Transcript Document
Human Research
Ethics Forum
A/Prof Tim Mathew
Chairman, Human Research Ethics Committee (TQEH/LMH/MH)
Melissa Kluge
Executive Officer, Human Research Ethics Committee (TQEH/LMH/MH)
& A/Research Governance Officer (TQEH/LMH/MH)
Newly released
SA Health Policies
> Research Ethics Operational Policy
> Research Governance Operational Policy
Mandated effective 2nd April 2012
The above policies are complementary documents that propose a
standardised approach for research ethics and research
governance.
> Fees for Review of Research Policy (effective July 2011)
Why these changes?
> 1st stage - State-wide consistency
> 2nd stage - National consistency (was HoMER, is
now ‘National Approach’)
• Consistent ethical and governance processes
across the state/country
• Less duplication in ethical process
• Documented risk management process
• State/national monitoring/recording
Key Terminology
Term
Definition
‘Online Forms’
• ‘Online Forms’ refers to a national website already used by the
Eastern States.
• SA now included - this is where you will lodge submissions,
amendments and annual reports.
• www.ethicsform.org/Au
NEAF - National
Ethics Application
Form
• NEAF has been used nationally for years.
• Revised version of NEAF is now to be completed through a national
‘Online Forms’ website.
LNR - Low &
Negligible Risk
• Previously referred to by this Committee as ‘Expedited Review’
• Refers to research in which the only risk is one of minimal or no
discomfort.
• Examples: Questionnaires & Interviews, Audits, Observational
Studies.
Key Terminology
Term
Definition
SSA – Site Specific
Assessment
• A new form created by SA Health (available through Online
Forms).
• Covers research governance matters including Indemnity,
Resources, Funding, Contracts, and site specific aspects of the
research.
RGO – Research
Governance Officer
• A new position required for each Intuition
• Receives and reviews Site Specific Applications and makes
recommendations to the General Manager
CPI – Coordinator
Principal Investigator
• The CPI is the lead investigator on a research study taking
overall responsibility for the conduct of the study at all of the
study sites.
HoMER or ‘National
Approach’
• Refers to the NHMRC Initiative on a national system for Single
Ethical Review
Key Changes
Change
Old…
New…
Separation of Ethics
and Governance
Processes
Ethics approval and Site approval
one process managed by the Ethics
Committee.
•
Online National Ethics
Application Form
(NEAF)
Option of submission through:
• Local HREC application form or
• National Ethics Application Form
(NEAF).
All research (with the exception of Low Risk
Research) must be through submission on:
• National Ethics Application Form (NEAF) –
through national ‘Online Forms’ website
Low & Negligible Risk
(LNR)
Previously referred to as ‘Expedited
Review’
Option of submission through:
• Local HREC application form or
• Local Investigator-prepared
Protocol.
Option of submission through:
• Local LNR Form available from our website, or
• Online National Ethics Application Form (NEAF).
Site Specific
Assessment
Previously no specific form for site
approval. Would be part of Ethics
application process.
• All research (including Low Risk Research) must
have Site Specific Approval.
• Site Specific Assessment (SSA) Form – through
national ‘Online Forms’ website
•
•
Ethics approval and Site approval now separate
processes.
Ethics review by Ethics Committee.
Site approval (SSA) by RGO & General
Manager.
Key Changes
Change
Old…
New…
Mutual Acceptance of
Ethical Approval
Ethical approval would be
required by SA Health Ethics
Committee that has involvement
in the research.
• Ethical approval only required by one SA Health Ethics
Committee.
• Automatic acceptance by other SA Health Ethics
Committees.
Appointment of
Research Governance
Officer (RGO)
Research Governance was
checked by Ethics Committee.
• Governance is separated by the SSA process, a RGO is
nominated at each site/service.
• The RGO receives and reviews SSAs, and makes
recommendations to the General Manager of that
site/service.
Amended Fee Structure
for sponsor-initiated
research
No State policy before July 2011.
• SA Health policy on fees for clinical trials.
• Consistency across the state.
• At this organisation, only applies to sponsor-initiated
research.
AU RED
Individual databases for each
committee, no consistency.
