ETHICAL ISSUES IN RESEARCH INTO ALCOHOL AND OTHER DRUGS: AN ISSUES PAPER EXPLORING THE NEED FOR A GUIDANCE FRAMEWORK

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1 ETHICAL ISSUES IN RESEARCH INTO ALCOHOL AND OTHER DRUGS: AN ISSUES PAPER EXPLORING THE NEED FOR A GUIDANCE FRAMEWORK An ethical framework is a set of ethical principles capable of being applied consistently and designed to guide our response to a particular problem or set of problems an ethical framework dictates not what is to be done, but what factors should be considered in deciding what is to be done. 2 2 Chan, S., & Harris J. (2007). Nuffield Council on Bioethics: An ethical review of publications (p. 7). Accessed on 20 April 2011 from:

2 Contents Section 1 Introduction Purpose Exclusions The National Drug Strategy Structure of the Issues Paper Target audience 3 Section 2 The Distinctive Nature of Alcohol and Other Drugs Research Distinctive nature of AOD research 4 Section 3 The Nature and Extent of Addiction to Alcohol and Other Drugs in Australia Extent of addiction to alcohol and other drugs in Australia Causative factors for addiction to AOD in Australia Genetic Factors 7 Section 4 A Taxonomy of the Types of Research Undertaken on Alcohol and Other Drugs The four domains of epidemiological and social science research The neurobiological basis of drug effects and of addictive or problem patterns of alcohol and other drug use Online developments in AOD settings 9 Section 5 Ethical principles The values of the National Statement The National Statement and research on persons with an addiction The National Statement and research involving illegal activity Community values and AOD research 13 Section 6 Examples of Ethical Issues in Alcohol and Other Drugs Research Participant Payment in AOD Research Consent in minors and parental consent Ethical issues concerning the dependants of participants Online methods in recruitment and data-collection Contingency management payments Legal risks of research for participants and researchers Protection of researchers 19 Section 7 Glossary of Terms and Phrases Glossary of terms and phrases Addiction Co-morbid Dependence Online research Harm Minimisation Illegal substance 21 i

3 7.8 Intoxication Legal substance Researchers Withdrawal 21 Section 8 Selected Bibliography 22 APPENDIX 1: Role of AHEC and membership of the expert Advisory Group 27 APPENDIX 2: Terms of reference for Advisory Group of AHEC 28 APPENDIX 3: Advisory Group Recommendations 29 ii

4 SECTION 1 Section 1 Introduction 1.1 Purpose One of the Principal Committees of National Health and Medical Research Council (NHMRC) is the Australian Health Ethics Committee (AHEC). The statutory functions of AHEC include providing advice, or preparing guidelines, about ethical issues in health. An aspect of that role includes providing guidance to researchers and Human Research Ethics Committees (HRECs) relative to the National Statement on Ethical Conduct in Human Research (2007) (National Statement) 3 and its companion document the Australian Code for the Responsible Conduct of Research (2007) (the Code) Since the publication of the 2007 version of the National Statement several innovations in Alcohol and Other Drugs (AOD) research have emerged (see section four). Consequently, AHEC has determined that there may be a need to expand the guidance provided in the National Statement for researchers and HRECs working in the AOD research area. This Issues Paper has been developed by a sub-group of AHEC with the aim of gaining a better understanding, via public submissions, of the distinctive ethical issues and challenges of AOD research Submissions to this Issues Paper will assist AHEC to determine the need for an expanded form of ethical guidance, and if such a need exists, to develop a guidance document (the proposed guidance framework) intended for use by researchers and HRECs working in the AOD field Those making a submission are invited to comment on: a. the distinctive ethical issues facing researchers and HRECs in the AOD setting; b. whether the Issues Paper identifies the most important new and emerging forms of AOD research; c. whether the values and principles put forward in Section five of the Issues Paper are adequate as a basis for ethical decision making in AOD research; and d. which issues other than those specifically identified in Section six of the Issues Paper, need to be addressed in the proposed guidance framework, and whether any issues identified in the Issues Paper should be excluded from such a guidance framework. 1.2 Exclusions This Issues Paper is confined to the Australian research, regulatory and clinical context The Issues Paper is concerned only with AOD research. It does not seek to include: a. ethical issues associated with evaluating clinically-based treatments; b. so-called addictive behaviours that do not involve AOD use e.g. problem gambling, or addictions to food or the internet; and c. ethical issues that may arise in the treatment of persons with an addiction and co-morbid mental illnesses. 3 National Health and Medical Research Council. (2007). National Statement on Ethical Conduct in Human Research. Accessed on 18 July 2011 from: 4 National Health and Medical Research Council. (2007). Australian Code for the Responsible Conduct of Research. Accessed on 18 July 2011 from: 1

