Iwk research ethics workshop series 2013 reb forms october 30 2013
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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

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

Bev White, Manager, Research Ethics

Research Services, IWK Health Centre


Objectives
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!


So many new forms
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 


So many new forms1
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


So many new forms2
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


What s new
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 


Eas form vs research summary
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


What s new1
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


What s new2
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


Hot off the press amendment form s
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


Multi site research update
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



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