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RACGP National Research and Evaluation Ethics Committee (NREEC)


Last updated 29 January 2024

Research Integrity and Ethics

The RACGP NREEC is one of more than 200 Australian human research ethics committees (HREC) registered with the National Health and Medical Research Council (NH&MRC). The NREEC complies with the NH&MRC requirements of HRECs, as per the National Statement on Ethical Conduct in Human Research 2023 (‘the National Statement’). The National Statement is an essential guide and outlines responsibilities for researchers, HRECs and others conducting ethical review of research. This helps ensure Australian researchers conduct quality, safe and ethically responsible research. 


The RACGP NREEC is primarily a research ethics committee with a focus on general practice research. Its responsibility is to ensure the ethical conduct of human subject research. The NREEC role is to assess the ethical merit of proposed research involving humans in Australian primary care settings, according to the National Statement. Download the NREEC Terms of Reference.

Name

Role

Emeritus Professor Siaw-Teng Liaw

Chairperson

Associate Professor Rowena Ivers

Research expertise (General Practice)

Associate Professor Kylie Vuong

Research expertise (General Practice)

Associate Professor Joel Rhee

Research expertise (General Practice)

Dr Rosemary Wyber

Research expertise (General Practice)

Dr Jessica Botfield

Professional care (Nursing and Primary Health Care)

The Reverend Dr Michael Nixon

Pastoral care

Ms Carol Geyer

Lawyer

Mr Stephen Mann Layperson
Vacancy Layperson


If you have any concerns or a complaint about the conduct of a study that has received RACGP NREEC approval, please contact the RACGP Research Ethics Manager at ethics@racgp.org.au or telephone 03 8699 0385. Download the copy of the RACGP NREEC Complaints procedure.

If you have concerns or a complaint about the conduct of the NREEC in consideration of your research proposal(s), please contact Dr Taryn Elliott, Research and Foundation Manager at Taryn.Elliott@racgp.org.au or telephone 08 8267 8337.


When is ethical approval required?

The National Statement defines human research as research conducted with or about people, or their data or tissue. Human participation in research may include:

  • taking part in surveys, interviews or focus groups
  • undergoing psychological, physiological or medical testing or treatment
  • being observed by researchers
  • researchers having access to their personal documents or other materials
  • the collection and use of their body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath
  • access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database

Almost all human research requires ethical review. Please ensure you refer to and understand the levels of risk defined by the National Statement on Ethical Conduct in Human Research when applying for ethical approval.

Submission deadline

(Monday)

NREEC meeting

(Monday)

Notification deadline

(Monday)

15 January 2024

5 February 2024

26 February 2024

4 March 2024

25 March 2024

15 April 2024

6 May 2024

27 May 2024

17 June 2024

8 July 2024

29 July 2024

19 August 2024

2 September 2024

23 September 2024

14 October 2024

11 November 2024

2 December 2024

23 December 2024

Please note that the review time may extend if the NREEC require external consultation regarding your application. Such consultation will occur only with the permission of the researchers, and any costs involved would be met by the researcher.


At present, the RACGP NREEC does not review applications for Authorised Prescribing of unapproved therapeutic goods. Medical practitioners wishing to obtain HREC endorsement as an Authorised Prescriber should first contact a hospital ethics committee. If a practitioner is unable to receive review from a hospital ethics committee, then it is recommended that a practitioner seek endorsement from an appropriate ethics committee. A list of HRECs is available from the NH&MRC website.

An approval of ethics applications by the NREEC is not an endorsement of any product associated with a project. This caveat must be included in any documentation relating to a study which refers to NREEC ethics approval.


Apply to NREEC for ethical review

Applications to the RACGP NREEC can be made via the RACGP Ethics Application Portal.

Click the Apply now  button to commence your application. Please read the submission information below before applying.

If you are an RACGP member use your RACGP credentials to log in. If you are not an RACGP member, please click on the button, then choose “create new login” option.

Apply now

 

Request for Invoice

Request for invoice web form

Requests can be made via our web form.

An invoice will then be sent to the applicant.

Payment is required before the application is reviewed by the NREEC.

The fee assists with the administration costs for ethics review.
 
The RACGP understand that general practitioners conducting individual research may not have funds for ethics review. It is not the intention of the RACGP that this be a barrier to them seeking or obtaining ethics approval. In such instances, that fee may be altered or waived for RACGP members at the discretion of the RACGP.

Please contact the NREEC office via RACGPEthics@racgp.org.au for information about fees and payments. 
 

