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Bioethics ISSN 0269-9702 (print); 1467-8519 (online) Volume 29 Number 7 2015 pp 462–469

doi:10.1111/bioe.12143

RETHINKING INFORMED CONSENT IN RESEARCH ON HEROIN-ASSISTED TREATMENT SUSANNE UUSITALO AND BARBARA BROERS

Keywords addiction, informed consent, voluntary choice

ABSTRACT Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts’ desires for heroin, whether these are irresistible and thus pose a problem for giving consent. Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts’ false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts’ views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way.

INTRODUCTION Informed consent is an ethical and legal requirement for healthcare professionals in their interaction with patients and research subjects and is rooted in the value of autonomy.1 In a setting of standard medical research in humans, informed consent is quintessential. The Declaration of Helsinki states that in order for consent to be valid, not only does the person have to be competent to

1 P.S. Appelbaum, J.W. Berg & C.W. Lidz. Informed Consent: Legal Theory and Clinical Practice. Cary NC: Oxford University Press; 2001. p. 3.

give consent but also he must voluntarily choose to give it.2 Recent bioethical work on analysing heroin addicts3 and their competence to give voluntarily informed consent to trials in which heroin (diacetylmorphine or 2 World Medical Association (WMA). 2013. The Declaration of Helsinki – Ethical Principles for Medical Research involving Human Subjects. Fortaleza: WMA. Available at: http://www.wma.net/en/ 30publications/10policies/b3/index.html [cited 2014 Feb 19]. Also Appelbaum et al., op. cit. note 1; T.L. Beauchamp & J.F. Childress. Principles of Biomedical Ethics. New York: Oxford University Press; 2001. 3 Neither DSM-5 nor ICD-10 actually recognize ‘addiction’, but they discuss Substance use disorders or Mental or behavioural disorders due to psychoactive substance use, respectively. We would rather say

Address for correspondence: Susanne Uusitalo, University of Turku, Department of Behavioural Sciences and Philosophy, Assistentinkatu 7, University of Turku, 20014 Finland. Email: [email protected] Conflict of interest statement: No conflicts declared © 2014 John Wiley & Sons Ltd

Rethinking Informed Consent in Research on Heroin-Assisted Treatment diamorphine) is prescribed to them has focused on desires.4 The cases of intoxication and withdrawal at the time of consenting have naturally been excluded from the analyses. Some argue that since the addictive desire is compulsive, the addict cannot give consent.5 Others consider the desire a strong appetitive-like desire that may feel intense, but is generally speaking resistible like other appetites.6 Even though most of the views regard addiction as not totally unfree, they differ in whether heroin addicts can freely make an autonomous choice of participating in research on heroin-assisted treatment. There have also been considerations on informed consent and heroin addicts beyond the scope of desire.7 Tom Walker, for instance, argues that the question of heroin addicts’ giving consent depends on the research design and not on the nature of desire; asking for addicts’ consent to a research that provides the addicts with heroin in too short a time, for example, is a matter that undermines the addict’s ability to consent voluntarily. Edmund Henden argues that it should not be presumed that heroin addicts are by default competent to give voluntarily informed consent to research in which heroin is prescribed to them. He, however, argues that the question is not about the strength of the desire, as the previous discussion against addicts’ competence has assumed. In his view, it cannot be ruled out that the wider social and psychological circumstances of severe heroin addiction are likely to affect the addicts’ beliefs; they may have incorrect beliefs about the nature of the options available. This affects their motivation and undermines the voluntariness of their consent.8 ‘heroin users’ which typically covers more than ‘addicts’, but we will use ‘addiction language’ to indicate our participation in the discussion referred to in the introduction. Here ‘addicts’ refers to a limited group of users. In fact, heroin prescription trials and programmes are for a specific group of heroin users who are severely dependent on heroin and typically have a history of repeated failures in conventional abstinenceor oral opiates substitution-based treatment. E.g. M. Ferri, M. Davoli & C.A. Perucci. Heroin Maintenance Treatment for Chronic HeroinDependent Individuals: a Cochrane Systematic Review of Effectiveness. J Subst Abuse Treat 2006; 30: 63–72. 4 E.g. L.C. Charland. Cynthia’s Dilemma: Consenting to Heroin Prescription. Am J Bioeth 2002; 2(2): 37–47; B. Foddy & J. Savulescu. Addiction and Autonomy: Can Addicted People Consent to the Prescription of their Drug of Addiction? Bioethics 2006; 20(1): 1–15; N. Levy. Addiction, Autonomy and Ego-depletion: a Response to Bennett Foddy and Julian Savulescu. Bioethics 2006; 20(1): 16–20. 5 Charland op. cit. note 4; on the (in)competence of addicts see also S.E. Hyman. The Neurobiology of Addiction: Implications for Voluntary Control of Behavior. Am J Bioeth 2007; 7(1): 8–11; A.I. Leshner. Ethical Issues in Taking Neuroscience Research from Bench to Bedside. In: Glannon W, editor. Defining Right and Wrong in Brain Science: Essential Readings in Neuroethics. New York: Dana Press: 2005. p. 75–82. 6 Foddy, Savulescu op. cit. note 4; H. Pickard. The Purpose in Chronic Addiction. AJOB Neurosci 2012; 3(2): 40–49. 7 T. Walker. Giving Addicts Their Drug of Choice: the Problem of Consent. Bioethics 2008; 22(6): 314–320. 8 E. Henden. Heroin Addiction and Voluntary Choice: the Case of Informed Consent. Bioethics 2013; 27(7): 395–401.