5 SECTION The regulatory and legislative environment in AOD research is complex and frequently different in each State and Territory of Australia. For this reason the Issues Paper cannot address in any detail the interaction between the ethical issues and the regulatory and legislative landscape in any specific jurisdiction Given the complexity and sensitivities associated with AOD research including (but not limited to) factors such as the social determinants of health and political imperatives, the proposed guidance framework will not be able to address each circumstance which may arise in AOD research in any detail. Other guidance documents exist for that purpose, e.g. professional practice policies and procedures issued by treatment facilities, by medical, nursing and allied health Colleges or by non-government organisations The proposed guidance framework would be intended to function as a high level guidance document that will inform decisions about the more specific operational level matters involved in AOD research. 1.3 The National Drug Strategy The Issues Paper is to be understood in conjunction with the National Drug Strategy : A framework for action on alcohol, tobacco, and other drugs (The National Drug Strategy). 1, The National Drug Strategy is a cooperative venture between Australian State and Territory governments and the non-government sector. It is aimed at improving health, social and economic outcomes for Australians by preventing the uptake of harmful drug use and reducing the harmful effects of licit and illicit drugs in our society The National Drug Strategy has an overarching approach of harm minimisation underpinned by three equally important pillars of demand reduction, supply reduction and harm reduction. It also has a commitment to evidence-based and evidence-informed practice, innovation and evaluation. It is advisable that researchers familiarise themselves with this strategy before undertaking AOD research. 1.4 Structure of the Issues Paper Section 1: Introduction (this section) - outlines the purpose, exclusions and structure of the Issues Paper Section 2: The Distinctive Nature of Alcohol and Other Drugs Research identifies the features of AOD research that raise distinctive ethical issues and thus create the need for this Issues Paper and the proposed guidance framework based upon it Section 3: The Nature and Extent of Addiction to Alcohol and Other Drugs in Australia summarises the extent of the problems that are the focus of AOD research Section 4: A taxonomy of the types of research undertaken on alcohol and other drugs Section 5: Ethical principles identifies principles and values relevant to AOD research Section 6: Examples of ethical issues in AOD research 5 Australian Government Department of Health and Ageing (2009). Evaluation of the Aboriginal and Torres Strait Islander Peoples Complementary Action Plan Final Report. 29th May Retrieved 18 May 2011 from: 2

6 SECTION Section 7: Glossary of Terms and Phrases Section 8: Selected Bibliography 1.5 Target audience As noted above, the Issues Paper has been developed with particular reference to the National Statement Its target audience is: a. AOD researchers who will design, conduct and analyse the findings of AOD research; and b. HRECs who will review and governing institutions who will monitor AOD research in accordance with the requirements of the National Statement and the Code. 3

7 Section 2 Section 2 The Distinctive Nature of Alcohol and Other Drug Research The distinctive Nature of Alcohol and Other Drugs Research 2.1 Distinctive nature of Alcohol and Other Drugs Research Alcohol and other drugs (AOD) research can be considered to be distinctive from an ethical perspective because: a. it deals with highly stigmatised forms of behaviour; b. it can involve criminal behaviour e.g. when some forms of drug use are prohibited by law or when individuals engage in criminal acts to fund their drug or alcohol use; c. it may involve the collection of sensitive personal information about AOD use and illegal activities, where there exists the real possibility of direct harm to research participants (e.g. workplace discrimination, criminal prosecution) if confidentiality is not protected; d. the use of addictive drugs often has adverse effects on family members and the wider community; and e. there are strong disagreements within the community about whether problem AOD use is best thought of as a medical disorder, a personal choice, or a combination of the two Each of these features can be found in other research fields, but in AOD research it is common for several of these issues to arise at once, and acutely. This creates a particularly demanding ethical landscape for researchers and Human Research Ethics Committees (HRECs) to negotiate In that context, specific ethical issues identified and addressed in Section Six of this paper are: participant payment in AOD research; consent in minors and parental consent; ethical issues concerning the dependants of participants; online methods in recruitment and data-collection; research involving contingency management payments; legal risks of research for participants and researchers; and protection of researchers. 4

8 section 3 Section 3 The Nature and Extent of Addiction to Alcohol and Other Drugs in Australia The Nature and Extent of Addiction to Alcohol and Other Drugs in Australia 3.1 Extent of addiction to alcohol and other drugs in Australia In Australia, as in most other developed countries, the majority of adults have used alcohol, a substantial minority are daily cigarette smokers, and a significant minority of adults have used illicit drugs sometime in their life, most often cannabis. A significant proportion of the Australian population is also addicted to alcohol and other drugs. 6 This includes: around 17% of Australians who are dependent on tobacco; 8% of Australians who are dependent on alcohol; and 4-6% who are dependent on illicit drugs (such as cannabis, amphetamines and heroin). 7, Tobacco use is a major contributor to the Burden Of Disease (BOD) in Australia, accounting for 7.7% of the total BOD. 9 Most of this is attributable to tobacco smoking that causes lung cancer, chronic obstructive pulmonary disease, ischaemic heart disease, cerebral vascular events or stroke and oesophageal cancer. Tobacco smoking is also the single largest contributor to the social costs of drug use (accounting for approximately $31.5 billion per annum) Alcohol abuse contributes 2.3% of the Australian BOD. 9 In younger users, the major contributor to disease burden is accidents, injuries, and suicide attributable to the effects of intoxication. 9 In older adults, alcohol use contributes to disease burden via alcohol dependence, liver cirrhosis, and psychosis. Alcohol use costs Australian society approximately $15.3 billion per year. One attempt to address these issues is NHMRC s Australian Guidelines to Reduce Health Risks from Drinking Alcohol The use of illicit drugs contributes around 2.0% of the total BOD 9. Heroin addiction is the major contributor (accounting for approximately 60% of the illicit BOD). Illicit drug use costs the Australian community approximately $3.8 billion per year There is an emerging body of epidemiological evidence suggesting that there is a correlation between vulnerable individuals who also use cannabis developing schizophrenia or more persistent psychotic symptoms. 6 Australian Institute of Health and Welfare (AIHW). (2007). National Drug Strategy Household Survey: detailed findings. In Australian Institute of Health and Welfare Report (2008). No.: PHE 107. Canberra. 7 Teesson. M., Hall. W., & Grigg. M. (2007). Substance-related disorders. In G. Meadows., B. Singh., and M. Grigg, (Eds.) Mental Health in Australia: Collaborative Community Practice. Oxford University Press: Melbourne. 8 Teesson, M., Hall, W., Slade, T., Mills, K., Grove, R., Mewton, L., Baillie, A. & Haber, P. (2010). Prevalence and correlates of DSM-IV alcohol abuse and dependence in Australia. Addiction, 105, Begg, S., Vos, T., Barker, B., Stevenson, C., Stanley, L. and Lopez, A. D. (2007). The burden of disease and injury in Australia Canberra, Australian Institute of Health and Welfare. 10 Collins. D., & Lapsley. H. (2007). The costs of tobacco, alcohol and illicit drug use to Australian society in 2004/05. In the Department of Health and Ageing National Drug Strategy Monograph no. 64. Canberra: Author. 11 National Health and Medical Research Council. (2009). Australian Guidelines to Reduce Health Risks from Drinking Alcohol. Accessed on 18 July 2011 from: 5

