The Research Ethics Review Process

at SJGHC[Presented at Research Readiness Education Program, SJOGHC Subiaco, 12 August 2015]

Ms Gorette De JesusExecutive Officer, SJGHC HREC

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

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.

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

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.

Overview of SJGHC HREC & SRC

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

10

Checklists for Research

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.

Checklists for ethical consideration of QI Projects

Participating Site Operational Approval (PSOA)

• 1st 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.

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.

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!

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.

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.

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.

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.

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).

Where to go: further info & assistance• SJGHC Research Handbook – is SOPs

• Ethics webpage: – 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

Any Questions?