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…
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–
–
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–
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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
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?
IWK Research Ethics - Workshop Series
Session #3
REB
Continuing Review and
Ongoing Study Management
October 24, 2013
Bev White, Manager, Research Ethics
Research Services, IWK Health Centre
Objectives
Continuing Review
• Why?
TCPS, Health Canada - Division 5,
CIHR and other funding agencies
• How?
Annual Renewal, Amendments,
Serious Adverse Events – SAE’s
Protocol Deviations & Violations
End of Study – Closure
Ongoing Study Management
• Organization is key!
• REB Audit
Let’s Chat
Continuing Review
Why?
Tri-Council Policy Statement – TCPS2
“Article 6.14 The REB shall make the final determination as to the nature
and frequency of continuing research ethics review in accordance with
a proportionate approach to research ethics review. At minimum,
continuing research ethics review shall consist of an annual status
report (for multi-year research projects), and an end-of-study report
(projects lasting less than one year).”
Continuing Review
Why?
Tri-Council Policy Statement – TCPS2
• This may include
– more frequent reporting to the REB,
– monitoring and review of the consent process,
– review of participant records,
– site visits.
– Other reporting mechanisms as required by funders, sponsors or
regulators.
Continuing Review
Why?
Health Canada – Good Clinical Practice (ICH-GCP)
“3.1.4 – The IRB/IEC (REB) should conduct continuing
review of each ongoing trial at intervals appropriate
to the degree of risk to human subjects, but at least
once per year.”
Continuing Review
Why?
CIHR Agreement
(Agreement on the Administration of Agency Grants and Awards by Research Institutions)
“3.4 The Institution shall, for all research involving humans
carried out under its auspices:
– comply with the Tri-Council Policy Statement: Ethical
Conduct for Research Involving Humans, second
edition ("TCPS2")…” and
– … ensure that funds are available to the Recipient only
while REB approval is maintained, unless the REB has
determined that the research no longer requires its
review and approval…
(Previously: “…the research must maintain REB approval for the duration of the project”)
Continuing Review
How?
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Annual Renewal
Amendments
Serious Adverse Events – SAE’s
Protocol Deviations & Violations
End of Study – Closure
Ongoing Study Management
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Organization is Key!
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Can you instantly put your hands on exactly what you need?
Clear documentation and historical reference for all research
activity.
Accurate record keeping.
Systematic and Organized.
Are you ready to be Audited?
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All research conducted at the IWK Health Centre may be subject
to Audit.
Additional Forms
• Diagnostic Imaging
• Database Review
• Health Records – Application for Access to Personal Health
Information for Research Purposes
• Tissue or Biological Samples for Research Purposes
• Industry Sponsored Research – Requisition for Ethics Review
(REB Fee)
Lets Chat