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Researcher User Guide (RUG)

1. Researcher User Guide RUG Office of Health and Medical Research Queensland Health July 2010 iea Queensland tag i AA Government Table of contents INTRODUCTION 3 DEFINITIONS AND APPREVIATIONS 4 HOW TO APPLY 8 1 Scientific and Ethical Review 9 1 1 National Ethics Application Form NEAF 9 1 2 Submitting an HREC Application to a reviewing HREC 12 1 3 What is the Australian Research Ethics Database AU RED 13 1 4 HREC decisions 13 2 Research Governance Review 15 2 1 Site Specific Assessment Form SSA Form 15 2 2 What happens next with my SSA Application 17 2 3 What is the Research Governance Office function 17 3 Access to Confidential Health Information for the Purposes of Research 18 4 Research Involving Adults with Impaired Capacity to consent 18 5 Research Involving Material from Coroners Autopsies 19 6 Research Involving Pathology Samples 19 7 Low and Negligible Risk Research exempt from full ethical review 19 8 Exceptional circumstances exempt from full ethical review 21 9 Quality Assurance Activities 21 10 Amendments to Research Post Authorisation 22 10 1 Amendments to the research study which may affect the ongoing ethical acceptability of the study 22 10 2 Amendments to the Research study which may affect both the ethical acceptability and site acceptability of the study 23 ee Amendments to the research study which only affect the ongoing site acceptability of the m study 10 4 Minor amendment
2. c ii Medicines Australia Standard Indemnity Form s e Section 8a iii b iii c iii Evidence of adequate insurance cover e Section 8d Medicines Australia Standard Clinical Trial Agreement s e Section 11 Departments and services involved in the research e Section 13 QH account number s cost centre details e Section 14 Finance authorisation e Section 13 a f Declarations and authorisations Amendments which may affect the ongoing site acceptability of a study should be reflected ina cover letter from the local Site Principal Investigator stating the changes and reasons for changes and accompanied by all relevant updated documents which have been uploaded through the online form by the local Principal Investigator Updated documents should be uploaded in two forms one with track changes and one clean copy Hard copies of the cover letter and all relevant updated documents must be submitted to the RGO as required as per normal approving RGO procedure An updated NEAF should not be submitted If an amendment requires any change to section s of the SSA Form other than those listed above then the amendment request must be submitted by the Principal Investigator or Coordinating Principal Investigator for multi centre studies to the approving HREC in the first instance Upon receipt of the written request for a site amendment the RGO will determine whether authorisation from the District CEO or
3. 6 of the National Statement on Ethical Conduct in Human Research describes research as Low Risk where the only foreseeable risk is one of discomfort Where the risk even if unlikely is more serious than discomfort the research Minor amendment MCR Negligible risk research Principal Investigator Quality Assurance is not low risk An amendment not requiring review by a full HREC Can receive approval outside of scheduled HREC meeting Changes to the details of research that have no significant implications for subjects or for the conduct management or scientific value of the study and can be regarded as minor amendments sometimes referred to as administrative amendments Examples as follows e Correction of typographical errors in the protocol or other study documentation Amended contact details for the sponsor or study staff e Appointment of new support staff Multi centre Research Research to be conducted at more than one site this may include sites other than Qld Health sites and within the jurisdiction of more than one HREC For MCR which is to be submitted to the CCS the research project will include sites which cross ethical jurisdictions and would have been reviewed previously by more than one HREC Section 2 1 7 of the National Statement describes research as negligible risk where there is no foreseeable risk of harm or discomfort and any foreseeable risk is not more than inconvenience W
4. AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 pdf 1 1 3 Obtaining authorisation signatures Click on the Authorisation tab on the NEAF application Click Request and then enter the email address of the person you want to sign the form and click Send request More than one electronic authorisation may be requested at the one time The recipient collaborating researcher will receive an automated email of an online forms electronic authorisation instructing them to log onto the Online Forms open the Requests for authorisation tab click the Navigate icon and click the Authorise Form button For further information please see Section The Authorisation tab in the User Manual https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20Vv1 padf 1 1 4 Transferring a NEAF to another user To transfer the NEAF to a collaborating researcher click on My projects Existing projects On the relevant application click on Manage Transfer and type in the person s email address and click Transfer to user Do not create a submission code before sending it to a collaborating researcher In order to transfer the form to a recipient they must have an account on the Infonetica online form system For further information please see Section The transfer tab in the User Manual https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20
5. and radiation safety The SSA process deals primarily with research budgets funding sources recruitment human resources contracts agreements and local site policies and will require approval prior to undertaking the research Importantly the Actual Monetary and In Kind costs for the research study are to be documented in the budget section of the SSA Failure to do so may prevent authorisation of the research at the nominated site Applicants should begin negotiations with relevant QH personnel responsible for resources and services that will be required for the study e g Heads of Departments or delegate s and Director of Finance or delegate as early as possible Negotiations pertaining to the research governance processes should commence and run parallel to the HREC approval cycle The final Declaration s however may only be signed off once your HREC approval has been given 2 1 1 To create a SSA Form All studies The SSA tab appears in the NEAF action tabs Selecting this tab allows you to create a new Site Specific Assessment SSA for your project On the SSA tab click Generate a new SSA Click on the relevant SSA Form select Queensland and SSA and complete your form The SSA Form is not available as a stand alone document it can only be created out of the online form NEAF For further information please see Section The SSA tab in the User Manual https ethicsform org Au Help AU 20Online 2
6. can create different categories e g obsolete archived etc Click on Manage categories under Project categories Expand the category the project is stored in and tick the project you want to move and transfer it to the relevant category For further information please see Section Project categories in the User Manual https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20Vv1 padf 1 2 Submitting an HREC Application to a reviewing HREC Single Site Studies Submit your application to the relevant HREC after first determining the number of hard copies the HREC requires Prior to submission of the application bundles collate separate documents in order so that each bundle contains one copy of all required documentation On receipt of the collated hard copies of the application with submission code the HREC Administrator will check to see whether the application is valid This is a simple administrative check to determine that the application is complete and has all the relevant supporting documentation Researchers are encouraged to consult the HREC Submission Checklist for Researchers prior to submission to ensure their application is valid A standard letter email acknowledging receipt of a valid research application may be sent from the HREC Administrator The letter will include a HREC Reference Number and the meeting date at which the study will be reviewed The HREC Reference Numb
7. delegate is required or if RGO approval only is necessary The RGO will notify the site Principal Investigator as to whether or not authorisation has been granted for the amendment to be implemented at the site The site investigator may commence the amendment at the site only once notification of amendment authorisation has been received For multi centre commercially sponsored clinical trials a CRA may be involved in distributing information between the CP I and P I s 10 4 Minor amendments to the Research Study which do not affect either the ethical acceptability or site acceptability of the study e g typographical errors addition to study team All studies Amendments which do not affect either the ethical acceptability or site acceptability of the study as per glossary minor amendments should be uploaded through the online form and submitted in hard copy to the HREC coordinator These should include a cover letter from the Principal Investigator or Coordinating Principal Investigator for multi centre studies stating the changes and reasons for changes and all relevant updated documents Updated documents should be submitted to the HREC administrator in two forms one with track changes and one clean copy An updated NEAF should not be submitted If unsure of the applicability of the amendment local site investigators or Coordinating Principal Investigators for multi centre studies are encouraged to contact th
8. documentation that is provided to the District CEO or delegate These documents collectively allow for consideration of all aspects of the research study governance arrangements and will assist the District CEO or delegate decision on granting authorisation to conduct the research at the site Research cannot be commenced at a site until the Governance Authorisation has been granted Detailed information about the Queensland Health process for submission and authorisation of research can be obtained at the Queensland Health Research Ethics and Governance Unit website http Awww health qld gov au ohmr html regu requ_home asp All researchers conducting studies within QH and or using QH resources should manage the research in accordance with this RUG with effect from 1 July 2010 DEFINITIONS AND APPREVIATIONS AuRED Central Coordinating Service CCS Coordinating Principal Researcher Clinical Research Coordinator Contact person CPI HREC Coordinator Low risk research A secure web based Research Ethics Database that allows researchers to complete and submit a NEAF application online The Central Coordinating Service CCS provides a one stop shop information service for the processing of multi centre research applications within Queensland Health sites Use of the Central Coordinating Service for multi centre research in Qld Health sites is mandatory from 1 July 2010 The investigator responsible for coordinat