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We argue that the bioethical discussion on informed consent and voluntariness in the context of research on heroin-assisted treatment partly rests on a flawed conceptualization of heroin addicts’ options. It seems to contain assumptions about heroin addiction that are untenable, yet it has not been questioned in previous discussions. Furthermore, we argue that careful attention should be paid to the kind of voluntariness that is applied in the context of informed consent in order to avoid implausible consequences. In what follows, we first provide an introduction to clinical research in this field and the general framework of informed consent and voluntariness. Second, we focus on the kind of options heroin addicts are assumed to have, and third, in relation to the options, we discuss a problematic account of voluntariness that has been suggested in this discussion by Henden. Even if our discussion explicitly involves Henden’s view, it serves as an exemplar of the conceptualization that is present in the preceding discussions.

INFORMED CONSENT IN RESEARCH ON HEROIN-ASSISTED TREATMENT AND VOLUNTARINESS The common assumption of heroin addicts’ options in research on heroin-assisted treatment gives us reason to look at the research designs typically used in the research.9 In Switzerland heroin-assisted treatment programmes are nowadays part of the treatment options provided to heroin users, based on the results of a randomized clinical trial and a prospective cohort study.10 There have also been trials in Germany, Spain, Canada, the Netherlands, and the UK.11 In these trials 9

Ibid: 395; Foddy, Savulescu op. cit. note 4, p. 7. See Eidgenössisches Department des Innem (EDI), Bundesamt für Gesundheit (BAG), Nationale Präventionsprogramme. Die Heroingestützte Behandlung/Behandlung mit Diacetylmorphin (HeGeBe) im Jahr 2011. Liebenfeld: Schweizerische Eidgenossenschaft; 2012; T.V. Perneger et al. A Randomised Trial of Heroin Maintenance Programme for Addicts who Fail in Conventional Drug Treatment. Br Med J 1998; 317: 13–18; and a prospective cohort study by J. Rehm et al. Feasibility, Safety, and Efficacy of Injectable Heroin Prescription for Refractory Opioid Addicts: a Follow-up Study. Lancet 2001; 358: 1417–1420. 11 German studies include C. Verthein, C. Haasen, J. Reimer. Switching from Methadone to Diamorphine – 2-year Results of the German Heroin-Assisted Treatment Trial. Subst Use Misuse 2011; 46: 980–991; C. Haasen et al. Heroin-Assisted Treatment for Opioid Dependence: Randomised Controlled Trial. Br J Psychiatry 2007; 191: 55–62; Spanish studies include: J.C. March et al. Controlled Trial of Prescribed Heroin in the Treatment of Opioid Addiction. J Subst Abuse Treat 2006; 31: 203–211; Canadian studies include: E. Oviedo-Joekes et al. Diacetylmorphine versus Methadone for the Treatment of Opioid Addiction. N Engl J Med 2009; 361(8): 777–786; Dutch studies include: W. van den Brink et al. Medical Prescription of Heroin to Treatment Resistant Heroin Addicts: Two Randomized Controlled Trials. Br Med 10

