Human Research Ethics and Governance

The Research Ethics and Governance Office oversee the coordination of concurrent ethical and site governance review processes for ACT Health. The Human Research Ethics Committee (HREC) provides ethical and scientific review and approval services for those submitting new research proposals.

The Committee is also responsible for monitoring ongoing research projects. To provide a full and comprehensive service to the research community, HREC incorporates specialist sub-committees to advise on the research merit and integrity of proposals.

The sub-committees are: the Clinical Trials Sub-Committee (CTSC) and the Social Research Sub-Committee (SRSC). HREC also employs the use of a Low Risk Sub-Committee to provide an avenue of expedited review for research that is considered low risk (according to the definition of the National Statement).

ACT Health HREC accepts multi-centre research proposals for ethical and scientific review. HREC and sub-committee terms of reference, policies and standard operating procedures can be provided upon request.

HREC operates in accordance with National Statement on Ethical Conduct in Human Research and is constituted according to the requirement of section 5.1.30 . The aim of HREC is to ensure the highest ethical standards are maintained in research projects carried out in the ACT and Australia. In addition to NHMRC guidelines, when carrying out its review functions, HREC considers jurisdictional cultural and social attitudes and legislative requirements.

Human research to be undertaken in ACT Health cannot proceed without approval from HREC. On this page you will find documents and further reading suggestions to guide you through the application and approval process. If your questions are not answered in these materials please contact the secretariat office on (02) 6174 5659 or acthealth-hrec@act.gov.au

Projects submitted to ACT Health HREC may be reviewed by a specialist subcommittee. See terms of reference for the Clinical Trials Sub-Committee and the Social Research Sub-Committee.

Requirements for HREC and Site Governance submission

ACT Health conducts concurrent ethical and site governance review processes (including insurance review by ACTIA). Documentation described below is to be submitted, by the HREC deadline, as one package; submissions should be sent via email to:

acthealth-hrec@act.gov.au

To facilitate prompt review and approval on all counts, please include the following documents with your HREC submission:

1. NEAF or ACT Health HREC application (signed PDF copy)
2. Protocol or Research Plan
3. Participant information sheet and consent form
4. Current Insurance Certificate - if applicable
5. Signed Medicines Australia Standard form of Indemnity - if applicable (Sponsors signature at the least)
6. Clinical Trial Agreement or other applicable agreements (Drafts are acceptable)
7. Where agreements are not used - correspondence outlining insurance and/or indemnity arrangements, if available.
8. Current CV for each investigator
9. Evidence of current GCP training for each investigator

Please Note: HREC approval should be taken to include ACTIA insurance approval. A separate site governance sheet will be provided by the secretariat office. Please direct queries to acthealth-hrec@act.gov.au or 02 6174 5659.

Insurance Requirements

The following is necessary to meet the Territory's requirements:

  • The insurance certificate must specifically name the Australian Corporate entity acting as commercial sponsor as a named insured under the relevant insurance policy
  • If the certificate is provided in the name of an overseas parent company, it must name the Australian entity as a subsidiary
  • The insurance certificate must include a valid coverage period for the policy
  • The insurer providing the cover must be approved by the Australian Prudential Regulation Authority and must have a minimum financial strength rating of A- or above
  • The insurance certificate must provide coverage of AUD$20 million for each and every occurrance and AUD$20 million in the annual aggregate against a class of insurance appropriate for the risk associated with the research.

Queries on insurance matters may be directed to acthealthILLU@act.gov.au or 02 6205 0928

Writing a Research Protocol or Research Plan

A protocol or research plan must be submitted as part of the HREC application. The following documents may provide useful information for those who are preparing research protocol or research plan documents.

The National Statement on Ethical Conduct in Human Research 2007 (Updated 2014)

The Australian Clinical Trials website guidance on Good Clinical Practice (GCP)

The World Health Organisation (WHO) recommended format for a research protocol

The Declaration of Helsinki - ethical principles for medical research involving humans

Template Forms

NEAF – use this form for multi-centre studies. If there is an existing NEAF (prepared for another jurisdiction), this can be updated to include ACT and local investigators.

ACT Health HREC Application Form - use this form to make an application for a new single-centre research project

HREC Application Cover Page - to be submitted with all ethical and site governance review applications, including multi-centre NEAF submissions

Site Governance Clearance Sheet - This sheet must be included with all CTN, Clinical Trial Agreement, Insurance and Indemnity documents submitted for ethical and site governance review.

Checklist - to be submitted with all HREC applications including multi-centre NEAF submissions

Participant Information Sheet

A participant information sheet and consent must be included with all submissions to HREC. Comprehensive guidelines and templates can be found on the NHMRC Human Research Ethics Portal (HREP).

The template below contains guidelines for ACT Health HREC requirements including HREC contact details and statements on privacy, confidentiality, data on withdrawal and compensation.