9. optional only insert this if you have been given an HREC reference number by the relevant HREC of the QH Central Coordinating Service Most HRECs will give you the HREC Ref number AFTER you have submitted your application Therefore this box will usually be blank when you submit the form NEAF Section 2 Entering researchers onto the NEAF The easiest way is to go to My Contacts on the top of the NEAF page Create a contact for each of the researchers associated with your study Then in the NEAF when details of researchers are requested you simply click on the icon which looks like a letter box or a book with a bookmark and this will take you to the Contact List Select one person at a time from the list click on View and check that the contact details are correct Then click on Copy Contact Details into the Form The contact details will upload into the form The Contact List is attached to your account not to the application so the list can be used for all subsequent applications NEAF Section 2 1 All studies MUST have a Chief Researcher Coordinating Principal Researcher Investigator even if the study is a single site study For single site studies the Chief Researcher 2 1 and Principal Researcher Investigator 2 2 will be the same For multi centre studies the Chief Researcher Coordinating Principal Researcher Investigator is the investigator nominated by the research team in collaboration with the sponsor to be resp
10. the Coordinating Principal Investigator multi centre studies or local Site Principal Investigator single site studies stating the changes and reasons for the changes The cover letter and all updated supporting documentation should be uploaded onto the online form by the Coordinating Principal Investigator multi centre studies or local Site Principal Investigator single site studies Two copies of the updated documents should be provided one with track changes and one clean copy A revised NEAF should not be submitted Hard copies of the cover letter and all relevant updated documents e g protocol participant information sheets etc should also be submitted to the HREC coordinator as required Single site studies submission to RGO Once the HREC approval has been given for the amendments the local Site Principal Investigator will submit a copy of the HREC approval letter a cover letter stating the changes and reasons for the changes and all updated supporting documentation to their local RGO for authorisation to implement the amendment at the site The updated documents should also be uploaded onto the online form by the local Site Principal Investigator Updated documents should be uploaded in two forms one with track changes and one clean copy Hard copies of the cover letter and all relevant updated documents must be submitted to the RGO as required as per normal authorising RGO procedure Upon receipt of
11. to have an electronic copy of all the documentation Supporting documents can still xii xiii Xiv XV xvi be uploaded even after the NEAF application has been submitted to the HREC Supporting documentation includes progress reports annual reports SAE reports DSMB reports and study amendments How do I know the Participant Information Sheets are at a Grade 8 level of reading In a WORD document on the Tools menu click Options and then click the Spelling amp Grammar tab Select the Check grammar with spelling check box Select the Show readability statistics check box and then click OK On the Standard toolbar click Spelling and Grammar When Microsoft Word finishes checking spelling and grammar it displays information about the reading level of the document Why can t the site details e g investigators be populated from the NEAF into the SSA This is because the designated persons on the NEAF are not the same as the SSA For example a person identified as an Associate Investigator on the NEAF may actually be a Principal Investigator at a site and therefore identified as a Principal Investigator on the SSA form It is not clear the timing of research governance application in relation to the ethics application Although the negotiations regarding the SSA application should be commenced early the actual submitting of the research governance documentation including the SSA Form to the RGO should not occur until after H
12. 0Forms 20for 20Research 20User 20Manual 20v1 pdf The SSA form will be partially electronically populated on line with information from your NEAF However you have a choice as to whether or not you accept the auto populated data To de select the auto populated data simply click on the Populate from NEAF box To edit the auto populated data you must copy it then de select the auto populated data and then paste and edit the text You will be required to complete those areas of the SSA that relate to your study once your study has been approved Examples on how to fill out a SSA can be found on the Queensland Research Ethics and Governance Unit website http www health qld gov au ohmr documents ssa_full suite docs pdf The SSA form is only completed once all application sections have been finalised and HREC approval is received Where there is Actual Monetary and In Kind costs that may have an impact on the District budget the District Finance Manager or delegate must sign off on the SSA Multi centre studies The Coordinating Principal Investigator or this may be the Clinician Research Associate CRA for commercially sponsored Clinical trials should create a Site Specific Assessment Form for each site where the research will take place by creating the required number of forms and transferring the form to the local Site Principal Investigator at each site to complete create a submission code and submit to their local
13. CTA A commercially sponsored CTA with a pharmaceutical company must only contain the Schedule 7 Special Conditions that have been issued to that pharmaceutical company as approved by QH If a site receives a contract containing non approved Schedule 7 clauses the contract must be submitted to QH REGU for legal review A fee may be levied for this process Names of companies with QH approved Schedule 7 clauses can be accessed on the REGU website http Awww health qld gov au ohmr documents Schedule 7 Clauses pdf 13 3 Parties to a Contract The State of Queensland is the contracting party for all QH agreements The various state government departments including QH are not separate legal entities and cannot enter into contracts Any wording which follows The State of Queensland is descriptive only and intended to assist the parties in identifying the relevant part area department within the State involved in the contract QH should be described on all research contracts as The State of Queensland acting through Queensland Health name of hospital district of Address of Institution 13 4 Insurance The Commercially Sponsored CTA and the CRO CTA both require the other party to have and maintain insurance with respect to its activities under the CTA s The insurance requirements must be stated in Schedule 4 The type and level of insurance required for each agreement will depend to some extent on the level and nature of the risks inv
14. Form is submitted by the Principal Investigator to the RGO for filing 14 Monitoring Requirements for Approved Research Each institution has ultimate responsibility for ensuring via its research governance arrangements that all its approved research is monitored National Statement Section 5 5 1 Researchers should follow the Australian Health Ethics Committee AHEC Position Statement Monitoring and reporting of safety for clinical trials involving therapeutic products MAY 2009 for reporting requirements http www nhmrc gov au files nhmrc file health_ethics hrecs reference 090609 nhmrc_ position statement pdf Mechanisms for monitoring can include reports from researchers reports from independent agencies such as a data and safety monitoring board review of adverse event reports random inspections of research sites data or consent documentation and interviews with research participants or other forms of feedback from them oA fp As a condition of ethics approval researchers must comply with all reporting requirements stipulated in the HREC approval letter and or Letter of authorisation to conduct research 14 1 Progress reports All studies Institutions are responsible for the ongoing monitoring of the ethical conduct of research studies for which they have granted ethical approval National Statement 5 5 As a minimum the institution will require at regular periods at least annually progress reports from investig
15. REC approval has been granted As a result of the HREC review the SSA Form and supporting documentation may require changes therefore it is not appropriate to submit the SSA Form for Research Governance review until after HREC approval has been granted However consultation with the supporting departments should occur as early as possible and begin prior to HREC submission to ensure all relevant services and resources are available and accessible Does the NEAF have to be completed and a submission code generated for the SSA to be populated No as soon as a SSA is generated it will be auto populated in certain sections from the NEAF even if the NEAF has not had a submission code generated Do you have to submit a NEAF and SSA Form Yes the NEAF and supporting documentation are submitted to the reviewing HREC for ethical approval and the SSA Form and supporting documentation is submitted to the local RGO for research governance review and recommendation to the District CEO for study authorisation http creativecommons org licenses by 2 5 au State of Queensland Queensland Health 2010 2
16. RGO A separate SSA Form must be completed for each study and for each site at which the study is to be conducted 2 1 2 Entering researchers onto the SSA Form The easiest way is to go to My Contacts at the top of the page Create a contact for each of the researchers associated with your study include your own details Then in the SSA Form when details of researchers contacts are requested you simply click on the icon which looks like a letter box or a book with a bookmark and this will take you to the Contact List Select one person at a time from the list click on View and check that the contact details are correct Update details if appropriate Then click on Copy Contact Details into the Form The contact details will upload into the form The Contact List is attached to your account not to the application so the list can be used for all subsequent applications 2 1 3 Uploading Supporting documents Any supporting documents to be submitted with the application e g CTN CTA investigator brochure protocol HREC approval letter etc must be electronically uploaded at this time Click on My projects Existing projects On the relevant SSA Form click on Manage Documents and then Upload and then upload the relevant files from your computer This ensures that the RGO receives all the supporting documentation Note Supporting documents can still be uploaded even after the SSA Form application has
17. User 20Manual 20v1 padf 1 1 4 1 What happens when a NEAF is transferred The recipient collaborating researcher will receive an automated email notifying them that the form has been transferred to their account and that they must log onto the Online Forms website to accept the application and access the form When a person receives this notification from the originator of the NEAF they will be able to view and change the NEAF To maintain version control ANEAF may only be transferred to one user at a time e After completing the relevant sections of the NEAF the collaborating researcher MUST transfer the NEAF back to the originator of the form for a submission code to be generated e Only the originator of a NEAF can create the NEAF submission code however a collaborating researcher can create a SSA form submission code 1 1 5 Retrieving a NEAF For the originator of a NEAF to retrieve a NEAF that has been transferred click on the Transfer and then retrieve button 1 1 6 Transferring a NEAF permanently to another user To permanently transfer the NEAF to a collaborating researcher follow the steps outlined above Once the collaborating researcher has accepted the form the originator of the NEAF must return to the Transfer Page for the application and click on Permanently Transfer This Form A NEAF that has been permanently transferred cannot be retrieved 1 1 7 What to do with NEAF applications created o
