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Ethical Issues in research into alcohol and other drugs submission

ID: 
26
Personal Details
First Name: 
Carolyn
Last Name: 
Day
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 seven issues identified in section 2.1.3 are indeed areas of ethical concern, but they are not particular to drug and alcohol. Issues related to consent in minors and that of parental consent, online methods in recruitment and data collection, legal risks for participants and researchers and protection of researchers are all issues that no doubt arise in other speciality areas such as mental health and adolescent health even where drug and alcohol information is not collected. Ethical issues concerning the dependants of participants and participant payments should not be viewed as specific to any speciality area and should always be considered under an umbrella framework for all research involving humans.

I would also like to point my concern that the discussion paper appeared to question the very concept of addiction. Drug and alcohol dependence is an internationally recognised medical disorder with clear diagnostic criteria set out in the World Health Organisation’s International Classification of Diseases (ICD) and the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM). These conditions are dealt with in our hospital system and a number of registered and subsidised medications are employed successfully in the treatment and management of these conditions. Indeed many of the treatment approaches are supported by level 1 evidence. It is therefore disturbing that the National Health and Medical Research Council would entertain the view that an addiction is a “personal choice”.   Whilst it is certainly the case that many people “choose” to use drugs and alcohol and that many of these people are not dependent and may never develop dependence, dependence cannot be considered an individual choice. Although drug and alcohol dependence are well recognised medical conditions, as with any other condition, it does not mean that those afflicted cannot make rational decisions and or are incapable of giving informed consent.

Section Five - 5.1: 

The National statement adequately addresses the drug and alcohol field. As a diverse and dynamic society, a broad National Statement such as the current statement should be sufficient to cover the vast array of health and medical research conducted in Australia. If the Statement had been found inadequate because of a large number of adverse events, complaints or some other documented difficulty associated with an area of research then such an expansion may be warranted. Based on my reading of the discussion paper this is not the case and similar or indeed entirely different but potentially “unique” concerns, might be raised for almost any other area of health and medical research covered by the National Statement. In short, there seems no empirical basis to alter a system that otherwise would seem to have been working effectively.

Section Five – 5.4: 

Drug and alcohol research is a very diverse area potentially encompassing a large proportion of the population making it difficult for any particular group to assume responsibility. For example, approximately one third of Australians have used cannabis, how is this group to be represented and by whom? From which organisation should the community endorsement come? Engagement of the targeted community is an important component of the ethical conduct of research, but the community engaged should be the community most directly affected by the research and engagement may take many and varied forms depending on the research question and methodology.  Community engagement should therefore be assessed on a case by case basis by HRECs, as is the current case with all Australian human research; there is no rationale for a specific and direct requirement for drug and alcohol research and more than there is for any other condition.

Much of the research conducted in drug and alcohol is not relevant to the organisations listed above, and therefore such an approach would likely confuse and hinder the broader field of drug and alcohol research. It is therefore much more appropriate that local HRECs assess the need for community engagement as they currently do.

Finally, obtaining ethical approval is already a detailed and often protracted process, any additional step is likely to stifle research in the drug and alcohol field, with no evidence that the desired outcome would be achieved.

Section Six : 

These areas are not specific to drug and alcohol and has I have detailed below are likely to be as relevant to other areas of research. It appears that in many cases a narrow reading of the issue has been taken. For example, how is a withdrawal different from another area where pain may be experienced by the participants (I personally have been approached to participant in research during childbirth), such as may be the case for a number of conditions (indeed, I personally have been approached to participant in research during childbirth), this arguably is the same issue manifested differently. Almost all issues outlined in the in discussion paper are either directly relevant to other areas of research or pose the same issue but in a different form.

Section Six – 6.1: 

There is already a distinct literature on the issue of participant reimbursement in drug and alcohol field (see for example Festinger, D. S. et al.  2005 Do research payments precipitate drug use or coerce participation? Drug and Alcohol Dependence, 78, 275-281; Festinger, D. S. et al 2008 Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion. Drug and Alcohol Dependence, 98, 128-135). Indeed there are many sound arguments to the contrary - some (myself included) would argue it is unethical not to reimburse research participants. Much of the research conducted is unlikely to directly benefit participants and although the research is anticipated to advance the field, this will usually occur in a protracted manner often after the participant is unable to benefit. Therefore small reimbursements to an otherwise marginalised community facilitates a truly reciprocal arrangement. I am aware of a number of organisations, my own included, which have guidelines and policies on appropriate reimbursement for clients participating in research and this issue is also closely monitored by HRECs. I am unaware of adverse events arsing directly and specifically from participant reimbursement.