9 section Given the health, economic and social burden arising from AOD use in Australia, there is an urgent need for more effective social policies to reduce the harms caused and for more effective treatments for persons who abuse alcohol or drugs, or develop addiction. AOD research can make a contribution to the development of such policies which are likely to then benefit Australian society. 3.2 Causative factors for addiction to AOD in Australia Risk factors for AOD dependence can be divided into: social and contextual factors, family factors, individual risk factors, and peer affiliations during adolescence. There are also 12, 13 genetic risk factors The major social and contextual factors affecting the likelihood of use are: drug availability, ready availability and use of tobacco and alcohol at an early age and social norms that are tolerant of alcohol or other drug use Family factors that increase the risk of illicit AOD use during adolescence are: poor quality of parent-child interaction and parent-child relationships; 15 parental conflict; 16 and parental and sibling use of alcohol or other drugs Individual risk factors include: male gender 13 ; the personality traits of high novelty seeking 18 and sensation seeking; 19 early behavioural problems, particularly oppositional behaviour and conduct disorders in childhood; and poor school performance and low commitment to education Affiliating with antisocial peers using AOD is one of the strongest predictors of adolescent alcohol and other drug use 13 and operates independently of individual and family risk 21, 13 factors. 12 Anthony. J. C. (2006). The epidemiology of cannabis dependence. In: Roffman. R. A., & Stephens. R. S. (Eds.) Cannabis dependence: Its nature, consequences and treatment (pp ). Cambridge: Cambridge University Press. 13 Fergusson. D. M., Boden. J. M., & Horwood. L. J. (2008). The developmental antecedents of illicit drug use: Evidence from a 25 year longitudinal study. Drug Alcohol Depend, 96, Lascala. E., Friesthler. B., & Gruenwald. P. J. (2005).Population ecologies of drug use, drinking and related problems. In Stockwell. T., Gruenwald. P., Toumbourou. J., & Loxley. W. (Eds.) Preventing harmful substance use: The evidence base for policy and practice. Chichester: John Wiley & Sons. 15 Cohen. D. A., Richardson. J., & LaBree. L. (1994). Parenting behaviors and the onset of smoking and alcohol use: A longitudinal study. Pediatrics, 94, Fergusson. D. M., Horwood. L. J., & Lynskey. M.T. (1994). Parental separation, adolescent psychopathology, and problem behaviors. Journal of the American Academy of Child and Adolescent Psychiatry, 33(8), , discussion Lynskey. M. T., Fergusson. D. M., & Horwood. L. J. (1994). The effect of parental alcohol problems on rates of adolescent psychiatric disorders. Addiction, 89(10), Cannon. D. S., Clark. L. A., Leeka, J. K., & Keefe, C. K. (1993). A reanalysis of the Tridimensional Personality Questionnaire (TPQ) and its relation to Cloninger s Type 2 alcoholism. Psychological Assessment 5, Lipkus. I. M., Barefoot. J. C., Williams. R. B., & Siegler. I. C. (1994). Personality measures as predictors of smoking initiation and cessation in the UNC Alumni Heart Study. Journal of Health Psychology, 13(2), Lynskey. M., & Hall. W. (2000). The effects of adolescent cannabis use on educational attainment: A review. Addiction, 95(11), Hawkins. J., Catalano. R., & Miller. J. (1992). Risk and protective factors for alcohol and other drug problems in adolescence and early adulthood: Implications for substance abuse prevention. Psychological Bulletin, 112,