18. al benefits The National Statement establishes different levels of ethical review based on the degree of risk involved There are three levels of risk Harm 7 Discomfort Inconvenience Researchers will need to check with the institution what processes are used for ethical review of low and negligible risk LNR research and are encouraged to contact the local HREC office RGO to gain an independent assessment of whether the study satisfies the criteria for alternate review rather than that of a full HREC before proceeding with their application The National Statement Section 2 1 7 describes research as negligible risk where there is no foreseeable risk of harm or discomfort and any foreseeable risk is not more than inconvenience to the participants Where the risk even if unlikely is more than inconvenience the research is not negligible risk The National Statement describes inconvenience as the least form of harm that is possible for human participants in research The most common examples of inconvenience in human research are filling in a form participating in a de identified survey or giving up time to participate in a research activity Institutions may choose to exempt from ethical review research that e is negligible risk research and e involves the use of existing collections of data or records that contain only non identifiable data about human beings The National Statement Section 2 1 6 describes research
19. as Low Risk where the only foreseeable risk is one of discomfort Discomforts may include minor side effects of medication discomforts related to measuring blood pressure or anxiety induced by an interview Where the risk even if unlikely is more serious than discomfort the research is not low risk Single site studies For all low and negligible risk research studies the following must be completed and submitted to the institution s low and negligible risk review panel e Checklist for Research that is Exempt from full HREC review http www health gld gov au ohmr documents low_ risk_app doc and e Application for Ethical Review of Negligible or Low Risk Research http www health qld gov au ohmr documents low_risk_app doc If the decision of the reviewing panel is unanimous that the protocol qualifies for negligible or low risk review the RGO or delegate will advise the investigator that approval has been granted At this stage the research may commence If the reviewing panel considers that the protocol poses more than low risk even if unlikely the protocol will not receive negligible or low risk approval and will be reviewed at a full meeting of the HREC The SSA component of the LNR research application must be submitted to the RGO at the site Multi centre studies To ensure standardisation of review and monitoring procedures if a coordinating investigator wishes to process a multi centre negligible risk or lo
20. ators on matters including Progress reports to date or outcome in the case of completed research Maintenance and security of records Compliance with the approved protocol and Compliance with any conditions of approval O OOQ The approving HREC determines the frequency type and format of reporting and monitoring which reflects the degree of risk of the research Progress reports should be uploaded onto the online forms by the researcher Single site studies The site Principal Investigator will send a progress report to the HREC If the HREC has concerns regarding the progress report they will then forward a copy of the progress report review outcomes to the RGO for review by the clinical governance committee In very specific cases of high risk research the HREC may recommend in its letter of approval that the RGO coordinate on site monitoring at recommended intervals or randomly throughout the research study The RGO will provide such on site monitoring reports to the HREC If a district site considers that it cannot comply with the monitoring recommendations made by the HREC then it should not grant authorisation of the research at the site district The coordination of on site monitoring by the RGO involves making the necessary arrangements for appropriate personnel internal and external to QH to conduct the monitoring activity within the given timeframe On site monitoring coordinated by the RGO may include attentio
21. been submitted to the RGO For further information please see Section The Documents tab in the User Manual https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 pdf 2 1 4 Transferring a SSA form To transfer a form to a collaborator the collaborator must first register as a user of the Online Forms website To register go to https ethicsform org Au Users CreateAccount aspx You only need to register once Click on the relevant SSA Transfer tab type in the person s email address and click Transfer to user The collaborator will receive an automated email notifying them that the form has been transferred to their account and that they must log on to the Online Forms website to access the form Do not create a submission code for the form before sending it to the local site investigator To maintain version control a form may only be transferred to one user at a time 2 1 5 Retrieving a SSA form To retrieve a SSA Form that has been transferred click on the Transfer and then Retrieve button 2 1 6 Obtaining authorisation signatures Click on the Authorisation tab on the SSA Form application Click Request and then enter the person s email address who you want to sign the form and click Send request More than one electronic authorisation may be requested at the one time The recipient collaborating researcher will receive an automated email noti
22. confidential information without consent for the purposes of research the provision of the Public Health Act 2005 Qld s282 must be considered This includes but is not limited to health information held and owned by QH from the Cancer Registry Perinatal Statistics Collection Pap Smear Register Register Screening Histories of Women Inpatient Data records Pathology samples from QH Clinical and State wide Services CaSS Any other Data base systems hard copy charts held by QH Prior to commencing the research the researcher must e Seek HREC approval for the protocol Discuss data requirements with the data custodian Complete a Public Health Act PHA application for release of data Submit PHA application to the QH REGU Complete an SSA Form Submit the PHA Approval letter with the SSA Form and all other required documentation to the site Research Governance Office Further information can be accessed at http Awww health qid gov au ohmr html regu aces_ conf hth info asp 4 Research Involving Adults with Impaired Capacity to consent If the research proposal involves participants who may be by reason of physical and mental incapacity incapable of giving informed consent to participate in the research approval from the Queensland Civil and Administration Tribunal QCAT is required Where a person is over the legal age of consent but is unable to give consent a written application to QCAT must be submitted after HREC approva
23. d determine whether District CEO or Delegate authorisation is required to implement the amendment at the Health Service District site The RGO will notify the local Site Principal Investigators as to whether or not authorisation has been granted for the amendment to be implemented at that site Authorisation to implement the amendment will only be granted when evidence has been provided of HREC approval The site Principal Investigator may not implement the amendment until the RGO has provided written notification that the amendment has been authorised at the Health Service District site The local Site Principal Investigators will then notify the CPI of the outcome at their site For commercially sponsored clinical trials a CRA may be involved in distributing information between the CP I and local site P I s 10 3 Amendments to the research study which only affect the ongoing site acceptability of the study All studies These are amendments which only impact upon the suitability of the research to be conducted at a particular site Amendment requests for an authorised research study may be submitted directly to the Research Governance Office r by passing the HREC by the local site investigator only when the amendment requires e No change to the authorised protocol and e Achange to one or more of the following sections of the QH SSA form which relate to the specific site only e Section 4 Training e Section 8a ii b ii
24. e approving HREC Administrator to discuss the amendment For all studies the outcome of the HREC review and any revised documentation pertaining to the research study must also be submitted by the local site Principal Investigators to the relevant site RGO for Health Service District noting For multi centre commercially sponsored clinical trials a CRA may be involved in distributing information between the CP I and P I s 10 5 Amendments for Urgent Safety Measures All studies Where it is necessary to eliminate an immediate hazard to the research participants amendments to the research study may be implemented without prior HREC review and authorisation from the District Manager delegate if necessary As soon as possible the implemented amendment should be submitted to the HREC and RGO For multi centre commercially sponsored clinical trials a CRA may be involved in distributing information between the CP I and P I s 11 Extension of a research study to an additional site Single site studies Where a single site study is to be extended to additional site s the local PI will take on the role of the CPI If the original approving HREC is not certified to approve multi centre research in the study field the CPI will be required to submit the study to a certified HREC for approval The CPI will be required to contact the Central Coordinating Service at QH REGU to determine which HREC will review the application If the
25. e authorised at that site and overseeing that authorised research at the site meets the appropriate standards The Research Governance Office r will provide a recommendation to the District CEO or delegate for authorisation to conduct research at the nominated site A letter of authorisation to conduct research will be issued to the applicant usually within 25 calendar days from submission The District CEO or delegate retains responsibility for authorising the conduct of research at the site Final QH Institutional authorisation will be contingent on HREC approval of protocol Completed Site Specific Assessment SSA Form and where required Approval to access confidential health information for the purposes of research under the Public Health Act Qld 3 Approval from QCAT for research involving adults with impaired capacity to consent e Approval from the Clinical and State wide Services CaSS to access tissue samples held by Queensland Health Approval from the Queensland Health Forensic and Scientific Services Human Ethics Committee where studies involve material from coroners autopsies Commencement of the research can only occur after District Authorisation has been provided HREC approval alone is not authorisation to conduct the research 3 Access to Confidential Health Information for the Purposes of Research If the research proposal involves access and use of identifiable or potentially re identifiable data and
