Ethics and Research

 

 

AH&MRC ETHICS COMMITTEE

The Constitution of the Aboriginal Health and Medical Research Council (AH&MRC) requires it to operate an Ethics Committee.

The AH&MRC Ethics Committee operates as a Human Research Ethics Committee under the National Health and Medical Research Council (NH&MRC) legislation. The Committee is assessed annually by the NH&MRC to ensure that it meets NH&MRC Guidelines.

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 1.The Committe
  a) Role of the Committee
   b) The Committee as a Representative of Aboriginal Communities
   c) History of the Committee
   d) Composition of the Committee
   e) External Reference Panel
 2. Meetings of the Committe
 3. Stages of an application
   a) Developing an Application – Obtaining Community Support
  b) Submitting an Application

  c) Assessement of an Application
  d) Approval
  e) Complaints
 
   AH&MRC Guidelines for Research in Aboriginal Health – Key Principles

1.The Committee


a) Role of the Committe

The role of the AH&MRC Human Research Ethics Committee (HREC) is to assess research proposals affecting the health and wellbeing of Aboriginal people and communities in NSW, and to monitor the collection of data on Aboriginal health to ensure these activities will be conducted ethically.

The role of the Ethics Committee is endorsed by the NSW Health Department and embodied within the NSW Aboriginal Health Information Guidelines which guide all NSW government agencies responsible for the management of Aboriginal health and health-related information. These Guidelines operate in conjunction with the NSW Aboriginal Health Partnership, a formal agreement between the NSW Government and the AH&MRC.

The AH&MRC and its Ethics Committee are committed to supporting high quality projects in health and medical research that increase scientific knowledge, are of benefit to Aboriginal communities, are sensitive to Aboriginal culture, ensure Aboriginal community control of the research, and build the capacity of Aboriginal communities and the Aboriginal health workforce to conduct and assess research.

b) The Committee as a Representative of Aboriginal Communities

The AH&MRC is the representative body of Aboriginal Community Controlled Health Services (ACCHSs) in New South Wales. ACCHSs have been established to ensure that Aboriginal people and Aboriginal communities have control over health services affecting them. A major role of the AH&MRC Ethics Committee in considering applications for ethical approval for a research project is to represent the views and interests of Aboriginal people across New South Wales.

The Ethics Committee is comprised of Aboriginal health professionals and community-based people, together with medical and legal members who have expertise and experience in Aboriginal health and research. This gives the Committee a unique capacity to assess the extent of the support of Aboriginal communities for a research project; the capacity of researchers to work ethically with Aboriginal people and communities; and the validity and usefulness of the research.

c) History of the Committee

The Committee was established in 1996 by the forerunner to the AH&MRC (the NSW Aboriginal Health Resources Cooperative) in response to the fact that for many years much health and medical research about Aboriginal people had been invasive, inappropriate, unnecessary, and undertaken without consultation with or approval by Aboriginal people and communities.

In the period since its establishment, the Committee has considered over 760 research proposals and data publications that have been referred to it for approval.

Since the beginning of 2007, the Committee has considered applications relating to over 190 projects. These applications have come from a very diverse range of fields, including ageing, blood thinners, brain injury, bone health, cancer, child welfare placements, chiropractics, chlamydia, chronic disease, coronary disease, dementia, diabetes, disability, domestic violence, drug and alcohol conditions and services, eye conditions, genetics, happiness, home medicines, homeless women and their children, immunisation, mental health, midwifery, otitis media, pharmacogenetics, pre-natal conditions and services, prisoners and young people in detention, postnatal depression, pregnancy, renal disease, sexually transmitted conditions and treatments, smoking, speech pathology, and swine influenza.

The projects for which applications have been made also include research on various programs and interventions, including   the role of ACCHSs in developing community capacity, brokerage with mainstream health services, community and family resilience, construction of health-related buildings, fruit and vegetable programs, general practitioner training, health promotion, housing for people with HIV, liveable communities paediatric clinics, privacy implications of epidemiological research, statistics on birth and deaths, water and sewerage programs.

Review of the Committee

In 2006, the AH&MRC Board commissioned the former Director-General of NSW Health, Michael Reid, to conduct a review of the Committee (Reid Review). Following the review, which was supported and funded by NSW Health, the membership and secretariat of the Committee were reconstituted from the beginning of 2007 and a range of measures have been put in place to enhance its operation. The first meeting of the new Committee was held in April 2007. A total of seven (7) meetings were held in each of 2007 and 2008.

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d) Composition of the Committee

The composition of the current AH&MRC Ethics Committee is in line with the recommendations of the Reid Review, the requirements of the National Statement on Ethical Conduct in Research Involving Humans (2007) and the requirements of the NSW Department of Health for ethics lead agencies.

