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Open Access-Canadian Harmonized REB SOPs ARE OUT OF THE BOX!!!

Explore the role of harmonized REB SOPs in promoting commonality and consistency in operating procedures for REBs that review human subject health research. Learn about the development, implementation, and benefits of these SOPs.

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Open Access-Canadian Harmonized REB SOPs ARE OUT OF THE BOX!!!

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  1. Open Access-Canadian Harmonized REB SOPs ARE OUT OF THE BOX!!! Alison van Nie Chair N2/CAREB REB SOP Committee & Karen Arts N2

  2. ENGLISH LANGUAGE VERSIONOCTOBER 2014

  3. HOT OFF THE PRESS FRENCH LANGUAGE VERSION April 2015

  4. The Cycle

  5. Anticipating the future…….. Role of harmonized REB SOPs in the promotion/development of commonality and consistency in operating procedures for REBs that review human subject health research

  6. Setting the stage………. historical record of the development of the harmonized SOPs in Canada [N2&CAREB, committee/member development]

  7. Planning the route………. principles, processes and other considerations during the development of the SOPs

  8. Catch and release: implementation of the SOPs at the centre/organizational level

  9. Some Reasons for Adoption… Preparation for: • Central review processes (e.g., CTO) • Qualifications review • National compliance (regs adoption ~CGSB) • Accreditation??? Expertise: • Developed by a specialized, expert national committee • Local organization may not have the resources or the expertise Ongoing Commitment: • To update the docs & maintain compliance

  10. More Leverage for: • the provision of resources by the organization to address missing elements (e.g., education, QA) Ability of the organization to: • demonstrate compliance with all requirements Relevant for: • accreditation reviews of organization

  11. Barriers to Adoption • No need to change • No mandated regulatory requirements • Current SOPs meet the needs • Not planning to be ‘qualified’ • Not planning to engage with central review processes • It would be confusing and difficult

  12. Invalidation of previous practices • Adapting to change… • Resistance from stakeholders • ‘Separation anxiety’ • Insecurity re ability to adapt appropriately • Non compliance with the new SOPs

  13. Processes for Adoption Best Practice: adopt as is • Prepare for adoption by doing a gap analysis • Determine implementation process – suggestions?? • Develop supplementary documents to address specifics • Provide education for: • Board members • Researchers • Organization • Etc…..

  14. GAP ANALYSIS

  15. Feeding back…………. process for submitting a response/comment/correction Developing new …. Suggestions…..

  16. Anticipating the future…….

  17. Thanks to….Sub committee members

  18. Contact: Alison van Nie /REB SOP Committee Chair alison.vannie@oicr.on.ca

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