Research
National Research and Evaluation Ethics Committee
Quick Links
Committee Objectives
Time Frame and Meeting Schedule
Format of Submissions
Lay Statement and Patient Consent Form
Protocol
Requirements for Clinical Trials
Fee Structure
Review by other authorised Ethics Committees
Monitoring of Projects
Contacts
Application Form
2005 ASC keynote address on ethics by Prof Nicholas
Zwar
The NREEC's primary task is to assess the ethical principles and associated guidelines for research involving humans in the Australian primary care setting, and to protect the welfare and rights of the participants in research. The committee shall also facilitate research that is or will be of benefit to the researcher's community or to humankind.
The membership of the NREEC is comprised according to NHMRC guidelines, specifically a chairperson, a vice chairperson, three lay people (two men and one woman), a minister of religion, a lawyer representative, a general practitioner representative and several members with current research experience that is relevant to research proposals that are regularly considered by the NREEC.
The NREEC's objectives are in accordance with the National Health and Medical Research Council's 'National Statement on Ethical Conduct in Human Research (2007). Booklets listing NHMRC statements on human experimentation and notes on institutional ethics committees, clinical trials and epidemiological research are available from the NHMRC or can be accessed via their website.
Time Frame and Meeting Schedule for 2008
Meetings of the National Research and Evaluation Ethics Committee are held every second month according to the following schedule. Applications should be submitted at least three (3) weeks prior to the next scheduled meeting so that materials can be prepared and sent to the committee members for reading.
- 4 February - papers due 14 January
- 7 April - papers due 10 March
- 2 June - papers due 5 May
- 11 August - papers due 14 July
- 29 September - papers due 1 September
- 1 December - papers due 3 November
Applicants should allow for a minimum of 6 - 8 weeks between submission of protocol and an initial decision from the committee. Letters to researchers outlining the outcome of the meeting will be sent as soon as possible after the meeting once the Chair has reviewed the minutes.
It is important to note that the time frame for a decision may be extended if the committee deems that outside consultation is required. Outside consultation will occur only with permission of the researchers and any costs involved will be borne by the researcher.
- Thirteen hard copies of the submissions are required. Application forms can be found below.
- Applicants must complete the checklist at the end of the application form and ensure that all relevant documents are attached.
- All pages are to be numbered sequentially with appropriate headers and footers.
- Each document submitted for review MUST have a version number and date.
- Amendments to study documentation should always be submitted as track changes, a clean copy should also accompany the track changes version document with a new version number and date.
As per NHMRC guidelines, the NREEC is composed primarily of non-medically qualified personnel. Applicants must include a brief (300 word) outline of the research plan in lay language.
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.
Patient Information Sheet and Consent Form
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 (thesis, publication, reports given to participants, sponsors etc.);
- Provide the details of the Ethics Approval.
Further details and instructions can be found on the form. The language of the form should be specific and understandable to persons of about a Year 7 reading level.
The 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 & expected benefits
- Eligibility for participation and sample size
- Participant recruitment strategy
- Method of data collection and analysis
- All researchers involved, their qualifications and experiences
- Any financial and legal agreements involving investigators and participants
- Detailed expansion of information given in the lay statement including detailed method of obtaining consent
Requirements for Clinical Trials
Summary of all available scientific data (13 copies only, if required)
When therapeutic agents are being investigated via CTN clinical trials, the full investigational drug brochures are required for ethics review according to the guidelines developed by the Therapeutic Goods Administration (TGA).
A subcommittee of 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 of same.
Clinical trial protocols will be assessed according to the December 1991 TGA document "Guidelines for Good Clinical Research Practice in Australia" as well as the previously mentioned NHMRC guidelines.
Clinical Trials Notification Forms
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.
Legal Indemnity
These trials have specific legal as well as ethical implications. The RACGP, in consultation with its legal advisers, deems that the Medicines Australia Form of Indemnity for Clinical Trials is the only form of indemnity accepted by the College in respect to clinical trails. 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.
For use where the Indemnified Party is providing premises for the conduct of the Study and HREC Review, or is providing premises only. There is a separate Form of Indemnity for use where the Indemnified Party is providing HREC review ONLY of the study (see below).
NOTE: This Form has been developed by Medicines Australia and is an adaptation of the form used by The Association of the British Pharmaceutical Industry (ABPI), for use in Australia. 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.
For use where the Indemnified Party is providing HREC Review ONLY for the study.
NOTE: This Form has been developed by Medicines Australia and is an adaptation of the form used by The Association of the British Pharmaceutical Industry (ABPI), for use in Australia. 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.
From July 2005, the fees are:
- Individual researchers $440
- Divisions of general practice $700
- Commercial
organisations $3,000
(All prices are inclusive of GST)
These fees are charged to cover the administration costs for ethics review. A request for invoice form is included in the application, which must be completed and returned with the application. An invoice will then be sent to the applicant. It is required that the fee will be paid at the time of the submission to the committee.
It is acknowledged that general practitioners conducting individual research may not always be able to obtain 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 waived for College members at the discretion of the Chair.
Review by other authorised ethics committees
It is a requirement of the NREEC that the Declaration of Prior Review (available below) regarding previous consideration of the submission by other committees be signed and returned with the submission.
In order to expedite this process for clinical trials, it is strongly recommended that the applicants submit to the NREEC only after any other authorised ethics committees to which the applicant intends to apply have given a final decision. For clinical trials it is requested that copies of the outcome of Scientific Assessment Reviews completed by other institutions be included with the application, or, the applicant consents to an independent scientific assessment conducted on behalf of the NREEC the cost of which will be met by the applicant.
Researchers are required to inform the committee of the progress of their projects. In addition to immediate notification of any serious adverse events, an annual progress report and a final report are requested.
For advice on the format of these reports, please email ethics@racgp.org.au.
For general ethics questions, please email ethics@racgp.org.au or contact:
Kaye Goldenberg
Ethics and Research Administrator
Royal Australian College of General Practitioners
College House, 1 Palmerston Crescent
South Melbourne VIC 3205
Phone 03 8699 0497
Fax 03 8699 0400
Email
kaye.goldenberg@racgp.org.au
(Monday, Tuesday & Friday)
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