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the study participants were randomized, one treatment arm including an individualized prescription of heroin, the other arm the ‘best available’ treatment, typically oral substitution treatment. All these treatments are ‘psychosocially-assisted pharmacological treatments’ as recommended by the World Health Organization with emphasis on the psychosocial treatment.12 This kind of clinical research raises the question whether the context of informed consent in research or treatment is relevant.13 Over the decades, requiring informed consent has become applicable to research conducted ‘in the context of clinical care where benefit to the individual patient may be forthcoming while new generalizable knowledge is generated’.14 The research on heroin-assisted treatment requires informed consent from the participants.15 When comparing the two, a point of difference can be seen in the goals. In treatment, the patient and the caregiver are supposed to share a common goal: the promotion of the patient’s health. Research, instead of primarily promoting the health of the patients, focuses on the goal of producing generalizable knowledge. It may well be that there are occasions in which the protection of the generalizability of data conflicts with the maximization of the benefit to the subject.16 In the heroin prescription trials, the situation does not seem to be polarized. The general goal of the trials is to investigate an effective treatment for heroin users with severe dependence. The currently best available treatment for heroin dependence is oral substitution treatment (methadone, buprenorphine), but for a minority of patients, these J 2003; 327: 1–6; P. Blanken et al. Outcome of Long Term Heroin Assisted Treatment Offered to Chronic, Treatment-Resistant Heroin Addicts in the Netherlands. Addiction 2009; 105: 300–308; and British studies include: R.L. Hartnoll et al. Evaluation of Heroin Maintenance in Controlled Trial. Arch Gen Psychiatry 1980; 37: 877–884; J. Strang et al. Supervised Injectable Heroin or Injectable Methadone versus Optimized Oral Methadone as Treatment for Chronic Heroin Addicts in England after Persistent Failure in Orthodox Treatment (RIOTT): a Randomised Trial. Lancet 2010; 375: 1885–1895. 12 World Health Organization (WHO). Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence. Geneva: WHO; 2009. 13 Some differences in consent to research and to treatment may be explained by their different histories. In the US, for instance, consent to treatment is the product of case law, while consent to research has been developed by professional codes, statutes and administrative regulations. Appelbaum et al. op. cit. note 1, p. 249. 14 Ibid: 250. 15 Giving consent to research on heroin-assisted treatment is hardly a singular moment of time. Participation requires many choices that are being made throughout the research starting with the preliminary meetings. See Haasen et al. op. cit. note 11, p. 56. Also, since individuals always have the possibility of withdrawing from the heroin prescription programme or changing to another treatment, the reflection about their own situation is an ongoing process. E.g. HeGeBe op. cit. note 9. Of course refusal to consent or withdrawing it is a single moment. 16 Appelbaum et al. op. cit. note 1, p. 279–80.

treatments fail.17 The trials are primarily an attempt to develop a more effective treatment for them. The efficacy of the treatments in the trials can be assessed on the basis of the number of participants continuing treatment, reduction in the use of illicit substances, and improvement of health and social functioning.18 If the goals are not in conflict, there can also be a problem with the conflation of the goals; it can be a case of therapeutic misconception.19 It has been suggested that research is sometimes structured in a way that allows intermixing and confusing therapeutic and research goals. The addicts may not be clear about which aspects of their treatment are ‘standard treatment and which aspects are controlled by the research protocol’.20 The trials we studied paid special attention to the point that the participants knew, for instance, about the randomization process and their chances of having heroin prescription.21 It has been argued that the purposes of informed consent in research resemble the purposes in treatment. Informed consent is meant to protect individual autonomy by enabling the individuals to make meaningful decisions about participating in research. Providing the individuals with information about the research, the possible risks, and requirements, informed consent also functions as a means of reducing inequalities of knowledge and power between the researcher and the participant. Thoroughly informing the individual also enhances 17

E.g. Strang et al. op. cit. note 11; Blanken et al. op. cit. note 11; van der Brink et al. op. cit. note 11. Also Henden op. cit. note 8, p. 399. 18 Ferri et al. op. cit. note 3. If the trials showed that heroin prescription is a better treatment for the participants, it would be problematic to end the trial and leave the addicts with less effective options. The scope of this issue is broader than we can discuss here. However, Perneger et al. op. cit. note 10 found that 62% of the participants in the six-month waiting list (methadone arm) did not choose to switch to heroin after waiting, since they were successfully treated in the optimized methadone treatment. They reported being satisfied with their personal situation or wanting to stop injecting drugs. Also, it could be argued that the goal of promoting the health of participants who were randomized to the methadone arm was overridden by the goal of the research because they were not given the best treatment according to the research, given the context. However, this objection does not hold, as the methadone arm was given so far the best treatment: optimized methadone treatment with more psychosocial services and individualized dosing offered more than the standard methadone treatment to sort out the effect of the substance. 19 See for instance U.C. Gupta, S. Kharawala. Informed Consent in Psychiatry Clinical Research: a Conceptual Review of Issues, Challenges, and Recommendations. Perspect Clin Res 2012; 3: 8–15. 20 Appelbaum et al. op. cit. note 1, p. 271. 21 For instance, the informed consent form used in the Canadian study is a document of 19 pages. Oviedo-Joekes et al. op. cit. note 11, p. 780 also state the figures for randomization, treatment and outcomes. In any case, questions of understanding the randomization and research are important, but heroin addiction does not add any specific challenges to these considerations. We consider addicts equivalent to other groups in this respect.

© 2014 John Wiley & Sons Ltd

Rethinking Informed Consent in Research on Heroin-Assisted Treatment his abilities to make decisions that protect his (bodily) integrity insofar as there is a threat on it in lieu of the research.22 Informed consent as such does not guarantee people’s voluntariness to give it, but the regulation of obtaining informed consent recognizes the problem of voluntariness. It is typically required that the consent is valid only if it has been obtained ‘under circumstances that provide the prospective subject . . . [with] sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence’.23 This has been taken into account in the discussion on heroin trials.24 Henden taps into this, too, and argues that in order to analyse addicts’ consent, we need to have an account of voluntariness that does justice to subtleties of ‘constrained choice (e.g. coercion)’.25 His fear is that heroin addicts’ consent fails to be voluntary because their beliefs about the nature of their options may be affected by the wider social and psychological circumstances in a way that undermines voluntariness. Next, we analyse whether the conceptualization of options prevalent in the discussion is plausible, given the already conducted trials. We do this by looking at Henden’s view of addict’s options and then focus on voluntariness.