10 section Exposure to these risk factors is often correlated. Young people who initiate substance use at an early age have: often been exposed to multiple social and family disadvantages; come from families with problems and a history of parental substance use; are impulsive; and have performed poorly at school where they affiliated with delinquent peers. Young people who have more of these risk factors are at highest risk of starting alcohol, tobacco and illicit drug use at an early age and of developing problems 13 Prospective studies in high-income countries have consistently found that early onset AOD use, and mental health problems, are risk factors for later dependent use Genetic Factors Familial studies consistently show that addiction runs in families and twin studies find that addiction is among the most heritable of the complex psychiatric disorders 23 despite the facts that an individual must engage in AOD use for the genetic predisposition to be expressed. Evidence from twin and adoption studies suggest that 40 60% of the risk of developing addiction is due to genetic factors Genes may affect: the way in which individuals respond to particular substances (e.g. drug metabolism, absorption and excretion, and activity or sensitivity to AOD); behavioural traits that influence an individual s willingness to try AOD (e.g. risk-taking behaviour, impulsivity, novelty-seeking); or the likelihood of developing problem use or dependence if a person uses AOD (e.g. how rewarding they find the effects). 25 Genetic predispositions to addiction can make some individuals more likely to find the acute effects of alcohol or other drugs rewarding and other individuals more or less susceptible to developing an addiction Despite the strong evidence of genetic contributions to addiction vulnerability, attempts to reliably identify specific addiction susceptibility genes have been disappointing to date. Large scale linkage and association studies have identified numerous promising genes that confer vulnerability to addiction 26, 27 but until recently, few of these alleles have been consistently replicated, and many of the associations only predict a modest increase in the risk of addiction. 28, 24 This indicates that addiction is a complex disorder in which there are likely to be many genes associated with addiction risk, most of which make a small individual contribution to risk. 26, 29, 30 Moreover, the effects of these genetic profiles will depend on environmental cues and triggers, such as stress, opportunity to use different AOD, and peer and parental AOD use. 22 Toumbourou. J., Stockwell. T., Neighbors. C., Marlatt. G., Sturge. J., & Rehm. J. (2007). Interventions to reduce harm associated with adolescent substance use. Lancet, 369, Goldman. D., Oroszi. G., & Ducci. F. (2005). The genetics of addictions: uncovering the genes. Nature Reviews Genetics, 6, Li. M. D., & Burmeister. M. (2009). New insights into the genetics of addiction. Nature Reviews Genetics, 10, Rhee. S. H., Hewitt. J. K., Young. S. E., Corley. R. P., Crowley. T. J., & Stallings. M. C. (2003). Genetic and environmental influences on substance initiation, use, and problem use in adolescents. Archives of General Psychiatry, 60, Ball. D. (2008). Addiction science and its genetics. Addiction, 103, Tyndale. R. F. (2003). Genetics of alcohol and tobacco use in humans. Annals of Medicine, 35, Ball. D., Pembrey. M. & Stevens. D. (2007). Genomics. In Nutt. D., Robbins. T., Stimson. G., Ince. M., & Jackson. A (Eds.) Drugs and the Future: Brain Science, Addiction and Society (pp ). London: Academic Press. 29 Hall. W., Gartner. C. E., & Carter. A. (2008). The genetics of nicotine addiction liability: ethical and social policy implications. Addiction, 103, Khoury. M. J., Yang. Q. H., Gwinn. M., Little. J., & Dana Flanders. W. (2004). An epidemiologic assessment of genomic profiling for measuring susceptibility to common diseases and targeting interventions. Genetics in Medicine, 6,

11 section 4 Section 4 A Taxonomy of the Types of Research Undertaken on Alcohol and Other Drugs A taxonomy of the types of research undertaken on alcohol and other drugs The diversity of AOD research reflects the diversity of disciplines with an interest in the topic. The following taxonomies of AOD research are intended to convey the variety of types of research that may be undertaken: it is not an exhaustive list. 4.1 The four domains of epidemiological and social science research Hando et al (1999) classified epidemiological and social science research on illicit drugs in Australia into four domains. These categories, listed below, could also be generalised to cover similar research on alcohol and other drugs (AOD). 31 a. Epidemiological and social science studies of prevalence and patterns of different types of drug use in the Australian population as a whole and within special populations e.g. high school students, youth, women, indigenous people, homeless people, injectors, prisoners. These studies can use a variety of different research methods that include quantitative household surveys and school surveys; qualitative interviews with drug users; and ethnographic studies of alcohol and other drug users. b. Epidemiological and social research on psychosocial and contextual risk factors for drug use e.g. age, social setting, personality traits, genetic vulnerability to addiction, other psychiatric disorders. These studies may also use a variety of methods that may include: ethnographic studies; cross-sectional surveys; and longitudinal studies of cohorts of young people. c. Epidemiological and social research on the prevalence and risk factors for drug-related harm, including premature mortality (e.g. from overdoses or blood borne infectious diseases) and morbidity (e.g. infections, ambulance attendances or hospitalisations for drug overdoses). These studies may also use a variety of methods such as: ethnographic studies; cross-sectional surveys; longitudinal studies of cohorts of young people; toxicological studies of drug-related deaths; and studies of hospital morbidity among drug users. d. Evaluations of interventions that are intended to reduce drug-related harms. These include: primary prevention (e.g. school based education and mass media campaigns to discourage drug use): secondary prevention (e.g. early intervention with risky drug users to encourage desistance or the adoption of less risky forms of drug use); and tertiary interventions that include harm reduction interventions (e.g. needle and syringe programs, injecting centres) and interventions to treat addiction (e.g. clinical trials of new pharmacotherapies, and diversion of addicted offenders into treatment). 31 Hando. J., Hall. W., Rutter. S., & Dolan. K (1999). Current state of research on illicit drugs in Australia : an information document. Readings in virtual research ethics. Issues and controversies (pp ). Canberra, ACT Australia: National Health and Medical Research Council. 8

