1. The Research Ethics Review Process at SJGHC [Presented at Research Readiness Education Program, SJOGHC Subiaco, 12 August 2015] Ms Gorette De Jesus Executive Officer, SJGHC HREC

3. Outline Overview: SJG Human Research Ethics Committee (HREC) & its Scientific Review Sub-Committee (SRC) SJGHC Research Governance Framework – 3 Pathways for Ethical Review of “Higher Risk”, “Low Risk” and “Negligible Risk” Research – “Human QI” Projects for Ethical Review – COMMON ISSUES & KEY POINTERS with Submissions Where to go for further info & assistance Questions

4. Overview of SJGHC HREC SJGHC HREC: constituted & operates according to National Health & Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007). SJGHC: certified under NHMRC National Certification Scheme for multi-centre ethical review processes.

5. SJGHC HREC: Key Features Aim of SJGHC HREC: Facilitate & support the development of a strong culture of research ethics within SJGHC. - Ethical decision-making is guided by our Catholic moral principles and values. Single Stream Submission: one submission for research conducted throughout all SJG Divisions/Hospitals. Work together with researchers & SJGHC participating sites/Divisions: excellence in research & ethical conduct

6. Overview of SRC GOOD SCIENCE IS ETHICAL BY DESIGN AND CONDUCT Scientific Review Sub-Committee (SRC) – Review for scientific merit (validity & safety) – Review for appropriate use of SJGHC biospecimens (& related health data) – Advises on research design & process – Makes recommendations to SJGHC HREC for approval or otherwise.

7. Overview of SJGHC HREC & SRC

8. 3 Pathways of Ethical Review for Research “Higher Risk” Research (risk of harm) – Formal/Full review “Low Risk” Research (discomfort) – Expedited review “Negligible Risk” Research (inconvenience) – Exempt from review

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11. Checklists for Research

12. Ethical Review of QI Projects Fine line between “research” (ie research question) & “quality improvement” (QI) (for internal evaluation purposes). ALL Quality Improvement (QI) should be subjected to the same ethical principles as research: - Research Merit & Integrity - Justice - Beneficience - Respect QI Projects can be described as: - “Pure QI” (processes, systems/programs) = NO HREC review. - “Human QI” (data about/samples from people) = HREC review. Determine risk of “Human QI” & thus pathway of ethical review.

13. Checklists for ethical consideration of QI Projects

14. Participating Site Operational Approval (PSOA) 1 st Step: Discuss proposed study with Exec of each SJGHC participating site (approval in principle). Complete PSOA in discussion with each SJGHC participating site. PSOA includes logistical questions about how study will occur at SJGHC, what resources will be required. Ensures “logistics” sorted out, AND research proposal aligns with Mission, values & strategic priorities.

16. Information & Advice for Researchers Making New Submissions SJGHC Research Handbook should be READ - NOT printed out. All forms & guides listed as separate docs throughout SJGHC webpages. Information & Advice for Researchers Making New Submissions is a dot-point summary based on frequently asked questions (FAQs) about new research submissions. Call SJGHC Ethics Office. - to determine WHO to discuss PSOA with at various SJGHC Divisions/Hospitals. - to plan research submission.

17. COMMON ISSUES & KEY POINTERS with Submissions 1.“I’m just doing an audit. It doesn’t need ethical review.” – Fine line between audit/QI & research. Internal review only OR Research question/hypothesis? – Same Ethical Principles should apply to ALL QI! – “Pure QI” or “Human QI”? – Checklist to determine risk level of “Human QI”, then follow relevant pathway of review. – Intend to publish? – QI projects with more rigor can make great research!

18. COMMON ISSUES & KEY POINTERS with Submissions 2. “It’s a low risk study, so it doesn’t need much of a research protocol.” – Good science = ethical research – Avoid “fishing expeditions”: what is Research question/research hypothesis? – Data analysis IMPORTANT. – Seek advice of a Biostatistician early on.

19. COMMON ISSUES & KEY POINTERS with Submissions 3. “Can I submit another Ethics Application other than the NEAF or SJGHC Low Risk Application Form?” – YES, absolutely. No need for duplication. – Cover letter to detail SJGHC site specific details. – OR amend existing NEAF/application form to include SJGHC site specific details. – Compare against relevant SJGHC Checklist. – Where possible, cooperate in completing submission paperwork to Ethics eg. where research conducted over more than one SJGHC site.

20. COMMON ISSUES & KEY POINTERS with Submissions 4.“When is the best time to submit my study?” – No submission date for “low risk” or “negligible risk.” – If approaching a SRC or HREC meeting, may table “low risk” study at meeting. – Submission dates for “high risk.” – Submission dates approx. a month before HREC meeting. – PLANNING AHEAD CRUCIAL. Early contact with Ethics Office encouraged.

21. COMMON ISSUES & KEY POINTERS with Submissions 5. “What should a Participant Information & Consent Form (PICF) look like?” – COMMENSURATE WITH THE RISK OF THE STUDY. – Brief & concise. – Plain language & seek consumer input. – Approved “pregnancy wording” as per SJGHC’s requirements. – Consent for biospecimen collection & Genetic sub-studies: Ethically defensible plan (S3.5.1 NS) & “researchers should recognise that data stored in an identifiable form cannot be used in research that is exempt from ethical review.” (S3.2.10 NS) – Date, version # & site (if more than one site) – Suggested Proformas in SJGHC Research Handbook.

22. COMMON ISSUES & KEY POINTERS with Submissions 6. “When can I start the research?” – Need “ethical approval” and “final approval.” – Final approval requires signed PSOA from each SJGHC participating site. – High risk research also needs SJGHC legal approval of insurance, indemnity & contractual arrangements. – Submit Insur. Certificate, Indemnity & CTRA ASAP! – Approvals confirmed in writing. – Final Approval letter issued by SJGHC GDMS, cc’ed SJGHC participating site(s).

23. Where to go: further info & assistance SJGHC Research Handbook – is SOPs Ethics webpage: – www.sjog.org.au/research/human_research_ethics.aspx www.sjog.org.au/research/human_research_ethics.aspx – Compass, under “Organisation”, “Ethics” Contact SJGHC Ethics Office: – (08) 9382 6940 – Level 3, St John of God House – ethics@sjog.org.au or gorette.de.jesus@sjog.org.au ethics@sjog.org.augorette.de.jesus@sjog.org.au

24. Any Questions?