FRAMING THE OPTIONS The common options usually stated in the literature on informed consent and heroin-assisted treatment are in Henden’s terminology: (1) ‘Consent to take part in trials and obtain26 free heroin’, (2) ‘Decline and obtain heroin from the street’, (3) ‘Abstain from heroin’ and (4) ‘Consent to take part in the trials, obtain free heroin and 22

Appelbaum et al. op. cit. note 1, p.279. Highlighting the research aspect of heroin-assisted treatment programmes has been very important for societal and legal reasons. For instance in Switzerland, before the referendum of 2008, it was illegal to prescribe heroin for patients under the Swiss Narcotics Law, but in research it was allowed. J. Savary, C. Hallam & D. Bewley-Taylor. The Swiss Four Pillars Policy: an Evolution from Local Experimentation to Federal Law. The Beckley Foundation Drug Policy Programme. Briefing paper 18, 2009. p. 4; B. Somaini & P. Grob. How and Why AIDS Changed Drug Policy in Switzerland. J Public Health Policy 2012; 33(3): 317–324. 23 Appelbaum et al. op. cit. note 1, p. 265. 24 Foddy, Savulescu op. cit. note 4. 25 Henden, op. cit. note 8, p. 396, fn.7 does not, however, argue that the setting of informed consent in research on heroin-assisted treatment is a case of coercion. 26 The choice of words may mislead. Obtaining free heroin sounds as if heroin addicts merely participate in the research and are handed their preferred drug, whereas the participation in research requires strict screening and medical assessment before the heroin can be prescribed by a physician to the participant who typically uses the drug in a controlled setting only.

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continue to obtain heroin from the street’.27 The way in which these options are set out focuses on whether or not the addict has access to heroin. To begin with, this is in our view a misrepresentation of the options that addicts have and believe they have.28 The typical trials are randomized and the consent is on the possibility to have heroin-assisted treatment as opposed to methadone. Thus, the option the heroin addict faces is not directly entering a heroin-assisted treatment, but typically having a 50–50% chance of starting it.29 Furthermore, the framing of the options can also be questioned in the sense that abstinence-oriented treatment with other treatments such as oral substitution treatment are combined in the abstinence option, but heroin-assisted treatment independent of the trial is left out altogether. The trials we studied propose the best available treatment against the heroin-assisted treatment, but the framing of the options in terms of heroin/no heroin leaves the different options within the scope of treatment aside. Refusing to consent to research can also mean that the addicts will consent to treatment outside the scope of research. In at least Switzerland, the UK and the Netherlands this treatment may also be heroinassisted treatment. Also, if the abstinence option is merely limited to abstaining from heroin as substance, the options seem even more puzzling. The distinction between heroin and other opioids seems arbitrary. If the heroin addict chose to switch to some illegal opioid derivative, it would be considered to be part of the abstinence option in the same way as choosing methadone substitution programme is part of the abstinence option.30 Of course it is an empirical question whether heroin addicts consider these two equivalents, but at the same time it seems clear that we have reason to question that they do. Something else seems to be relevant here. In order to capture the reality of those addicts, we need to rethink that the options which they face might not simply be whether or not to have access to heroin in different contexts. The purpose of heroin (or other substances) seems to play a role too, that is, whether the drug is part of treatment or part of the problem the addicts try to deal with. In light of these considerations, we ask whether the prevailing framing actually does justice to the issue of informed consent to research on heroin-assisted treatment. 27

See Henden op. cit. note 8; Foddy, Savulescu op. cit. note 4. See e.g. J. Neale, S. Nettleton & L. Pickering. The Everyday Lives of Recovering Heroin Users. London: RSA; 2012. p. 20–67. 29 Also, the options seem to juxtapose abstinence from heroin with heroin-assisted treatment, but there is evidence that heroin-assisted treatment has turned out to be a step to abstinence. After engaging in heroin-assisted treatment, addicts have swopped to abstinence-oriented programmes and succeeded in them. Rehm et al., op. cit. note 11. 30 This seems to break the rule on the basis of which the other options are laid out: to use illegal drugs or not use them. 28

