Townsville HHS Research Governance (Site-Specific Assessment) information

Every type of human research conducted within the Townsville HHS is assessed and governed by the Townsville HHS Research Governance Office .

Principal Investigators (PIs) submit a Site Specific Assessment (SSA) application which consists of an SSA form and the necessary supporting documents. This is used to determine suitability of a research study to a site. 

A human research project may only commence at Townsville HHS if it holds both ethics approval and RG authorisation. The SSA considers the following matters:

• The appropriateness of the research project in terms of the research goals of the Townsville HHS and whether the institution wishes the research to be conducted at its site.
• The resource (financial, human, equipment, infrastructure) implications of the research project for the HHS and whether these resources are considered to be appropriate, accountable and available.
• The expertise and experience of researchers, ensuring that relevant training for researchers is conducted before the research commences at the site.
• The compliance of the research project with relevant laws, policies and codes of conduct relating to matters such as privacy, confidentiality, consent, bio-safety, professional standards, contracts, intellectual property and radiation safety.
• The legal requirements of the research project.

The site specific assessment (SSA) forms are generated through the Ethics Review Manager (ERM) website.

Before you start completing your SSA form in ERM you will need to prepare any site specific supporting documents.

Supporting documents

Your SSA application is the form that is submitted to RG for consideration, if you are ready to begin the application process you must have already prepared the documents listed below (as relevant for your study).

• Cover letter* outlining all documentation submitted for review and authorisation
• Protocol* (this should have been prepared for your HREC application)
• HREA or LNR form *
• CVs and resumes for all researchers involved in the research at Townsville HHS.*
• Master participant information sheets and consent forms
• Site specific participant information sheets and consent forms, as required, with the following in the footer: THHS site-specific participant information sheet and consent form (PICF) Vx Dated xx/xx/xxxx BASED ON Master PICF Vx Dated xx/xx/xxxx .
• Quotes from supporting departments e.g Pharmacy; Pathology; Medical Imaging etc
• Declarations of support from the:
  • Head of Department where the research will be conducted at THHS*. Can be electronically in ERM or using the declaration form template
  • Head of Supporting Department(s)* e.g Pharmacy; Pathology; Medical Imaging etc. Can be electronically in ERM or using the declaration form template
  • Relevant data custodians* using the declaration form template
• Budget and THHS Service Group Business Service Manager sign off if costs to Townsville HHS are > $5000
• Research agreement if conducting research with parties external to Queensland Health

* Mandatory documents for RG submission

Please also refer to the research checklist on the documents required to be submitted to the RG.

• Townsville HHS RG authorisation cannot be granted until HREC approval has been granted. However, you are encouraged to submit your RG application and the supporting documents to the RGO concurrently with your HREC application.
• The major components of the RG application can be assessed before HREC approval is granted.
• Once you have received HREC approval, submit your HREC approval letter and any updated documents to the RGO via the ERM IT platform and, for studies >low risk, provide the RGO with one hard copy of all updated documents.
• Concurrent HREC and RG submissions have been shown to reduce start up time for studies.

3.1 Townsville HHS RG submission, review and authorisation pathway

3.1.1 Creation of SSA and submission

• All Townsville HHS RG applications are created and submitted online through the Ethics Review Manager (ERM) IT platform.
• You will need to generate your SSA application from a HREC form (either a LNR Form, a MDF form or a HREC form) by creating a ‘sub form’.
• You will be given three options in your SSA under ‘What is the purpose of this form?’
  • To submit a NEW Site Specific Assessment Form (default option to be used)
  • To submit a Site Specific Assessment Form that was signed off in AUOnlineForms but not submitted to an RGO before 13 July 2018 (only use this option if the RGO informs you to do so)
  • As directed by the RGO for example when full SSA completion is not required or to allow the creation of subforms for an authorised Site Specific Assessment Form that is NOT already in ERM (only use this option if the RGO informs you to do so)
• Upload all supporting documents to ERM and identify all documents submitted for RG review and authorisation in your cover letter.
• Ensure all supporting documents (with the exception of the CVs) are correctly formatted with footers, version numbers, and version dates.
• For studies < low risk, no hard copies of all documentation are required to be submitted to the Townsville HHS RGO.
• For studies >low risk, one hard copy of all documentation is required to be submitted to the Townsville HHS RGO.
• For studies < low risk , the local site principal investigator can sign the SSA application on behalf of all site investigators.
• For studies > low risk , all local site investigators must sign the SSA application.

Helpful hint!

Staple each of your documents before submitting the hardcopy to the RGO and place each document in the same order they are listed on your cover letter. Do not bind your documents.

3.1.2 Review of RG application

• The RG may not immediately approve your application. The Research Governance Administrator (RGA) may request more information, clarification, or ask that the research team make changes. The researcher needs to address the changes, concerns, and requests of the RGA and then respond to the HREC with any updated documents.
• You must use track changes on your study documents if they need to be changed. The RGA needs to see easily what changes you have made.
• All updated documents in both tracked changes and clean copies and the response to the RGA questions need to be uploaded to ERM and, for studies > low and negligible risk, one hard copy of all updated documentation submitted to the RG Office.
• You will have been assigned an ERM Reference number when you created your HREC application
  • Every email and or you send to RGO should have the ERM reference number in the subject field.
• If you have not responded in full to the RG questions within three months of receiving the RG review queries the RGO may withdraw your application. If you still wish to conduct the research a complete new Townsville HHS RG application will be required

See also: THHS Research governance review pathway standard operating procedure: THHSCOR160992v3

3.1.3 Townsville HHS authorisation

• All SSA applications are reviewed by the Research Governance Administrator, then if applicable, each application is endorsed by the Townsville HHS Research Governance Officer (RGO). Finally, they are sent to the Townsville HHS Chief Executive (CE) who has final approval over all research taking place within the Townsville Hospital and Health Service.
• You will receive a letter from the Townsville HHS RGO with the decision and, if authorised, any conditions of authorisation.

