Human Research Ethics Forum

A/Prof Tim MathewChairman, Human Research Ethics Committee (TQEH/LMH/MH)

Melissa KlugeExecutive Officer, Human Research Ethics Committee (TQEH/LMH/MH) & A/Research Governance Officer (TQEH/LMH/MH)

Newly releasedSA 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 DefinitionSSA – 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.

• Ethics approval and Site approval now separate processes.

• Ethics review by Ethics Committee.• Site approval (SSA) by RGO & General

Manager.

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

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 HEALTHETHICS 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 …

> University Committees not in this model

> Interstate Committees are not yet in this model.

Choosing a Lead SA HREC

TYPE OF RESEARCH

Single-Site Multi-Site(involving only 1 SA Health Site)

Multi-Site(involving 2 or more SA Health Sites)

LEAD HREC SA HREC where the research is being conducted

SA HREC where the research is being conducted

Any SA HREC involved in the Research

CONSIDERATIONS • SA HEALTH HRECMust review research involving an SA Health database /registry (e.g. OACIS, Cancer Registry Data)

• Women’s & Children’s Health Network HRECMust 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 - Checklistapplies 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 - Checklistapplies 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 HEALTHFEES 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 ProposalHREC Review

(RAH)$3850

(GST inclusive)

SSA Review(RAH)

$3300(GST inclusive)

SSA Review(TQEH)$3300

(GST inclusive)

SSA Review(LMH)$3300

(GST inclusive)

$13750(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?