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The focus on heroin in the categorization of the options seems to imply that the only thing that matters is the addicts’ desire for heroin. This seems surprising, given the recent criticism on the desire-centred view of addiction. Addictive desire has been fundamental in the bioethical discussion concerning addicts’ abilities to consent to research on heroin-assisted treatment.31 Henden identifies three ways in which addictive desires have been regarded as irresistible in theoretical discussions. First, the addictive desire is a reflex-like event in which the agent is unable to prevent it. Second, the addictive desire hijacks the agent’s choice-mechanism in a way that prevents the agent from not choosing the option with heroin. Third, the irresistible desire is not addictive desire, but it is a result of a fear of withdrawal pain. As Henden nicely points out, each of these views is problematic. First, it seems clear that addictive behaviour is intentional unlike for instance a knee jerk. Second, it remains unclear why addicts would not be able to choose the option of using heroin from the street if their choicemechanism had been hijacked and harnessed to coerce the addict to give consent because of the irresistible desire for heroin. Third, similarly to the second possibility, it seems unclear why the addicts could not still choose the street as they previously have; nothing in the layout of the options in the setting of research has erased this option. Furthermore, there is evidence that addicts may intentionally undergo withdrawal to lower their tolerance.32 This is in line with the WHO’s guidelines: desire in heroin addiction is not automatically a reason to deem a person with opioid dependence incompetent to give informed consent in matters regarding wellbeing.33 Our critique on the conceptualization of the options is relevant to the question of informed consent in two ways. First, it raises the question of what kind of role the notion of wellbeing involved in the options plays in analysing the addicts’ ability to give informed consent voluntarily to research on heroin-assisted treatment; and second, how these options relate to voluntariness in giving consent.

important in providing the option of participation in the research.34 As we pointed out, the distinction between treatment and no treatment should be included in the addicts’ options because without it, the options fail to capture the reality in which the choices are made. The concerned addicts have histories of failures in traditional treatments and this can be understood as an indication that their motivation is not solely on the access to heroin but also on improving or at least changing the current state they are in. Heroin addicts might have a variety of different reasons for using heroin, ranging from self-medication to pleasure seeking,35 and obviously also for stopping using illegal heroin and participating in research on heroinassisted treatment – of course improving wellbeing is probably common, but surely not the only reason.36 In fact, it is dangerous to presume that people always choose on the basis of their own wellbeing and that they prefer options that promote this over a certain threshold. This kind of generalization may not be accurate in the medical context. Consider, for instance, a woman who is suffering from treatment-resistant aggressive cancer. She faces a decision between dying of cancer in one month or participating in research on a new treatment that has unpleasant side-effects, such as nausea. This new treatment may postpone her death by a couple of months. If she chooses not have the new treatment, she will die sooner. Her decision may depend on how she sees the situation as it affects her wellbeing; but it could also depend on an altruistic reason, i.e. whether she wants to help the clinical research, or on some other issue that for instance concerns her family. The basis of the ethics of informed consent lies in the value of individual autonomy and the principle of respect for autonomy. Heroin addicts can always choose not only whether to participate but also to opt out from research insofar as they are acknowledged self-governing agents. The generally accepted model for consenting to research or treatment in bioethics is the procedural account of 34

WELLBEING AND HEROIN USERS The trials on heroin-assisted treatment aim at finding better treatment for addicts and, as mentioned above, the results are assessed in relation to the possible changes in their wellbeing. This implies that the addicts’ wellbeing is 31 See Charland op. cit. note 4; Foddy, Savulescu op. cit. note 4; Levy op cit, note 4. This is also relevant to questions of voluntariness, as whether or not addictive desires are allegedly irresistible has been considered to be decisive in determining whether addicts can give consent voluntarily. 32 Henden op. cit. note 8, p. 397–398; for the third reply see also G. Ainslie. A Research-Based Theory of Addictive Motivation. Law Philos 2000; 19: 82. 33 WHO op. cit. note 12, p. 9.

The modern research on human beings is required to be concerned with the wellbeing of participants. World Health Organization (WHO). 2011. Standards and Operational Guidance for Ethics Review of HealthRelated Research with Human Participants. Geneva: WHO. Available at: http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf ?ua=1 [cited 2014 Jul 21]. 35 See Pickard op. cit. note 6; J. Kennett, S. Matthews & A. Snoek. Pleasure and Addiction. Front Psychiatry September 2013; (4), article 117: 1–11. 36 See C. Fry & R. Dwyer. For Love or Money? An Exploratory Study of why Injecting Drug Users Participate in Research. Addiction 2001; 96: 1319–1325; World Health Organization (WHO) & Joint United Nations Programme on HIV/AIDS (UNAIDS). 2010. Ethical Engagement of People who Inject Drugs in HIV Prevention Trials. Istanbul, Turkey: WHO & UNAIDS. Available at: http://www.unaids.org/ en/media/unaids/contentassets/documents/meetingreport/20100618 -Ethical-engagement-people-inject-drugs-HIV-prevention-trials_en.pdf [cited 2014 Aug 1].