The Committee includes representatives of the AH&MRC Board, members of local ACCHSs, Aboriginal elders, lay representatives of the Aboriginal community, and members who have qualifications and long experience in medicine, medical research, clinical work, and health-related law.

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e) External Reference Panel

The Reid Review recommended that “The Ethics Committee should establish a specialist reference panel to provide advice to the Committee, when required, on the scientific merit of research proposals.” 

It was not intended that the Panel would meet as a group, but rather be comprised of a number of experts with scientific and technical expertise in their field who can be asked for advice as required on specific applications for ethics approval or on broader issues affecting their field.

The External Reference Panel is now well-established, and will continue to be developed. Over thirty people who are eminent in their field and experienced in working with indigenous people, have accepted membership of the Panel. The members of the Panel cover a diverse range of health and medical fields.

2. Meetings of the Committee

The Committee meets every 2 months. All meetings are held on a Monday. There are arrangements to enable approvals to be given between meetings.

An application must be received two weeks before a meeting if it is to be considered by that meeting.

2010
The final meeting for 2010 will be held on December 13.

2011

The planned meeting dates for 2011 are as follows:

            Meeting Number         Applications              Meeting Date                
                                            Closing Date                                                  

                  01/11                    January 31                February 14                
                  02/11                    March 28                  April 11                   
                  03/11                    May 23                     June 6                        
                  04/11                    July 25                      August 8                       
                  05/11                    September 26            October 10              
                  06/11                    November 28              December 12  
                    
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3. Stages Of An Application

a) Developing an Application – Obtaining Community Support

One of the Committee’s major criteria in assessing an application is to ensure that there is Aboriginal community involvement in, and control over, the research.

Researchers will need to show evidence that they have the support of each local Aboriginal Community Controlled Health Service (ACCHS) where the research is being conducted.

Where research is being conducted in a community where no ACCHS operates or the ACCHS is unable to participate in the research, the required support may be obtained from an alternative appropriate Aboriginal organisation (subject to the agreement of the Ethics Committee). The AH&MRC regional representative in the region may be able to provide assistance in identifying an appropriate alternative organisation.
click here for a list of our regional representative by Region and a Map

An alternative organisation must be one that ensures the research is subject to Aboriginal community control, including people with experience and expertise in health. For example, an Aboriginal drug and alcohol agency or ADAN (Aboriginal Drug and Alcohol Network) may be appropriate for research on substance abuse.

Researchers should work with the relevant ACCHSs or an appropriate alternative body from the earliest stages in the development of their application. This will help to ensure that their research agenda is consistent with the needs of Aboriginal people and that their methodology is both acceptable to Aboriginal people and able to produce the most accurate and useful results. It will also help to ensure that the application meets the Committee’s requirements. 

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b) Submitting an Application

Click HERE for detail on the procedures and requirements for submitting an application to the Ethics Committee. Note that an application must be received two weeks before a Committee meeting if it is to be considered by that meeting.

c) Assessment of an Application

Click HERE for an explanation of the processes by which an application is assessed by the Committee.

d) Approval of an Application

Click HERE for further information about the conditions of approval by the AH&MRC Ethics Committee.

e) Complaints

The AH&MRC and the Ethics Committee have established procedures for addressing complaints about ethical matters in current research in Aboriginal health.  In general, this is meant to cover research projects that have been approved by the Ethics Committee, but assistance may be provided for complaints relating to Aboriginal people or communities in general health research.

All correspondence containing complaints or concerns about research should be sent to:

                            The Chairperson

                            AH&MRC Ethics Committee
                            Aboriginal Health & Medical Research Council of NSW
                            PO Box 1565
                            STRAWBERRY HILLS   NSW  2012

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SUBMITTING AN APPLICATION

Researchers should work with ACCHSs and other relevant Aboriginal community groups from the earliest stages in the development of their application. This will help to ensure the application meets the Committee’s requirements. 

Who should submit an application?

The Committee considers applications relating to research that may affect the health and well-being of Aboriginal people and communities.

The project should involve research in, or concerning, New South Wales.  Where projects also involve research outside New South Wales, an ethics application must also be made to the relevant Aboriginal HREC(s) in the other states and territories.

An application should be made for research for which any one of the following applies:

Applications are received from the full range of people and organisations conducting research that meet the above criteria, including staff from universities, research institutes, Aboriginal Community Controlled Health Services (ACCHSs), the NSW Department of Health, and community agencies; undergraduate and post-graduate students; and independent researchers.

Seeking advice

If you are unsure whether an application should be submitted, you can contact the AH&MRC Ethics Committee Secretariat for advice (Ph. 02-92124777, or email ethics@ahmrc.org.au).

There are a number of different types of research where researchers have sought advice in the past. The following provides some examples as guidance for researchers.

