Transcript The IWK Research Ethics Board How can we help you?

IWK Research Ethics - Workshop Series
Session #2
REB Review Procedures
How to submit …
October 24, 2013
Bev White, Manager, Research Ethics
Research Services, IWK Health Centre
Objectives
• How do I start?
• Delegated vs. Standard Submission
• Forms, Forms, Forms…
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Researcher Checklist
Ethics Application Submission – EAS Form
Consent vs. Authorization
Assent - Form vs. Process
Introduction letters
Scripts - Telephone, Focus Groups, etc.
Data collection tools, Surveys, Questionnaires
Advertisements – Posters, PULSE, other media
• Tools
• Questions
Objectives
• How do I start?
• Delegated vs. Standard Submission
• Forms, Forms, Forms…
–
–
–
–
–
–
–
–
Researcher Checklist
Ethics Application Submission – EAS Form
Consent vs. Authorization
Assent - Form vs. Process
Introduction letters
Scripts - Telephone, Focus Groups, etc.
Data collection tools, Surveys, Questionnaires
Advertisements – Posters, PULSE, other media
• Tools
• Questions
How do I start?
• Allow time to prepare your REB Submission.
• Know the deadlines
– Standard submissions - 1st Tuesday, every month* Meeting is on
the 3rd Tuesday*. (* except January & August)
– Expedited – anytime
• Response from the REB – Our goal:
– Standard - 1 week following the meeting
– Delegated - 14 days from submission
• Come and talk to us
Delegated vs. Standard
• Delegated = Minimal Risk
– TCPS definition: “…research in which the probability and magnitude of
possible harms implied by participation in the research is no greater
than those encountered by the participants in those aspects of their
everyday life…” [TCPS2, Section 2.8(B)
– Non Invasive, questionnaires, surveys, naturalistic observation, for
example.
– “Research proposals may be reviewed by an delegated review process
if a co-chair is confident that the research can be expected to involve
minimal risk.” [IWK REB SOP]
Delegated vs. Standard,
• Consider:
– Vulnerability of your participants
– Sensitivity of information/data
– Health Records or Database review
• Participant contact?
• Identifiable information? (or small cell size)
• Come and talk to us.
cont’d
Forms, Forms, Forms…
• Submission requirements:
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Researcher Checklist *
Ethics Application Submission – EAS Form *
Protocol *
Consent / Authorization Forms*
• Your submission must include every document you
intend to use in the conduct of your research
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Documents found on the Research Ethics Website
http://www.iwk.nshealth.ca/research/application-materials-forms
And more forms…
• Assent Form vs. Assent Process *
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Scripts - Telephone, Focus Groups, etc.
Data collection tools, Surveys, Questionnaires
Advertisements – Posters, PULSE, other media.
Introduction Letters
Letters of Support or Approval
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Documents found on the Research Ethics Website
http://www.iwk.nshealth.ca/research/application-materials-forms
Tools
• Investigator Tools
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The Website
SOP’s & Guidance documents
New links to external online tools and tutorials
FAQ page
• REB Reviewers' Tools *
– Primary Reviewer Criteria
– Secondary Reviewer Criteria
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Documents found on the Research Ethics Website
http://www.iwk.nshealth.ca/research/application-materials-forms
Contacts
• IWK Health Centre - REB guidelines
http://www.iwk.nshealth.ca/research/application-materials-forms
Bev White – 470-8520
[email protected]
Joanne Street – 470-7879
[email protected]
• Dalhousie Office of Research Ethics Administration
http://researchservices.dal.ca/research_1482.html
Catherine Conner, Director – 494-1462
• CDHA Research Ethics Board
http://www.cdha.nshealth.ca/discovery-innovation/ethics
Ken Jenkins, Manager – 473-8426
Questions?