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Ethical Issues in research into alcohol and other drugs submission

ID: 
9
Personal Details
Organisation Name: 
Drug Policy Modelling Program
C. Additional Information
Please identify the best term to describe the Organisation: 
University
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: 

This submission is made on behalf of the Drug Policy Modelling Program. The views presented in this submission represent the majority of the Drug Policy Modelling Program Chief Investigators, Associate Investigators, and staff.

The researchers with the Drug Policy Modelling Program regard ethical processes as essential and fundamental to conducting research with a marginalised and potentially vulnerable population. Between us we have more than 50 years experience of research in AOD. We see areas for improvement in relation to ethical governance of AOD research – including ensuring all researchers are appropriately trained in informed consent procedures; appropriate discussions around participant payment that are specific to the study under consideration and that adequately weigh up risks and benefits; and effective and sustained engagement with the stakeholder communities (including those who consume alcohol, tobacco and illicit drugs). The work of AIVlL for injecting drug users has been vital in this regard, and we strongly support the role of AIVL, NUAA and other advocacy organisations in having an important stake in research. However, none of this leads us to think that a national framework, specific to AOD research, is sensible or appropriate. It is stigmatising, and has the potential to create more harm than good – marginalising both AOD research participants and researchers. 

Section 2

The issues raised in the guidance framework for AOD research are not sufficiently distinctive of AOD research to merit specific guidelines. The establishment of separate guidelines for AOD research is unnecessary and potentially stigmatising. We note that the NHMRC only has two other special guidelines over and above the guidelines for human research (Assisted Reproductive Technology; ATSI Health Research). Alcohol and other drugs research is not sufficiently different from any research which involves the protection of potentially vulnerable research participants. Indeed, the existence of guidelines for this particular population group only serves to further marginalise the research participants and the researchers from mainstream health research.

Of particular note, the payment in AOD research should conform to all participant payment in human research. Likewise consent for minors, and the requirement for parental consent should also follow all other human research guidelines.

The online methods in recruitment and data collection are not the sole purview of AOD research. Indeed, NHMRC could well consider new guidelines for all research, which concerns online methods. It is peculiar and stigmatising to include a section on online methods in this AOD document.

The section on research involving contingency management payments appears misplaced. Contingency management is an emerging form of treatment (with many USA studies now completed) and should be subject to the usual rigorous research processes that any new treatment would be subject to. There is no reason to include one particular new intervention within AOD research guidelines.

Section Five - 5.1: 

The ethical values and principles articulated in the national statement do not require any expansion in order to be applied appropriately and effectively with AOD research. Again we reiterate it is stigmatising to assume that a person with a substance use disorder or who engages in illicit drug use is any different from other research participants for example those with intellectual disabilities, mental health disorders, or compromised health status.

Section Five – 5.4: 

Section 5.4 Engagement of stakeholders

As a principle of the national statement, engagement of all stakeholders, including potential research participants in the development of research is essential. Again, there is no reason why AOD research should be any different from any other standard that applies to human research, whereby engagement with the “affected community” is important. Indeed, as noted in the document, we already have a number of documents, for example those developed by AIVL, which provide an extremely useful overview of the issues and procedures in AOD research. Given that these already exist, there is no need for NHMRC to have a separate statement on AOD research in relation to stakeholder engagement. What may be required is better implementation of the existing protocols and requirements for meaningful engagement of stakeholders in AOD research.  DPMP has strong collaborations with users groups, and is frequently engaged in collaborative research. The consumer advocacy organisations play a crucial role in research consultation and liaison that requires recognition and funding. There is little point making reference to ethics engagement when representative groups are unable to participate in such processes due to a lack of funding.

Section Six : 

Section 6 Participant payment

There is no reason that people who use drugs or experience a substance use disorder should not be remunerated in an identical fashion to any other human research subject (Ritter et al., 2003). In some instances research participants are not remunerated, in others they are. Ethical judgements needs to be exercised across all human research (not just AOD) in relation to appropriate participant reimbursement for out-of-pocket expenses. Following standard principles of ethical evaluation of potential risks and benefits, a decision can readily be reached regarding participant payment. The fact that individuals who may use substances choose to spend funds they receive from research participation on purchasing drugs is no one’s business other than the individual’s. In addition, money is fungible. If I give a drug user $30 and she spends it on drugs she has an extra $30 to spend on food etc. Secondly, we have no idea what ‘regular’ people do with their participant payment – they could use it for gambling, prostitution, porn, drugs/alcohol, overeating.

