Who Should Obtain NIIM HREC Approval?

All NIIM researchers must obtain ethical approval from the National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee (HREC) prior to commencement of their research project.

External researchers from outside NIIM may apply to the NIIM HREC for approval of their research proposal. The Chief Investigator must be able to demonstrate their ability to adhere to the requirements of the Australian Code for the Responsible Conduct of Research.

All NIIM researchers must adhere to the NIIM Research Code of Conduct and the NHMRC’s
National Statement on the Ethical Conduct in Research Involving Humans.

All researchers should comply with the NHMRC’s National Statement on the Ethical Conduct in Research Involving Humans 2007 (Updated May 2018) and the Australian Code for the Responsible Conduct of Research.

Research projects may not commence without HREC (ethics) approval.

Submitting an HREC (Ethics) Application

The Chief Investigator is responsible for the research project and for ensuring that all aspects of the research undertaken comply with the NHMRC’s National Statement on the Ethical Conduct in Research Involving Humans and the Australian Code for the Responsible Conduct of Research.

Required Documentation

• NIIM HREC Application Form, signed by the Chief Investigator and all associate investigators.
• Where human participants are involved in research, a Participant Information Form and Informed Consent Form must be completed and submitted with the HREC application. For research projects conducted by NIIM, researchers must use the NIIM templates. External applicants may choose to use their own Participant Information and Informed Consent Forms.
• Any form of communication in relation to the research project such as advertisements, posters etc must be approved by the HREC and must form part of the application as attachments.

Notes:

1. Version-control: please number and date the HREC Application, Research Protocol, Participant Information Form, Informed Consent Form or any external communication in a footer on each document or form. Example:V1.0_12 Jan 2023 for an original submission, V1.1_14 Feb 2023 for a first amendment
2. Any application fees payable should be made at the date of submission (see section on Application Fees).

Additional Requirements for External Applicants

The Chief Investigator must have an established affiliation with an Australian education institution or hospital or research institution, and be able to demonstrate their ability to adhere to the requirements of the NHMRC’s National Statement on the Ethical Conduct in Research Involving Humans 2007 (Updated May 2018) and the Australian Code for the Responsible Conduct of Research
In addition to the application documents detailed in the previous section, external applicants must also provide evidence of indemnity insurance.

Templates

Application Deadline

Applications must be received at least four (4) weeks prior to the next HREC meeting date to be considered at that meeting (see section on HREC Meeting Dates).

Contact Details for Application Submission

The complete HREC application including all attachments should be emailed to the NIIM HREC Secretary, at [email protected]

HREC Meeting Dates

The NIIM HREC meets 6 times per year. Note that applications must be received at least 4 weeks ahead of the HREC meeting date.

NIIM HREC Meeting Dates 2025

HREC (Ethics) Application Assessment Process

On submission of the HREC application, the NIIM HREC Secretary will check that the application has been completed correctly (i.e. HREC application signed, all required attachments submitted). If the HREC Secretary is satisfied that the HREC application is completed, she will forward the application to the NIIM HREC Executive Commitee for a pre-meeting review prior to the formal review at the next available HREC meeting. If not, she will contact the Chief Investigator by email, advising of necessary changes.

After the application has been reviewed, the HREC Secretary will notify the Chief Investigator of the feedback. There are four possible outcomes from the HREC review:

• ‘Approved’– the application is approved outright and the research project may commence.
• ‘Amendments Required’– the application has not been approved and the research may not commence. The researchers are required to make some revisions to the application and resubmit to the NIIM HREC. Once resubmitted, the application is reviewed by the Chair of the HREC.
• ‘Withheld’– the application has not been approved and the research may not commence. You are required to make considerable revisions to your application. Once resubmitted, the application is reviewed by the entire NIIM HREC.
• ‘Rejected’– the application has not been approved and elements have been deemed to be unethical. The research project will not receive ethical approval in its current form. The researchers are provided with feedback as to why the research protocol has been deemed unethical.

For ‘Amendments Required’ and ‘Withheld’ applications, the specific revisions required to be made will be communicated to the Chief Investigator via email. Once the required revisions have been made to the HREC application, it should be submitted to the HREC Secretary who will forward it to the Chair or the entire HREC as appropriate, where it will undergo a second formal review. The application may be approved or the researchers may be required to make further changes. This will be communicated to the Chief Investigator via email.

Research projects may not commence until they have been formally approved by the HREC.

Once the Ethics Application is formally approved, the research project is approved for a period of 3 years.

Key Issues in Preparing a HREC Application

Attention should be paid in particular to the following issues:

• Ensuring there is clear evidence in support of the rationale for the research. Where journal articles are cited, full references should be provided.
• Ensuring there is a clear and detailed description of all procedures/methodologies
• Providing evidence that the researchers have the appropriate qualifications and/or experience and skills to undertake the research
• Providing evidence that demonstrates that the researchers have considered the effects of participation in the research upon the participant(s), and that there are clear processes in place to ensure that participants are fully informed about what is involved in participation, that they know they may withdraw from the study at any time, and give informed consent to participate in the research project. Participant Information Forms and Informed Consent Forms need to be written in plain language that would be readily understood by a layperson who is not involved in medicine or research. It should be free of jargon, and any terms that are unfamiliar should be explained clearly.
• Ensuring that any potential risks, including likelihood and severity of risks or inconveniences to the participant, are fully explained in the HREC application and in the Participant Information Form. Risks may involve physical, psychological, social and/or legal aspects, and may include risks to the researchers and NIIM, as well as to participants. Where there are potential risks, steps to minimise risks should be documented.
• Ensuring that processes to protect participant privacy and confidentiality are clearly specified, including collection, storage and disposal of data.
• Ensuring the HREC application has been signed by all investigators.

