Ethical issues in research into alcohol and other drugs: an issues paper exploring the need for a guidance framework Essay

 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

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2 Chan, S., & Harris J. (2007). Nuffield Council on Bioethics: An ethical review of publications (p. 7). Accessed on 20

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

SECTION 1

Section 1 – Introduction
1.1

Purpose

1.1.1
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).4

1.1.2
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.

1.1.3
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.

1.1.4

Those making a submission are invited to comment on:
a. the distinctive ethical issues facing researchers and HRECs in the AOD setting; b. hether the Issues Paper identifies the most important new and emerging forms w
of AOD research;
c.  hether the values and principles put forward in Section five of the Issues Paper are w
adequate as a basis for ethical decision making in AOD research; and d. hich issues other than those specifically identified in Section six of the Issues Paper, w
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

1.2.1

This Issues Paper is confined to the Australian research, regulatory and clinical context.

1.2.2

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: http://www.nhmrc.gov.au/publications/synopses/e72syn.htm
National Health and Medical Research Council. (2007). Australian Code for the Responsible Conduct of Research. Accessed on 18 July 2011 from: http://www.nhmrc.gov.au/publications/synopses/r39syn.htm

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ETHICAL ISSUES IN RESEARCH INTO ALCOHOL AND OTHER DRUGS:

AN ISSUES PAPER EXPLORING THE NEED FOR A GUIDANCE FRAMEWORK

1

SECTION 1

1.2.3

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.

1.2.4

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.

1.2.5

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 2010-2015

1.3.1

The Issues Paper is to be understood in conjunction with the National Drug Strategy 2010-2015: A framework for action on alcohol, tobacco, and other drugs (The National Drug Strategy).1, 5

1.3.2

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.

1.3.3

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

1.4.1

Section 1: Introduction (this section) – outlines the purpose, exclusions and structure of the Issues Paper.

1.4.2

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

1.4.3

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

1.4.4

Section 4: A taxonomy of the types of research undertaken on alcohol and other drugs

1.4.5

Section 5: Ethical principles – identifies principles and values relevant to AOD research

1.4.6

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 2003- 2009. Final Report. 29th May 2009. Retrieved 18 May 2011 from: http://www.nationaldrugstrategy.gov.au/internet/drugstrategy/publishing.nsf/Content/indigenous-drug-strategy-lp .

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

SECTION 1

1.4.7

Section 7: Glossary of Terms and Phrases

1.4.8

Section 8: Selected Bibliography

1.5

Target audience

1.5.1

As noted above, the Issues Paper has been developed with particular reference to the National Statement.

1.5.2

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.

ETHICAL ISSUES IN RESEARCH INTO ALCOHOL AND OTHER DRUGS:
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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

2.1.1

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.

2.1.2

2.1.3

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

4

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.

• protection of researchers.

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

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

3.1.1

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, 8

3.1.2

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).10

3.1.3

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.11

3.1.4

The use of illicit drugs contributes around 2.0% of the total BOD9. 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.10

3.1.5

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.
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, 2085-2094. 9

Begg, S., Vos, T., Barker, B., Stevenson, C., Stanley, L. and Lopez, A. D. (2007). The burden of disease and injury in Australia 2003. 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: http://www.nhmrc.gov.au/your_health/healthy/alcohol/index.htm 7

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section 3

3.1.6

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

3.2.1

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 genetic risk factors. 12, 13

3.2.2

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.14

3.2.3

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.17

3.2.4

Individual risk factors include: male gender13; the personality traits of high novelty seeking18 and sensation seeking;19 early behavioural problems, particularly oppositional behaviour and conduct disorders in childhood; and poor school performance and low commitment to education. 20

3.2.5

Affiliating with antisocial peers using AOD is one of the strongest predictors of adolescent alcohol and other drug use13 and operates independently of individual and family risk factors.21, 13

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. 58-105). Cambridge: Cambridge University Press.
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, 167-77. 14
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, 368-75.

16
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), 1122-31, discussion 31-3.

17
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), 1277-86. 18
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, 62-66. 19

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), 149-55. 20

Lynskey. M., & Hall. W. (2000). The effects of adolescent cannabis use on educational attainment: A review. Addiction, 95(11), 1621-30.
21
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, 64-105. 13

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ETHICAL ISSUES IN RESEARCH INTO ALCOHOL AND OTHER DRUGS:
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section 3

3.2.6

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 problems13 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. 22

3.3

Genetic Factors

3.3.1

Familial studies consistently show that addiction ‘runs in families’ and twin studies find that addiction is among the most heritable of the complex psychiatric disorders23 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.24

3.3.2

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.