26. e whether an application should be submitted to the HREC the individual group should provide a brief outline of the study in writing to the HREC Office For Quality Assurance activities including clinical audits and quality assurance individuals should submit their application to a local QA Committee or the institutional body authorised to approve QA activities For further information on Quality Assurance Committees please refer to the Clinical Practice Improvement Centre website http www health qld gov au cpic quality strategy quality assur _com asp 10 Amendments to Research Post Authorisation Investigators are required to obtain ethical approval before implementing any amendment to a previously approved study There are five types of amendments e Amendments to the research study which may affect the ongoing ethical acceptability of the study e Amendments to the Research Study which may affect both the ethical acceptability and site acceptability of the study e Amendments to the Research Study which may affect the ongoing site acceptability of the Study e Minor amendments to the Research Study which do not affect either the ethical acceptability or site acceptability of the study e g typographical errors addition to study team e Amendments for Urgent Safety Measures 10 1 Amendments to the research study which may affect the ongoing ethical acceptability of the study All studies These are amendments that as a c
27. ed Approval is contingent on certain conditions and reporting requirements to ensure the research is conducted in an ethical manner The approval letter will list these conditions If the research proposal is rejected the HREC will give justifications based on the principles in the NHMRC National Statement on Ethical Conduct in Human Research 2007 A HREC Approval is not authorisation to commence research Authorisation to commence the research is granted by the QH District CEO or delegate after the SSA has been reviewed by the Governance Office r 2 Research Governance Review 2 1 Site Specific Assessment Form SSA Form A SSA form documents all aspects of research governance arrangements for a study at a particular Queensland Health site The form can only be created out of the Infonetica NEAF The NHMRC NEAF does not contain an SSA Form so if used it must be converted to the Infonetica NEAF The site specific assessment considers the following matters e Adequate resources financial human equipment and infrastructure for the research to proceed at the site and identified as appropriate accountable and available e Researchers have the necessary expertise and experience if not relevant training is planned before carrying out their role in the research study e Compliance with relevant laws policies and codes of conduct relating to matters such as privacy confidentiality consent bio safety professional standards
28. ed by the QH HSD District CEO or delegate to conduct research at the Health Service District Site Authorisation is contingent upon receiving HREC approval and a completed site specific assessment Research Governance Office r Function The Office or coordinated function within an institution district which is responsible for assessing the site specific aspects of research applications make a recommendation to the District CEO delegate as to whether a research study should be granted authorisation at that site and overseeing that authorised research at the site meets appropriate standards research governance Research to be conducted at one site only within the QLD public health system If only one SSA needs to be generated the research is single site research An investigator who acts as Principal Investigator at a study site in a multi centre research study i e the investigator responsible for the overall conduct of the research study at an individual site within a Health Service District of QH For single centred studies the terms Coordinating Principal Investigator Coordinating Principal Researcher Site Principal Investigator and Principal Investigator are all synonymous An amendment request for an authorised research study that may be submitted by the applicant to the site District Research Governance Office r only by passing the HREC The person designated by the PI to be responsible for liaisi
29. er must be cited on all future correspondence with the HREC for ease of reference All the information from your application will then be automatically uploaded into the Australian Research Ethics Database AU RED For advice on where to submit the HREC application for ethical review refer to Where do I submit my protocol for ethical review http www health qld gov au ohmr html regu for_researcher asp Multi centre Studies Approximately five working days before the HREC application is ready to be submitted to a reviewing HREC the CPI or delegated person should contact the Queensland Health Central Coordinating Service CCS line to request allocation of the application to a reviewing certified HREC on 07 3234 0654 The Central Coordinating Service will require applicants to identify the HREC certification category that most closely applies to the project and the field of research from the lists on the REGU website www health qld gov au ohmr himl regu multicentre_research asp When the CPI delegated caller telephones the CCS to book an application for ethical review the researcher will be asked a series of questions relating to the study This is to ensure that the application is reviewed by an appropriately certified HREC To facilitate the process the CPl delegated caller should have the NEAF in front of them The call will take approximately fifteen minutes A standard email acknowledging receipt of a research application will be sen
30. es Advice to ethics committees and researchers http Awww health qid gov au ohmr html regu hrec_contacts asp 6 Research Involving Pathology Samples The Coordination Planning and Research Unit CPRU is responsible for managing Clinical and Statewide Services CaSS research activities CaSS Authorisation to Proceed is required for any research project using information for which CaSS including Pathology Queensland Forensic and Scientific Services Medication Services Queensland and other branches of CaSS is the data custodian for any research project involving CaSS staff or resources New clinical trials or research projects must be approved by the Director of Pathology local Laboratory Manager relevant Supervising Scientist and Pathologist in charge of the departments involved whichever is relevant For use of human tissue that is held by Queensland Health contact Clinical and Statewide Services http Awww health qld gov au ghcss default asp Clinical and Statewide Services Coordination Planning and Research Unit http www health gld gov au qhcss research info asp Pathology Queensland http www health qld gov au qhcss qhps default asp 7 Low and Negligible Risk Research exempt from full ethical review The National Health and Medical Research Council NHMRC National Statement on Ethical Conduct in Human Research 2007 recognises that human research involves a wide range of activities that have variable risks and potenti
31. es within or in association with Queensland Health The policy requirements are consistent with the National Health and Medical Research Council NHMRC National Statement on Ethical Conduct in Human Research 2007 and the NHMRC and Universities Australia Australian Code for the Responsible Conduct of Research 2007 and relevant State legislation and regulations You may also consider having a discussion with the reviewing HREC Administration Office or local site district Research Governance Office r prior to submission to clarify any local submission requirements Single Site Studies If undertaking a single site study applicants must determine the most suitable HREC for submission for ethical review The QH REGU webpage http www health gqld gov au ohmr html regu regu_home asp lists all QH HRECs and their meeting dates Generally the site at which potential participants will be recruited from will determine the location of the reviewing HREC For those sites that do not have an HREC please refer to the Where do I submit my protocol on the REGU Website Information for Researchers section to determine the responsible HREC If you are unsure contact the Research Ethics and Governance Unit on 07 3234 0034 In addition applicants should be aware of the individual administrative requirements for each HREC This includes e the number of ethics application copies required and e closing dates for ethics submissi
32. fication of an online forms electronic authorisation request instructing them to log onto the Online Forms to open the Requests for authorisation tab click the Navigate icon and click the Authorise Form button For further information please see Section The Authorisation tab in the User Manual https ethicsform org Au Help AU 200nline 20Forms 20for 20Research 20User 20Manual 20Vv1 padf 2 1 7 What happens when a SSA form is transferred The transferee will receive an email from the transferor notifying them when they are able to access and complete the Site Specific Assessment form To access the form the recipient must be registered as an Online forms website user When a person receives notification from the coordinating investigator they will be able to view change create a submission code and print the SSA form and then submit the form to their local RGO 2 2 What happens next with my SSA Application The completed SSA is submitted to the site Research Governance Office r Research Governance contact details are available on the REGU website http Awww health qid gov au ohmr html regu for_researcher asp and are updated regularly 2 3 What is the Research Governance Office function The Research Governance Office function is responsible for assessing site specific aspects of research applications making a recommendation to the Health Service District Manager delegate as to whether a research study should b
33. go to https ethicsform org au Users CreateAccount aspx You only need to register once The Infonetica electronic NEAF may be accessed on hitp ethicsform org au Click Create new project Proceed with the preparation of your NEAF submission systematically working through the screens Please note that if you print your Infonetica NEAF before you have generated a submission code it will indicate on the front of the form that it is incomplete and the word Draft will be watermarked on the pages DO NOT SUBMIT complete the form and generate a submission code by clicking on Manage then Submission Generate submission code The submission code will be printed on the lower right hand side of each page Then proceed as indicated below depending on the type of study For further information please see Section Creating a new project in the User Manual https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 pdf Negotiations pertaining to the research governance processes District amp Legislative requirements as documented on the SSA Form should commence and run parallel to the HREC approval cycle Do not submit your SSA Form to the HREC administrator The SSA Form is submitted to the RGO after HREC approval is granted Note The NEAF on the NHMRC website and the NEAF on the Infonetica online forms website ask identical questions The only difference is the order in whic