Reimbursement for research participation is rarely likely to result in the scenario hypothesised in section 6.1.3. Firstly, as above many organisations have guidelines on assessing participants for intoxication and withdrawal. Secondly, intoxication, withdrawal and drug induced psychiatric conditions are practical issues for drug and alcohol researchers – they make it difficult (if not impossible) to engage participants and if interviewed, even briefly, the data collected would be of questionable quality.

There are many areas of research where competence to provide informed consent needs to be assessed, such as with elderly individuals who may be in the early stages of dementia or where English may be the second language but an interpreter is deemed unnecessary or unavailable. How different are these issues to say, a terminally ill patient's consent to participate in a trial of treatment intended to prolong life? Risk and benefit abound in all areas of research and HRECs must balance these issues and provide individual research project with guidance, an expansion of the National Statement to one specific area will not help this situation. Currently, in all such cases, judgements are made and the National Statement provides guidance. These projects are then regulated and monitored through local HRECs, to my knowledge there is no evidence that this has not been performed effectively, especially in the drug and alcohol field and therefore should not be treated any differently to other areas of research.

Section Six – 6.2.2: 

Whilst this is certainly an area of concern for drug and alcohol researchers, it is by no means the only field; surely this is an issue for sexual health and sexuality research also? Minors should be able to provide their own consent when they are judged mature enough to understand the risks and benefits associated with the research. Once again, the National Statement adequately addresses this issue in such a way that makes it applicable across numerous research fields.

Section Six – 6.2.3: 

The National Statement provides adequate guidance and this issue is not specific to drug and alcohol as stated above.

Section Six – 6.3: 

Drug and alcohol is not the only area where dependants of research participant could be impacted by research involvement, this may occur in many research areas, especially any research where parenting practices are assessed. In my experience HRECs are cognisant of these issues and provide guidance. Whilst such guidance may currently be inadequately covered in the National Statement any expansion should be applicable to all research and not specific drug and alcohol.

Section Six - 6.4: 

I do not believe there is anything specific to drug and alcohol research that could not be addressed by general guidance incorporated into the National Statement.

Section Six– 6.5: 

This issue is not specific to drug and alcohol research and despite a vast literature internationally on the benefits of this method to the drug and alcohol field there is currently little work conducted in Australia. Contingency management is, however, already practiced at the population level in a non-drug and alcohol context – the national maternity immunisation payment scheme. Therefore any expansion of the National Statement to address this issue should not be specific to drug and alcohol.

Section Six – 6.6: 

This issue is not specific to drug and alcohol and could occur in many fields. As with previous ethical issues raised in the discussion paper, no evidence is presented to suggest that these issues are more prevalent in drug and alcohol (e.g. subpoenaed data) or that more adverse events related to these issues have resulted. A number of practices already operate in the drug and alcohol field to reduce or eliminate this risk and such practices may indeed be more common in the drug and alcohol field than others. However, as no such data exist this cannot be determined.

Section Six - 6.7: 

Researcher safety is an important occupational health and safety issue and has been addressed specifically in the drug and alcohol field. See for e.g., Day, C. & Topp, L. (2003) Safety in drug and alcohol research. Addiction, 98, 1641-1643; Day, C. et al.  (2002) Interview Safety in the Drug and Alcohol Field: Development of a Safety Protocol for the National Drug and Alcohol Research Centre. Sydney, National Drug and Alcohol Research Centre, University of New South Wales. These issues are typically and appropriately managed through risk management polices including occupational health and safety policies and procedures and therefore beyond the scope of the National Statement. Moreover, as queried throughout this response, is there any evidence, in the many years of high intensity drug and alcohol research in Australia, that the prevalence of adverse events is higher in the drug and alcohol field? If there are no more adverse events in this field than others why is additional guidance required, especially as the field already has developed guidelines?

Page reviewed: 26 October, 2012