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Ethical Issues in research into alcohol and other drugs submission

ID: 
31
Personal Details
Organisation Name: 
The University of Melbourne
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: 

AOD research does raise ethical issues which are sufficiently distinctive and of sufficient ethical weight and complexity to warrant specific guidance. The following issues in the proposed guidance framework merit specific consideration there: participant payment, consent of minors/parental consent, legal risks for participants and researchers, risks to researchers. The other issues raised (on-line recruitment and data collection, contingency management payments and ethical issues concerning dependants) are not so closely related to AOD research, and would be better addressed more generally in other places. In particular, online recruitment and data-collection is a rapidly growing approach to research in many fields, and should be addressed specifically in the next iteration of the National Statement. So-called contingency management payments actually form part of an intervention, not of research evaluating that intervention, and for this reason it is not appropriate for them to be addressed in this context. Risk to dependants, insofar as it is caused by legal risk to participants in AOD research, should be addressed there. Otherwise, this sort of risk is best addressed more generally in terms of risks to third parties in research.

Section Five - 5.1: 

No comment.

Section Five – 5.4: 

Whilst ‘ethics engagement’ in general is a valuable idea and worthwhile undertaking, it is not so clear how it could work in relation to specific guidance for researchers and HRECs on AOD research. It would, however, potentially have a valuable role in establishing the baseline approach to AOD research and the ethics of it. The key contentious issue for AOD research is that the research participants whom researchers seek to involve in such research are often involved in an on-going way in criminal activities. However, the purpose of AOD research is not to uncover criminal activity (hence the section in the National Statement on this should not be seen as relevant to AOD research). The purpose of AOD research is ultimately to improve the health and well-being of users of AODs, either through improved service delivery or improved government policy. That is, AOD research is health research – or at least, it is seen that way by AOD researchers. This is a very important philosophy, as it implies that the focus is on the health and well-being of research participants, protecting them from harm and making sure they are able to make a free and informed choice about participation in research. The aim of AOD research is not to find out about, report on, or stop criminal activity. However, not all sections of the community see AOD research in this way and there may be neither community understanding nor acceptance of AOD research as health research. It would be very useful to have community discussion of this basic philosophy, of the need to do AOD research and the benefits for the community of doing the research, and importance of protecting participants if the research is to have any chance of producing meaningful results. Having community understanding and support is important because of the controversial nature of the area and the range of strongly held views in the community.

Section Six : 

AOD research does raise ethical issues which are sufficiently distinctive and of sufficient ethical weight and complexity to warrant specific guidance. The following issues in the proposed guidance framework merit specific consideration there: participant payment, consent of minors/parental consent, legal risks for participants and researchers, risks to researchers. The other issues raised (on-line recruitment and data collection, contingency management payments and ethical issues concerning dependants) are not so closely related to AOD research, and would be better addressed more generally in other places. In particular, online recruitment and data-collection is a rapidly growing approach to research in many fields, and should be addressed specifically in the next iteration of the National Statement. So-called contingency management payments actually form part of an intervention, not of research evaluating that intervention, and for this reason it is not appropriate for them to be addressed in this context. Risk to dependants, insofar as it is caused by legal risk to participants in AOD research, should be addressed there. Otherwise, this sort of risk is best addressed more generally in terms of risks to third parties in research. This can happen in almost any field of research.

Section Six – 6.1: 