Event Reporting

Serious Adverse Event Reporting - use this template to report serious adverse events, or SAEs, which have occurred at a Health Directorate site.

SUSAR/Line Listing Coversheet - all submissions of SUSAR/Line Listing, Annual Safety Reports etc must be accompanied by this cover sheet. Please ensure to answer question 2 on the template and the Principle Investigator sign the form.

Annual Project Reports and Requests for Extension of Ethical Approval

It is a requirement of the National Statement and a condition of ACT Health HREC approval that researchers provide a report, at least annually, on the progress of their projects. The template form below is available to assist with this requirement.

HREC approves research projects for a maximum period of five years. Approval is current from the date of the approval letter. An annual report is due each year on the anniversary of approval.

The period of ethical approval may be extended; an extension may be requested up to 12 months ahead of the date of expiry of the current approval period. Researchers should submit a Final Report when their project is completed.

For a full account of the annual report and extension process, please refer to the Standard Operating Procedures.

Standard Operating Procedure – This document details the process for annual reporting and requesting an extension of the ethical approval period.

Annual Project Report and Extension Request Template - Use this template to inform HREC of your project progress and to seek an extension of the ethical approval period for your project.

Final Report Template - a final report is required by the committee, please forward this report when your study is complete.

Fees

Research Ethics and Governance services include ethical, scientific and site governance review of new human research proposals. This includes insurance vetting and ongoing monitoring of approved research proposals. To recover costs associated with this work, fees are charged for services provided.

Fees will be invoiced on receipt of submission. Please ensure that any requirements to secure a payment authority are completed BEFORE submission to the Research Ethics and Governance Office. Where a purchase order number or goods receipted authorisation is required please provide evidence of these with your submission. A full list of ethics and governance fees is below.

NOTE: The Ethics and Governance fee schedule has been reviewed and fees will increase from 1 July 2015. Please see below the fee schedule that will apply to all items submitted from 1 July 2015 onwards.

Meeting Dates

HREC meets once per month between February and December. A list of meeting and submission dates in below.

The low risk ethics committee meets approximately every two weeks. Submission can be made at anytime by emailing acthealth-hrec@act.gov.au Once received submissions will be allocated to the next available meeting. Applicants will receive an acknowledgement email containing the meeting date and project reference.

Low Risk Sub-Committee

The Low Risk Sub-Committee (LRSC) provides an expedited review process for research that meets the National Statement definition of low and negligible risk (see National Statement Chapter 2).

The LRSC meets fortnightly, or as required, and reports to the ACT Health Human Research Ethics Committee (HREC). Membership of the LRSC is made up of three HREC or former members; the HREC Chair, one medical researcher and one social science researcher.

Applications to the LRSC may be made at any time and should be sent electronically to the Secretariat Office. Please sign your application, scan and email to acthealth-hrec@act.gov.au

If you do not have access to scan/email facilities, you can deliver a hard copy, with signatures, to the Secretariat Office, Level 6 Building 10, Canberra Hospital.

Sometime types of data release require a waiver of consent.

Please consult the National Statement Chapter 2.3 on the requirements for waiving consent. A waiver of consent is not required when accessing de-identifiable data.

If a waiver of consent is required, please complete the template form below and submit with your low risk application. The LRSC will provide ethical review of your project and forward the waiver of consent request to the next available meeting of HREC for consideration.

Please note that approval from the Low Risk Sub-Committee, or approval of a waiver of consent from the HREC, does not provide authorisation to release data. Data release is at the discretion of the relevant data custodian.

Application for Low Risk Research - use this form when submitting your low risk proposal.

Waiver of Consent Template - use this form if a waiver of consent is required.

Participant Information Sheet Template

NOTE: Please note that a fee for low risk ethics submissions will be introduced from 1 July 2015. Please refer to the ‘Fees’ section of this page for the detailed fee schedule.

Do Quality Improvement/Assurance Activities Need Ethical Approval – advice for ACT Health Staff

ACT Health HREC has introduced a policy on the requirements for ethical review relating to Quality Improvement/Quality Assurance (QI/QA) projects.

In response to a March 2014 NHMRC paper ethical approval is not always required for QI/QA projects.

BMJ Quality and Safety released a statement in April 2014 that ethical approval is not a requirement for publication of QI/QA projects. The policy (below) should be considered with the NHMRC and BMJ statements.

Decisions taken by HREC in 2013 - This presentation was given by the Chair of HREC, Dr Louise Morauta PSM, at the CHARM conference on 12 August 2014. The presentation was prepared by Dr Morauta and Ms August Marchesi and provides a statistical summary of decisions taken by the HREC and LRSC in 2013.

Contact us

Matthew Wafer

(02) 6244 3949

acthealth-hrec@act.gov.au