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Ethical Issues in research into alcohol and other drugs submission

Personal Details
Organisation Name: 
Centre for Research Excellence into Injecting Drug Use
C. Additional Information
Please identify the best term to describe the Organisation: 
Biomedical research institute / organisation
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 Steering Committee and staff and students of the NHMRC-funded Centre for Research Excellence into Injecting Drug Use (CREIDU).  The Steering Committee is comprised of the Chief and Associate Investigators of CREIDU. The Steering Committee includes some of Australia’s leading community organisations and researchers working in the area of injecting drug use. The views presented in this submission represent the majority of CREIDU Steering Committee members, staff and students.

Section 2 of the Public Consultation Document identifies ways in which AOD research can be considered distinct from other types of human research. Section 2.1.1 specifies some features of alcohol and other drug research such as the fact that it may deal with highly stigmatised behaviour, or illegal activities. Importantly, section 2.1.2 highlights how these considerations may also apply in other research fields. Section 2.1.2 also states that the issues discussed in Section 2.1.1 can arise in combination in ways that are challenging for stakeholders in the ethics process (eg participants, HRECs, community representatives, researchers). It is presumably this potential for combination that sits at the heart of the case being made for a special guidance framework for AOD research.

We believe that it is correct to suggest that a combination of some of the factors detailed in 2.1.1 is potentially challenging for Human Research Ethics processes. However, these combinations regularly feature in other types of research. All of the points made in relation to 2.1.1 could equally be applied to other vulnerable populations such as the homeless and those suffering from mental health problems. Mechanisms for managing all of the issues raised are already present in the most recent NHMRC National Statement. Therefore, ethics processes need to be sufficiently sensitive to the issues raised in 2.1.1 to ensure that all participants are adequately protected irrespective of background and the different types of research undertaken in the community. There is no need for separate guidance on AOD use and associated research.

Section 2 is framed almost entirely in relation to considerations related to illicit drug use or dependent drug use. This is inappropriate. For example, the degree to which AOD use is stigmatised varies across substances and drug using behaviours. Some drug using behaviours are not stigmatised. For example, moderate drinking may even actively encouraged in some circumstances. Similarly, other behaviours that may be stigmatised by some sections of society are well-accepted by others such as risky drinking by young people or occasional cannabis use.

Throughout the consultation document there is a lack of recognition of the continuum of attitudes and behaviours regarding AOD use in Australia, with terms such as ‘dependence’ and ‘addiction’ used interchangeably in various sections. While this is in part reflective of the differences of opinion about how problem AOD use should be framed (as per 2.1.1e), this is not unique to the AOD field meaning that imprecision such as this does not warrant the development of a separate guidance document. Rather, stakeholders in the ethics review process need to be cognisant of these issues as they apply to AOD research.

Section 2.1.3 details the specific ethical issues that are covered in later sections of our submission. Given that we dispute the need for a separate guidance framework, our position is that these issue are covered by the current National Statement.

Section Five - 5.1: 

The National Statement covers all of the issues relevant to AOD research, including research involving people who inject drugs. As noted earlier in the submission we believe that the issues raised in the public consultation document are not unique to AOD research. Therefore, the National Statement does not need to be expanded.

Section Five – 5.4: 

Our response to Section 2.1 highlights how the issues identified in the Public Consultation document apply to other areas of research meaning that AOD research is not sufficiently distinctive to merit specific consideration. Indeed, we would argue that the development of a specific guidance framework serves to stigmatise participants in AOD research. Given that the focus of CREIDU is on people who inject drugs we believe that this may lead to further marginalisation of our participants who are often already marginalised and stigmatised by wider societal structures.

Section Six : 

Our response to Section 2.1 highlights how the issues identified in the Public Consultation document apply to other areas of research meaning that AOD research is not sufficiently distinctive to merit specific consideration. Indeed, we would argue that the development of a specific guidance framework serves to stigmatise participants in AOD research. Given that the focus of CREIDU is on people who inject drugs we believe that this may lead to further marginalisation of our participants who are often already marginalised and stigmatised by wider societal structures.

Section Six – 6.1: 

There is a mismatch between the text provided in relation to the Public Consultation Questions (p viii and the question provided on this online form) and the issue described on page 15 of the Public Consultation Document, which is described only as “6.1 Participant Payment in AOD research”. Clearly the issues raised in the subsequent points under section 6.1 are broader than participant payment alone, and include capacity to consent. We consider participant payment and capacity to consent below.