• AU RED is a system used nationally, ready for
implementation of the ‘National Approach’.
• All SA Health Ethics Committees using AU RED.
• All Research Governance Officers using AU RED.
• Tracking/Monitoring of applications, including 60-Day
Clock
Research Ethics & Governance
Flow Chart
SA HEALTH
ETHICS POLICY
SA Health Single Ethical Review
Model
> Applies to all multi-site research taking place within the
SA public health system.
> Approval through one SA HREC only (referred to as the
‘lead’ committee).
> Ethical approval is accepted by all other SA public health
system HRECs without the requirement for further
ethical review.
> University Committees not in this model.
> Interstate Committees are not yet in this model.
> When choosing a lead HREC, there are a number of
considerations that should be noted by the ethics
applicant regarding their selection …
Choosing a Lead SA HREC
TYPE OF
RESEARCH
Single-Site
LEAD HREC
SA HREC where
the research is
being conducted
CONSIDERATIONS
• SA HEALTH HREC
Multi-Site
Multi-Site
(involving only 1 SA
Health Site)
(involving 2 or more
SA Health Sites)
SA HREC where the
research is being
conducted
Any SA HREC
involved in the
Research
Must review research involving an SA Health database /registry
(e.g. OACIS, Cancer Registry Data)
• Women’s & Children’s Health Network HREC
Must review research involving children and young people
• SA Aboriginal Health Research Ethics Committee
(AHREC)
Must review research where Aboriginal people are an explicit
focus of all or part of the research; the information has an impact
on one or more Aboriginal communities; or Aboriginal health
funds are a source of funding.
HREC Submission – Online Forms
> To start a NEAF application:
•
Go to https://www.ethicsform.org/au
•
Create a user account (first time only)
•
Sign in and go to ‘My Projects’ from the tab bar
•
Then ‘Create New Project’.
•
Select ‘SA’ from the tick box below, followed by ‘NEAF’ application.
•
Then takes you through steps to complete the form.
HREC Submission – Online Forms
(cont)
>
>
>
The application can be saved and you can return to it at any stage.
For multi-site research, you will need to work collaboratively with
other institutions when completing the Ethics application
Once the application is complete, upload all supporting documents
electronically.
IMPORTANT: Generating a Submission Code
>
A submission code MUST be generated once the application is complete
>
Print final version AFTER generating submission code and collect
signatures
HREC Submission - Checklist
applies to TQEH/MH/MH HREC only
>
Final proof and spelling check
>
Submission for preliminary-review (optional)
>
Supporting documents uploaded to Online Forms (correctly
labelled with version numbers & document dates)
>
NEAF submitted through Online Forms (submission code
generated)
>
NEAF signed by the local (SA) Investigators
>
TGA Clinical Trials Notification (CTN) for each SA Health Site
>
Fee Form provided (For Sponsor-Initiated Studies Only)
HREC Submission - Checklist
(cont.)
> 28x hard copies of:
• NEAF
• Participant Information Sheet & Consent Forms (for all
sites / or Master SA Template)
• All Letter templates (for participants, GPs, etc)
• Advertisements or other recruiting material
• Questionnaires
• Radiation Safety Reports
> 4x copies of:
• Study Protocol
• Investigator’s Brochure (if applicable)
> Copies are collated, and then clipped or stapled.
Low & Negligible Risk (LNR)
Research
> Examples: Questionnaires/Interviews, Retrospective Audits,
studies that have no or minimal discomfort for the Participant
If unsure, contact us before you start your application.
> Submitted on local LNR Ethics Application Form (available on
our Ethics Webpage - not Online Forms).
> Site Specific Assessment (SSA) application is required for all
research, including LNR Research.
> LNR Research is reviewed by the Chairman out-of-session
(does not undergo by the full HREC)
> The LNR pathway is designed to allow for a more efficient
review of research that does not carry much risk. It may
involve minimal or no discomfort to the participant.
SA HEALTH
GOVERNANCE POLICY
Site Specific Assessments (SSA)
> SSA approval is separate to Ethical approval
> SSA review process is used to determine whether a
project has satisfied the research governance
requirements of the site.
