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Human Research Ethics Forum

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1 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) Welcome [Introduce Tim, Mel, Maria] The purpose of today’s presentation is to speak about new SA Health research policies which have been mandated and have create significant changes in how we apply for ethics across SA Health Sites. We have provided a copy of our presentation today to allow you to take it with you, and also to make any notes as we go through the presentation We have also provided an Information Pack with a copy of the policies, flowcharts and other information we feel will be helpful to have whilst we go through the presentation, but also for you to take with you and keep for future reference. There will be ample time for questions at the end of the presentation, and I ask that we leave questions until the end. You may find the information ties together further into the presentation and your question may be answered. If you cannot hear me, or if you need me to repeat something, please feel free to raise you hand at any time.

2 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)

3 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 1st stage - State-wide consistency - Getting us ready for : 2nd stage - National consistency (Some would be of the NHMRC imitative to introduce a National approach to Ethical Review called HoMER, this is now referred to as the ‘National Approach’) No longer being driven by the NHMRC but has been taken over by the Health Ministers Advisory Committee. Has had continuous delays we believe the anticipated start won’t be until next year. We are undergoing Certification so when the National Approach is in effect we can be one of the Committee’s included in that National system. All SA Health Sites have applied for certification. Less duplication in ethical process Documented risk management process State/national monitoring/recording

4 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. 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. Online Forms

5 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 Online Forms

6 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’ Local Investigator-prepared Protocol. 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 Separation of Ethics & Governance processes Ethics & Governance are now a complete separate process Both avenues are required for ALL research (including low and negligible risk) Online submission of National Ethics Application Form (NEAF) Ethics applications (with the exception of Low & Negligible Risk (LNR) Research) must be prepared and submitted an electronic NEAF through the Online Forms Website New LNR Research Application form Separate process for LNR Research. Introduction of Site Specific Applications (SSA’s) The SSA Form is required for ALL research and for EACH site. The SSA application covers the governance issues such as Indemnity, Contracts, Resourcing, Funding. The SSA is also prepared electronically through the Online Forms Website: https://www.ethicsform.org/Au Mutual Recognition of Ethical Approval across SA Health Ethics approval is now mutually accepted across SA Health HRECs. Therefore once approval has been granted by an SA Health HREC (e.g. RAH, Southern Adelaide, SA Health, or CYWHS Ethics Committee), you do not need to re-apply to the TQEH/LMH/MH Ethics Committee. Please note Governance approval is separate and an SSA application is still required at each site. Nomination of a Research Governance Officers (RGO) for each Institution Each SA Health Institution has nominated a RGO who will receive and process SSA applications. I am currently the RGO for TQEH/LMH/MH/PHC whilst each institution are reviewing an ongoing structure that suits their individual needs Each institution is different and some have a separate Ethics Officer to a Research Governance Officer, please be aware of this when you are submitting your applications. A list of Research Governance Officers is available on the SA Health Website, there is a link from our webpage. Not all statewide services have nominated an RGO, for example, Mental Health Services. If the information is not on the SA Health website, please contact SA Health for more information as they may be able to update you. State Fee-Structure in place for sponsor-initiated research In effect since mid-2011. Will go into more detail later on

7 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 Separation of Ethics & Governance processes Ethics & Governance are now a complete separate process Both avenues are required for ALL research (including low and negligible risk) Online submission of National Ethics Application Form (NEAF) Ethics applications (with the exception of Low & Negligible Risk (LNR) Research) must be prepared and submitted an electronic NEAF through the Online Forms Website New LNR Research Application form Separate process for LNR Research. Introduction of Site Specific Applications (SSA’s) The SSA Form is required for ALL research and for EACH site. The SSA application covers the governance issues such as Indemnity, Contracts, Resourcing, Funding. The SSA is also prepared electronically through the Online Forms Website: https://www.ethicsform.org/Au Mutual Recognition of Ethical Approval across SA Health Ethics approval is now mutually accepted across SA Health HRECs. Therefore once approval has been granted by an SA Health HREC (e.g. RAH, Southern Adelaide, SA Health, or CYWHS Ethics Committee), you do not need to re-apply to the TQEH/LMH/MH Ethics Committee. Please note Governance approval is separate and an SSA application is still required at each site. Nomination of a Research Governance Officers (RGO) for each Institution Each SA Health Institution has nominated a RGO who will receive and process SSA applications. I am currently the RGO for TQEH/LMH/MH/PHC whilst each institution are reviewing an ongoing structure that suits their individual needs Each institution is different and some have a separate Ethics Officer to a Research Governance Officer, please be aware of this when you are submitting your applications. A list of Research Governance Officers is available on the SA Health Website, there is a link from our webpage. Not all statewide services have nominated an RGO, for example, Mental Health Services. If the information is not on the SA Health website, please contact SA Health for more information as they may be able to update you. State Fee-Structure in place for sponsor-initiated research In effect since mid-2011. Will go into more detail later on