3.3.3

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 addiction26, 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, 1391-401.
Goldman. D., Oroszi. G., & Ducci. F. (2005). The genetics of addictions: uncovering the genes. Nature Reviews Genetics, 6, 521-532.
24
Li. M. D., & Burmeister. M. (2009). New insights into the genetics of addiction. Nature Reviews Genetics, 10, 225-231. 25
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, 1256-1264.

26
Ball. D. (2008). Addiction science and its genetics. Addiction, 103,
360-367. 27
Tyndale. R. F. (2003). Genetics of alcohol and tobacco use in humans. Annals of Medicine, 35, 94-121. 28
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. 89-132). 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, 350-359.
30
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, 38-47.

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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

4.1.1

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. 288-315). Canberra, ACT Australia: National Health and Medical Research Council.

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ETHICAL ISSUES IN RESEARCH INTO ALCOHOL AND OTHER DRUGS:
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section 4

4.2

The neurobiological basis of drug effects and of addictive or problem patterns of alcohol and other drug use

4.2.1

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
4.3.1

Online methods and their effects are a topic of research in their own right, but this lies outside the scope of this paper.

4.3.2

The AOD research field is a setting where online methods are becoming increasingly common.32

32

Kypri. K., & Lee. N. (2009). New technologies in the prevention and treatment of substance use problems.

Drug and Alcohol Review, 28(1), 1-2.

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section 4

4.3.3

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.

4.3.1

‘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.

4.3.2

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), 25-30.
34
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, 169-174. 35

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), 437-450.

36
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), 48-53. 37
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), 1021-32.

38
Barratt. M., & Lenton. S., (2010). Beyond recruitment? Participatory online
research with people who use drugs. International Journal of Internet Research Ethics, 3(1), 69-86. 39
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), 1677-88. 40
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), 766-77.

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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

5.1.1

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.

5.1.2

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).

5.1.3

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).

5.1.4

The values and principles of ethical conduct articulated in the National Statement, form the basis of the proposed guidance framework.

5.1.5

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.

5.1.6

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).

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SECTION 5

5.2

The National Statement and research on persons with an addiction

5.2.1

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).

5.2.2

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.41

5.2.3

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.

5.2.4

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.

5.2.5

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.

5.2.6

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),

675-700.
Corrado. M. L. (1999). Addiction and Responsibility: An Introduction. Law and Philosophy, 18(6), 579-588. 43
Charland. L. C. (2002). Cynthia’s Dilemma: Consenting to Heroin Prescription. American Journal of Bioethics, 2(2), 37-47.
44
Foddy. B., & Savulescu. J. (2006). Addiction and Autonomy: Can Addicted People Consent to the Prescription of their Drug of Addiction? Bioethics, 20(1), 1-15
45
Yaffe. G. (2001). Recent Work on Addiction and Responsible Agency. Philosophy and Public Affairs, 30(2), 178-221. 46
Levy. N. (2006). Addiction, Autonomy and Ego-Depletion: A Response to Bennett Foddy and Julian Savulescu. Bioethics, 20(1), 16-20.

47
Mackenzie. C., & Stoljar. N. (Eds.) (2000). Relational Autonomy: Feminist Perspectives on Autonomy, Agency, and the Social Self. New York: Oxford University Press.
42

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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 means for the ethics of addiction in the bioethics literature. 48, 43

5.3

The National Statement and research involving illegal activity

5.3.1

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).3

5.3.2

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.

5.3.3

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 (4.6.5 – 4.6.7).

5.4

Community values and AOD research

5.4.1

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.

5.4.2

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.50

5.4.3

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.51

48

Walker. T. (2008). Giving Addicts Their Drug of Choice: The Problem of Consent. Bioethics, 22(6), 314-320.

49

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: http://www.nhmrc.gov.au/guidelines/publications/cp72

50
National Health and Medical Research Council. (1999b). How to present the evidence for consumers: preparation of consumer publications. Reference number: CP66. Accessed from: http://www.nhmrc.gov.au/guidelines/ publications/cp66

51
National Health and Medical Research Council. (2004). Communicating with Patients: Advice for Medical Practitioners. Reference number: E58. Accessed from: http://www.nhmrc.gov.au/guidelines/publications/e58

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SECTION 5

5.4.1

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).54

5.4.2

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 Victoria55, 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 use56.

