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IWK Research Ethics - Workshop Series 2013 REB Forms October 30, 2013

IWK Research Ethics - Workshop Series 2013 REB Forms October 30, 2013. Bev White, Manager, Research Ethics Research Services , IWK Health Centre. Objectives. So Many New Forms! What's New? EAS Form vs. Research Summary Hot off the Press – Amendment Form(s) Multi Site Research Update

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IWK Research Ethics - Workshop Series 2013 REB Forms October 30, 2013

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  1. IWK Research Ethics - Workshop Series 2013REB Forms October 30, 2013 Bev White, Manager, Research Ethics Research Services, IWK Health Centre

  2. Objectives • So Many New Forms! • What's New? • EAS Form vs. Research Summary • Hot off the Press – Amendment Form(s) • Multi Site Research Update • Lets Chat!

  3. So Many New Forms! • www.iwk.nshealth.ca/research/application-materials-forms • New Submissions - Required Forms • Clinical Trials – Ethics Approval Submission (EAS) Form • Non-Interventional Studies – Ethics Approval Submission (EAS) Form • Researcher’s Checklist for Submissions: Full Board Review • Researcher’s Checklist for Submissions: Delegated Review  • Research Team Contact Page  • New Submissions - Guidelines and Templates • Protocol Components • Consent, Authorization and Assent Documents - guidelines • Consent and Authorization Documents General Requirements (Minimal Risk)- guidelines • Telephone Consent - script and guidelines • Letter of Support Template 

  4. So Many New Forms! • Additional Information • Application for Access to Personal Health Information for Research Purposes • Diagnostic Imaging Review • Database Review • Tissue or Biological Samples for Research Purpose • Case Report Review • Amendment • Additional Amendment Document List • Annual Approval Request (Renewal) • Study Closure Reporting Form • Premature Study Termination Form • Industry Sponsored Research - Ethics Review Fee - guidelines • Industry Sponsored Research - Requisition for Ethics Review - form • Self Declared Income Statement for Research Participants – Form

  5. So Many New Forms! • SAE Reporting • SAE Reporting SOP • SAE Reporting - memo September 2009 • Serious Adverse Event Initial Report • Serious Adverse Event Follow Up Report • SAE Summary Table • Major Study Violation Reporting Form • Minor Study Deviation Reporting Form • REB Reviewers' Tools • IWK REB Review Criteria - Primary Reviewer • IWK REB Review Criteria - Secondary Reviewer

  6. What's New? EAS Forms: • Clinical Trials – Ethics Approval Submission • Non-Interventional Studies – Ethics Approval Submission Checklists: • Researcher’s Checklist for Submissions: Full Board Review • Researcher’s Checklist for Submissions: Delegated Review  • Research Team Contact Page 

  7. EAS Form vs. Research Summary • The “Research Summary” • 17 open ended questions • Intended to be flexible • Produced inconsistent results • Now  The EAS Form – 7 Sections • A – Investigator Team, Funding & Regulatory details • B – Study Details • C – Protocol Details: Participants, Standard of Care, Placebo & Safety details • D - Compensation, COI • E - Participant Identification & Consent Process • F - Privacy • G – Other Stuff PHIA

  8. What's New? • Application for Access to Personal Health Information for Research Purposes • Access to Health Records • Paper or Electronic • Chart, DI, Meditech, Pax, etc. • Agreement between the Custodian & the Researcher • Amendment Form(s) – I want your input! • Annual Approval Request (Renewal) • Study Closure Reporting Form • Premature Study Termination Form PHIA

  9. What's New? REB Reviewers' Tools • Serious Adverse Event Initial Report • Serious Adverse Event Follow Up Report • Major Study Violation Reporting Form • Minor Study Deviation Reporting Form REB Reviewers' Tools • IWK REB Review Criteria - Primary Reviewer

  10. Hot off the Press – Amendment Form(s) • Amendment Cover Page • Amendment Detail Forms • A – EAS Form/Protocol • B – Personnel Changes (Addition/Deletions/Inactive) • C – Consent Changes • D – Other - Supporting Document Changes

  11. Multi Site Research Update • IWK / CDHA / Dalhousie  • Long standing • Renewal Pending • Continue as usual • IWK / CDHA • Target to alleviate duplicate application when and when possible • Alignment of form/process • But still independent REB’s, authority and responsibility • Provincial Multi Site Board  • Online application system planned • DOH to host Website • Organizational management provided by CDHA • REB representation from each participating district & the IWK • Stay tuned

  12. Questions?

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