12 section The neurobiological basis of drug effects and of addictive or problem patterns of alcohol and other drug use Over the past decade research on the neurobiological basis of drug effects and of addictive or problem patterns of AOD use has integrated several approaches: a. Animal models of drug use and addictive behavior have enabled researchers to identify the neural circuitry on which addictive drugs act and the brain mechanisms underlying reward and learning. b. Human neuropathology the genetic, molecular and cellular studies of human brain tissue and cell cultures. Neuropharmacological and neuropathological approaches often involve molecular and cellular studies of post mortem neural tissues taken from individuals with an addiction. These studies enable researchers to assess the effects that chronic alcohol and other drug use has on brain chemistry and structure. c. Cognitive neuroscience the neuropsychological study of behaviour and brain function in living humans while using drugs or humans who have become addicted to alcohol and other drugs. The use of non-invasive brain imaging techniques has enabled researchers to identify structural and functional changes in the neurochemistry and neuroanatomy of addicted individuals brains in response to acute and chronic AOD use. Some neuroscientists also use cognitive and behavioural tasks to assess the effects of alcohol and other drug use on cognition, behaviour and brain functioning. d. Psychiatric genomics the genomic and molecular study of behaviour in human participants. This research allows scientists to assess the role of genetics in the acquisition and development of addiction in a human population, and to identify genes and their molecular products that may be involved in the development of addiction, or that may predict response to treatment, maintenance of abstinence or susceptibility to relapse. 4.3 Online developments in AOD settings Online methods and their effects are a topic of research in their own right, but this lies outside the scope of this paper The AOD research field is a setting where online methods are becoming increasingly common Kypri. K., & Lee. N. (2009). New technologies in the prevention and treatment of substance use problems. Drug and Alcohol Review, 28(1),

13 section Communication technologies provide new means to enhance access to and engagement of specific target groups. Examples include: mobile-phone based data collection and health promotion research; 33 Internet-based surveys; 34, 35 counselling trials; 36, 37 other online research; 38 photo/video research to engage specific target groups in research; 39 and electronic data linkage of health and other personal records. 40 It is likely these applications will continue to expand in Australia Virtual participation in online research can have a variety of forms and potential impacts. For example, recruitment and data collection can be planned or opportunistic (e.g. creating new web-sites and materials, or using existing sites that did not originate for research purposes). The collection and use of images in online research can occur through either phone, digital or laptop camera (or CCTV records). Mobile phone recruitment and data collection options are equally diverse (e.g. SMS surveys, structured palmtop questionnaires, location tracking). Online methods can fundamentally alter the nature, dynamics and potential consequences of participation Specific ethical issues in AOD research are amplified in the online context, for example, around issues such as age and legal status, cognitive capacity, reporting of illicit behaviour, health rights, risk and vulnerability. 33 Kauer. S. D., Reid. S. C., Sanci. L. A., & Patton. G. C. (2009). Investigating the utility of mobile phones for collecting data about adolescent alcohol use and related mood, stress and coping behaviours: Lessons and recommendations. Drug and Alcohol Review, 28(1), Miller. P. G., Johnston. J., McElwee. P. R., & Noble. R. (2007). A pilot study using the internet to study patterns of party drug use: processes, findings and limitations. Drug and Alcohol Review, 26, Miller. P. G., Johnston. J., Dunn. M., Fry. C. L., & Degenhardt. L. (2010). Comparing probability and nonprobability sampling methods in ecstasy research: implications for the internet as a research tool. Substance Use & Misuse, 45(3), Swan. A. J., & Tyssen. E. G. (2009). Enhancing treatment access: Evaluation of an Australian Web-based alcohol and drug counselling initiative. Drug and Alcohol Review, 28(1), Calear. A. L., Christensen. H., Mackinnon. A., Griffiths. K. M., & O Kearney. R. (2009, December). The YouthMood Project: a cluster randomized controlled trial of an online cognitive behavioral program with adolescents. Journal of Consulting and Clinical Psychology, 77(6), Barratt. M., & Lenton. S., (2010). Beyond recruitment? Participatory online research with people who use drugs. International Journal of Internet Research Ethics, 3(1), Drew. S., Duncan. R. E., & Sawyer. S. M. (2010). Visual Storytelling: A Beneficial but Challenging Method for Health Research with Young People. Qualitative Health Research, 20(12), Holman. C. D., Bass. A. J., Rosman. D. L., Smith. M. B., Semmens. J. B., Glasson. E. J., Stanley. F. J. (2008). A decade of data linkage in Western Australia: strategic design, applications and benefits of the WA data linkage system. Australian Health Review, 32(4),

14 SECTION 5 Section 5 Ethical principles Ethical principles This section discusses the ethical principles which should underpin the proposed guidance framework. It reiterates the principles at the heart of the current National Statement on Ethical Conduct in Human Research (2007) (National Statement) 3 and identifies additional principles which may be needed to complement these in AOD research. 5.1 The values of the National Statement The National Statement is intended for use by researchers, members of ethical review bodies such as HRECs, and potential research participants. Recognising that all research involving humans has ethical dimensions, and that research can give rise to important and sometimes difficult ethical questions for research participants, the National Statement sets out national standards for the ethical design, review and conduct of human research Section One of the National Statement describes the relationship between researchers and research participants as the ground on which human research is conducted, and states that the values and principles of ethical conduct help to shape that relationship as one of trust, mutual responsibility and ethical equality. (pg 11) The values and principles of ethical conduct articulated in the National Statement are: a. respect for human beings (recognising the value of human autonomy, providing protection, empowering, helping); b. research merit and integrity; c. justice (fair distribution of research benefits and burdens, and fair treatment of participants); d. beneficence (assessing risks of harm and potential benefits to participants and wider community) The values and principles of ethical conduct articulated in the National Statement, form the basis of the proposed guidance framework The National Statement acknowledges: a. that there are other values that can inform the researcher-participant relationship and research practices related to that (e.g. altruism, cultural diversity); b. the utility of other specialised ethical guidelines and codes for specific research areas; and c. the importance of appreciating context when seeking to apply agreed values and principles for ethical human research The National Statement also notes that as an ethical guideline, the values and ethical principles it contains: are not simply a set of rules. Their application should not be mechanical. It always requires, from each individual, deliberation on the values and principles, exercise of judgement, and an appreciation of context. (p13). 11