8 Research Ethics & Governance Flow Chart
There is a copy of this flow chart in your information packs. The flow chart depicts the separation of Ethics and Site approval and that both are required before Research can commence. These processes also apply to Low and Negligible Risk Research. The idea is that the Ethics and Site Specific Reviews can run in parallel. Although it’s important to note the Ethics approval is required before the Site can approve. However rather than submitting the SSA after you are granted Ethical approval, you do have the ability to submit the SSA and have that process in motion so it won’t take too long to process once the Ethics is granted.

9 SA HEALTH ETHICS POLICY
This contact details sheet is in your information pack We aim to keep our webpage up-to-date with all the latest templates and information If down the track you have any questions or concerns, Please feel free to contact me, or you are welcome to set up a time to meet with me if you prefer

10 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 SA Health Single Review Model The SA Health Single Review Model applies to all multi-site research taking place within the SA public health system. The Single Review Model is a streamlined model of ethical review, whereby applicants undertaking research across multiple SA Health sites or institutions are able to seek ethical and scientific approval through one HREC only (referred to as the ‘lead’ committee). This approval will then be accepted by all other SA public health system HRECs and institutions without the requirement for further ethical or scientific review. If applying for single review, the ethics applicant will firstly need to consider which HREC will provide the lead ethical and scientific review. There are a number of considerations that should be noted by the ethics applicant regarding the selection of the lead HREC. University Committees not in this model (although they often accept our approvals) Interstate Committees are not yet in this model.

11 Choosing a Lead SA HREC Single-Site Multi-Site
TYPE OF RESEARCH Single-Site Multi-Site (involving only 1 SA Health 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 HREC 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. Single Site Research local HREC where the research is being conducted Multi-site Research –1 SA Health site local HREC where the research is being conducted Multi-site Research - 2 or more SA Health sites local HREC of your choice, with the following considerations: Applications involving a SA Health database or registry – SA HEALTH HREC Any multi-site or whole of state project where the primary data being used for the project is held centrally by SA Health (e.g. OACIS, ISAAC, Cancer Registry Data) must be submitted to the SA Health HREC for review as the lead HREC. Applications involving children and young people – Women’s & Children’s Health Network HREC Ethics applications involving multiple sites including Women’s and Children’s Health Network (WCHN), and where the primary research participants are children and young people, or where the project involves access to paediatric data primarily held by WCHN, must be submitted to the WCHN HREC for review as the lead HREC. Aboriginal Projects Research applications that fall into the following categories are required to be submitted to the Aboriginal Health Research Ethics Committee (AHREC) in SA even if they are submitted to and reviewed by a SA Health HREC: o The experience of Aboriginal people is an explicit focus of all or part of the research; or o Data collection is explicitly directed at Aboriginal peoples; or o Aboriginal peoples, as a group, are to be examined in the results; or o The information has an impact on one or more Aboriginal communities; or o Aboriginal health funds are a source of funding.

12 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. The first time you use Online Forms, you will be required to create a user account. Once an account has been created and the applicant has signed in, ‘My Projects’ should be selected from the tab bar, followed by ‘Create New Project’. Following this, the applicant should select ‘SA’ from the tick box below, followed by ‘NEAF’ application. The applicant may then proceed to complete the form (see screenshot over the page for assistance).

13 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 The application does not need to be completed in a single session, and applicants are able to save the ethics application and return to it at any stage. You can print out or save DRAFT copies. Once the application is complete, the ethics applicant should upload all supporting documents electronically (where possible).

14 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 This Checklist is in your Information Packs This Checklist has been created for HREC submissions made to the TQEH/MH/MH HREC only – Other committees will have their own Final proof and spelling check of all documents Electronic Submission to for preliminary-review (optional) Have all supporting documents been uploaded through Online Forms (and correctly labeled with version numbers and dates) Has the NEAF been submitted through Online Forms ( a submission code will be generated and DRAFT will not appear watermarked across document) Has the application been signed by the local (SA) Investigators Is a Clinical Trials Notification (CTN) for each SA Health Site attached (must be signed by PI first) 1x Fee for Consideration of Clinical Trials Form is attached (For Sponsor-Initiated Studies Only) Participant Information Sheet & Consent Forms – either a ‘Master SA Version’ is submitted, or each individual PIS for each site Advertisements or other recruiting material - for each site Radiation Safety Reports- for each site conducting the scans as radiation can differ of different equipment Study Protocol – it is expected all research has a formal study protocol and this should accompany the NEAF application. Copies are collated, and then clipped or stapled.