Participant payment in research with people who inject drugs has been the subject of numerous studies and recommendations have emerged from this body of work, as detailed in the Public Consultation Document. These recommendations are all consistent with the guidance currently provided by the National Statement (2.2.10) around the limits to participant reimbursement (as detailed in the Public Consultation Document). Further, the National Statement also states in Section 2.2.11 that “Decisions about payment or reimbursement in kind, whether to participants or their community, should take into account the customs and practices of the community in which the research is to be conducted.” We believe that this guidance is sufficient to manage the issue of participant reimbursement in research in AOD research, including that involving people who inject drugs. Importantly this provision implies that communities should be engaged in reimbursement decisions, and our response to 5.4 details how these processes can be put in place.

Issues around capacity to consent are also covered adequately in the National Statement. The principles embodied in the informed consent processes outlined highlight the extent to which researchers need to be properly trained in understanding and obtaining informed consent. The question above implies that people with AOD problems or ‘addiction’ have difficulty with autonomous decision making. Many people with AOD problems clearly have the capacity for autonomous decision making but there are certainly circumstances in which this may not be the case. However, as outlined in the National Statement, there is a variety of conditions where autonomous decision making is an issue and special provision is provided for addressing some of the issues that arise (Section 4.5). While there may be some need to refine the National Statement in relation to issues of intoxication, for example, there is certainly no need to establish a separate guidance document.

Section Six – 6.2.2: 

The current National Statement covers circumstances under which it is appropriate to seek consent from minors alone, such as the case when they should be considered ‘mature’ minors or when seeking parental/guardian consent may disclose AOD use to parents/guardians. These should be applied to AOD research, including that involving people who inject drugs.

Section Six – 6.2.3: 

As indicated above, we believe that the provisions of the National Statement are a useful guide for research in the AOD sector. In the past we have made specific application to Human Research Ethics Committees that some of our participants be considered as mature minors. In our experience Committees need to be made fully aware of these provisions, and how they should be applied. Nevertheless, these provisions need to be applied to all human research and so there is no need for them to be considered as part of a separate guidance document.

Section Six – 6.3: 

The situations and issues considered in relation to Section 6.3 apply to all research practice, and so there is no specific need to focus on AOD research per se. Consent processes need to ensure that the limits to confidentiality are explained in detail to prospective participants, and this includes legal risks about disclosures of child abuse and neglect. This needs to be tailored specifically to the staff involved in the study with due consideration to state legislation as to who is mandated to report on such issues.

Section Six - 6.4: 

On-line research participation is increasingly common in many areas of AOD research. To our knowledge, however, such methods have not been applied to studies that are specifically focused on people who inject drugs in Australia. This is partly a question of access and so, as internet-based technology reaches further into the community, this may change. The apparent anonymity of the internet masks the true limits to confidentiality, with IP and MAC address information meaning that confidential information could potentially be traced to individual computers. These limits need to be understood by Human Research Ethics Committees and properly described in study information. These issues apply to all human research.

Section Six– 6.5: 

Contingency Management (CM) approaches in the AOD and other sectors are used in an effort to manage and change behaviours. In AOD research CM payments are a part of treatment and prevention, not to be confused with the research process. As CM is also used in programs and research in other sectors, any consideration of CM should apply to all research sectors.

Section Six – 6.6: 

The legal risks to participants in AOD research relate primarily to the limits to confidentiality. This is currently covered in Section 4.6 of the National Statement and means that it is beholden on researchers to fully explain the limits to confidentiality to potential participants. These legal risks apply outside of the AOD research field and need to be managed appropriately in all forms of human research. The risks around limits to confidentiality are related to specific state-based legislation. The NHMRC could work with other institutions that have identified these as a barrier to privacy and confidentiality to develop new confidentiality provisions, either through legislation such as the ACT Epidemiological Studies (Confidentiality) ACT (1981) or national reviews of privacy provisions.

Section Six - 6.7: 

Researcher safety should be of paramount concern to organisations involved in research. Occupational Health and Safety legislation demands this and these considerations apply to all forms of research. Indeed, we are concerned that the Public Consultation Document seems to discriminate against participants in AOD research, including people who inject drugs, by suggesting that a special case should be made for AOD research.

General Comments

As detailed in our response to the specific questions, we believe that the NHMRC National Statement addresses issues connected  to ethics in AOD research adequately. Therefore, we believe that there is no need for a guidance framework specific to AOD research. Indeed, the development of such could serve to further marginalise and stigmatise participants in AOD research.

Page reviewed: 26 October, 2012