15 SECTION The National Statement and research on persons with an addiction One distinctive feature of AOD research is that participants may have an addiction. The implications of addiction appear very different depending on whether AOD use is viewed as a personal choice or as a symptom of a disease (addiction) If we adopt the first viewpoint, addiction is a powerful desire for the addictive substance and addictive behaviours are choices motivated by that desire. A very strong version of this view has been defended by some economists: Persons with addictions are rational agents who value their substance of addiction more than the other physical and social goods that they are willing to sacrifice to obtain it If we adopt the second viewpoint, addiction is the result of pathological functional and structural states of the brain that cause addictive behaviours. This viewpoint is more supportive of the widely-held belief that addictive behaviour is different in kind from most other forms of motivated behaviour If considered independently, these two views of addiction lead to very different interpretations of key ethical issues in AOD research. For example, they suggest opposite views on whether or not people with addictions are responsible for their AOD use and the problems that it may cause to themselves and others. 42 They suggest very different views of whether people with addictions can give meaningful consent to participate in research that involves receiving the alcohol or other drug of dependence. 43, 44 A balanced ethical discussion of addiction should take account of both viewpoints, recognising that the reasoning and decision processes of people with addictions are impaired in some respects and to some degree, whilst recognising that they remain in other respects rational, moral agents Due weight can be given to both the disease and the personal choice views of addiction through the key ethical concepts of person and personhood. Human beings are uniquely deserving of respect because they are persons, that is, creatures able to exercise moral agency and whose actions are appropriately subject to praise and blame. Personhood in this sense is both a description of how human beings are much of the time and an ideal of how a human being should be. There is a complex continuum between this ideal and those severely impaired human beings who have no moral responsibility for their actions. No one is a perfectly rational moral agent, and persons with an addiction may be impaired to a greater or lesser extent. 45, 46 It is important to acknowledge that there is quantitative variation in people s capacity to make decisions, with many people having problems of self-control to varying degrees at various times over activities that give them pleasure Treating autonomy as ideal exercise of personhood, or moral agency, makes it clear that autonomy is not an all or nothing matter. Moreover, some contexts are more conducive to autonomous choice than others, an idea that has been labelled relational autonomy. 47 The idea that respectful treatment of human persons involves not only recognising their 41 Becker. G. S., & Murphy. K. M. (1988). A Theory of Rational Addiction. The Journal of Political Economy, 96(4), Corrado. M. L. (1999). Addiction and Responsibility: An Introduction. Law and Philosophy, 18(6), Charland. L. C. (2002). Cynthia s Dilemma: Consenting to Heroin Prescription. American Journal of Bioethics, 2(2), Foddy. B., & Savulescu. J. (2006). Addiction and Autonomy: Can Addicted People Consent to the Prescription of their Drug of Addiction? Bioethics, 20(1), Yaffe. G. (2001). Recent Work on Addiction and Responsible Agency. Philosophy and Public Affairs, 30(2), Levy. N. (2006). Addiction, Autonomy and Ego-Depletion: A Response to Bennett Foddy and Julian Savulescu. Bioethics, 20(1), Mackenzie. C., & Stoljar. N. (Eds.) (2000). Relational Autonomy: Feminist Perspectives on Autonomy, Agency, and the Social Self. New York: Oxford University Press. 12

16 SECTION 5 autonomy, but also supporting and promoting that autonomy is recognised in the National Statement, which states that respect for human beings involves allowing scope for their capacity to make decisions (1.12) and empowering people with diminished decisionmaking capacity to whatever extent is possible (1.13). There is some discussion of what this 48, 43 means for the ethics of addiction in the bioethics literature. 5.3 The National Statement and research involving illegal activity Chapter 4.6 of the National Statement sets out ethical principles for research involving participants who may be involved in illegal activity. Research specifically designed to expose illegal activity should be approved only where the illegal activity bears on the discharge of a public responsibility or the fitness to hold public office. (p67) Research which does not have the primary purpose of exposing illegal activity may nevertheless have the effect of exposing illegal activity. In AOD research it is often predictable that research will have this effect The proper relationship between researchers and participants described in the National Statement, and the ethical principles which sustain that relationship, apply equally to research which has the effect of exposing illegal activity by participants. For instance, risks imposed on participants by the exposure of their illegal activity must be justified by the benefits arising from the research, like any other risks arising from research (4.6.2); the consent process should ensure that participants are aware of the risks to them from potential exposure of illegal activity, of the measures, if any, that will be taken to ensure their confidentiality, and of how researchers will respond to orders from government agencies or the courts for the disclosure of information about illegal activity ( ). 5.4 Community values and AOD research The National Statement frames the researcher-participant relationship as one of trust, mutual responsibility and ethical equality, informed by the values and ethical principles listed above. The National Statement also acknowledges that there are other values that can inform the researcher-participant relationship and the related research practices A key value underpinning NHMRC community engagement is the use of best available evidence and research to promote and maintain high ethical standards. The engagement process requires the identification of consumer needs and preferences for receiving information and assessing effectiveness of evidence based information sharing. 49 In general NHMRC ethics engagement relies on robust and proven approaches which take into account the values of the entire community. It is then suggested that the engagement practices be tailored around the researcher-participant relationship NHMRC recognises that there are many potential obstacles to effective researcherparticipant engagement, some of these can be mitigated through the development of effective communication skills, and tailoring the engagement to the target audience Walker. T. (2008). Giving Addicts Their Drug of Choice: The Problem of Consent. Bioethics, 22(6), National Health and Medical Research Council. (1999a). How to Prepare and Present Evidence-based Information for Consumers of Health Services: A Literature Review Summary information. Reference number: CP72. Accessed from: 50 National Health and Medical Research Council. (1999b). How to present the evidence for consumers: preparation of consumer publications. Reference number: CP66. Accessed from: publications/cp66 51 National Health and Medical Research Council. (2004). Communicating with Patients: Advice for Medical Practitioners. Reference number: E58. Accessed from: 13