15 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. HREC Submission Checklist This Checklist is in your Information Packs This Checklist has been created for HREC submissions made to the TQEH/MH/MH HREC only – Other committees will have their own Final proof and spelling check of all documents Electronic Submission to for preliminary-review (optional) Have all supporting documents been uploaded through Online Forms (and correctly labeled with version numbers and dates) Has the NEAF been submitted through Online Forms ( a submission code will be generated and DRAFT will not appear watermarked across document) Has the application been signed by the local (SA) Investigators Is a Clinical Trials Notification (CTN) for each SA Health Site attached (must be signed by PI first) 1x Fee for Consideration of Clinical Trials Form is attached (For Sponsor-Initiated Studies Only) Participant Information Sheet & Consent Forms – either a ‘Master SA Version’ is submitted, or each individual PIS for each site Advertisements or other recruiting material - for each site Radiation Safety Reports- for each site conducting the scans as radiation can differ of different equipment Study Protocol – it is expected all research has a formal study protocol and this should accompany the NEAF application. Copies are collated, and then clipped or stapled.

16 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. Loosely defined as A Low & Negligible Risk (LNR) application is the terminology we are now using for what we used to call an Expedited Review. Interventions and therapies, including clinical and non-clinical trials of new treatments; Human genetics; Human stem cells; Women who are pregnant and the human foetus; People who are highly dependent on medical care who may be unable to give consent; People with a cognitive impairment; People with an intellectual disability or a mental illness Research specifically targeting Aboriginal or Torres Strait Islanders as the focus of the project; People who may be involved in illegal activities. It’s not always clear cut and if you are not sure whether your project qualifies under Low & Negligible Risk please contact us to find out first. Can be submitted on the NEAF or our local LNR Ethics Application Form. SA Health are in the process of drafting an LNR Form to be loaded onto Online Forms and can then also be submitted electronically. The Chairman reserves the right to not class something as LNR and insist on a full application on to the full HREC

17 SA HEALTH GOVERNANCE POLICY
This contact details sheet is in your information pack We aim to keep our webpage up-to-date with all the latest templates and information If down the track you have any questions or concerns, Please feel free to contact me, or you are welcome to set up a time to meet with me if you prefer

18 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) SA Health Single Review Model The SA Health Single Review Model applies to all multi-site research taking place within the SA public health system. The Single Review Model is a streamlined model of ethical review, whereby applicants undertaking research across multiple SA Health sites or institutions are able to seek ethical and scientific approval through one HREC only (referred to as the ‘lead’ committee). This approval will then be accepted by all other SA public health system HRECs and institutions without the requirement for further ethical or scientific review. If applying for single review, the ethics applicant will firstly need to consider which HREC will provide the lead ethical and scientific review. There are a number of considerations that should be noted by the ethics applicant regarding the selection of the lead HREC. University Committees not in this model (although they often accept our approvals) Interstate Committees are not yet in this model.

19 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 As I said earlier an SSA is required for each site, including the site that conducting the HREC Review. An SSA is required for all research, regardless of whether single-site or multi-site, or reviewed by the full committee or classed as LNR Research. There are two key components involved in the processing of a SSA by a Health Site: Review of the SSA by the delegated Research Governance Officer (RGO), who will provide a recommendation to support / not support the project; and Endorsement of the recommendation by the Chief Executive or delegate of the institution, a process referred to as project authorisation. A project cannot commence until authorisation has been supplied, even if ethics approval has been granted. To start an SSA application: Go to https://www.ethicsform.org/au Sign in to your account and go to ‘My Projects’ from the tab bar Then 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 If the applicant has used Online Forms to complete the NEAF, the key project information will be populated into the relevant fields in the SSA to reduce the need for duplication.

20 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 The application does not need to be completed in a single session, and applicants are able to save the ethics application and return to it at any stage. You can print out or save DRAFT copies. Once the application is complete, the ethics applicant should upload all supporting documents electronically (where possible). A printed copy with signatures is sent to the Site’s Research Governance Officer