•
e.g. Project details relative to the site, Evidence of
Indemnification, Funding arrangements, Resourcing (staff,
equipment), Research Contracts.
> Submission of SSA to the Site Research Governance
Officer (RGO), does not go to Ethics Committee.
> SSA is required for every research proposal
> Is required at every site/service where the research is
being conducted (including the site reviewing the ethics)
Site Specific Assessment (SSA)
Submission – Online Forms
> To start an SSA application:
•
•
•
•
Go to https://www.ethicsform.org/au
Sign in to your account and go to ‘My Projects’
Select the NEAF the SSA applies to (for LNR Research you
will create a ‘dummy’ NEAF).
Click on the ‘SSA’ tab and select ‘Create a new SSA’ form
SSA Submission – Online Forms
(cont)
>
Application can be saved and you can return at any stage.
IMPORTANT: Generating a Submission Code
>
A submission code MUST be generated once the application is
complete (separate to NEAF code)
>
Print final document AFTER generating submission code and
collect signatures
>
Printed copy with signatures is sent to the Site’s RGO
SSA Submission - Checklist
applies to TQEH, LMH, Modbury Hospital and PHC only
> SSA submitted through Online Forms
(submission code generated)
> SSA signed by the Site Principal Investigator (not
study coordinator)
> SSA signed by ALL Site Depts/Services affected
by the research , for example:
•
Pharmacy – for all studies involving the use of drugs
•
Medical Imaging/Radiology – where staff or equipment
is required
•
Medical Unit Heads – where patients/staff are impacted
SSA Submission - Checklist
(cont.)
> SSA supporting documents (Hard copy):
•
TGA Clinical Trials Notification (CTN) for the Site
•
Fee Form (For Sponsor-Initiated Studies Only)
•
Ethics Approval Letter (only if reviewing HREC is not TQEH/LMH/MH)
•
Approved NEAF is attached (only if reviewing HREC is not TQEH/LMH/MH)
•
PIS to be used at this Site
•
Advertising / Recruitment material to be used at this Site
•
Site Radiation Safety Report (if applicable)
•
Biosafety Advisory Committee Approval (if applicable)
•
Confirmation of Indemnity is attached OR Indemnity
Agreements for signature
•
Clinical Trial Research Agreements for signature
•
Site Principal Investigator CV
SA HEALTH
FEES FOR CLINICAL
TRIALS POLICY
SA Health Fees for Research Policy
>
Policy effective mid-2011 however not in full operation until now.
>
A ‘Fee Form’ needs to be completed and included in your HREC
and SSA submissions.
>
Will apply to both single-site and multi-site research.
>
All Investigator-Initiated research, including Collaborative Trial
Groups will be excluded.
>
$3850 for Ethics Submission, $660 / $220 For Ethics Amendments
>
$3300 for each SSA Application
>
EXAMPLE of multi-site application:
SA Multi-Site Research Proposal
HREC Review
(RAH)
SSA Review
(RAH)
SSA Review
(TQEH)
$3850
$3300
(GST inclusive)
(GST inclusive)
$3300
(GST inclusive)
$13750
(GST inclusive)
SSA Review
(LMH)
$3300
(GST inclusive)
Ethics – Post Approval
Amendments
> At this stage, can be submitted in hard-copy to the
Chairman of the Lead HREC
> Eventually will be through Online Forms
> Processing of post-approval documents…
Document
Lead SA
HREC
Local SA
HREC
Site (RGO)
Amendment to Protocol, PIS, Study
Material
Broader Serious Adverse Events
(includes SUSARs, Line Listings)
Local Serious Adverse Event (SAE)
Ethics Annual Reporting
FUTURE
DEVELOPMENTS
> Formal appointment/nomination of Research
Governance Officers for each site/service
> Development of SA Low and Negligible Risk (LNR)
Ethics Application form
> Development of SA Low and Negligible Risk (LNR)
Site Specific Assessment Application form
> Availability of LNR Forms through the ‘Online Forms’
website
> Implementation of ‘National Approach’
> Certification for our Committee to be ready for
‘National Approach’
> Electronic Committee
More Information…
QUESTIONS?