Requirements for HREC and Site Governance submissions

Requirements for HREC and Site Governance submissions

ACT Health conducts concurrent ethical and site governance review processes (including insurance review by ACTIA).

Prior to all submissions to the ACT Health Research Ethics and Governance Office (REGO) please ensure all study personnel are familiar with the following:

Single Site Study Application

  1. The application will be evaluated via the standard HREC review. Approval will not be included in National Mutual Acceptance (NMA) scientific and ethical review of multi-centre human research. Researchers can make a multi-site NMA application at a later date.

    Applications for single site research must be made electronically using the REGIS platform.  Applications are to be made using the HREA form and need to be accompanied by a separate protocol document and any supporting documentation.

National Mutual Acceptance Applications for Multi-site Studies

This process is for multi-site projects which were or are to be approved on or after 1 August 2016.

  • ACT Health Lead Site Ethics and Governance applications will be evaluated via the standard HREC and Governance reviews. As the lead HREC ACT Health HREC will accept ethical responsibility for the conduct of the project at all study sites. Please note as a Lead site the Coordinating Principal Investigator and Study Coordinator will be responsible for the research conduct, administrative coordination and study safety reporting requirements at all sites. If you intend to submit a Lead Site application, please contact the Research Ethics and Governance Office for additional information.
  • To add an ACT Health site to an NMA approved multi-site study a Site Governance Application is required. Please ensure that the ACT Health site has been added as an approved site by the Lead HREC prior to your Governance Application. The lead HREC will accept ethical responsibility for the conduct of the project at ACT Health.
  • Please note there are a number of study types excluded from the ACT Health HREC NMA proces​

ACT Health Certified HREC Exemption Applications

This process is used to add ACT Health as a new site to a multi-site study that has been approved by an NMHRC Certified Lead HREC prior to 1 August 2016.

  • To add an ACT Health site to an NHMRC Certified HREC approved multi-site study a Site Governance Application is required. ACT Health has agreed to accept ethical and scientific approval from NHMRC certified HRECs without requiring additional duplicate review. Projects approved under the exemption rule are managed in the same as any NMA project.

Please note: The ACT Health Certified HREC Exemption process was introduced on 5 Jan 2016 and was designed to bring the benefits of NMA to ACT Health researchers. In line with its obligations under the National Statement chapter 5.3 (minimising duplication of ethical review) ACT Health HREC agreed to accept ethical responsibility for the conduct of these projects on the basis of the certified HREC review and approval. These arrangements were reviewed and approved by the legal unit and ACT Health insurer. Exemption applies to multisite projects excluded from NMA due to the 1 August 2016 start date agreed by NMA jurisdictions.

HREC and Site Governance submission requirements

ACT Health uses the Human Research Application Form (HREA) via the Online Forms website or through the REGIS platform.  Researchers can complete the HREA or Site specific Assessment Forms online and upload all supporting documents.
To facilitate prompt review and approval on all counts, please check the HREC and Site Governance documentation requirements below and follow the subsequent processes:

  • Upload all study documents to the Online Forms website.
  • Once all the required study documentation is uploaded, please submit the application to Online forms to generate a Submission code.
  • Please email the following by the relevant meeting deadline to ethics@act.gov.au or research.governance@act.gov.au:
    • A signed Cover Page
    • The Online Forms submission code
    • Electronic copies of all study documentation

Please note that email submissions must be limited to 10Mb per email, multiple emails may be required. The server does not receive emails over 10Mb and does not generate and bounce-back notification to the sender.

Please include the following documents with your submission:

  1. Cover Page
    This is required for all ethical and site governance review applications.
  2. Human Research Application Form (HREA)
    An electronic application form signed by ACT based researchers must be provided.
  3. Protocol or Research Plan:
    The ACT Health HREC will not accept submissions without a protocol or research plan
  4. Participant information sheet (PIS):
    An updated PIS for the ACT is required for all applications that include participant recruitment.
  5. Consent form (CF):
    An updated CF for the ACT is required.
  6. Site PICF Checklist:
    This is required for all applications that include participant recruitment.
  7. Current CV for each investigator:
    An updated CV for each investigator is required for both ethical and site governance applications.
  8. Evidence of current Good Clinical Practice (GCP) training for each investigator
    This is required all clinical applications. Each Investigator and research team member must provide evidence of GCP training for both ethical and site governance applications
  9. ACT Health Site Governance Checklist
    This is to be submitted with all site governance applications including multi-centre NEAF submissions.

Additional documentation for applications which include an agreement or contract with ACT Health

  1. Clinical Trial Agreement or other applicable agreements
    This must be final version with approved budget
  2. Signed Medicines Australia Standard form of Indemnity - if applicable
    This must be signed by the sponsor
  3. Current Insurance Certificate – if applicable: see requirements below
    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 research.governance@act.gov.au or 02 6174 7968
  4. ACT Health Site Governance Clearance Sheet
    This sheet must be included with all Clinical Trial Agreement and Indemnity documents submitted for ethical and site governance review. 

Supplementary Application Documents

  1. 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.
  2. Radiation Safety Report
    This is required for research studies involving exposure of persons with ionising radiation.

FAQs

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 Committee also wishes to draw to the attention of researchers the value of seeking peer review of proposals prior to submission to assist in ensuring the quality of the material put forward.

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

Good Clinical Practice (GCP) training

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The GCP guidelines detail the requirements for trial documentation, protocol amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants.

Each Investigator and research team member must provide evidence of GCP training.

A free online GCP training course can be found at: https://globalhealthtrainingcentre.tghn.org/elearning/short-courses/