Note: Some study sponsors may require more than one copy of supporting documents to be submitted e.g clinical research agreements may be required to be submitted in triplicate.

See: THHS Research requirements post-authorisation standard operating procedure: THHSCOR161008v2

4.1 Monitoring and reporting

Both the approving HREC and the THHS RGO are responsible for monitoring research practice and assuring adherence to the NHMRC National Statement on Ethical Conduct in Human Research (2007), including ICH GCP and the Australian Code for the Responsible Conduct of Research (2018) when required.

All research authorised to be conducted at Townsville HHS is monitored, regardless of the level of the risk.

Resources

Factsheet reporting to RGO

See: THHS Research monitoring at THHS standard operating procedure: THHSCOR181236v1

4.1.1 Commencement of research

Within 30 calendar days of study commencement, the Coordinating Principal Investigator (CPI) must complete and submit a Notification of Commencement form to the approving HREC and relevant RGO(s). For Townsville HHS HREC and Townsville HHS RGO only electronic submission is required, with the commencement form uploaded to Ethics Review Manager (ERM).

4.1.2 Progress reports

• Researchers are required to provide at least an annual study progress report and a final report to the RGO. The progress report provides an overview of your study activity to the RGO, including any issues encountered.
• Progress reports must be submitted in the ERM web portal for researchers, by creating a sub-form under the relevant project and application form. Once submitted online it is received immediately by the RGO. A hard copy or email copy is not required.
• For progress reports to be submitted to the Townsville HHS RGO, where the Townsville HHS HREC has approved the study, the Townsville HHS progress report template must be used.
• For progress reports to be submitted to the Townsville HHS RGO, where another HREC has approved the study, the approving HREC progress report template can be used. However, the progress report MUST indicate the Townsville HHS information e.g. number of participants recruited at Townsville HHS, any local issues etc. If this information is not on the ‘global’ HREC progress report then the local Townsville HHS Principal Investigator should add these details to the reports and sign the report.
• The Townsville HHS RGO will send an acknowledgment of the report to the local site principal investigator and study coordinator (if applicable).

4.1.3 Adverse events and safety reporting (AE/SAE/SUSARS)

• The HREC approval letter will include the requirements for safety reporting for your study. The Townsville HHS RG authorisation letter may include some reporting requirements additional to the HREC requirements. For further information on safety reporting requirements for all studies, please refer to the NHMRC Australian Health Ethics Committee (AHEC) Position Statement: Safety monitoring and reporting clinical trials involving therapeutic products (November 2016).
• Safety reports must be submitted in the ERM web portal for researchers, by creating a sub-form under the relevant project and application form. Once submitted online it is received immediately by the RGO. A hard copy or email copy is not required.
• The Townsville HHS RGO will send an acknowledgment of the report to the local site principal investigator and study coordinator (if applicable).

4.1.4 Reports of protocol deviations/ violations

• Protocol violations are those variations to a protocol that implicate participant consent, participant safety or data integrity that compromises the ethical acceptability of the project.
• Protocol deviations relate to other more minor matters and do not require notification to or review by a HREC or RGO.
• The Townsville HHS RGO will send an acknowledgment of the report to the local site principal investigator and study coordinator (if applicable) and may include some suggestions for future conduct of the study.

Note: The distinction between protocol violations and protocol deviations is neither clearly understood nor consistently applied amongst Australian HRECs or RGOs. Therefore, if a researcher is unsure if an event is a protocol deviation or violation they should seek advice from the approving HREC and or local RGO.

4.2 Amendments

• You may need to change aspects of your study or study documents after Townsville HHS authorisation.
• Any changes to your study must first be approved by the HREC and then submitted to the Townsville HHS Research Governance Officer for Townsville HHS authorisation.
• Your amendment request should describe the changes and provide a rationale for the changes. The amendment request can be a standard letter.
• If a study document (e.g. Study Protocol or Participant Information Sheet) is changing, you must also provide a tracked and clean copy with updated version number and date.
• Amendment requests and supporting documents can be submitted to the RGO anytime in the ERM web portal for researchers, by creating a sub-form under the relevant project application form. Once submitted online it is received immediately by the RGA.
• Hard copies are only necessary when the amendment is greater than 10 pages.
• The RGA may require further clarification or information regarding the amendment prior to granting approval. The Principle Investigator should respond to these queries promptly in writing by resubmitting the amendment request with additional information and/or documents in ERM.
• Amendments should not be submitted to the TownsvilleHHS RGO until they have received HREC approval.
• You will receive a letter from the THHS RGO with the decision and, if authorised, any conditions of authorisation.

Important information!

You may not implement your changes until you have updated approval from both ethics and governance unless the changes are for URGENT safety measures.

4.3 Feedback and complaints

Any concerns or complaints regarding the conduct of a study (including research misconduct), please contact the site Research Governance Office or the HREC Coordinator.

Concerns relating to the RGO review process, including requests for appeal, please contact the Research Governance Officer.

Sue Jenkins-Marsh
Research Governance Officer
Townsville Research Education, Support and Administration (TRESA) Unit 
IMB 101 | PO Box 670 | Townsville | QLD | 4810
Email: {"ct":"9finQSV\/MsCmQliGKHNBS9PAyxpZyzK1LODkiLpRDqI=","iv":"085357e337d7a1ac290b69543e3359f2","s":"58ecc44e590b8c77"}
Ph: (07) 4433 1358

See also: Townsville HHS Research complaints and misconduct management Standard Operating Procedure: THHSCOR161031v2