1. Streamlining Ethics Review Using Standard Project Parameters CAREB Pre-Conference Workshop April 29, 2015 Nancy Ondrusek Public Health Ontario

2. PublicHealthOntario.ca Outline WHY? WHAT? HOW? SPP Development and Approval Review of Projects using SPPs WHAT ELSE? 2

3. 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

4. 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

5. 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

6. PublicHealthOntario.ca WHY? Pressures and Constraints 6 Expanded Scope Increased volume Demands for efficiency Finite resources TCPS 2 compliance Quality reviews

7. 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

8. PublicHealthOntario.ca WHAT?: Standard Project Parameters (SPPs) 8 Generic project template—a set of Ethics Review Board (ERB) approved parameters or conditions Mechanism to streamline approval of routinely used project protocols

9. PublicHealthOntario.ca 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 9

10. 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.

11. 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

12. 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 12

13. PublicHealthOntario.ca HOW?: SPP Development 13 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

14. 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 14

15. PublicHealthOntario.ca How? Privacy Section Example 15 You are designing an SPP for projects that will include online surveys. What conditions will you cover in your SPP?

16. 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 16

17. 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 17

18. PublicHealthOntario.ca HOW?: Review of Projects Using SPPs 18

19. PublicHealthOntario.ca 19 PHO Ethics Review Process

20. PublicHealthOntario.ca 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 20

21. PublicHealthOntario.ca Acknowledgements Don Willison Vinita Haroun Judith Friedland Maggie Civak Maria McDonald PHO Ethics Review Board PHO Staff 21

22. PublicHealthOntario.ca What Else? 22 ©iStock.com CDC/ Lt. Cmdr. Gary Brunette