Bev White, Manager, Research Ethics Research Services, IWK Health Centre

 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!

  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

 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

 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

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

 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

 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

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

 Amendment Cover Page  Amendment Detail Forms ◦ A – EAS Form/Protocol ◦ B – Personnel Changes (Addition/Deletions/Inactive) ◦ C – Consent Changes ◦ D – Other - Supporting Document Changes

 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