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National Research and Evaluation Ethics Committee

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Committee Objectives
Scope of RACGP NREEC Review
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 RACGP NREEC is now accepting applications for ethics approval via the National Ethics Application Form 2 (NEAF2)

Committee Objectives

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 acc or ding to NHMRC guidelines, specifically a chairperson, a vice chairperson, three lay people, 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.

Scope of RACGP NREEC Review

The RACGP NREEC is primarily a research ethics committee with a focus on general practice research. As such the committee will review all general practice related research proposals.

At present, the RACGP NREEC does not review applications for Authorised Prescribing of unapproved therapeutic goods.

Medical Practitioners wishing to obtain HREC end or sement 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 end or sement from an appropriate ethics. A list of HRECs can be accessed via www.nhmrc.gov.au/health_ethics/HRECs/hreclist.htm

Time Frame and Meeting Schedule for 2010

Review of new applications and responses to the committee

Full meetings of the RACGP NREEC 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.

• Monday 1 February 2010 (Paper submission-Monday 11 January 2010)
• Monday 12 April (Paper submission – Monday 22 March 2010)
• Monday 7 June 2010 (Paper submission-Monday 17 May 2010)
• Monday 2 August 2010 (Paper submission-Monday 12 July 2010)
• Monday 27 September 2010 (Paper submission-Monday 6 September 2010)
• Monday 6 December 2010 (Paper submission-Monday 15 November 2010)

Upon request from investigators and if deemed necessary, and appropriate by the Chair, the NREEC may also meet via teleconferenceto undertake urgent review of research proposals.

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.

Format of Submissions

From 2009 the RACGP NREEC will review applications via the National Ethics Application Form, Version 2 (NEAF 2). Researchers are invited to submit all new applications for ethics approval to the NREEC in the NEAF 2 format.

The NEAF 2 can be accessed by creating a free new user account at the NEAF 2 website, www.neaf.gov.au. Once a NEAF 2 account is created investigators and other invited account holders (e.g. co-investigators) may edit or review a specific proposal. Further details about the NEAF 2 including a list of all questions included in the form can be obtained from the NEAF 2 website.

• Thirteen hard copies and one electronic copy of each submission are required.
• Applicants must 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.

Lay Statement

As per NHMRC guidelines, the NREEC is composed primarily of non-medically qualified personnel. Applicants must include a brief (200 word) outline of the research plan in lay language. (NEAF 2 item 6.3.1)

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.

Sample Participant Informed Consent Items

Protocol

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

Clinical 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.

Medicines Australia Form of Indemnity for Clinical Trials - Standard

F or use where the Indemnified Party is providing premises f or 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.

Medicines Australia Form of Indemnity for Clinical Trials - HREC Review Only

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.

Fee Structure

The RACGP fee structure is:

• 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 below. This 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.

Request for tax invoice

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. (NEAF 2 item 4.1)

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.

Declaration of Prior Review

Monitoring of Projects

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.

NREEC Annual Report Template

NREEC Final Report Template

Contacts

For general ethics questions, please email ethics@racgp.org.au or contact:

Dr. Jiri Rada	Dinithi Ranathunga
Research Foundation Manager	Research Foundation Administrator
Phone 03 8699 0496	Phone 03 8699 0497
Fax 03 8699 0400	Fax 03 8699 0400

Publication Date: 13 April 2010
Authorised By: Research