Bev White, Manager, Research Ethics Research Services , IWK Health Centre

1. IWK Research Ethics - Workshop Series Session #2REB Review Procedures How to submit …October 24, 2013 Bev White, Manager, Research Ethics Research Services, IWK Health Centre

2. 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

3. 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

4. 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

5. 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]

6. Delegated vs. Standard, cont’d • 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.

7. Forms, Forms, Forms… • Submission requirements: • 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 • Documents found on the Research Ethics Website http://www.iwk.nshealth.ca/research/application-materials-forms

8. And more forms… • Assent Form vs. Assent Process * • Scripts - Telephone, Focus Groups, etc. • Data collection tools, Surveys, Questionnaires • Advertisements – Posters, PULSE, other media. • Introduction Letters • Letters of Support or Approval • Documents found on the Research Ethics Website http://www.iwk.nshealth.ca/research/application-materials-forms

9. Tools • Investigator Tools • 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 • Documents found on the Research Ethics Website http://www.iwk.nshealth.ca/research/application-materials-forms

10. Contacts • IWK Health Centre - REB guidelines http://www.iwk.nshealth.ca/research/application-materials-forms Bev White – 470-8520 bev.white@iwk.nshealth.ca Joanne Street – 470-7879 joanne.street@iwk.nshealth.ca • 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

11. Questions?