34. h the HREC and RGO 17 Complaints 17 1 Complaints concerning the conduct of a project Any concern allegations or complaints about the conduct of a project must be reported in the first instance to the approving HREC institution s Designated Person for handling research complaints including research misconduct through the secretariat of the approving HREC and to the local site RGO where the complaint applies 17 2 Complaints concerning the HREC s review process including the HREC s rejection of an application Any concern or complaint about the HREC s review process should be directed to the attention of the Chairperson of the HREC detailing it in writing 17 3 Complaints concerning the RGO review process including the District CEO or Delegate rejection of an application The Site Principal Investigator may appeal the decision of the site specific assessment Any concern or complaint about the RGO s review process should be directed to the attention of the RGO detailing it in writing 18 Frequently asked questions FAQ Vi vii viii Xi Do I have to use the Infonetica online forms NEAF Yes If you have created a NHMRC NEAF you will need to import this as an xml file into the Infonetica NEAF portal in order to complete your application Please see below What to do with NEAF applications created on the NHMRC NEAF portal for guidance NEAF Section 1 The HREC Application Reference Number on page 1 is
35. h the questions are asked Once your NEAF is completed generate a submission code for your form by clicking on Manage then Submission Generate submission code Prior to submission upload all supporting documentation onto the online forms website against the application For details on uploading supporting documents see Section Uploading Supporting Documents or Section The Documents tab in the User Manual https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 padf For further information please see Section The submission tab in the User Manual https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 pdf 1 1 2 Uploading supporting documents Any supporting documents to be submitted with the application e g cover letter participant information sheets investigator brochure protocol etc should be electronically uploaded when completing the NEAF Click on My projects Existing projects On the relevant application click on Manage Documents and then Upload and then upload the relevant files from your computer This ensures that the HREC receives all the supporting documentation Note Supporting documents can still be uploaded even after the NEAF application has been submitted to the HREC For further information please see Section The Documents tab in the User Manual https ethicsform org Au Help
36. health qld gov au or REGU health qld gov au 1 Scientific and Ethical Review 1 1 National Ethics Application Form NEAF All applications submitted to a QH HREC for review and approval single site and multi centre must be made on the online Infonetica National Ethics Application Form NEAF The NEAF has been designed to meet the requirements of the NHMRC National Statement on Ethical Conduct in Human Research 2007 The National Statement asks the researcher to respond to the fundamental ethical principles and considerations for HRECs and researchers in determining the ethical acceptability of a research study Refer to the National Statement when you are preparing your NEAF application as it will answer any queries you have about what a HREC will be looking for from the responses you provide The NEAF builds a customised ethics application form according to the type of research study by disabling questions and sections that are not relevant You will only see questions relevant to your research proposal It is important that all questions of the NEAF are completed correctly to allow the HREC to undertake a full ethics review Use the G button on the online NEAF application for guidance on how to complete the NEAF 1 1 1 Creating a NEAF application on the online Infonetica NEAF site All Studies To access the Infonetica online NEAF you will first need to register online through the ethicsform portal website To register
37. here the risk even if unlikely is more than inconvenience the research is not negligible risk An investigator who acts as Principal Investigator at a study site i e the investigator responsible for the overall conduct of the research study at an individual site within a Health Service District of QH For single centred studies the terms Coordinating Principal Investigator Coordinating Principal Researcher site Principal Investigator and Principal Investigator are all synonymous An activity where the primary purpose is to monitor evaluate or improve the quality of health care delivered by a health care provider an individual a service or an organisation is a quality assurance study Attempts to clearly separate quality assurance from research are difficult What really matters is that a quality assurance is undertaken for a valid purpose and its outcomes are used to improve health care b those who undertake quality assurance adhere to relevant ethical principles and State Territory and Commonwealth legislation and c where quality assurance proposals could infringe ethical principles that guide human research independent REGU Research Authorisation RGO Single site research Site Principal Investigator Site specific Amendment Site coordinator 60 day clock ethical scrutiny of such proposals should be sought Research Ethics and Governance Unit Authorisation issu
38. hich might warrant review of the approval of the study including serious and unexpected adverse events SAE s SUSARS SUDR s Such events must be reported to the HREC in the format specified by the HREC and review outcomes should be forwarded by the Site Principal Investigator to the RGO The local Principal Investigator researcher must capture and report AEs in accordance with the protocol and HREC and institutional requirements SAEs which occur at their site must be reported to the sponsor within 24 hours of finding out about the SAE in accordance with the study protocol and GCP guidelines as adopted by the TGA Multi centre studies For multi centre studies the local Pls will send all AE amp SAE reports as per the NHMAC Australian Health Ethics Committee AHEC Position Statement Monitoring and reporting of safety for clinical trials involving therapeutic products MAY 2009 to the CPI who will collate and submit these to the approving HREC for review In the instance of commercially sponsored clinical trials the CRA may be involved in this communication 15 Suspension or Withdrawal of Authorisation for a research 15 1 Suspension or Withdrawal of HREC approval A HREC may consider it appropriate that the adverse event s including SAE s SUSAR s SUADR s and or monitoring reports requires the immediate suspension or discontinuation of the ethical approval of the research study or where the QH District CEO or delegate is sa
39. information for researchers on how to obtain authorisation to commence a research study within or in association with Queensland Health This involves a two step process Step 1 Seeking ethical and scientific approval of the research protocol by a Human Research Ethics Committee HREC and Step 2 Completing the research governance component of a Site Specific Assessment SSA on line Why do we need research governance The NHMRC National Statement on Ethical Conduct in Human Research 2007 and NHMRC and Universities Australia Australian Code of Conduct for the Responsible Conduct of Research 2007 requires institutions to establish good research governance and management practices Research Governance is the framework for effective oversight of research such that it meets appropriate standards of quality safety privacy risk management financial management and ethical acceptability The scientific and ethical review is conducted by a HREC The Committee is responsible for the review of the research scientific methods ethical standards safety and welfare of research participants The research governance component requires completion of a Site Specific Assessment SSA at each participating site to determine the level of support and suitability of a research study to be conducted and completed at a site whether that study is multi centre or single site The outcomes of the HREC review and SSA together make up the final
40. ing a research study For single centred studies the terms Coordinating Principal Investigator Coordinating Principal Researcher site Principal Investigator and Principal Investigator are all synonymous The person designated by the Principal Investigator PI to be responsible for liaising with the HREC research governance office r May also be known as the site coordinator contact person study liaison officer The person designated by the PI to be responsible for liaising with the HREC research governance office r May also be known as the site coordinator clinical research coordinator study liaison officer Coordinating Principal Investigator The investigator responsible for coordinating a multi centre research study and the submission and communication of all subsequent requests and notifications to the site Principal Investigators For single centred studies the terms Coordinating Principal Investigator Coordinating Principal Researcher site Principal Investigator and Principal Investigator are all synonymous An employee of the institution who provides administrative support and advice on the institution s process of ethics review of research studies The coordinator reports to the Chair of the HREC in matters related to the activities of the Committee The terms HREC administrator HREC coordinator and HREC secretariat are all synonymous Section 2 1
41. inical research coordinator site coordinator and study liaison officer are all synonymous An amendment to the terms of the HREC application or to the protocol or any other supporting documentation that is likely to affect to a significant degree e the safety or physical or mental integrity of the subjects of the trial e the scientific value of the trial e the conduct or management of the trial e the quality or safety of any investigational medicinal product used in the trial The period of 25 days allowed for the SSA decision by the District CEO or delegate of a research application The clock starts on receipt of a valid SSA An administrative check carried out by an HREC or RGO Administrator to verify that an application is complete and accepted for review Decisions on validation should be made within one week of receipt For research not requiring review at a full HREC meeting the date on which a valid application is received by a HREC For research requiring review at a full HREC meeting the relevant HREC meeting closing date For research governance the date on which a valid application is received by a RGO HOW TO APPLY Before preparing your application researchers should first consult the Queensland Health Research Management Policy RMP at http Awww health qld gov au ohmr html regu regu_home asp This policy outlines the Research Management Framework for the conduct of all research activiti
42. l is gained QCAT can be contacted on Queensland Civil and Administrative Tribunal Level 9 Bank of Queensland Centre 259 Queen Street Brisbane QLD 4000 GPO Box 1639 Brisbane 4001 T 1300 753 228 0830 hrs 1700 hrs W http Awww qcat gld gov au index htm Research Application Form http www qcat qid gov au Formsfinalcanbesaved F16 Ap con c rsrch pdf 5 Research Involving Material from Coroners Autopsies Research involving access to coronial material must be referred to the Queensland Health Forensic and Scientific Services Human Ethics Committee FSS HEC for ethical and legal approvals This also applies to clinical research studies where there is a component involving coronial material In this context examples of coronial material include tissues from coronial autopsies slides and blocks blood samples autopsy reports and other documents and data relating to coronial autopsies The use of material from coronial autopsies for research requires the approval of the State Coroner If the research involves access to coronial documents approval as a genuine researcher under s53 of the Coroners Act 2003 is also required These approvals are subject to reviews by an ethics committee whose membership includes representatives of the State Coroner For further information please refer to the Forensic and Scientific Services Human Ethics Committee Site requirements Research Involving Material from Coroners Autopsi