17 SECTION Fry and others, 52, 53 have argued an alternative method for an applied communitarian ethics or ethics engagement approach to research in the AOD field, as a way of reframing existing power relations through clarification of stakeholder values (researcher, participants etc.). Such an approach requires community input (in this case from drug users and representative organisations) on their own values, ethics and interests (p. 457) The peak drug user representative bodies in Australia, for example Australian Injecting & Illicit Drug Users League (AIVL), NSW Users & AIDS Association s (NUAA) and Harm Reduction Victoria 55, have made similar calls for community participatory approaches informed by a commitment to consultation, engagement, reciprocity and advocacy. For example, Australia s peak drug user representative organisation, the AIVL, has promoted discussion and action on ethical issues through the development and release of a national statement on ethical issues in research into illicit drug use At the time of writing, AIVL and NUAA were undertaking a Community Ratification Pilot in NSW 57. They have proposed the establishment of a NSW Research Ethics Ratification Committee, and developed a set of criteria for assessing ethical standards for research into illicit drug use. 52 Fry. C. L., Treloar. C., & Maher. L. (2005). Ethical challenges and responses in harm reduction research: Promoting applied communitarian ethics. Drug and Alcohol Review, 24(5), Fry. C. (2007). Making values and ethics explicit: A new code of ethics for the Australian alcohol and other drug field. Canberra: Alcohol and other Drugs Council of Australia. Accessed on 18 July 2011 from: images/publications/ethics_code.pdf 54 Fry. C. L., Treloar. C., & Maher. L. (2005). Ethical challenges and responses in harm reduction research: Promoting applied communitarian ethics. Drug and Alcohol Review, 24(5), Australian Injecting & Illicit Drug Users League (AIVL); New South Wales Users and AIDS Association (NUAA); Harm Reduction Victoria (formerly VIVAIDS). 56 Australian Injecting & Illicit Drug Users League (2003). A national statement on ethical issues for research involving injecting/illicit drug users (Report). Canberra: Australian Injecting & Illicit Drug Users League. Accessed on 18 July 2011 from: 57 Australian Injecting & Illicit Drug Users League (2010) AIVL update: Research and Policy, accessed on 26 October 2011 from: (issue%206).pdf 14

18 Section 6 Section 6 Examples of ethical issues in Alcohol and Other Drugs research Examples of ethical issues in AOD research This section canvasses some specific issues that arise in AOD research in the light of the ethical principles identified in the preceding section. 6.1 Participant Payment in AOD Research The National Statement takes the view that it is unethical to offer incentives that will encourage participants to take risks that they would not otherwise take: It is generally appropriate to reimburse the costs to participants of taking part in research, including costs such as travel, accommodation and parking. Sometimes participants may also be paid for time involved. However, payment that is disproportionate to the time involved, or any other inducement that is likely to encourage participants to take risks, is ethically unacceptable (p20) Existing guidance on the application of this principle focuses on clinical trials. 58 Payment in research involving AOD addicted participants raises distinctive ethical and empirical questions Individuals who are experiencing withdrawal symptoms, 60 who are intoxicated, or suffering an acute drug induced psychiatric condition 61 could potentially be unduly influenced by research payments or other participatory incentives. The offer of money may serve as an undue inducement to participate because it may fund the purchase of AOD that could alleviate severe withdrawal symptoms. 62, 61 Individuals in this predicament may ignore the possibility of research risks (e.g. disclosure of illegal activity), or unfavourable demands of certain studies (e.g. intrusive questions about sensitive topics) that in other circumstances would possibly discourage participation National Health and Medical Research Council. (2009). Using the National Statement 1: Payments to participants in research, particularly clinical trials. Accessed on 18 July 2011 from: hrecs/hrecalerts.htm 59 Fry. C. L., Hall. W., Ritter. A., & Jenkinson. R. (2006). The ethics of paying drug users who participate in research: A review and practical recommendations. Journal of Empirical Research on Human Research Ethics, 1(4), Gorelick. D., Pickens. R. W., & Benkovsky. F. O. (1999). Clinical research in substance abuse: Human subjects issues. In H. A. Pincus, J. A. Lieberman, & S. Ferris (Eds.), Ethics in psychiatric research: A resource manual for human subjects protection ( pp ). Washington, DC: American Psychiatric Association. 61 Tarter. R., Mezzich. A., Hsieh. Y-C, & Parks. M. (1995). Cognitive capacities in female adolescent substance abusers: Association with severity of drug abuse. Drug and Alcohol Dependence, 39, U.S. Department of Health and Human Services. (2006). Harris. L. S. (Ed.) Problems of Drug Dependence 1995: Proceedings of the 57th Annual Scientific Meeting The College on Problems of Drug Dependence, Inc. National Institute of Drug Abuse [NIDA] Research Monograph 162, Accessed on 20 July 2011 from: drugabuse.gov/pdf/monographs/162.pdf 63 Grant. R. W., & Sugarman. J. (2004). Ethics in Human Subjects Research: Do Incentives Matter? Journal of Medicine and Philosophy, 29(6),