5.4.3

At the time of writing, AIVL and NUAA were undertaking a Community Ratification Pilot in NSW57. 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), 449–459.
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: www.adca.org.au/ 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), 449–459 55
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: http://www.aivl.org.au/files/EthiicalIssuesforResearchInvolvingUsers.pdf 57

Australian Injecting & Illicit Drug Users League (2010) AIVL update: Research and Policy, accessed on 26 October 2011 from: http://www.aivl.org.au/database/sites/default/files/AIVL%20Research%20and%20Policy%20Update%20 (issue%206).pdf

53

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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

6.1.1

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: 2.2.10 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).

6.1.2

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.59

6.1.3

Individuals who are experiencing withdrawal symptoms,60 who are intoxicated, or suffering an acute drug induced psychiatric condition61 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. 63

58

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: http://www.nhmrc.gov.au/health_ethics/ 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), 21-36. 60

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. 177–218). 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, 15-21. 62

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:
http://archives. 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), 717 – 738.

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Section 6

6.1.4

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.63, 61, 62 Such conditions may not be apparent at first research contact, especially to untrained or inexperienced researchers.

6.1.5

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.64

6.1.6

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

6.2.1

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.

6.2.2

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 2007 –

Updated 2009. Retrieved on the 26 September 2011 from: http://www.nhmrc.gov.au/guidelines/publications/e72
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, 439. 66
Levine. R. J. (1995). Adolescents as research subjects without permission of their parents or guardians: ethical considerations. Journal of Adolescent Health, 17, 2878-297.
67
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, 336-338. 68
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, 396-409.

69
Santelli. J. (1997). Human subjects protection and parental permission in adolescent health research. Journal of Adolescent Health, 21, 384-387.
70
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: http://www2.ohchr.org/english/law/crc.htm 71

Gillick v West Norfolk and Wisbech Area Health Authority (1986) AC 112 (Australia.). 65

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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.

6.2.3

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. 4.2.8 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. 4.2.9 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

6.3.1

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.

6.3.2

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.

6.3.3

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.

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Section 6

6.4

Online methods in recruitment and data-collection

6.4.1

In the past decade a new online specialty area has emerged. The National Statement was published before the ethical issues raised by these developments became apparent so it currently provides no specific guidance for Internet-based or other forms of online research. International evidence has already emerged of researcher, health professional and ethics committee confusion around the ethical challenges posed by new online methods.72 Some have warned that the current lack of ethical guidelines and knowledge in this area has the potential to “result in researchers acting with less consideration, and even behaving unethically towards their study subjects”.73

6.4.2

Online methods pose new ethical challenges because these new forms of research and practice are significantly different from traditional means of target group access, data collection and analysis, and data use.

6.4.3

Ethical issues still being debated in relation to online methods include:72, 74,75 a.consent requirements for online and mobile phone research; b.child
and adolescent risk considerations in open-recruitment web-surveys, and intervention/treatment trials with online or mobile phone methods; c.confidentiality in virtual spaces; and

d.duty of care in anonymous online intervention trials and research with vulnerable groups.

6.5

Contingency management payments

6.5.1

The treatment of payment to participants in the National Statement is primarily concerned with compensation offered for participation in clinical trials (NS 2.2.10 – 2.2.11 and the related guidance document).59 However, an emerging form of social science research with direct application to AOD involves trials of treatment protocols which seek to modify behaviour through financial incentives for engaging in healthy behaviour e.g. not using alcohol or other drugs.76

6.5.2

The primary role of incentives in these trials is different from that of incentives for research participation per se. Rather than incentivising participation in an activity which may involve risks of harm, they incentivise beneficial behaviour. Nevertheless, any financial contingency may also act as an inducement to participate in the research.

72

Buchanan. E. A., & Hvizdak. E. E. (2009). Online survey tools: Ethical and methodological concerns of human

research ethics committees. Journal of Empirical Research on Human Research
Ethics, 4(2), 37-48. Bober. MC (2004) Virtual youth research: an explanation of methodologies and ethical dilemmas from a British perspective. In E.A Buchanan (Ed.), Readings in virtual research ethics. Issues and controversies (pp. 288-315. London: Information Science Publishing.