Payment of participants in AOD research is an important issue to address in the guidance framework. For both researchers and HRECS, guidance on strategies for increasing the likelihood that the potential participants will be able to make free and informed decisions about participation would be welcome. HRECs often have neither expertise nor experience in these matters. Other matters on which specific guidance would be helpful relate to:
1. Inclusion of people who have already consented to participate, but who appear to be affected by drugs or alcohol at the time of data collection. What sort of processes need to be in place to assess this (is formal assessment required)? Should affected participants always be excluded from that instance of data collection (even if they to return at a re-scheduled time, or unlikely to be unaffected then? How detailed a plan should researchers have in place to deal with apparently intoxicated participants? This is a general concern about competence, rather than anything to do with incentives. Note that withholding of an offered payment does not deal with this issue – the question is whether or not the participant is competent to make the decision to participate now (even if he or she previously agreed or consented).
2. HRECs are sometimes concerned that participants in AOD research will use cash payments to buy drugs or alcohol, and hence do further harm to themselves. This is not necessarily in the context of seeing the payment as an irresistible motivator to the participant who is desperate to alleviate withdrawal symptoms. It is simply a recognition that drug users may use money from research to buy drugs, whether they are addicted or not, or suffering withdrawal symptoms or not. Guidance would be very helpful on whether HRECs should even consider or be concerned about this. Should this be seen as a potential risk to participants, which should be taken into account when considering ethical acceptability of the research? If it is seen this way, researchers have an obligation to remove or minimise potential harm, which they would be responsible for if it came about. Or should this possible use of incentives given to a participant be seen as outside the purview of HRECs and the ethics of the research? It could be argued that it is not relevant to the ethics of the research what the participants choose to do with any money they derive from it. Participants in clinical trials are often paid, as indeed are GPs who participate in research, but questions are not raised about what they will do with the money, and whether it is unethical to pay them if they might use the money for “bad purposes”. This is an issue that troubles some HRECs, and there is a clear current and felt need for guidance.

Section Six – 6.2.2: 

The provisions currently set out in the National Statement for research to which only minors consent do not fit AOD research very well. In particular:
• 6.2.3.b. NS 4.2.9 (b) says that HREC may approve research to which only the minor (of possible vulnerability due to immaturity) consents, provided the research is no more than low risk. Given the legal risks, a great deal of AOD research could not be considered as no more than low risk, even if the actual data collection methods themselves are only of negligible risk. If we want this sort of research (eg research involving younger drug users, perhaps under 15) to be able to be approved, this may need to be changed.
• 6.2.3.b. NS 4.2.9(d)(ii) adds the condition that it would be contrary to the best interests of the young person to seek consent from parents. In AOD research, this would not be the main reason for not seeking parental consent. This condition envisages, for example, an abusive parent. In AOD research, although this may be the case on occasion, the main concern is that if parental consent is required, young people will either not agree to participate, or will not give accurate responses, because they do not want their parents to know about their use of alcohol or drugs. The concern is primarily privacy, not safety. This could perhaps be included under the rubric of “best interests”, but it would be very helpful to have clear guidance on whether this is an acceptable reason to not seek parental consent. The reasoning would be that important research might not be able to go ahead if parental consent is required.

Section Six – 6.2.3: 

See response in section 6.2.2 above.

Section Six – 6.3: 

See response in Section 6 above. Risk to dependants, insofar as it is caused by legal risk to participants in AOD research, should be addressed. Otherwise, this sort of risk is best addressed more generally in terms of risks to third parties in research. This can happen in almost any field of research.

Section Six - 6.4: 

See response in Section 6 above.On-line recruitment and data collection would be better addressed more generally in other places. In particular, on-line recruitment and data-collection is a rapidly growing approach to research in many fields, and should be addressed specifically in the next iteration of the National Statement.

Section Six– 6.5: 

See response in Section 6 above. Contingency management payments form part of an intervention, not of research evaluating that intervention, and for this reason are not appropriate to be addressed in this context

Section Six – 6.6: 

Legal risk to participants is the most pressing concern in AOD research. Guidance on this is certainly required. All issues listed in 6.6.2 on p.19 would be the most appropriate areas for guidance. In the long term, legal protection for participants in AOD research may be the most effective way of dealing with this issue and allowing AOD research to proceed and produce meaningful results which will benefit users and the community. This could be achieved by granting special legal protection to researchers’ records, and even to research activities, so that participants would not be subject to legal risks of being arrested, charged, convicted because of their participation in research. Of course NHMRC cannot singlehandedly cause this to happen, but it is in a position to make policy recommendations in this regard.

Section Six - 6.7: 

Researcher safety is potentially at risk in a number of areas of research, not just AOD research. However, it is reasonable to say that there are some particular types of risks to researchers in AOD researcher which are foreseeable, and hence can be managed and minimised. So it is appropriate to give guidance on this. Guidance needs to do more than just identify what the risks might be, as 6.7 currently does. Also needed is guidance on strategies for minimising these risks without compromising the design and quality of research. HRECs are in need of guidance on the extent to which it is within their remit to reject research if they consider risks to researchers are too high, or have not been adequately minimised. In the final analysis, is this legitimately the call of researcher, or of the HREC?

Page reviewed: 26 October, 2012