What to Do After Your Research Project is Approved

After your research project has received written approval, your research project may commence (but not before). The Chief Investigator is required to submit annual progress reports and a final report at the end of the project. Since a research project is usually approved for 3 years, if you require an extension you must apply to the HREC. Where there are any changes or amendments from the approved research project documents (including study protocol, Participant information Form, Informed Consent Form, advertising etc), these changes must be approved by the HREC.

Annual and Final Reports

The Chief Investigator is required to submit annual reports on the research project status using the template below. At the conclusion of the research project, the Chief Investigator is required to submit a final report using the template below.

Template:

• HREC Annual/Final Report Form

Amendments to Research

If any amendments are required to be made to an approved research protocol, including changes to the Participant Information Form, Informed Consent Form or any external public communication about the research project, an amendment to the HREC Application must be submitted for approval to the HREC. The HREC Approved Research Project Amendment Form should be completed.

In addition, the Chief Investigator must submit:

• A copy of the revised HREC application, with changes made using the ‘track change’ function, signed by the Chief Investigator
• One clean copy of the revised HREC application (track changes accepted)
• A copy of the revised protocol (Investigator’s Brochure) (one track-changed copy and one clean copy)
• Revised Participant Information Form (one track-changed copy and one clean copy) (if applicable)
• Revised Informed Consent Form (one track-changed copy and one clean copy) (if applicable)
• Revised advertising (one track-changed copy and one clean copy) eg. flyers (if applicable)
• Revisions of any other documents that may be given to study participants (one track-changed copy and one clean copy)

Fees may apply for application resubmissions after HREC approval has been granted- see HREC Application Fees section. The HREC Secretary will forward your request to the HREC Chair for review and advise you of the outcome of your request via email.

Version-Control of Documents

Where an HREC application, Participant Information Form, Informed Consent form or any external communication advertising the research has been amended, the new version should be numbered and the date of approval of change included in a footer on the form.

Example:

Original version: V1.0_12 Jan 2023

Amended version: V1.1_28 Nov 2023

Template:

• HREC Approved Research Project Amendment Form

HREC Application Extension

Once the Ethics Application is formally approved, the research project is approved for a period of 3 years. Where a project requires extension of HREC approval, the Chief Investigator should apply for an extension using the HREC Research Approval Extension Form

Template:

• HREC Research Approval Extension Form

HREC Application Fees

Payment of the Application Fee should be made within 7 days of the invoice being raised. Applications will not be assessed where payment has not been received.

• HREC Application Fees – From May 2023

Fees for HREC Application Resubmissions After Approval

Where an HREC Application Form is required to be resubmitted to the HREC for approval of changes to a research protocol, Participant Information Form, Informed Consent Form and/or advertising associated with a research project AFTER the research project has been granted approval, fees may apply.

Note: Fees are applied to each resubmission or version change of the HREC Application Form/ Research Protocol document. Amendment fees do not apply to minor administrative changes or minor changes to Participant Information Forms and Informed Consent Forms or advertising material.

Adverse Events

The Chief Investigator must immediately inform the HREC of all unexpected adverse effects on participants and any unforeseen events. Adverse events may affect the continued ethical acceptability and approval of the project.

Failure to report an adverse or unforeseen event will result in immediate withdrawal of approval and the research must immediately cease. The researchers may also face disciplinary action.

Complaints About Research Conduct

Complaints may be made about the conduct of authorised research activities by participants, researchers, staff or others. Complaints may be made in relation to:

• breaches of privacy/confidentiality
• conflicts of interest
• failure to obtain informed consent
• careless or inappropriate recording of data
• falsifying data, plagiarism or misrepresentation or misappropriation of data
• other departures from good research practice or concerns in relation to the conduct of research

Complaint Management Process

All complaints are dealt with in a serious and impartial manner. Complaints should be directed in writing to the Secretary of the NIIM HREC. In order to respond to complaints, complainants are requested to include their name and contact details. This information is treated confidentially. Complaints are recorded by the Secretary on behalf of the NIIM HREC.

• Where a complaint involves a NIIM staff member, it will be managed under the Staff Research Misconduct Complaints and Resolution Procedures.
• Where the complaint involves an external researcher (external to NIIM), the complaint will be directed to the NIIM HREC Chair for management.

Management of a Complaint Against an External Researcher

The NIIM HREC Chair or delegate will investigate the matter as expediently as possible. All parties to the complaint will be informed of the nature of the complaint within 7 working days of receipt of the complaint. Time-frames for duration of management of the complaint will depend on the nature of the complaint, investigation process, response from all parties, and appeals process. Parties may contact the HREC Secretary for a status update on progress of the matter. The complainant will be notified of the outcome of the investigation relating to their complaint.

Complaints may be directed via email to:

Secretary of NIIM HREC: [email protected]

Contact Us

For further information about the HREC application process, please contact the NIIM HREC Secretary, at [email protected]