74 Spriggs. M. (2009, December) Consent in cyberspace: Internet-based research involving young people. Monash Bioethics Review, 28(4), 32.1-15.
75 Spriggs. M. (2010) Ethical difficulties with consent in research involvingn children: Findings from key informant interviews. The American Journal of Bioethics Primary Research, 1 (1), 34-43. 76

Marteau. T., Ashcroft. R., & Oliver. A. (2009, April). Using financial incentives to achieve healthy behaviour. British Medical Journal, 338, 983-985.
73

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Section 6

6.6

Legal risks of research for participants and researchers

6.6.1

Use of some drugs is a criminal offence and AOD use is often linked to other forms of criminal behaviour. AOD research may expose participants to very substantial legal risks if identifiable data becomes available to the authorities. It may also impose substantial legal obligations on researchers who acquire knowledge of criminal activity, or who are responsible for storing data about such activity. Failure to understand and act on these
obligations may place researchers at risk of prosecution. The legal issues which researchers need to be aware of in order to design and conduct research ethically are complex and vary between jurisdictions. 77,78,79

6.6.2

The proposed guidance framework would develop more detailed guidance on the application to AOD research of the National Statement’s approach to research involving illegal activities (see 5.3 of this paper). Issues to be discussed might include: a. the range of legal obligations which researchers may need to take account of in designing research;

b.measures that can be taken in research design to minimise legal risk (e.g. managing identifiability of data);
c. whether there are circumstances in which it would be unethical to conduct research because of the legal consequences that may result; and
d.consent processes which adequately communicate complex legal risks to participants, especially those from vulnerable groups.

6.7

Protection of researchers

6.7.1

Some forms of AOD research impose substantial risks on researchers, as they involve close contact with participants under the influence of alcohol or other drugs, experiencing withdrawal, or experiencing drug-induced psychoses. Moreover, topics of enquiry in AOD are often sensitive and may cause feelings of anxiety and discomfort for participants. Interviews with illicit drug users may also occur in settings that are potentially dangerous for researchers: in order to protect participant confidentiality in face-to-face surveys in the field, illicit drug users are often interviewed in settings out of the public gaze.

6.7.2

Other safety issues concern the level of interviewer support, back-up and training; protocols for responding to crises that may require confidentiality to be broken (for example, suicide risks); and carrying valuable personal and research items such as a laptop, mobile telephone or cash.

77 Fitzgerald.

J., & Hamilton. M. (1996). Confidentiality, disseminated regulation and ethico-legal liabilities in research with hidden populations of illicit drug users. Addiction, 92, 1099-1107. 78 Loxley. W., Hawks. D., & Bevan. J. (1996). Protecting the interests of participants in research into illicit drug use: two case studies. Addiction, 92, 1081-1085.

79 Lawlor. D. A., & Stone. T. (2001). Public health and data protection: an inevitable collision or potential for a meeting of minds? International Journal of Epidemiology, 30, 1221-1225.

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Section 7

Section 7 – Glossary of Terms and Phrases
7.1

Glossary of terms and phrases

7.1.1

The glossary has been prepared in conjunction with the Alcohol and other
Drugs Council of Australia’s publication Tips and tricks for new players…a guide to becoming familiar with the alcohol and other drugs sector80 and EMCDDA Monographs: Addiction neurobiology: Ethical and social Implications.81

7.1.2

It contains only key terms, acronyms and definitions used in the paper. The details are not exhaustive, neither do they address every issue that may arise. Readers are encouraged to seek further assistance from appropriate resources if they decide that they need them in their particular circumstance/s.

7.1.3

Whilst the National Health and Medical Research Council has taken every care to provide accurate and up to date information, readers are advised to confirm resources and weblinks.

7.2

Addiction
The repetitive engagement in the use of alcohol or other drugs despite the negative consequences that it causes. Addiction usually involves intense craving for the alcohol or other drug/s and an impaired ability to control use. These aspects of addiction are sometimes referred to as psychological dependence. Addiction also often involves the development of tolerance towards the AOD of abuse, and symptoms of withdrawal upon cessation of use. This is often referred to as physical dependence.81, 82

7.3

Co-morbid
Comorbidity is when a person has one or more substance use problems and one or more mental health problems at the same time. It is sometimes called ‘dual diagnosis’. 81

7.4

Dependence
Dependence is when a person has a strong desire to use a drug or drugs and finds it very difficult to control their use despite the harmful effects that using the drug/s is having on their life. Dependence on a drug may have physical and/or psychological elements as the body and/or the mind adapt to the drug.82