43. made within 60 calendar days The review 60 day clock stops when information is requested back to the researcher by the HREC and re starts when all the information is received Therefore a review time of 60 calendar days or less requires both the HREC and the researcher to deal with requests and information in a timely manner The progress of your application to an HREC may be monitored by logging in to your user account at_www ethicsform org au_ and clicking on the Project Progress tab under the relevant application This tab will only be visible if you have generated a submission code for your application submitted the application to a reviewing HREC and the HREC administrator has logged the application onto AU RED In some cases the research application will undergo a process of scientific review prior to HREC consideration This involves review by either a scientific sub committee or a panel of one or more independent expert scientific reviewers For industry sponsored research independent scientific review may be required for first in human protocols and possibly other phase studies At times an independent review may be used to inform the decision of the Committee and the cost if any of independent review will be invoiced to the sponsor at cost recovery At the HREC meeting the Committee may decide to seek clarification on specific issues before it makes its decision This will be in the form of a written request for cla
44. n the NHMRC NEAF portal If you have created a NEAF on the NHMRC NEAF portal as opposed to the Infonetica online NEAF portal you will need to import this as an xml file into the Infonetica NEAF portal in order to complete your application and access the SSA form To do this you will need to save your NHMRC NEAF application as an xml file 1 1 7 1 Saving the NHMRC NEAF as an xml file When you have the particular proposal open on the NHMRC NEAF web site click the Save to Disk button at the top right of screen In the pop up box that appears select XML from the list and this will allow you to save in XML format You can save this file where you need to on your computer just like a PDF Do not open the xml file at any stage opening the xml file will corrupt the document and you will not be able to import it Once you have saved your NHMRC NEAF application onto your computer as an xml file click on the My project page on the Infonetica NEAF website and then click on Import xml NEAF amp other forms to import your NHMRC NEAF into the Infonetica NEAF portal You can then complete your application as per usual For further information please see Section Importing the NEAF from www neaf gov au in the User Manual https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 pdf 1 1 8 Moving the NEAF to another category When you have finished with your NEAF you can move it to another category Users
45. n to o auditing inspection of research conduct in compliance with the agreed protocol and conditions of approval including consent documentation current number of recruits commencement completion withdrawal dates o auditing inspection of research conduct in accordance with ICH GCP o auditing inspection of data storage and security o interviews or other forms of feedback with research participants Multi centre studies The local site Principal Investigators will send a progress report to the Coordinating Principal Investigator and local RGO The CPI will coordinate the reports and send them to the approving HREC If the HREC has concerns regarding the progress report they will then forward a copy of the progress report review outcomes to the CPI to be submitted to the applicable local Pls and local RGOs for possible review by the local clinical governance committee In very specific cases of high risk research the HREC may recommend in its letter of approval that the RGO coordinate on site monitoring at recommended intervals or randomly throughout the research study The RGO will provide such on site monitoring reports to the HREC If a district site considers that it cannot comply with the monitoring recommendations made by the HREC then it should not grant authorisation of the research at the site district The coordination of on site monitoring by the RGO involves making the necessary arrangements for appropriate perso
46. ng with the HREC District Site research governance personnel The terms contact person clinical research coordinator site coordinator and study liaison officer are all synonymous The period of 60 days allowed for the issue of an ethical decision on an application For research not requiring review at a full HREC meeting the clock starts on receipt of a valid application For research requiring review at a full HREC meeting the clock starts on the relevant HREC meeting closing date SSA Stop Clock facility Study liaison officer Substantial amendment 25 day clock Validation Validation date Site Specific Assessment The mechanism used by health service facilities within Queensland Health to document the level of support and suitability of a research study to be conducted at a site whether that study is multi centre or single site For HREC applications the time when the 60 day clock is stopped while awaiting a satisfactory response from the applicant to a written request from the HREC for further information or clarification For SSA applications the time when the 25 day clock is stopped while awaiting a satisfactory response from the applicant to a written request from the District Site RGO for further information or clarification The person designated by the PI to be responsible for liaising with the HREC District site research governance personnel The terms contact person cl
47. nnel internal and external to QH to conduct the monitoring activity within the given timeframe On site monitoring coordinated by the RGO may include attention to o auditing inspection of research conduct in compliance with the agreed protocol and conditions of approval including consent documentation current number of recruits commencement completion withdrawal dates o auditing inspection of research conduct in accordance with ICH GCP o auditing inspection of data storage and security o interviews or other forms of feedback with research participants 14 2 Final Reports A report to document the completion of the study Final reports should include the final study report or any publications that have arisen from the research findings The submission of final reports should follow the same process as submission of annual reports Final reports should be uploaded onto the online forms by the researcher 14 3 Data Safety Monitoring Board Reports Institutions responsible for the conduct of clinical research should require that for a large multi centre trial a Data and Safety Monitoring Board DSMB is used and there is a mechanism for informing the HREC of any relevant emerging data from the DSMB DSMB reports provided to the CPI PI should be uploaded onto the online forms by the researcher For studies where there is no independent DSMB the HREC may report safety concerns to the Institutional Clinical Review commi
48. olved with the study However as a general guideline QH should include the following insurance requirements in Schedule 4 The Sponsor Local Sponsor must have and maintain for the term of this Agreement and for a period of 6 years thereafter the following insurances a Clinical Trial Product Liability insurance for an amount not less than 10m per claim b Public liability insurance for an amount not less than 10m per claim c Professional indemnity insurance for an amount not less than 10m per claim d Workers compensation insurance in accordance with applicable legislation It is recommended that you seek legal advice if you intend to include insurance requirements in Schedule 4 different from those specified above 13 5 Clinical trials conducted under the CTN Scheme All Studies The order of signing should be e Local Site Principal Investigator e HREC Chair delegate e Institutional Authority Approving The Conduct Of The Trial e Trial sponsor For guidance on the roles and responsibilities of the Sponsor see Page 2 of the Notification of Intent to Supply Unapproved Therapeutic Goods under the Clinical Trial Notification CTN Scheme http www tga gov au docs pdf unapproved ctnform pdf Single site studies The sponsor should complete Sections 1 1 1 5 and submit the CTN Form to the Local Site Principal Investigator who then signs the form and submits it to the reviewing HREC After the study has received HREC app
49. ondition of HREC approval the local site investigator or Coordinating Principal Investigator for multi centre studies is required to submit a request for approval of the proposed amendment to the approving HREC Amendments that require approval by a HREC include changes to the following e The safety physical and or mental integrity of the participants in the trial The scientific value of the trial The quality or safety of any investigational medicinal product used in the trial Amendments which may affect the ongoing ethical acceptability of a study are considered major substantial amendments and should be reflected in a cover letter from the Coordinating Principal Investigator multi centre studies or local Site Principal Investigator single site studies stating the changes and reasons for the changes The cover letter and all updated supporting documentation should be uploaded onto the online forms by the Coordinating Principal Investigator multi centre studies or local Site Principal Investigator single site studies Two copies of the updated documents should be provided one with track changes and one clean copy A revised NEAF should not be submitted Hard copies of the cover letter and all relevant updated documents e g protocol participant information sheets etc should also be submitted to the HREC coordinator as required The HREC may require further clarification or information regarding the amendment p
50. onduct in Human Research 2007 Section 3 3 12 and the updated Declaration of Helsinki http www wma net en 30publications 10policies b3 index html if you are conducting a clinical trial as defined by the International Committee of Journal Editors http Avww icmje org clin_ trials you should register your trial on an authorised publicly accessible clinical trial registry prior to the commencement of the clinical phase of the trial Researchers can register their clinical trials for free on the Australian New Zealand Clinical Trials Registry ANZCTR http www anzctr org au 13 2 Clinical Trial Agreements Queensland Health QH in collaboration with the Victorian Medical Insurance Authority VMIA interstate health departments Medicines Australia MA and industry agencies have developed a set of uniformly accepted standard Clinical Trial Agreements CTA s These documents are available on the Medicines Australia website at http www medicinesaustralia com au pages page39 asp The terms contained in the body of the standard CTA s must not be altered or amended in any way Schedule 7 clauses are to be used for the inclusion of Sponsor unique operational requirements that must be accommodated to allow for the conduct of the trial QH in conjunction with VMIA and NSW Health has pre approved a number of Schedule 7 requests from individual pharmaceutical companies and clinical research organisations CRO for the commercially sponsored