Fee Structure

 

New Projects

Item Fee (excluding GST) Fee (including GST)

New project: Corporate, Government, Statutory Body or equivalent, and any commercially funded/sponsored studies (including not-for-profit organisations for projects with external or grant funding)

$6000

$6600

New project: Not for Profit organisations – projects without external funding

$1000

$1100

New project: Individual researcher

$500

$550

Extension/renewal of existing long-term project

$5000

$5500

Extension/renewal of existing long-term project – not for profit projects without external funding

$800

$880

Extension of short-term project

$500

$550

Surcharge for applications that are poorly written or incomplete and require extensive review and input by our administrative team (applied at the discretion of RACGP).

$200

$220


Amendment fees

Item Fee (excluding GST) Fee (including GST)

Major amendment

$600

$660

Minor Amendment/administrative change

0

0

Please note:
  • The RACGP retains the right to change fees as required.
  • A purchase order or request for tax invoice form must be submitted with a new project application or major amendment request.
  • Individual investigators funding their own research project may contact the Research Ethics Manager to discuss fees.
  • Fees may be waived in limited circumstances.
  • For fee and other enquiries, please contact the Research Ethics Manager via email: ethics@racgp.org.au

Definitions
Item Definition

Corporate, Government, Statutory Body or equivalent

Private corporate entities, Australian, State/Territory or local government departments or their agents (e.g. private consultants funded by government to undertake research).

Commercially funded/sponsored studies

Any study that is commercially funded or sponsored, regardless of the type of organisation submitting the application.

Not for Profit organisation – projects with external or grant funding

Projects undertaken by not-for-profit organisations that are funded by grants or other external sources.

Not for Profit organisations – projects without external funding

Projects undertaken by not-for-profit organisations that are funded internally.

Individual researcher

Investigators undertaking small research projects, for example GPs in practice, students.

New project

A new submission to the RACGP NREEC.
Fee includes:

  • NREEC review of the initial submission, and any resubmission based on feedback from the initial review
  • Minor amendments to the approved project
  • Review of progress and final reports.

Major Amendment

Any change that occurs after ethical approval by the NREEC that substantially changes the study design or analysis plan and requires NREEC review.
For example:

  • Changes to a protocol
  • Changes to investigator brochure
  • Changes to Participant Information and Consent Form/s (PICF)

The fee covers review and administrative costs.

Minor Amendment

Any variations to an active project that do not have an impact on the main aims and outcomes of the study.
For example:

  • Changes to research team information (except leading investigators)
  • site name or address
  • minor variations to PICF, brochures/information sheets and other materials.

Extension of existing long-term project

Extension of original ethical approval for long term projects requiring a full review of all current and proposed project documentation. For ongoing long term projects, a full review is required for a multi-year extension.


First, complete a Human Research Ethics Application (HREA) form, accessible via the NH&MRC HREA website. You will need to create a free user account on that site, if you do not have one.

Once an account is created, investigators and other invited account holders (e.g. co-investigators) may edit or review the project proposal.

When you have completed the HREA form, you must download it manually and then upload it to the RACGP Ethics Application portal; there is no link between the HREA website and the RACGP NREEC.

Please upload other relevant documents, as listed on the RACGP Ethics Application Portal.

  1. Please include a cover letter explaining the amendments and listing all documents

  2. Please name files succinctly, commencing with the NREEC project number e.g., ‘23-999_Output form_ v2_tracked_ DDMMYY’

  3. Please number all pages sequentially.

  4. Each document submitted for review MUST have an updated version number and date e.g., 23-999_File Name (brief, please)_DDMMYY (date submitted for amendment)_ V2 or V3 etc.

  5. Please submit a ‘tracked’ and ‘clean’ copy of each amended document.

  6. Please do not resubmit unamended documents.

  7. To facilitate an efficient review process, please tabulate your responses to NREEC review comments, including columns for ‘NREEC comment’ and ‘Researcher response’.

Please email your amendment to ethics@racgp.org.au with:

  • a cover letter summarising the amendment/s requested
  • a list of the attached documents.

If you are unsure of any aspect of the amendment process, please contact the Research and Ethics Office on ethics@racgp.org.au

PLEASE DO NOT UPLOAD AMENDMENTS VIA THE PORTAL


As per NH&MRC guidelines, applicants must include a brief (150 word) outline of the research plan in lay language. (HREA Q1.2) 

The Lay Statement must 

  • Provide a brief outline of the project in language that is free from jargon and is comprehensible to lay people. Please explain any technical terms or discipline-specific phrases. 
  • Include anticipated benefits and costs of the proposed research. 
  • Detail what participants will be required to do. 


