Transcript IWK Research Ethics - Workshop Series REB Forms 2013

Bev White, Manager, Research Ethics
Research Services, IWK Health Centre
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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!
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www.iwk.nshealth.ca/research/application-materials-forms
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New Submissions - Required Forms
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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
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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
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SAE Reporting
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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:
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Clinical Trials – Ethics Approval Submission
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Non-Interventional Studies – Ethics Approval Submission
Checklists:
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Researcher’s Checklist for Submissions: Full Board Review
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Researcher’s Checklist for Submissions: Delegated Review
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Research Team Contact Page
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The “Research Summary”
◦ 17 open ended questions
◦ Intended to be flexible
◦ Produced inconsistent results
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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
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Application for Access to Personal Health
Information for Research Purposes
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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!
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Annual Approval Request (Renewal)
Study Closure Reporting Form
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Premature Study Termination Form
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REB Reviewers' Tools
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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
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Amendment Cover Page
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Amendment Detail Forms
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A – EAS Form/Protocol
B – Personnel Changes (Addition/Deletions/Inactive)
C – Consent Changes
D – Other - Supporting Document Changes
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IWK / CDHA / Dalhousie 
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IWK / CDHA 
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Provincial Multi Site Board 
◦ Long standing
◦ Renewal Pending
◦ Continue as usual
◦ Target to alleviate duplicate application when and when possible
◦ Alignment of form/process
◦ But still independent REB’s, authority and responsibility
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Online application system planned
DOH to host Website
Organizational management provided by CDHA
REB representation from each participating district & the IWK
Stay tuned