The notion that people who use drugs, or who meet diagnostic criteria for substance use disorder are somehow specially impaired, relative to people who meet other diagnostic criteria, for example brain cancer, mental health disorders, is stigmatising and further marginalises this population.

 

Section Six – 6.1: 

See above comment

Section Six – 6.2.2: 

See above comment - not different from any other reserach with young people.

Section Six – 6.2.3: 

See other comments.

Section Six – 6.3: 

See other comments.

Section Six - 6.4: 

There is NO need to include ethical guidance specific to AOD research, in relation to online research. The ethical issues associated with online research are important and require consideration by NHMRC, but are not special or specific to AOD research.

Section Six– 6.5: 

As noted earlier the inclusion of a particular emerging form of treatment (contingency management) should not be the subject of separate guidelines, but can be appropriately dealt with under the national statement.

Section Six – 6.6: 

This is certainly an important ethical issue in AOD research. But again it is not unique to AOD research; there are many forms of research that involve discussing and being made aware of illegal behaviours. (All criminological research has exactly this concern. Even outside of criminology research you often to come across “illegalities” eg  when talking to Centrelink customers their fraudulent behaviour does/can be discussed; in talking to people about their paid employment they can discuss potentially illegal things they have done at work).

Having conducted research in this area for many years, in our experience there have been appropriate ethical responses to the issue of legal risk. Ethics committees can work through the important risks and benefits when considering legal risks. Again, there is little reason to have a separate set of guidelines that apply to an already marginalised and stigmatised participant group.

General Comments
Comments: 

There is no definition of what is referred to by AOD research – is it suggested that NHMRC guidelines would apply to all AOD research, including tobacco studies, and studies where the primary issue is not AOD per se, but data are collected along the way that address AOD? How unwieldy, impractical and discriminatory would it be to be doing research, say, on low income people, bankers, sports people etc  if you had to identify and treat differently those with alcohol and drug issues. This fuzzy boundary is another reason why there should not be separate NHMRC guidelines for AOD research. If the notion is that the guidelines would only apply to certain types of AOD research, for example those who inject drugs, or those who are dependent (meet diagnostic criteria), it is once again a stigmatising approach, and would not be readily implementable. The existing human research guidelines provide the appropriate coverage, and capacity by Ethics Committee to exercise sound judgements regarding all AOD research.

The four domains of epidemiological and social sciences research (Section 4.1) is a peculiar way of categorising types of research. We suggest there are seven broad types of research: Epidemiology; Clinical Research; Ethnographic research; Economic research (drug markets research); Criminological research; Law enforcement and policing research; and Sociological research. The four types from 1999 are considerably dated, represent a particular view of AOD research, do not reflect the diversity of disciplines, and do not convey the variety of types of research that may be undertaken. Of the four listed they focus almost exclusively on prevalence and patterns of drug use, risk factors and drug related harm. This section of the document could be substantially improved.

We are very concerned that throughout the document there is stigmatising language. The Section 5.2 discussion about addiction implies the inability to provide informed consent (notions of the rational moral agent). It is clear that the authors of the guidelines appreciate that there are different views of drug use and addiction. But the fact that this appears in a national ethical research document absolutely leaves the impression that people who use drugs or experience substance use disorders somehow have impaired control and are therefore less likely to be able to provide informed consent. All researchers must take due care in establishing whether an individual, irrespective of drug use, is capable of providing informed consent. Drug users are not different in this regard from any other prospective research participant. 

References

Ritter, A. J., Fry, C. L., & Swan, A. (2003). The ethics of reimbursing injecting drug users for public health research interviews: What price are we prepared to pay? The International Journal of Drug Policy, 14(1), 1-3.

Page reviewed: 26 October, 2012