51. ons and dates of HREC meetings Information about these individual requirements is found on the REGU webpage Multi centre Studies A Coordinating Principal Investigator CPI must be nominated for all multi centre research studies The Coordinating Principal Investigator must be employed and professionally based in an Australian organisation For international studies with a Coordinating Principal Investigator outside Australia a health professional based in Australia must be nominated as the Coordinating Principal Investigator responsible for the conduct of the research in Australia The Coordinating Principal Investigator or delegate will be responsible for correspondence relating to the ethical review and the HREC in accordance with the National Statement on Ethical Conduct in Human Research 2007 Chapter 5 2 This function in part may be delegated to a person who will act as a contact person on behalf of the Coordinating Principal Investigator The Coordinating Principal Investigator must contact the Central Coordinating Service CSS to enable allocation of the study to the appropriate reviewing HREC The allocation of the study to the reviewing HREC is the decision of the CCS in consultation with the CPI This service will also provide advice on supporting documentation requirements If contemplating undertaking multi centre research you should contact the Central Coordinating Service CSS at QH REGU on 07 323 40654 or via email QHCCS
52. onsible for the coordination of the research study in Australia NEAF Section 2 4 The Contact Person is the person who will be the liaison person between the research team and the HREC RGO This is usually the clinical study coordinator NEAF Section 4 Ensure all sites in Australia are documented on the NEAF Only include overseas sites if the study is being conducted as per the National Statement Chapter 4 8 when a researcher from an Australian institution proposes to conduct research in another country NEAF Section 5 1 If any elements of the research study have a clinical component Clinical research must be ticked NEAF Section 5 6 Ensure that there is a demonstrated understanding of and respect for the knowledge systems cultural practices heritage beliefs experiences and values of Aboriginal or Torres Strait Islander individuals and communities for all research sites NEAF Section 6 1 All boxes must be answered either a b or c NEAF Section 10 For research where the researcher is not from a Qld Health institution eg a university the Head of Department HOD is the HOD of the university department overseeing the researcher Declaration b on the SSA Form is the declaration by the Department Head s at the site where the research will be conducted Do I have to upload all the supporting documents onto the online forms Yes This ensures that all documentation is automatically uploaded into AU RED and enables the HREC
53. ontinue with the research if the District CEO or Delegate has suspended or withdrawn authorisation for the research to be conducted at that site A CRA may be involved in this process if the study is a commercially sponsored clinical trial 16 Study Closure Termination at a site Single site studies Where an authorised research study is to be closed at a site the site Principal Investigator must notify the approving HREC in writing The investigator will also be required to notify in writing the RGO Where a research study at a site is terminated or suspended by the site Principal Investigator prematurely the HREC and RGO should be promptly informed and provided with a detailed written explanation of the circumstances AU RED must be updated accordingly by both the HREC and RGO Multi centre studies Where an authorised research study is to be closed at a site the Site Principal Investigator must notify the CPI who will notify the approving HREC in writing The Site Principal Investigator will also be required to notify in writing the RGO Where a research study at a site is terminated or suspended by the site Principal Investigator prematurely the Site Principal Investigator must notify the CPI who will notify the approving HREC in writing providing a detailed written explanation of the circumstances The Site Principal Investigator will also be required to notify in writing the RGO AU RED must be updated accordingly by bot
54. original approving HREC is certified to approve multi centre research in the study field and originally approved the study after 1 July 2010 the CPI will submit an amendment to the original approving HREC In all cases for studies approved prior to 1 July 2010 the study will need to be submitted through the Central Coordinating Service for allocation to a suitable HREC this is to ensure that the original reviewing HREC is certified in the study field to approve the research study The approving HREC will notify the CPI once HREC approval is granted The CPI will notify the local PI who will then apply to the local RGO for district authorisation The research will not be able to commence at each additional site until each respective district site has granted authorisation For those studies conducted under CTN CTX conditions the TGA must be notified of the new site s by completion of the appropriate paperwork Multi centre studies If the original approving HREC is not certified to approve multi centre research in the study field the CPI will be required to submit the study to a certified HREC for approval The CPI will be required to contact the Central Coordinating Service at QH REGU to determine which HREC will review the application Where a multi centre study has been approved by a certified HREC in the study field and originally approved the study after 1 July 2010 and is to be extended to include additional site s the CPI will ap
55. ply for approval from the approving HREC for the addition This ensures that the approving HREC has the relevant information to correctly monitor the study For studies approved prior to 1 July 2010 the study will need to be submitted through the Central Coordinating Service for allocation to a suitable HREC this is to ensure that the original reviewing HREC is certified in the study field to approve the research study The reviewing HREC will notify the CPI once HREC approval is granted The CPI will notify the local PI who will then apply to the local RGO for district authorisation The research will not be able to commence at each additional site until each respective district site has granted authorisation 12 Fees for HREC Review and Site Specific Assessment For fully sponsored industry trials a fee for ethics review and site specific assessment is charged First in Human and in some situations early Phase trials may require an independent expert review and a fee may be applicable Fees for review of commercially sponsored research by HRECs and Governance Review site specific assessments can be accessed at http Avww health qid gov au ohmr html regu regu_home asp Fees may be levied by QH Forensic and Scientific Services to recover costs associated with ethical review and monitoring of research projects from applicants external to QH 13 Clinical Trials 13 1 Clinical Trial Registry In line with the National Statement on Ethical C
56. rcumstances review the HREC Chair will advise Coordinating Principal Investigator and the District CEO or Delegate through the local RGO of the recommendation to conduct the research and monitoring responsibilities In such circumstances the local site Principal Investigator s may be exempt from completing an SSA form subject to local administrative research governance requirements Multi centre Studies Applications submitted for review under exceptional circumstances should be submitted to the local RGO as per the normal single ethical review process for multi centre research and should include e Completed NEAF or original submission if not on NEAF and time factor does not allow time for NEAF to be completed e Evidence of a certified HREC approval e Study protocol and supporting documentation The RGO will review the application and make a recommendation to the District CEO or Delegate In such circumstances the local site Principal Investigator s may be exempt from completing an SSA form subject to local administrative research governance requirements If the study has not been reviewed by a certified HREC the study must be submitted for single ethical review through the QH Central Coordinating Service with a request for review under exceptional circumstances 9 Quality Assurance Activities Where an individual group approaches a HREC Administrator for advice on whether a project falls within the definition of research and therefor
57. rification or further information and or the applicant may be invited to attend the meeting to discuss the proposal This offer is at the Committee s discretion At this time the 60 day clock is stopped and will not be restarted until the response from the applicant is received It is the applicant s responsibility to provide a prompt written response to the Committee s request The investigator should not be asked to submit a revised NEAF but should be asked to provide a cover letter clearly addressing the questions asked by the HREC and must provide all the revised documentation in both track changes and clean forms It is important to remember that the time taken to respond will impact on the overall amount of time in which a final committee decision will be made Requests for clarification or further information may also be made to the applicant for response prior to HREC review or forwarded directly to the HREC for further consideration at the time of the meeting If the response received is not satisfactory then the Committee may give an unfavourable opinion or it may decide if the majority of concerns were answered satisfactorily to let the applicants have a further opportunity to respond to any outstanding questions In the latter case the clock will again be stopped until such time as a response from the applicant is received The final decision of a HREC for a research proposal will be either Approved or Not Approv
58. rior to granting approval The applicant should respond to these queries promptly in writing The amendment can be implemented once HREC approval is granted The outcome of the HREC review and any revised documentation pertaining to the research study must also be submitted by the site Principal Investigator to the relevant site RGO for the Health Service District noting For multi centre commercially sponsored clinical trials a CRA may be involved in distributing information between the CP I and P I s 10 2 Amendments to the Research study which may affect both the ethical acceptability and site acceptability of the study All studies submission to HREC Amendments which may affect both the ongoing ethical acceptability and site acceptability of a study are considered major substantial amendments Where a proposed amendment to the research study may affect both the ethical acceptability and site suitability of the study the Coordinating Principal Investigator multi centre studies or local Site Principal Investigator single site studies must firstly submit an amendment request to the approving HREC as per Amendments which may affect the ethical acceptability of the study The HREC will review the amendment request according to standard procedures and will notify the CPI multi centre studies or local Site PI single site studies in writing of its decision Details of the amendments should be reflected in a cover letter from