19 Section Similar concerns arise in the case of intoxicated research participants, about consent and vulnerability to undue influence to participate in research they may otherwise avoid. Such conditions may not be apparent at first research contact, especially to untrained or inexperienced researchers. 63, 61, In August 2009, NHMRC released a minor amendment to the National Statement, Chapter 4.5 People with a cognitive impairment, an intellectual disability or a mental illness, which deals with consent in people whose capacity to consent may be temporarily impaired Where there are concerns about participant capacity to assess the acceptability of risks and harms related to particular studies, researchers might consider options such as: 60 a. actively screening participants for withdrawal symptoms during the informed consent process; b. rescheduling research interviews to a time when the participants condition does not interfere with the persons capacity to give consent; c. withholding payment in circumstances where risk of harm to certain participants is elevated, and providing it at a later time where these concerns have passed; or d. removing monetary payments from the study design (in favour of nonmonetary payment types). 6.2 Consent in minors and parental consent There are many reasons why AOD researchers may seek to conduct research on minors to which only the minors are asked to consent. Prospective participants may not be in current contact with their parents/guardians and/or may not wish for them to be alerted to their alcohol or other drug use. This issue arises in surveys of adolescents e.g. school surveys, and in studies of vulnerable populations e.g. street youth or illicit drug using youth contacted in street settings or public places Various authors 65,66,67,68,69, 70 have argued the following in relation to the issue of obtaining consent in youth health research: a. Adolescent health research with vulnerable populations has been hampered by absolute requirements for parental consent. b. Society is increasingly recognising adolescent autonomy and decision-making capacities as evidence by the emergence of the legal concept of mature minors 71 which depends on achieved level of maturity rather than age per se. 64 National Health and Medical Research Council National Statement on Ethical Conduct in Human Research Updated Retrieved on the 26 September 2011 from: 65 Haller. D. M., Sanci. L. A., Patton. G. C., & Sawyer. S. M. (2005). Practical evidence in favor of mature-minor consent in primary care research. The Medical Journal of Australia, 8, Levine. R. J. (1995). Adolescents as research subjects without permission of their parents or guardians: ethical considerations. Journal of Adolescent Health, 17, Sanci. L., Sawyer. S., Weller. P. J., Bond. L. M., & Patton. G. C. (2004). Youth health research ethics: time for a mature minor clause? The Medical Journal of Australia, 180, Santelli. J. S., Smith Rogers. A., Rosenfeld. W. D., DuRant. R. H., Dubler. N., Morreale. M.,... Schissel. A. (2003). Guidelines for adolescent health research: a position paper of the Society for Adolescent Medicine. Journal of Adolescent Health, 33, Santelli. J. (1997). Human subjects protection and parental permission in adolescent health research. Journal of Adolescent Health, 21, United Nations Office of the High Commissioner for Human Rights (1990). Convention on the Rights of the Child [Report], Retrieved on 18 July 2011 from: 71 Gillick v West Norfolk and Wisbech Area Health Authority (1986) AC 112 (Australia.). 16

20 Section 6 c. An absolute requirement for parental consent is possibly unethical if it denies mature adolescent autonomy and poses a barrier to participation, study validity and improved health outcomes through research findings. This would deny the benefits of research to specific, high-risk groups such as homeless youth, intravenous drug users, or school truants The National Statement already recognises certain conditions under which it may be ethical to conduct research on minors to which only the minors consent: a An ethical review body may approve research to which only the young person consents if it is satisfied that he or she is mature enough to understand and consent, and not vulnerable through immaturity in ways that would warrant additional consent from a parent or guardian. (p56) b A review body may also approve research to which only the young person consents if it is satisfied that: (a) he or she is mature enough to understand the relevant information and to give consent, although vulnerable because of relative immaturity in other respects; (b) the research involves no more than low risk (see paragraph 2.1.6, page 18); (c) the research aims to benefit the category of children or young people to which this participant belongs; and (d) either: (i) the young person is estranged or separated from parents or guardian, and provision is made to protect the young person s safety, security and wellbeing in the conduct of the research (see paragraph 4.2.5). (In this case, although the child s circumstances may mean he or she is at some risk, for example because of being homeless, the research itself must still be low risk); or (ii) it would be contrary to the best interests of the young person to seek consent from the parents, and provision is made to protect the young person s safety, security and wellbeing in the conduct of the research (see paragraph 4.2.5). (p56) 6.3 Ethical issues concerning the dependants of participants Research into AOD may create risks for persons other than the direct research participants. It may also create a duty of care by the researcher to people other than participants, and require researchers to manage conflicts arising from the different interests of persons to whom the researcher has a duty of care One obvious group of persons who may be affected by AOD research are the dependants of research participants. Disclosure of illegal activity may affect not only participants but also their dependants, by, for example, exposing the participant to criminal sanctions which impair their ability to maintain the family unit Researchers may also encounter situations in which they have a duty of care to the dependants of participants, e.g. an interview revealing child abuse or neglect. They may also incur legal obligations to act to protect the dependant. These obligations may require balancing of these obligations with the researchers obligations to the participants themselves. For example, it might be argued that if discoveries of this sort can reasonably be expected to arise as a result of the study, then this should be made clear to participants during the consent process. 17

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