It is emphasised that the following points provide guidelines only and that each specific case will need to be considered against the particular circumstances of that case.  If you are unsure, you should contact the Secretariat.

a) Research concerning the general population

Research that is not specifically directed at Aboriginal people or communities, such as for the total population or a sub-population (eg. rural NSW, people over 50 years old) can still potentially impact on Aboriginal people.

However, an application for such research need only be made to the Committee if any one of the following applies:

b)Research where health is not a major focus

Some research may have some reference to health issues, but be essentially about other matters, such as education, social welfare, justice, etc, and thus an application to this committee may not be necessary. However, terms such as ‘resilience’ and ‘well-being’ in the description and design of the project may indicate that it has important health implications.

c) Program planning, monitoring, and quality improvement activities

Organisations undertake a range of research-type activities aimed at planning, monitoring, or ensuring the quality of their policy, programs, and operation.

There are two government documents that provide guidance on how to determine if a project is predominantly ‘quality improvement ’ rather than research:

In general, even where such activities involve a study of client records and/or interviews with clients, an application to the Committee is not necessary if all of the following apply:

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Applications to Other Human Research Ethics Committees

If your research project meets the above conditions you should submit an application to the AH&MRC Ethics Committee even if you have obtained approval from the HREC in your institution or organisation.

Most research projects for which the AH&MRC Ethics Committee receives applications are also submitted to at least one other Human Research Ethics Committee (eg. a University HREC, or a NSW Department of Health Area Health Service HREC).

For some projects, University and Area Health Service HRECS have required researchers to obtain AH&MRC approval before they will grant ethics approval.

The AH&MRC Ethics Committee is prepared to accept an application at any stage of its progress with another HREC. Each individual researcher can decide whether he/she will seek AH&MRC approval before submitting to other HRECs, or after approval by other HRECs, or simultaneously.

Your application to the AH&MRC Ethics Committee should enclose copies of:

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Aboriginal HRECs in other States and Territories

Where projects also involve research outside New South Wales, an ethics application must also be made to the relevant Aboriginal HREC(s) in the other states and territories.

The following Aboriginal HRECs operate outside New South Wales: 

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Content of an Application

All applicants must complete an Application Cover Sheet.Click HERE for a copy of the Application Cover Sheet.
Please include the completed CHECKLIST (page 2 of cover sheet) with your application.

An application must include the following four sets of documents:

1) A statement (1-2 pages) addressing the AH&MRC’s five criteria in relation to the project.

2) A copy of a completed ethics application form

3) Signed Organisational Consent Forms or Letters of Support from Aboriginal Community Controlled Health Services (ACCHSs) or an appropriate alternative     Aboriginal community body

4) A copy, or summary, of the study protocol for the research.

 Other Documents

There are a number of other documents that applicants could consult to ensure that their applications are consistent with the ethical standards required for Aboriginal health and medical research. These include:

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Documents Required

Copies

Applicants should forward:

Attachments

Preferred Font

The preferred font for an application is Times New Roman 12 Point, although material previously prepared (eg. copy of an ethics application already submitted to another HREC) will be accepted. 

Some Points to Note

To ensure a timely assessment of applications, researchers should ensure that the following matters are addressed in their application:

Deadlines

An application must be received two weeks before a Committee meeting if it is to be considered by that meeting.

Receipt and Acknowledgement of Applications

An application is considered to have been submitted on the date when the four hard copies meeting all of the requirements set out above have been received.

Applications will be acknowledged in writing within two week of the date of submission.

The acknowledgement (and future formal communications) will be sent to the person designated as Chief Investigator on the Application Cover Sheet.

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CHECKLIST

Have you consulted with relevant ACCHSs or appropriate
Aboriginal organisations?                                                                                         

Have you included all of the following with your application?

Application Forms

1.   Application Cover Sheet                                                                                      
2.   A brief statement addressing the AH&MRC’s five criteria                                
3.   A completed ethics application form - this can be a copy of
      an application to another HREC                                                                         
4.   A copy, or summary, of the research study protocol                                          
5.   All necessary signatures have been obtained                                                      
6.   A copy of any requests from other HRECs for further information
      about your application, together with your response to the request.
7.   A copy of Approval letters from other HRECs.
      Information and consent forms.
8.   Participant Information Statement(s)                                                                  
9.   ‘Aboriginal Health and Medical Research Council Ethics
     Committee’ included on the Participant Information Statement
     as a body to which participants can raise concerns or complaints 
10. Pro forma Consent Form(s) for Individual Participants                                      
11. Signed Organisational Consent Form or Letter of Support from all
     relevant ACCHSs or appropriate Aboriginal community bodies                        

Attachments
12. All attachments numbered or lettered                                                                 
13. A summary list of attachments has been provided                                              

Form and Number of Copies
14. Four (4) hard copies of the application have been provided as follows:
      a)   Three (3) hard copies, stapled and presented in final form                                
      b)   One unstapled copy, in the same order as [a]                                                

15. An electronic copy has been sent to ethics@ahmrc.org.au 

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ASSESSMENT OF APPLICATION

Processes for Assessment

Preliminary Assessment

In order to assist the timely processing of applications, the Committee Secretariat will generally seek to review an application before it goes to the Committee, and give applicants the opportunity to provide supplementary material to address any gaps or likely issues before the Committee formally considers the application. It is thus desirable to submit an application as early as possible before the next meeting to enable a preliminary assessment.

