Streamlining Ethics Review Using Standard Project Parameters CAREB Pre-Conference Workshop April 29, 2015 Nancy Ondrusek Public Health Ontario
Streamlining Ethics Review Using Standard Project Parameters CAREB Pre-Conference Workshop April 29, 2015 Nancy Ondrusek Public Health Ontario.
Dec 28, 2015
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Streamlining Ethics Review Using Standard Project ParametersCAREB Pre-Conference WorkshopApril 29, 2015
Nancy OndrusekPublic Health Ontario
PublicHealthOntario.ca
Outline• WHY?
• WHAT?
• HOW?• SPP Development and Approval• Review of Projects using SPPs
• WHAT ELSE?
2
PublicHealthOntario.ca
WHY? A Brief History
3
You are going to grind public
health to a halt!
©iStock.com/GlobalStock
We are expanding the scope of ethics review beyond
research!
Courtesy D Willison
PublicHealthOntario.ca
A Brief History (Cont’d)
4
Don’t worry—we’ll make it
easy!
Courtesy D Willison
I’ll believe it when I see
it!
©iStock.com/GlobalStock
PublicHealthOntario.ca 5
"Administrative burden" by Pizarros - Own work. Licensed under CC BY-SA 3.0 via Wikimedia Commons - https://commons.wikimedia.org/wiki/File:Administrative_burden.JPG#/media/File:Administrative_burden.JPG
PublicHealthOntario.ca
WHY? Pressures and Constraints
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Expanded ScopeIncreased volume
Demands for efficiency
Finite resourcesTCPS 2 compliance
Quality reviews
PublicHealthOntario.ca
WHY? Solution Requirements• Quality review
• Reduce turn-around-time
• Reduce burden on teams and REB
• Adaptable
• Investigators engage in ethics review
7
SPPs
PublicHealthOntario.ca 8
WHAT?: Standard Project Parameters (SPPs)
• Generic project template—a set of Ethics Review Board (ERB) approved parameters or conditions
• Mechanism to streamline approval of routinely used project protocols
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Standard Project Parameters (SPPs)
Parameters to be standardized may include:• Recruitment method
• Limits to data collection, use and disclosure
• Need for and approaches to obtaining consent
• Data storage, retention and destruction
PublicHealthOntario.ca
SPP for Expert Consultation
Data Collection and Use:No identifying information other than professional role and
type of organization unless consent to do so.
No collection of opinions regarding specific individuals or specific organizations.
No collection of information expected to be potentially harmful to participants, named organizations or other individuals if released.
10
For projects involving professionals sharing their knowledge about a content area.
PublicHealthOntario.ca
HOW?: SPP Development• Identify suitable project type • Frequency of use (cost-benefit)• Generalizability of project elements
relevant to ethics
• Work with project teams—get examples (3+)
11
©iStock.com/Kay&Ella
PublicHealthOntario.ca
HOW?: SPP Development• Make table of common elements, e.g., • General purpose of project• Scope of data• Data sources• Recruitment and consent approaches• Etc.
• Determine appropriate scope of SPP
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PublicHealthOntario.ca
HOW?: SPP Development
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adults
identifiers
reporting individual level results
children
data linkage
potentially stigmatizing results
video recordings
deception focus groups
reports using aggregated data
business contact info
consent
password protected data
PublicHealthOntario.ca
HOW?: SPP Development
• Develop general statements that encompass desired range of activity
• Exclude activities that warrant additional ethics scrutiny
• Work with project teams to ensure list of statements align with projects
• Frame statements as checklist of conditions to be satisfied (e.g., “Project does not include…”)
• Develop consent form/script templates if applicable
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How? Privacy Section Example
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You are designing an SPP for projects that will include online surveys.
What conditions will you cover in your SPP?
PublicHealthOntario.ca
How? SPP Development• Submit draft SPP (i.e., checklist of conditions) to Ethics Review
Board (ERB) for review
• Revise as needed
• SPP approved for three years
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PublicHealthOntario.ca
How?: Review of Projects Using SPPs• Applicant works through checklist to determine alignment of
project with SPP
• Completed checklist and project description sent to ethics office for validation
• Ethics staff may:• approve as is• ask for additional details or revisions (e.g., consent form changes)• determine SPP does not fit
• Applicant sent approval letter OR Applicant instructed to follow routine ethics review process
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SPP Experience to date• Approved SPPs:• Expert Consultation• ICES data• Evaluation of an Educational Activity• Evaluation of PHO Knowledge Product or Resource (in progress)
• Turnaround time:• Hours to days
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PublicHealthOntario.ca
AcknowledgementsDon Willison
Vinita Haroun
Judith Friedland
Maggie Civak
Maria McDonald
PHO Ethics Review Board
PHO Staff
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PublicHealthOntario.ca
What Else?
22
©iStock.com
CDC/ Lt. Cmdr. Gary Brunette
CDC/ Lt. Cmdr. Gary Brunette
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