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
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?