A requirement of the NREEC is that participants in a study receive full information about the research in language that they can understand. Information sheets and consent forms should be produced in the native language of non-English speaking participants, if required .

The Patient Information Sheet and Consent Form should contain the following elements - for more detail please refer to the application form:

  • Study title
  • Investigators' names and contact details
  • Introduction
  • Purpose of study
  • Study procedures including what participants will be asked to do and the time commitment
  • Eligibility to participate
  • Risks and any debriefing arrangements as required
  • Other treatments
  • Clause regarding voluntary participation and non-involvement in the project will not affect ongoing management or treatment of existing patients
  • Clause regarding stopping the study if events indicate
  • Treatment and compensation for injury
  • Possible benefits of participation
  • Details of data collection, storage, use and disposal
  • Informing participants of access to research findings
  • Proposed reporting of findings, such as thesis, publication, reports given to participants, sponsors
  • Details of the Ethics Approval
  • How to raise an issue or make a complaint, including the team member contact and the ‘RACGP Research Ethics Manager at ethics@racgp.org.au’

Sample Patient Information and Consent Forms are available on the NH&MRC website.


Your research protocol should include a description of the following

  • The research questions or hypotheses
  • Literature review, including the estimated effect of this research on current knowledge
  • Research plan, time frame and expected benefits
  • Eligibility for participation and sample size
  • Participant recruitment strategy
  • Method of data collection and analysis
  • Qualifications and experiences of all researchers involved
  • Any financial and legal agreements involving investigators and participants
  • Detailed expansion of information given in the lay statement including detailed method of obtaining consent.


The NH&MRC require that any previous consideration of the submission by a HREC committee is declared in the HREA form and in your application form. 

In order to expedite clinical trials, please submit applications to the NREEC only after any other authorised ethics committees to which the applicant intends to apply has made a final decision.

For clinical trials, please include copies of the outcome of Scientific Assessment Reviews completed by other institutions with your application. Alternatively, the applicant will be required to consent to an independent scientific assessment conducted on behalf of the NREEC, the cost of which would be met by the applicant.


Requirements for clinical trials


When therapeutic agents are being investigated via Clinical Trial Notification (CTN), the full investigational drug brochures are required for ethics review according to the guidelines developed by the Therapeutic Goods Administration (TGA). The NREEC will assess this information. Comments from independent experts such as clinical pharmacologists and toxicologists may be requested. In such cases, applicants are required to meet the costs involved.

Clinical trial protocols will be assessed according to the current TGA document (Australian Clinical Trial Handbook), and as per current NH&MRC requirements.


If CTN forms are required for the TGA, they are to be completed by the applicant for each participating centre, and included with the submission for the Chair of the NREEC to sign on approval of the project.


Clinical trials have specific legal as well as ethical implications. The RACGP, in consultation with its legal advisers, deem that the Medicines Australia Form of Indemnity for Clinical Trials is the only form of indemnity accepted by the College in respect to clinical trials. There are two versions of the form depending on whether the indemnified party is providing premises for the conduct of the study and HREC review, or is providing premises only. These documents provide indemnity for the RACGP and its agents. A signed copy of the relevant Indemnity Form should be included with the submission for clinical trials. 

The Form of Indemnity for Clinical Trials - Standard is for use where the Indemnified Party is providing premises for the conduct of the Study and HREC Review, or is providing premises only. It is to be regarded as the basis for agreements between pharmaceutical companies sponsoring clinical studies and the institution that hosts the study to be conducted. Non-members of Medicines Australia are encouraged to use this Form of Indemnity.

The Form of Indemnity for Clinical Trials - HREC Review Only is for use where the Indemnified Party is providing HREC review ONLY of the Study. It is to be regarded as the basis for agreements between pharmaceutical companies sponsoring clinical studies and the institution that has oversight of the study to be conducted. Non-members of Medicines Australia are encouraged to use this Form of Indemnity.

The two forms have been developed by Medicines Australia and are an adaptation of the forms used by The Association of the British Pharmaceutical Industry (ABPI) for use in Australia.

Download the forms from the Medicines Australia web site.


Contact the Research Ethics Manager

For all ethics enquiries, please email the RACGP Research Ethics Manager at:

 03 8699 0385

 ethics@racgp.org.au

NREEC Postal Address

RACGP
100 Wellington Parade
East Melbourne VIC 3002

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