59. roval the HREC Administrator should submit the CTN Form to the institutional authority for signing Once signed by the institutional authority the CTN Form is submitted back to the Local Site Principal Investigator for submission to the sponsor A copy of the completed signed CTN Form should be submitted to the RGO for filing Multi centre studies A separate CTN must be created for all the Australian trial sites The process is e The sponsor completes Sections 1 1 1 5 of each of the CTN forms except for the signature page Section 1 6 Sponsor submits the CTN forms to the Coordinating Principal Investigator CPI CPI forwards the CTN forms to each local site Principal Investigator for signing for their site Local Site Principal Investigators signs the CTN and returns signed CTN form to CPI CPI submits the CTN forms to the reviewing HREC After the study has received HREC approval the HREC Chair delegate signs the CTN forms and then submits the CTN forms back to the CPI e CPI submits CTN forms to each local site Principal Investigator for local institutional authority signing Local site Principal Investigators submit signed CTN form back to CPI CPI submits the completed CTN Forms to sponsor Sponsor signs completed CTN forms and submits CTN Forms to TGA A copy of all the completed signed CTN forms are submitted to the CPI CPI submits the copy of the completed signed CTN form to the local site Pls A copy of the completed signed CTN
60. s who will then notify the local RGO This should be followed by a notice in writing within 3 working days An investigator cannot continue with the research if ethical approval has been suspended or withdrawn and must comply with any special conditions imposed by the HREC Upon receipt of the HREC decision to suspend or withdraw ethics approval the RGO must promptly advise the QH District CEO or Delegate to suspend or withdraw authorisation to conduct the research at the HSD site A CRA may be involved in this process if the study is a commercially sponsored clinical trial 15 2 Suspension or withdrawal of authorisation by the site at which the research is being conducted Where the QH District CEO or Delegate is satisfied that circumstances have arisen as such that is no longer appropriate to conduct a research study at the site district the HSD may suspend or withdraw its authorisation to conduct the research at that District site In such circumstances the RGO is required to immediately notify both the site Principal Investigator and HREC The RGO must consult with the HREC first to ensure the safety and welfare of research participants is protected This notification must be confirmed in writing within three working days For multi centred studies the local PI must notify the CPI of the date and reason for the suspension or withdrawal of authorisation by the site The CPI must then notify the approving HREC An investigator cannot c
61. s to the Research Study which do not affect either the ethical acceptability or site acceptability of the study e g typographical errors addition to study team 25 10 5 Amendments for Urgent Safety Measures 25 11 Extension of a research study to an additional site 12 Fees for HREC Review and Site Specific Assessment 13 Clinical Trials 13 1 Clinical Trial Registry 13 2 Clinical Trial Agreements 13 3 Parties to a Contract 13 4 Insurance 13 5 Clinical trials conducted under the CTN Scheme 14 Monitoring Requirements for Approved Research 14 1 Progress reports 14 2 Final Reports 14 3 Data Safety Monitoring Board Reports 14 4 Adverse event reporting 15 Suspension or Withdrawal of Authorisation for a research 15 1 Suspension or Withdrawal of HREC approval 15 2 Suspension or withdrawal of authorisation by the site at which the research is being conducted 16 Study Closure Termination at a site 17 Complaints 17 1 Complaints concerning the conduct of a project 17 2 Complaints concerning the HREC s review process including the HREC s rejection of an application 17 3 Complaints concerning the RGO review process including the District CEO or Delegate rejection of an application 18 Frequently asked questions FAQ 26 27 27 27 27 27 28 28 29 29 30 31 31 32 32 32 34 34 34 34 34 35 QUEENSLAND HEALTH RESEARCHER USER GUIDE RUG INTRODUCTION This user guide provides
62. t from the Central Coordinating Service The email will include a HREC Reference Number the HREC which has been allocated the study for review reviewing certified HREC the HREC closing date for submissions and the HREC meeting date at which the study will be reviewed The Coordinating Principal Investigator will then need to submit all collated hard copies of the NEAF and supporting documentation as required by the reviewing certified HREC The HREC Reference Number must be cited on all future correspondence with the HREC for ease of reference All the information from the application will then be automatically uploaded into the Australian Research Ethics Database AU RED 1 3 What is the Australian Research Ethics Database AU RED AU RED is a secure web based Research Ethics Database which links to the Infonetica NEAF form allowing researchers to complete the NEAF and SSA application online All details on your NEAF amp SSA submission will be electronically uploaded into the Research Ethics Database AU RED This data including your personal information is stored in the AU RED application in the United Kingdom and protected by British privacy legislation the Data Protection Act 1998 UK Confidential personal information that is stored by Queensland Health is protected by the Department s Information Standard 42A Privacy 1 4 HREC decisions A final decision about the ethical acceptability of a research proposal should be
63. the amendment request the RGO will review the amendment and determine whether District CEO or Delegate authorisation is required to implement the amendment at the Health Service District site The RGO will notify the local Site Principal Investigator as to whether or not authorisation has been granted for the amendment to be implemented at that site Authorisation to implement the amendment will only be granted when evidence has been provided of HREC approval The site Principal Investigator may not implement the amendment until the RGO has provided written notification that the amendment has been authorised at the Health Service District site Multi centre studies submission to RGO Once the HREC approval has been given for the amendments the CPI will provide the local Site Principal Investigators with a copy of the HREC approval letter a cover letter stating the changes and reasons for the changes and all updated supporting documentation for submission to each RGO for authorisation to implement the amendment at the site Updated documents should be uploaded onto the online form by the local Site Principal Investigators Updated documents should be uploaded in two forms one with track changes and one clean copy Hard copies of the cover letter and all relevant updated documents must be submitted to the RGO as required as per normal authorising RGO procedure Upon receipt of the amendment request the RGO will review the amendment an
64. tisfied that circumstances have arisen such that it is no longer appropriate to conduct a research study at the Health Service District site In both circumstances the researcher will be advised of the decision to suspend or withdraw the research as soon as possible The researcher cannot continue with the research if either the HREC or District CEO or delegate has suspended or withdrawn authorisation Single site studies Where the approving HREC considers it appropriate that the adverse event s and or progress reports requires the immediate suspension or discontinuation of the ethical approval of the research study the HREC should immediately notify the Site Principal Investigator and RGO This should be followed by a notice in writing within 3 working days An investigator cannot continue with the research if ethical approval has been suspended or withdrawn and must comply with any special conditions imposed by the HREC Upon receipt of the HREC decision to suspend or withdraw ethics approval the RGO must promptly advise the QH District CEO or Delegate to suspend or withdraw authorisation to conduct the research at the HSD site Multi centre studies Where the approving HREC considers it appropriate that the adverse event s and or progress reports requires the immediate suspension or discontinuation of the ethical approval of the research study the HREC should immediately notify the CPI who will notify the local Site Principal Investigator
65. ttee or other similar committee In some instances the HREC may request an independent DSMB be set up to regularly review the study Details on how to set up a DSMB can be obtained by contacting REGU on REGU health qld gov au or 07 323 40034 14 4 Adverse event reporting It is the responsibility of researchers HRECs and the institution they advise to protect the safety of participants in clinical trials In order to effectively undertake this responsibility HRECs need to receive sufficient reliable information about the implications of adverse events or reactions All studies Please refer to the table of requirements for adverse event reporting to HRECs by investigators from the NHMRC Australian Health Ethics Committee AHEC Position Statement Monitoring and reporting of safety for clinical trials involving therapeutic products MAY 2009 http www nhmrc gov au files nhmrc file health_ethics hrecs reference 090609 nhmrc_ position statement pdf All reports including the cover letter reporting template should be uploaded onto the online forms by the researcher Researchers should request sponsors submit the reports in an electronic version as well as hard copy version if requested by the reviewing HREC in order for the researcher to be able to upload the reports onto the online forms Single site studies As a condition of ethical approval for research the site Principal Investigator must immediately report to the HREC anything w
66. w risk research study through the single ethical review process for review and approval by a certified HREC a LNR research application form must be completed and submitted as per normal procedure for multi centre studies for single ethical review through the QH Central Coordinating Service The SSA component of the LNR research application must be submitted to the RGO at each site after HREC approval is granted 8 Exceptional circumstances exempt from full ethical review All studies There may be wholly exceptional circumstances where as a matter of public policy and in the national interest it is essential that an application should be reviewed urgently to allow a health related research study to commence as quickly as possible Note that application for review under exceptional circumstances is never justifiable solely on the grounds of a researcher s claim to the need for urgent review of their project based on failure to meet deadlines Single Site Studies Applications submitted to the local HREC for review under exceptional circumstances should contain e Completed NEAF or original submission if not on NEAF and time factor does not allow time for NEAF to be completed e Study protocol and supporting documentation e A request for exceptional circumstances review in writing and containing the reason for requesting review under exceptional circumstances and justification for the request If the application qualifies for exceptional ci

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