80

Alcohol and other Drugs Council of Australia. (2011). Tips and tricks for new players….a guide to becoming

familiar with the alcohol and other drugs sector (3rd ed.). Accessed 30 May 2011 from: http://www.adca.org.au/ content/view/37/64/
81
Carter. A., Capps. B., & Hall. W. (2009). EMCDDA Monographs: Addiction neurobiology: Ethical and social Implications. Portugal: European Monitoring Centre for Drugs and Drug Addiction. 82
ADCA: Alcohol and other Drugs Council of Australia. Tips and tricks for new players: A guide to becoming familiar with the alcohol and other drugs sector. 3rd ed. 2011. Alcohol and Other Drugs Council of Australia. Accessed 22 September 2011 from http://adca.org.au/ndsis/uploaded_files/fck/file/Tips%20and%20Tricks%20 3rd%20ed_.pdf

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7.5

Online research
The use of electronic health information systems to conduct research, including but not restricted to:
• Internet and mobile phone research
• Open-recruitment web-surveys
• Anonymous intervention trials.

7.6

Harm Minimisation
Harm minimisation initiatives encompass a range of policies and programs that aim to reduce AOD-related harm. They include strategies that prevent anticipated harms as well as those that reduce actual harms. Harm minimisation is consistent with a comprehensive approach to AOD related harm, involving a balance between the three core elements of demand reduction, supply reduction and harm reduction.81, 83

7.7

Illegal substance
A drug whose production, sale or possession is prohibited. For examples: marijuana, heroin, and cocaine84.

7.8

Intoxication
A person is said to be intoxicated when they have taken a quantity of a substance that exceeds their tolerance, and behavioural or physical changes occur. • Intoxication refers to any alteration of physiological processes by a psychoactive • drug, and not just the substantial impairment of awareness normally associated • with the term “intoxicated”.85

7.9

Legal substance
A drug whose production, sale or possession is not prohibited. For examples: Alcohol and tobacco.85

7.10 Researchers
A person or persons who undertake investigations to gain knowledge and understanding, or to train other researchers.

7.11 Withdrawal
Withdrawal is the process of stopping or reducing use of a drug or drugs, especially after heavy use or use over a long period. Withdrawal can also refer to a range of physical and psychological symptoms experienced when a person ceases or reduces their drug use, as the body adjusts to functioning either without the drug or with less of the drug. This is also called withdrawal syndrome, withdrawal symptoms or withdrawal effects.81 of Health and Ageing. (2011). National Drug Strategy 2010–2015:A framework for action on alcohol, tobacco and other drugs [Report]. ISBN: 978-1-74241-406-5. Canberra: Author. 84 National Centre for Education and Training on Addiction (NCETA). Consortium. (2004), Alcohol and Other Drugs: A Handbook for Health Professionals. Australian Government: Department of Health and Ageing 85

Rickwood. D., Crowley. M., Dyer. K., Magor-Blatch. L., Melrose. J., Mentha. H., & Ryder. D. (2005) Perspectives on Psychology: Substance use. Australian Psychological Society, Melbourne. Accessed 22 September 2011 from: http:// www.psychology.org.au/Assets/Files/perspectives_substance_use[1].pdf 83 Department

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Section 8

Section 8 – Selected Bibliography
Selected Bibliography
Alcohol and other Drugs Council of Australia. (2011). Tips and tricks for new players….a guide to becoming familiar with the alcohol and other drugs sector (3rd ed.). Accessed 30 May 2011 from: http://www.adca.org.au/content/view/37/64/

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. 58-105). Cambridge: Cambridge University Press.

Australian Government Department of Health and Ageing. (2009). Evaluation of the Aboriginal and Torres Strait Islander Peoples Complementary Action Plan 2003- 2009. Final Report. 29th May 2009. Accessed 18 May 2011 from: http://www.nationaldrugstrategy.gov.au/internet/drugstrategy/ publishing.nsf/Content/indigenous-drug-strategy-lp

Australian Institute of Health and Welfare. (2007). National Drug Strategy Household Survey: detailed findings. In Australian Institute of Health and Welfare Report (2008). No.: PHE 107. Canberra: Author.

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26

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

appendix 1

APPENDIX 1: Role of AHEC and membership of
the expert Advisory Group
The statutory functions of the Australian Health Ethics Committee (AHEC) includes providing advice, or preparing guidelines, about ethical issues in
health. The National Health and Medical Research Council Act 1992 stipulates the diverse composition of AHEC and the necessity for public consultation in the development of guidelines. AHEC therefore understands that it is the will of the Parliament that AHEC seeks to prepare advice and guidelines that reflect and to some extent define the values of the Australian community.

