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?

12. IWK Research Ethics - Workshop SeriesSession #3REB Continuing Review and Ongoing Study ManagementOctober 24, 2013 Bev White, Manager, Research Ethics Research Services, IWK Health Centre

13. 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

14. Continuing ReviewWhy? 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).”

15. Continuing ReviewWhy? 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.

16. Continuing ReviewWhy? 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.”

17. Continuing ReviewWhy? 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”)

18. Continuing ReviewHow? • Annual Renewal • Amendments • Serious Adverse Events – SAE’s • Protocol Deviations & Violations • End of Study – Closure

19. Ongoing Study Management • Organization is Key! • 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? • All research conducted at the IWK Health Centre may be subject to Audit.

20. 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)

21. Lets Chat