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?