UBC-O) University of Northern BC University of Victoria Simon Fraser University Interest Institutions: First Nations Health Authority Emily Carr University of Art + Design British Columbia Institute of Technology Thompson Rivers University Kwantlen Polytechnic University Langara College

  8. History

  9. Funding • MSFHR had provided key project management coordination support with funding of $1M 2011-2015 • Sustainability Grant has been provided until Feb. 2018 • Project management and coordination provided by SFU • Funding for the platform development at UBC

  10. REBC Setup from 2014 • Senior Leaders • VP or designate with decision making authority for each partner institution • Senior Leaders Team is responsible for high level decisions regarding model adoption, technology solutions and sustainability • Advisory Committee • Key people on the ground that deal with the day to day, e.g. REB administrators and REB chairs

  11. Advisory Committee members represent: • Partner organizations • Geographical regions: North, Interior, Vancouver Island, Lower Mainland • Institutional perspectives: health authority, academic and research • Roles: REB Chair, REB Administrator • Key areas of expertise: behavioural, clinical, minimal risk, above minimal risk

  12. Minimal Risk Model PREP algorithm determines Board of Record (BoR) Researcher contacts their local REB Local REB engages other REBs to decide BoR & level of risk BoR conducts review and provides draft provisos to other REBs BoR works with researcher to address provisos BoR approves & provides docs to other REBs & researcher Other REBs provide provisos based on local requirements

  13. Above Minimal Risk PREP algorithm determines Board of Record (BoR) Researcher contacts their local REB Local REB engages other REBs to decide BoR & level of risk BoR coordinates a Full Board review, including at least one rep from each other REB involved BoR works with researcher to address provisos BoR approves & provides docs to other REBs & researcher Other REBs participate in Full Board or provide provisos based on local requirements

  14. www.researchethics.ca

  15. Platform • Common Interface • Maintain REB Autonomy • Common application forms (Clinical and Behavioural) • Increase efficiencies • Tracking, Reports, and Metrics

  16. Vision • A continued collaborative BC Ethics Process • Maximal reciprocity • Expanding use of the models outside of partner institutions to smaller institutions • Capacity building • Network of expertise

  17. Where to start [text]

  18. Institutional Warriors…

  19. Really where to start • With a problem • Our problem: • Multiple ethical review hoops that BC researchers were having to jump through to do research • Our solution: • A single system for review for all of BC’s health authorities and major academic institutions

  20. 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?

  21. Start line… • Be realistic about where each institution is • Not everyone will be at the same starting point and that needs to be ok • Identify key players • Commitment from individuals members • Institutional support • Technology

  22. Vulnerability?

  23. Key Principles • Collaborative governance • Trust and respect • High standards of ethical review • Sustainability Objectives • Facilitate reciprocity between BC institutions • Improve timeliness and efficiency of ethical review processes • Improve system effectiveness

  24. Build a community

  25. Measure your progress • Determine what is success and how you will measure it • Consider administrative and end users time • Don’t collect things that you don’t need • Use qualitative and quantitative measures • Consider having an expert do this piece

  26. Don’t shy away from differences • Academic versus health authority perspectives and expertise • Differing policies & administrative processes across REBs • Separation of operational approvals & grants from research ethics process • Technology platform learning curve

  27. Must haves • Patience! • Good people • Time to build relationships • Willingness to be flexible • Listen to feedback from all stakeholders • Standardize language and processes • Communication!

  28. Conclusions • Fail early, fail often • What doesn’t work, let it go • Vulnerabilities (roles, institutions, reason for project – e.g. everyone losing their jobs) • Find common ground in policies, guidelines, and stories from ‘the administrative trenches’

  29. Compared to previous applications that I have made involving multiple jurisdictions, this has been extremely smooth.” - A happy researcher

  30. Impromptu Rock Choir, Ain’t No Mountain High Enough: https://www.youtube.com/watch?v=3sw7R4gj1hQ

  31. Sarah Bennett, Chair - REBC Manager, Research Ethics &Compliance – Island Health 250.519.6706 elizabeth.bennett@viha.ca Jean Ruiz, Unit Director - REBC Senior Research Ethics Analyst – UBC 604.827.5310 jruiz@bcahsn.ca

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