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Ethical Issues in research into alcohol and other drugs submission

ID: 
10
Personal Details
First Name: 
Pip
Last Name: 
Marks
Specific Questions
Those making a submission are encouraged to comment on the need for an ethical guidance framework, on whether the values and principles in the National Statement are adequate to address the ethical issues in AOD research, on whether the specific issues identified in this paper are sufficiently distinctive of AOD research to merit specific consideration in the proposed ethical guidance framework, and on whether there are additional issues that should be specifically considered in that framework.
Section Two – 2.1.3: 

The public consultation document identifies several ethical issues that are considered to perhaps require additional guidance. However these issues are not sufficiently distinctive to AOD research. These could be addressed by revising the current ethical guidance on research conduct documents, the National Statement of Ethical Conduct in Research involving Humans and the Australian Code for Responsible Conduct of Research.

Section Five - 5.1: 

The ethical considerations raised in the discussion paper are not restricted to AOD research and therefore the ethical values and principles articulated in the National Statement are sufficient to cover AOD research and do not need to be expanded. There are little data to suggest that the current National Statement is inadequate for guiding AOD research. There is an adequate system currently in place for research participants to report issues or concerns. There is also an adequate system in place to report research misconduct. In order to have a simple, robust, efficient and transparent system for ethical oversight of research one ethical framework that applies to all fields of research is required. 

Section Five – 5.4: 

The most effective way to ensure that research is ethical and acceptable to the community is to engage the community or community organisations in the design and development of the research project. Adding an additional step in the ethical review process such as the proposed NSW Research Ethics Ratification process will act as barrier to AOD research and will unnecessarily slow down the scientific discovery pathway.

Section Six : 

We currently have an excellent set of ethical principles and research conduct guidelines that adequately cover all types of human research regardless of the research field or population. There are a large number of marginalised and minority populations in Australia and it is not practical to have a separate set of ethical guidance documents for each. Our goal should be to make the process of research design, approval and conduct as streamlined as possible while still protecting the rights and well being of research subjects to ensure that high quality research is conducted in the appropriate populations in a meaningful and timely manner.

Section Six – 6.1: 

The ethical concern of autonomous decision making in research is not unique to AOD research. Regardless of whether AOD use is viewed as personal choice or as a symptom of a disease (alcohol or drug dependency) AOD researchers have a responsibility to ensure that the principles of respect for humans, research merit and integrity, justice and beneficence are maintained. These principles are adequately articulated in the current National Statement and require researchers to ensure that the individual participant’s rights and wellbeing are not significantly compromised for the greater good of society. 

AOD researchers are aware of these concepts and there are little data to suggest that the current framework is inadequate. There is not a higher rate of complaints to ethics committees from participants in AOD research than from research participants in other fields. There has also not been a higher rate of reported research misconduct in AOD researchers compared to researchers in other fields.

Section Six – 6.2.2: 

It may be ethical to conduct research on minors to which only the minors are asked to consent when the conditions specified in the National Statement are met and the relative maturity of the minor is sufficient to understand;

  • the research proposal including the potential risks and benefits; and
  • the legal implications (if any) of participation.
Section Six – 6.2.3: 

The issue of conducting research on minors is complex. However, these issues are not specific to AOD research. The National Statement details the guidelines for ethical research in young people and the circumstances under which young people can provide consent to research. Its principles are based on the maturity level of the young person. The NSW supplement provides further guidance on this issue by including ages at which autonomous consent can be given by a minor. The addition of age ranges provides further guidance but they should not be mandatory as they do not take into consideration factors such as maturity level, intelligence level, emotional maturity and circumstances such as homelessness. 

Section Six – 6.3: 

Many fields of research may reveal information that may impact the dependents of participants such as illegal activity or child abuse or neglect. These issues may be more common but are not specific to AOD research and therefore do not require a separate guidance framework. These issues may however, require additional guidance to be included in the current guidance framework so that it is available for all researchers across all fields.

Section Six - 6.4: 

Many research fields now use online recruitment and data collection methods. These issues are not specific to AOD research and therefore do not require a separate guidance framework. However, these issues may require additional guidance to be included in the current guidance framework so that it is available for all researchers across all fields.

Section Six– 6.5: 

Participant payments, whether to reimburse for the time and expenses of participation or to incentivize positive or healthy behavior, are not specific to AOD research. The current National Statement provides guidance on participant reimbursements, but does not cover financial incentives for positive or healthy behaviour. Additional guidance is required but should be included in the current guidance framework so that it is available for all researchers across all fields.

Section Six – 6.6: 

Many fields of research have the potential to reveal illegal activities such as illicit drug use and criminal activities.  These issues may be more common but are not specific to AOD research and therefore do not require a separate guidance framework. The current National Statement details the specific ethical considerations for research involving people who may be involved in illegal activities. No additional guidance is required.

Section Six - 6.7: 

The issue of researcher safety may be more relevant, but is not specific to AOD research. This is also an occupational health and safety issue, not an ethical one, and therefore should be dealt with at an Institution level.

General Comments
Comments: 

Many of the issues raised in the discussion paper are relevant to alcohol and other drug (AOD) user populations however they are not unique to AOD users or research. Some issues are perhaps more common in this population and hence may warrant special consideration when designing and implementing AOD research. AOD users are often highly marginalized, vulnerable due to their dependency, sometimes unable to give freely informed consent due to intoxication and may be easily incentivized due to low socio-economic status however these issues are not unique to AOD research.  The current National Statement provides a framework for researchers and ethics committees to ensure that the values and principles of respect for humans, research merit and integrity, justice and beneficence are applied to all human research. These principles apply to all human subjects regardless of race, gender, sexuality, economic status or disease status. The National Statement carefully identifies sub-groups where additional ethical considerations are warranted due to age, vulnerability and disease or health specific factors that may impact on the researcher-participant relationship.

 

The Australian Code for Responsible Conduct of Research provides additional guidance to researchers on responsible conduct of research and encourages honesty and integrity and respect for human research participants. These guidelines are intended to specify the unique responsibilities researchers have to ensure that research subjects are protected and research conduct is meritorious.

 

Our opinion is that AOD research does not require specific ethical guidance because;

1) The ethical issues discussed are not specific to the AOD research population. Our goal should be to have one ethical guidance document (National Statement) that covers all research populations including AOD users. There are a number of minority populations and marginalized populations in Australia and it is not practical to have separate ethical guidance documents for each. There are some ethical issues it raises that perhaps do need more guidance but these are relevant to more than just the AOD user community and therefore should be addressed in either the National Statement or the Australian Code for Responsible Conduct of Research.  

2) There are no data to suggest that the current framework (National statement) is not providing sufficient ethical guidance for AOD researchers or ethics committees;

3) There are no data to suggest that the AOD users require additional ethical protection  i.e. we have not seen more complaints to ethics committees about AOD research compared to other research areas;

4) There is a good system in place to report research misconduct and good policy documents describing ethical and responsible research conduct guidelines;

5) The AOD research field is aware of the ethical issues that may impact participation and conducts its research ethically as evidenced by point 3 above; and

6) Adding in additional review steps for AOD research may act as a barrier to research and a subsequent reduction in AOD research being conducted.

Page reviewed: 26 October, 2012