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Rethinking Informed Consent in Research on Heroin-Assisted Treatment autonomy.37 In order to make an autonomous choice, the addict needs to be physically and psychologically competent, to have authentic desires and beliefs, and to have the power to implement these into choices.38 In a medical context, it is expected that competent patients or subjects are capable of understanding the material information, judging the information in light of their values, intending a certain outcome, and freely communicating their views to care-givers or investigators.39 If a person is not capable of doing one or more of these things, he is considered to fail to fulfil the criteria for competence. As mentioned, the strength of their desire does not make heroin addicts incompetent; but addiction is not only about desire. Henden argues that instead of irresistible desires, competence may be undermined by the beliefs the addicts hold towards the options. He elaborates that social and psychological circumstances ‘may lead many addicts to form beliefs that giving consent is the only [acceptable] option’.40 This highlights the point that heroin addiction is associated with depression, anxiety and other psychological disorders, as well as social malfunctions. Severely dependent heroin addicts typically fail to be functioning citizens.41 We agree that addiction is more than mere desires, and we too criticize the tunnel vision of this kind of desire-based view.42 However, Henden stresses that it should be presumed that vulnerable addicts cannot voluntarily give informed consent to the research until they are proven otherwise.43 37

E.g. Beauchamp, Childress op. cit. note 2. Even the critics of this view do not typically require that the consenter should make the decision in favour of wellbeing: if the requirements for autonomy are fulfilled, there is no reason to question the person’s choice, were it an option that does not promote one’s wellbeing. E.g. N.C. Manson & O. O’Neill. Rethinking Informed Consent in Bioethics. Cambridge: Cambridge University Press; 2007. 38 J. Räikkä. On the Morality of Avoiding Information. In J. Pietarinen, J. Räikkä & V. Launis editors. Genes and Morality. Amsterdam: Rodopi; 1999. p. 63–75. 39 Beauchamp, Childress op. cit. note 2, p. 71. This can be tested, for instance, with MacArthur competence assessment tool. Gupta, Kharawala op. cit. note 18, p. 10. 40 Henden op. cit. note 8, p. 399. 41 Ibid: 398. 42 We are also critical of the simplistic free-unfree distinction that seems to prevail in some philosophical literature. For criticism see Foddy, Savulescu op. cit. note 4. For the problems of conceptualizing psychopathology in binary terms see H. Pickard. Psychopathology and the Ability to Do Otherwise. Philos Phenomenol Research 2013: 1–29. Viewing addiction simply as a result of irresistible desire seems to have little ground in the actual phenomenon. 43 It should be highlighted that the vulnerability of heroin addicts does not stem from an inherent characteristic as, for instance, with infants or severely handicapped patients, but is more a consequence of using illegal heroin. As Oviedo-Joekes et al. op. cit. note 10, p. 778. state, typical health problems of heroin addicts, such as infections, concern the circumstances of injection and accidents whilst intoxicated. Also the illegal status of heroin may explain why addicts may engage in criminal activities and face other social problems. See Global Commission on Drug Policy. War on Drugs. Rio de Janeiro: Global Commission on

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There seems to be an underlying premise implying that the option involving heroin-assisted treatment is problematic. Of course, it could be that the additional option, namely the chance of participating in research on heroinassisted treatment, is considered to be a so-called constraining option. Offering this kind of option to the choice-set of the heroin addict does not promote his selfgovernance, but does the opposite. By choosing the constraining option, the agent continues to remain in the circumstances that undermine his autonomy.44 If we accept that heroin addicts’ choice to give informed consent to research on heroin-assisted treatment falls into this category, we need to have more premises about heroin addiction. This kind of view requires that heroin addiction is considered to undermine the agent’s autonomy and that it is heroin as a substance, or the agent’s dependence on that substance, that undermines autonomy. In light of evidence, however, this drugcentred view of addiction seems too narrow.45 It is true that heroin is necessary for heroin addiction, but it is far from clear that the substance per se would be the sole cause for loss of autonomy in heroin addiction. In fact, heroin prescription seems not only to work as a factor that maintains physical dependence but also provides stability in the addict’s life without major organ toxicity. In light of this latter point, heroin prescription provides a means to promote addicts’ wellbeing.46 Henden suggests that it should not be presumed that addicts with psychological issues such as anxiety and depression, as well as harsh social circumstances, are able to give informed consent voluntarily. This is because they may view the research as the only acceptable option even when it is not. Henden argues that addicts’ lack of selfefficacy may make abstinence a non-option. Since these social and psychological factors have been empirically proven to be present in the target group of research on heroin-assisted treatment, it should not be presumed that these heroin addicts can give informed consent voluntarily. We agree, of course, that if the heroin users have a mental condition which deems them incompetent to Drug Policy. 2009. Available at: http://www.globalcommissionon drugs.org/wp-content/themes/gcdp_v1/pdf/Global_Commission _Report_English.pdf [cited 2014 Mar 13]. 44 J.S. Taylor. Autonomy, Constraining Options, and Organ Sales. J Appl Philos 2002; 19(3): 278. 45 As C. Hart points out, in his autobiographical High Price: Drugs, Neuroscience and Discovering Myself. London: Penguin Books; 2013, the narrow scope of addiction research in its search for the ‘core’ problem (that is the drug itself) may hinder the promotion of drug addicts’ wellbeing by providing false assumptions about addiction. 46 E.g. Rehm et al. op. cit. note 11. Also, as heroin belongs to opioids that are used for pain relief, its toxicity and harmfulness seem to be on a different scale from, for instance, alcohol. Oviedo-Joekes et al. op. cit. note 11.

