Townsville HHS HREC information

• To conduct research within THHS researchers are required to seek approval from an appropriate ethics review body, either a Human Research Ethics Committee (HREC) or a low and negligible risk review committee for project approval.
• HRECs and low and negligible risk review committees review research proposals involving human participants to ensure that they are ethically acceptable in accordance with relevant ethical standards and guidelines. In undertaking this role, all HRECs and low and negligible risk review committees are guided by relevant national standards.
• In addition to approving single-centred research studies, the Townsville HHS Human Research Ethics Committee (HREC) is certified by the National Health and Medical Research Council (NHMRC) to review and approve multi-centre research under the national approach. The Townsville HHS HREC has a wide range of certification categories in Australia. For more information download the full list of certified categories.

2.1.1 Register your project with the relevant site department. You will need to contact your local Research Governance Officer if you are unaware who this person is.

This ensures that:

• The organisation is aware of the use of confidential health information, without consent of the patient or NOK, for a secondary purpose.
• Protection is provided to the organisation and QH staff member for the use of confidential health information for a secondary purpose, without consent of the patient, under section 150 of the HHB Act: Section 150 Disclosure for purposes relating to health services:
  • A designated person may disclose confidential information if -
    • the disclosure is to another designated person for evaluating, managing, monitoring or planning health services; or
    • the disclosure is to an entity prescribed under a regulation for this paragraph for evaluating, managing, monitoring or planning health services as stated in the regulation.

2.1.2 If there is a plan to present outside of Queensland Health or publish the findings:

• After the staff member has registered the activity with the relevant site quality manager a Townsville HHS HREC endorsement that the project has been assessed as non-research is required by:
  • Completing the LNR application on the ERM IT platform (only the first six short questions are required to be answered) and uploading the project plan onto the ERM platform.
  • No hard copies required.

The application is reviewed out of session by the HREC Chair

This ensures that:

• Protection is provided to the organisation and QH staff member that the project has been assessed and endorsed as non-research by a HREC.

Once you have determined if you are conducting research or non-research you will need to prepare your application for the HREC.

The first step is determining the level of risk involved in your project as this will determine the kind of ethics review the HREC will undertake. The application process for Ethics and Governance approval is dependent on the risk level of the research. Download the Ethics Review Pathway.

The National Statement on Ethical Conduct in Human Research 2.1.6: "Research is 'low risk' where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk."

Examples of discomfort:

• Low intensive exercise.
• Non-invasive tests or samples.
• Personal questions that are not of a 'sensitive' nature.

National Statement 2.1.7: "Research is 'negligible risk' where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk."

Examples of inconvenience:

• Attending additional appointments.
• Completing forms that are not of a 'sensitive' nature.
• Taking part in surveys that are not of a 'sensitive' nature.
• Interviews or focus groups that are not of a 'sensitive' nature.
• Observational research.

To assist you in making a decision: The ethics review pathway is available for download.

All Townsville HHS HREC applications are completed on a Human Research Ethics Application (HREA) form generated through the Ethics Review Manager (ERM) website. Before you start completing your HREA form in ERM you will need to prepare your supporting documents.

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

Your application is the form that is submitted to HREC 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).

• Protocol guidance template*
• CVs and resumes*
• Cover letter*
• Information sheets and consent forms. Note it is recommended that the NHMRC standardised forms are used

* Mandatory documents for HREC submission

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

Low or Negligible Risk (LNR) research Townsville HHS HREC submission, review and approval pathway

7.1 Submission to HREC

• LNR research applications must be submitted on a Human Research Ethics Application (HREA) form, through the ERM IT platform
• No hard copies required
• All supporting documents must be uploaded to ERM and you must identify all documents submitted for HREC review and approval in your cover letter
• Ensure all supporting documents (with the exception of the CVs) are correctly formatted with footers, version numbers, and version dates. Please visit our formatting guide for detailed information on how to prepare each of these documents.
• You can submit a low risk submission at any time for HREC review, as these applications are reviewed outside of a HREC meeting
• Only the Coordinating Principal Investigator (CPI) is required to sign the HREA form, unless the CPI is a student; then the student supervisor is also required to sign the HREA form.

7.2 HREC review

• Low risk submissions are reviewed outside of HREC meetings by a minimum of two committee members and the Chairperson.
• Low risk reviews usually take between 1-2 weeks for feedback or approval to the applicant.
• The HREC may not immediately approve your application. The Committee may request more information, clarification, or ask that the research team make changes. This feedback is conveyed on the Committee's behalf through the HREC Coordinator. The researcher needs to address the changes, concerns, and requests of the Committee 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 HREC reviewers need to see easily what changes you have made.
• All updated documents in both tracked changes and clean copies and the response to the HREC questions need to be uploaded to ERM. No hard copies required.
• Once you have submitted to HREC (regardless of the application being valid or invalid) you will be assigned an ERM reference number (e.g. HREC/QTHS/#####)
  • Every email you send to HREC should have the HREC ERM reference number in the subject field.
  • Every letter you send to HREC must have the HREC ERM reference number in the "Regarding" field.
• If you have not responded in full to the HREC questions within 3 months of receiving the HREC review queries the HREC may withdraw your application. If you still wish to conduct the research a complete new HREC application will be required

7.3 HREC decision

• You will receive a letter from the HREC Chair with the decision and, if approved , any conditions of approval.