Consideration by the Committee

The application will be reviewed on the basis of Criteria and Guidelines for Assessment that have been established by the Committee.

The Committee may draw on the advice of the External Reference Panel and any supplementary material provided by the researcher(s) in considering any application.

Comments on Broader Research Methodology

The AH&MRC and the Ethics Committee have a broad objective to improve the quality of research in Aboriginal Health and consider the quality and validity of research to be an essential condition of its ethical acceptability.

As a means of contributing to improving the quality of research, the Ethics Committee and its External Reference Panel may comment on aspects of the research design that are not directly ethical requirements of the Committee, but are aimed to assist researchers to enhance the quality of the research and its benefit to Aboriginal people and communities. Where this occurs, the specific ethics requirements of the Committee will be clearly distinguished from any broader advice.

External Reference Panel

In line with the recommendations of the Reid Review, the Ethics Committee has established an External Reference Panel to assist it in assessing applications.

The Panel does not meet as a group, but rather is comprised of experts with scientific and technical expertise in their field who can be asked for advice as required on specific applications for ethics approval or on broader issues affecting their field.

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Criteria and Guidelines for Assessment  

In evaluating applications for ethical approval of proposed research and data collection projects, the Committee ensures the projects meet the requirements of three main documents. 

1) AH&MRC Guidelines for Research in Aboriginal Health – Key Principles

The AH&MRC document Guidelines for Research in Aboriginal Health - Key Principles, is the core document used by the Committee in assessing applications.

As noted in that document, in order to obtain approval from the AH&MRC Ethics Committee, research projects must meet all of the following five (5) criteria:

Guidelines for Research in Aboriginal Health - Key Principles also sets out (Section 4) the key principles underpinning these criteria.

2) National Statement on Ethical Conduct in Research Involving Humans (NH&MRC, 2007)

3) NSW Aboriginal Health Information Guidelines

Researchers should work with ACCHSs and other relevant Aboriginal community groups from the earliest stages in the development of their application. This will help to ensure the application meets the above requirements. 

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APPROVAL OF AN APPLICATION
When the AH&MRC Ethics Committee grants approval for an ethics application, it sets seven (7) standard conditions for all projects subject to applicability (eg. Condition [2] below may not be relevant for an epidemiological project). The Committee may also set additional special conditions for a particular project.  The seven  standard conditions are:

Standard Conditions of Approval (where applicable to the project)

  1. The approval is for a period of one year, with extension for an additional period subject to providing a report on the research prior to the end of year. (Nb. Actual dates are given for each application).
  2. All research participants are to be provided with a relevant Participant Information Statement and Consent Form in the format provided with the application.
  3. Copies of all signed participant consent forms must be retained and made available to the Ethics Committee on request. A request will only be made if there is a dispute or complaint in relation to a participant.
  4. Any changes to the staffing, methodology, timeframe, or any other aspect of the research relevant to continued ethical acceptability of the project must have the prior written approval of the Ethics Committee.
  5. The research must comply at all times with:
    • the AH&MRC Guidelines for Research in Aboriginal Health- Key Principles
    • the National Statement on Ethical Conduct in Research Involving Humans (April 2007); and
    • the NSW Aboriginal Health Information Guidelines.
  6. The final draft of the report from the research, and any publication or presentation prior to that report where new data or findings are presented, must be provided to the AH&MRC Ethics Committee to be reviewed for compliance with ethical and cultural criteria prior to:
    • any submission for publication; and/or
    • any dissemination of the report.
  7. A copy of the final published version of any publication is to be provided to the AH&MRC Ethics Committee.

The Committee may also set special conditions for a particular project.

It is the responsibility of the applicant to ensure that all conditions can be met.  For example, where the applicant has been commissioned to undertake the research by another organisation (eg. a Government department), the applicant should ensure that the commissioning body agrees to Condition [6] in writing.  An application may be submitted while this agreement is being sought.

The approval letter from the Committee also contains a request that the researcher(s) agree that the AH&MRC may, on request, obtain access to data from the research in order to assist the future development of policy and programs in Aboriginal health. This is not a condition of approval.

Draft publications sent for review under Condition [6] must be provided with adequate time for the Committee to consider it before any publishing /presentation deadlines. In general, at least two weeks should be allowed before any deadlines

Last Revised: 22 February 2011

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