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make decisions, this should matter. In such cases, it would not be merely the problem of voluntariness, but also a problem of giving consent in light of procedural autonomy. The problem in our view is that insofar as the only option is acceptable for the addict, why would it matter that it is based on an incorrect belief when the correctness of the belief would not change the acceptability of the option? Henden answers this by saying that had the addict more belief in his self-efficacy, abstinence would become an acceptable option too. It would not, however, take away the acceptability of this other option. If the research offers addicts an option that they believe to be an acceptable option in their situation in terms of wellbeing, it does not change if the addicts suddenly think there are more acceptable options. There could be an implicit assumption that abstinence is always a better option than the treatment offered in the research. Also, we could argue that if abstinence which includes other kinds of treatments apart from heroin-assisted treatment is a non-option for addicts, because of their lack of self-efficacy, why would they then have enough self-efficacy to choose the treatment in research? We will next take a look at Henden’s account of voluntariness that, in our view, seems to be part of the problem.

VOLUNTARINESS AND RESPECT FOR AUTONOMY In Henden’s account of voluntariness,47 in order for a choice to be voluntary, one needs either to have at least two acceptable options or, if there is only one option, the agent has to choose it because he likes it so much that he would choose it even when there were other options available. So in the latter case the option needs to be chosen for a right kind of reason. The acceptability of options is here determined in terms of an objective standard of wellbeing which is not specified further. There are three different options of acceptability. The first set of options can be categorized as ‘unacceptable’. The agent strongly dislikes these options because they bring his wellbeing below a certain threshold. Second, there are options that are acceptable even though the agent does not particularly like them. The agent still holds them acceptable in the sense that the options bring one’s wellbeing over the threshold. The third set of options contains options that bring one’s wellbeing high over the threshold and the 47 Henden stresses the distinction between freedom and acting freely. On his account, freedom to act requires the principle of alternative possibilities, but ‘what matters for voluntary acting are the conditions in which the action is carried out’. Henden op. cit. note 8, p. 398. For criticism of Principle of Alternative possibilities see H.G. Frankfurt. Alternate Possibilities and Moral Responsibility. In Frankfurt HG, editor. The Importance of What We Care About. Cambridge: Cambridge University Press; 1988. p. 1–10.

agent likes them so much that he chooses the options because of that.48 The agent’s ‘liking’ of the options has a conceptual link to his wellbeing. The liking involves a substantive criterion of the importance of wellbeing over other matters. This is a strong statement in a medical context. It is one thing to say that addicts make choices in light of their wellbeing. It is another to require that the voluntariness of their choices is determined on the basis of what they believe the options’ effect on their wellbeing to be in relation to an objective standard and whether those options cross a threshold. Of course it depends on the criteria of an objective standard of wellbeing but, for instance, cases of voluntary euthanasia are hardly cases in which one chooses euthanasia for the reason that it brings one’s wellbeing to such high a level, by this objective standard, that one chooses it for that reason. Nor do people voluntarily consenting to euthanasia typically have two acceptable options available in this sense. Does this mean that their informed consent is invalid because it has been given non-voluntarily? Voluntary euthanasia would be an oxymoron. Also, if the woman with treatment-resistant cancer chose the new treatment, we would have to say that either 1) she cannot have chosen it voluntarily, as the option does not promote her wellbeing over a threshold to such high a degree that she would want to choose it because of that; or 2) in any case the she does not have two acceptable options and so cannot make a voluntary choice. It may be important that in a healthcare setting the providers of options link the acceptability of options to a threshold of wellbeing; but whether competent subjects make their decisions on the basis of wellbeing should be left to them, out of respect for their autonomy. Henden is concerned that chronic heroin addicts’ lives in ‘impoverished environments often associated with criminal activity, anxiety and high levels of risk’ have implications for voluntariness.49 He argues that these affect addicts’ decision-making. We agree. It would be strange if those factors did not play a role in the decisionmaking. In fact, we think it is probable that these kinds of issues are reasons for which some of them give consent to the trials, but not as making it a constraining option. It is far from clear that heroin-assisted treatment would keep the addict in his present autonomy-undermining circumstances. Instead of superficially seeing heroin-assisted treatment as opposite to abstinence-oriented treatment, it could be regarded as a step in promoting heroin addicts’ wellbeing which may (or may not) involve abstinence.50 48