Greater than low risk research Townsville HHS HREC submission, review and approval pathway

7.2.1 Submission to HREC

• Greater than LNR research applications are submitted on a Human Research Ethics Application (HREA) form through the ERM IT platform.
• No hard copies required
• The Townsville HHS HREC meets on the first Thursday of the month.
• Submissions must be received no later than 12pm ten days prior to the HREC meeting closing dates.
• All supporting documents must be uploaded to ERM and you must identify all documents submitted for HREC review and approval in your cover letter.
• Ensure all supporting documents (with the exception of the CVs) are correctly formatted with footers, version numbers, and version dates. Please visit our formatting guide for detailed information on how to prepare each of these documents.
• Only the Coordinating Principal Investigator (CPI) is required to sign the HREA form, unless the CPI is a student; then the student supervisor is also required to sign the HREA form.

7.2.2 HREC review

• HREC feedback or approval is given to applicants within seven days of the meeting date.
• The HREC may not immediately approve your application. The Committee may request more information, clarification, or ask that the research team make changes. This feedback is conveyed on the Committee's behalf through the HREC Coordinator. The researcher needs to address the changes, concerns, and requests of the Committee 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 HREC reviewers need to see easily what changes you have made.
• All updated documents in both tracked changes and clean copies and the response to the HREC questions need to be uploaded to ERM and one hard copy of all updated documentation submitted to the HREC Office.
• Once you have submitted to HREC (regardless of the application being valid or invalid) you will be assigned an ERM reference number (e.g. HREC/QTHS/#####)
  • Every email and or letter you send to HREC should have the HREC ERM reference number in the subject field.
• If you have not responded in full to the HREC questions within three months of receiving the HREC review queries the HREC may withdraw your application. If you still wish to conduct the research a complete new HREC application will be required

7.2.3 HREC decision

• You will receive a letter from the HREC Chair with the decision and, if approved, any conditions of approval.

For more information about ethics review processes see Townsville HHS HREC Review Pathways Procedure and the NHMRC National Statement on Ethical Conduct in Human Research.

8.1 Monitoring and reporting

The Townsville HHS HREC is responsible for monitoring research practice and assuring adherence to the NHMRC National Statement on Ethical Conduct in Human Research (2007), (chapters 3.3.19-3.3.22 and 5.5.1-5.5.10), including ICH GCP and the Australian Code for the Responsible Conduct of Research (2018) when required.

All research approved by THHS HREC is monitored, regardless of the level of the risk. Click here for a factsheet on reporting to the HREC.

Following commencement of a research project, the Research Governance Office (RGO) will also be responsible for monitoring of approved research projects and handling complaints relating to the conduct of research. Click here for a factsheet on reporting to the RGO.

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

8.1.1 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.

8.1.2 Progress reports

• Researchers are required to provide at least an annual study progress report on the 30th April each year and a final report to the reviewing HREC (and RGO if applicable). The progress report provides an overview of your study activity to the HREC, 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 HREC coordinator. A hard copy or email copy is not required.
• The HREC Chair will send an acknowledgment of the report to the CPI and study coordinator (if applicable)

For progress reports to the Townsville HHS the Townsville HHS progress report template must be used.

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

• The HREC approval letter will include the requirements for safety reporting for your study. 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 HREC coordinator. A hard copy or email copy is not required.
• The HREC Chair will send an acknowledgment of the report to the CPI and study coordinator (if applicable)

8.1.4 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 HREC Chair will send an acknowledgment of the report to the CPI 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.

8.2 Amendments

• You may need to change aspects of your study or study documents after ethics approval. Any changes to your study must first be approved by the HREC and the site/s Research Governance Officers.
• Your amendment request should describe the changes and provide a rationale for the changes. The amendment request can be a standard letter. Amendment requests can be submitted through ERM.
• 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 HREC 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 HREC coordinator.
• No hard copies required
• The Chair or Coordinator will review the amendments and make a decision outside of the HREC meeting, or refer the amendment to the next scheduled HREC meeting for review.
• The HREC, HREC Chairperson or Coordinator 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.
• You will receive a letter from the HREC Chair or HREC Coordinator with the decision and, if approved, any conditions of approval.

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.

8.3 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 HREC's review process, including requests for appeal, please contact the HREC Coordinator.

HREC Coordinator
Name: Sara Potts
Phone: (07) 4433 1440
Email: {"ct":"Ekg9X3KUttUobFNN3Lmw6wUEsD\/fTg4ftCo2LI9WGa\/vc5t\/BKy1aZzOx4fDdkDD","iv":"bd53324c8f7811a4f0da9f19ba3acc99","s":"4a270b63e8b806e6"}

HREC Chairperson
Name: Dr Hudson Birden
Phone: (07) 4433 1440
Email: {"ct":"Ekg9X3KUttUobFNN3Lmw6wUEsD\/fTg4ftCo2LI9WGa\/vc5t\/BKy1aZzOx4fDdkDD","iv":"bd53324c8f7811a4f0da9f19ba3acc99","s":"4a270b63e8b806e6"}

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