21 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 This Checklist is in your Information Packs This Checklist has been created for SSA submissions made to the TQEH/MH/MH/PHC only – Other sites will be similar but may have their own Supporting documents been uploaded through Online Forms (correctly labeled with version numbers and dates) SSA been submitted through Online Forms (a submission code should be generated) SSA signed by all of the Site’s Depts/Services affected by the research - (separate sheets can be copied and attached if not enough room). SSA application been signed by the Site Principal Investigator 1x Clinical Trials Notification (CTN) for the Site is attached (must be signed by Site Principal Investigator and Lead Reviewing HREC Chairman) 1x Fee for Consideration of Clinical Trials Form is attached (For Commercially-Sponsored Studies Only) 1x copy of signed and completed SSA is attached 1x copy of Ethics Approval is attached (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of approved NEAF is attached (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of approved PIS to be used at this Site is attached (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of approved advertising or other recruitment material to be used at this Site is attached (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of Site Radiation Safety Report is attached (if applicable) - (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of Biosafety Advisory Committee Approval is attached (if applicable) 1x copy of Confirmation of Indemnity is attached OR 3x Indemnity Agreements are attached- for signature 3x Clinical Trial Research Agreements are attached- for signature 1x Site Principal Investigator CV is attached

22 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 SSA Submission Checklist This Checklist is in your Information Packs This Checklist has been created for SSA submissions made to the TQEH/MH/MH/PHC only – Other sites will be similar but may have their own Supporting documents been uploaded through Online Forms (correctly labeled with version numbers and dates) SSA been submitted through Online Forms (a submission code should be generated) SSA signed by all of the Site’s Depts/Services affected by the research - (separate sheets can be copied and attached if not enough room). SSA application been signed by the Site Principal Investigator 1x Clinical Trials Notification (CTN) for the Site is attached (must be signed by Site Principal Investigator and Lead Reviewing HREC Chairman) 1x Fee for Consideration of Clinical Trials Form is attached (For Commercially-Sponsored Studies Only) 1x copy of signed and completed SSA is attached 1x copy of Ethics Approval is attached (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of approved NEAF is attached (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of approved PIS to be used at this Site is attached (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of approved advertising or other recruitment material to be used at this Site is attached (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of Site Radiation Safety Report is attached (if applicable) - (only if the reviewing HREC was not TQEH/LMH/MH HREC) 1x copy of Biosafety Advisory Committee Approval is attached (if applicable) 1x copy of Confirmation of Indemnity is attached OR 3x Indemnity Agreements are attached- for signature 3x Clinical Trial Research Agreements are attached- for signature 1x Site Principal Investigator CV is attached

23 SA HEALTH FEES FOR CLINICAL TRIALS POLICY
This contact details sheet is in your information pack We aim to keep our webpage up-to-date with all the latest templates and information If down the track you have any questions or concerns, Please feel free to contact me, or you are welcome to set up a time to meet with me if you prefer

24 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) $3850 (GST inclusive) SSA Review $3300 (TQEH) (LMH) $13750 A copy of the Policy is in your information Pack Policy effective mid-2011 however not in full operation until now. Applies to HREC submissions and SSA submission There is one submission fee for ethics There is a submission fee for EVERY SSA application A ‘Fee Form’ needs to be completed and included in your HREC and SSA submissions Also applies to HREC amendments The forms are available on the website Policy implies it is in place for multi-site research but can be applied to single-site research. This HREC applies it to all sponsor-initiated research regardless of whether it is multi-site or single-site. Policy implies fees can be negotiated for Investigator-Initiated Collaborative Group Trials with sponsorship. This HREC hasn’t ever invoiced for Investigator-Initiated Collaborative Group Trials, and at this stage will continue not to. $3850 for Ethics Submission $660 / $220 For Ethics Amendments $3300 for EACH SSA Application

25 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

26 FUTURE DEVELOPMENTS This contact details sheet is in your information pack We aim to keep our webpage up-to-date with all the latest templates and information If down the track you have any questions or concerns, Please feel free to contact me, or you are welcome to set up a time to meet with me if you prefer

27 Availability of LNR Forms through the ‘Online Forms’ website
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 This contact details sheet is in your information pack We aim to keep our webpage up-to-date with all the latest templates and information If down the track you have any questions or concerns, Please feel free to contact me, or you are welcome to set up a time to meet with me if you prefer

28 More Information… This contact details sheet is in your information pack We aim to keep our webpage up-to-date with all the latest templates and information If down the track you have any questions or concerns, Please feel free to contact me, or you are welcome to set up a time to meet with me if you prefer If in the event you need to speak with Tim Mathew, you can contact him through switchboard. We are here to help you, and this is a time for change for us as well, and we hope we can work together to make this time of change run as smoothly as possible. There has been, and will continue to be teething issues, and we encourage you to use the Infonetica help desk for website questions, or to contact us with any questions you may have.

29 QUESTIONS? This contact details sheet is in your information pack
We aim to keep our webpage up-to-date with all the latest templates and information If down the track you have any questions or concerns, Please feel free to contact me, or you are welcome to set up a time to meet with me if you prefer

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