Henden op. cit. note 8, p. 396–397. Henden op. cit. note 8, p. 399. 50 The promotion of wellbeing in the heroin-assisted treatment has been seen in terms of reduction in illicit drug use and criminal activity, improvements in physical and mental health as well as in social functioning. See T. Kerr. Science and Politics of Heroin Prescription. Lancet 2010; 375(May29): 1849–1850. Also, if it is argued that 49

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Rethinking Informed Consent in Research on Heroin-Assisted Treatment However, Henden’s worry seems to be that addicts incorrectly believe that consenting to the research is their only option; and this option does not qualify as one of the acceptable options that do not require alternatives. The reason why he argues this is because he considers it as proof that there are many addicts who have refused to participate in these kinds of trials. So he argues that either these two groups of addicts (the ones with self-efficacy to refuse the research and those without) regard the research option as not so desirable that they would choose it no matter what; or that the action of addicts with self-efficacy can safely be interpreted to indicate that the research option is merely sufficiently choiceworthy but not sufficiently attractive. In our view neither assumption is justified, given the argued evidence. The account of voluntariness Henden proposes seems too demanding. In practice, there is a considerable number of cases of informed consent which would fall outside the scope of voluntariness in medical and healthcare settings. The requirement that either the options patients have at their disposal should be acceptable (in the sense that they keep or promote their wellbeing on and over a certain threshold determined by an objective standard of wellbeing) or that there should be more than one of that kind of option, seems unrealistic. If we decided to stay with Henden’s account, major adjustments would be required to set clinical research and treatment to an ethically acceptable level in many situations. For instance, patients with treatment-resistant cancer either cannot give voluntary consent to new treatments or the actual research cannot even take place because the setting does not allow the patients have at least two acceptable options, in terms of an objective standard of wellbeing, when the options in question are not attractive enough in themselves. Also, there would be cases in which the patients’ autonomy would conflict with voluntariness when voluntariness requires agents to like the option in the sense that it is above a certain threshold of wellbeing. Decisions that rest on other issues than those of wellbeing would then be autonomous but not made voluntarily. Again, in a healthcare setting, the consequences of that kind of view seem implausible. In medical and healthcare ethics, the requirement for substantive criteria for the wellbeing of the subject in his own subjective decisionmaking seems too demanding for both the agent and the healthcare setting.

CONCLUDING REMARKS We have tried to argue that reframing the discussion on informed consent and heroin-assisted treatment is imporheroin-assisted treatment keeps the addicts dependent, it may be asked why consent to methadone or buprenorphine would not pose the same kind of problem when they do not provide the agent with freedom from dependence.

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tant for several reasons. This has been illustrated with a discussion of the commonly made categorization of the options as well as with a discussion on the voluntariness of informed consent. We have argued that describing the options in a way that does justice to the actual setting in research on heroin-assisted treatment has implications for the analysis of the voluntariness of informed consent. This discussion also seems to reveal assumptions that have not previously been questioned. In our view, the desire-centred view of heroin addiction provides too narrow a scope for discussing informed consent in this context. Also, the prevailing framing of the options and their conceptual connections still reveal some of the misconceptions of heroin addiction and addiction research in general. If the desire for the drug is not a decisive issue in informed consent, why not also question the sole focus on heroin in determining the options? Do we assume that abstinence from heroin is the only acceptable goal for promoting the wellbeing of addicts in the long run, even if it means a life-long commitment to a substitution programme? Could prescription of heroin be seen as analogous to other medication that people may need to maintain, say, healthy levels of blood pressure? Furthermore, the kind of account of voluntariness that is linked to an objective standard of wellbeing from the chooser’s point of view is simply implausible in the context of healthcare, as its consequences have too high a price.51

Acknowledgements We thank the anonymous reviewers, Andreas Albertsen, Greg Bognar, Suzanne Brissette, Yvette van der Eijk, Mauro Guarinieri, Samia Hurst, Jasper Littmann, Kristian Läksy, Michael Schaub, Helena Siipi, Minna Soini, Jukka Varelius, and Veli Virmajoki for comments, providing important background information and help in their fields of expertise. We also thank the Brocher Foundation and the Finnish Academy of Science and Letters for providing Susanne Uusitalo the resources to write the article. Susanne Uusitalo is a PhD candidate in philosophy in the Department of Behavioural Sciences and Philosophy at the University of Turku. She works on philosophical questions concerning addiction and teaches bioethics. Barbara Broers is a clinician, head of the Dependencies Unit at the Department of Community Medicine and Primary Care of the Geneva University Hospitals. She has worked in a heroin-assisted treatment programme and participated in its evaluation. 51

Henden’s account of voluntariness has been developed and argued for in the context of free market in political philosophy. E.g. S. Olsaretti. Freedom, Force and Choice: against the Right-Based Definition of Voluntariness. J Polit Philos 1998; 6(1): 75. It is far from evident that the model designed for the free market works in a healthcare setting, which seems to contain many agents who, due to their own conditions, may not be so fortunate to have two acceptable options available. The discussion to what extent the free market and healthcare resemble each other unfortunately falls outside the scope of our article.