Membership of the Advisory Group
Name

Membership category and relevant experience

Dr Sandra
Hacker, AO

Australian Health Ethics Committee, Chair, 2009-2012 triennium

Professor Paul
Griffiths

Australian Health Ethics Committee, Member, 2006-2009 and 2009-2012 triennia

Professor
Clifford
Hughes, AM

Australian Health Ethics Committee, Member, 2009-2012 triennium

Professor
Helen Milroy

Australian Health Ethics Committee, Member, 2009-2012 triennium Australian Aboriginal and Torres Strait Islander Health Advisory Committee, Member in common with AHEC, 2009-2012 triennium

Professor

Wayne Hall

NHMRC Australia Fellow – advisor to the Advisory Group, 2010-2012

Associate
Professor Craig
Fry

NHMRC Career Development Fellow (2011-14) – advisor to the Advisory Group, 2011 – 2012.

ETHICAL ISSUES IN RESEARCH INTO ALCOHOL AND OTHER DRUGS:
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Appendix 2

APPENDIX 2: Terms of reference for Advisory
Group of AHEC
In relation to the ethical considerations of research into alcohol and other drugs, the Advisory Group will:
1. Identify gaps in the National Statement
2. a. Conduct a critical evaluation of the relevant literature b. Evaluate potential emerging issues
3. Prepare an Issues Paper for public consultation
4. Based on the public consultation, develop a guidance document for AHEC.

28

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

APPENDIX 1
APPENDIX 3

APPENDIX 1: Role of AHEC and membership of
APPENDIX 3: Advisory Group Recommendations
the expert Advisory Group
These recommendations were noted by the Australian Health Ethics Committee in May 2012. They werestatutory functions of the Australian after consideration of the (AHEC) includes providing The developed by the Advisory Group Health Ethics Committee submissions to the public consultation to help inform guidelines, about ethical issues in health. The National Health and Medical advice, or preparing the development of future ethical guidance. Research Council Act 1992 stipulates the diverse composition of AHEC and the necessity for public The Advisory the development of to AHEC AHEC national understands that it research of the consultation inGroup recommendedguidelines.that no thereforeguidance specific to is the willconcerning alcohol AHEC seeks to prepare advice and guidelines recommended that some extent define Parliament that and other drugs is required. However, it was that reflect and to during revision of the National Statement on the Ethical Conduct in Human Research (2007) consideration be given to the values of the Australian community.

providing ethical guidance on the following issues which can arise in various types of research: Membership of the Advisory Group
1. Online Research Methods – It is recommended that additional ethical guidance be developed Name and incorporated into the existing and relevant experience issues raised by online Membership category framework to address the

research methods (including research undertaken on mobile phones). Dr Sandra
Australian Health Ethics Committee, Chair, 2009-2012 triennium Hacker, AO
2. Contingency Management Payments – Further guidance is recommended for research which Paul
Professor studies the impacts Health Ethics Committee, Member, 2006-2009 and 2009-2012 triennia Australian of contingency management payments as this type of research invariably involves payments to research participants some of whom may be asked to take risks. Griffiths

Professor
Australian Health Ethics Committee, Member, consent – Further guidance is 3. Research on minors to which only minors are asked to 2009-2012 triennium Clifford
recommended on the conditions under which this may be regarded as ethical when conducting Hughes, AM
research using social science methods.
Professor
Australian recommended that additional ethical guidance on this Australian 4. Researcher Safety – It isHealth Ethics Committee, Member, 2009-2012 trienniumissue be proHelen Milroy Aboriginal and Torres Strait Islander Health Advisory Committee, Member in vided within the existing framework. Consideration should be given to factors such as training common with AHEC, 2009-2012 triennium

for researchers, the psychological impact on researchers of situations they encounter in their Professor and guidance to enable Fellow –Researchto the Advisory Group, 2010-2012the level of NHMRC Australia Human advisor Ethics Committees to determine research,

Wayne of a project to researchers.
risk Hall
Associate
NHMRC Career social implications of the research – to the Advisory 5. Obligations arising from theDevelopment Fellow (2011-14) – advisor Further guidance is Professor Craig on ethical obligations arising from interactions which occur as a consequence of recommended Group, 2011 – 2012.

Fry
conducting research, especially in relation to:
• legal and ethical issues concerning the dependants of participants, and • ethical obligations arising from the conduct of research on communities where historical, cultural, minority status or other factors require greater consideration to avoid unintended consequences or where there is no
perceived benefit gained by the community itself.

6. Responsibilities of institutions – Consideration should be given to broadening the guidance provided on the responsibilities of institutions within any upcoming review of the National Statement.

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

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