In 1973, Rittel and Webber coined the term ‘wicked problems’, which they viewed as pervasive in the context of social and policy planning.1 Wicked problems have 10 defining characteristics: they are not amenable to definitive formulation; it is not obvious when they have been solved; solutions are not true or false, but good or bad; there is no immediate, or ultimate, test of a solution; every implemented solution is consequential, it leaves traces that cannot be undone; there are no criteria (...) to prove that all potential solutions have been identified and considered; every wicked problem is essentially unique; every wicked problem can be considered to be a symptom of another problem; a wicked problem can be explained in numerous ways and the choice of explanation determines what will count as a solution and the actors are liable for the consequences of the actions they generate.1 One needs only a passing familiarity with the history of HIV prevention research, and with the intellectual traditions of research ethics, to appreciate that the perils and opportunities arising from proposals to conduct research with people who inject drugs in some of the most precarious social and political circumstances around the world and the challenges associated with implementing the findings satisfy Rittel's and Webber's criteria for ‘wicked problems’. HIV prevention research has contributed important new knowledge about the feasibility, efficacy or relative efficacy of various prevention strategies in a variety of contexts around the world. But the pathways and timelines for how this knowledge has contributed to improvements in public health practice and/or the establishment of policies that ensure unfettered access to appropriate healthcare services for PWID are less clear and decidedly non-linear. One account of the transition from trial to policy …. (shrink)

Medicine interacts with the social, legal and political elements of life. For example, UK homelessness leads to a reduction in life-expectancy of around 30 years.1 This issue is a daily reality for practicising clinicians. In research and research ethics, vulnerable groups, including the socially vulnerable, are frequently excluded from research. While there are good reasons for this, it can mean exclusion from benefits as well as from risks. In our feature article this month, Dawson et al make a compelling and (...) nuanced case — and a practical proposal — for designing research protocols for HIV prevention measures that allow for the inclusion of people who inject drugs without compromising their safety from a legal and social perspective as well as a medical one. Along the way, they reference some of the public health damage caused by legal and social policy. To take one example: ‘if police beatings were eliminated in Odessa, Ukraine, HIV incidence among PWID would decrease up to 19% over a 5 year period’.2 For those of us in the university sector, measuring ‘impact’ has become a major, and sometimes controversial, way that our output is judged. This paper highlights the real-world importance of research impact as well as the kinds of difficulties researchers face. A series of commentaries probe the practical proposal put forward in the paper by Dawson et al. Lavery applies Rittel and Webber’s concept of ‘wicked problems’ to the dilemmas facing researchers in this context: > Wicked problems have 10 defining characteristics: they are not amenable to definitive formulation; it is not obvious when they have been solved; solutions are not true or false, but good or bad; there is no immediate, or ultimate, test of a solution; every implemented solution is consequential, it leaves traces that cannot be undone; there …. (shrink)

In 1973, Rittel and Webber coined the term ‘wicked problems’, which they viewed as pervasive in the context of social and policy planning. 1 Wicked problems have 10 defining characteristics: they are not amenable to definitive formulation; it is not obvious when they have been solved; solutions are not true or false, but good or bad; there is no immediate, or ultimate, test of a solution; every implemented solution is consequential, it leaves traces that cannot be undone; there are no (...) criteria to prove that all potential solutions have been identified and considered; every wicked problem is essentially unique; every wicked problem can be considered to be a symptom of another problem; a wicked problem can be explained in numerous ways and the choice of explanation determines what will count as a solution and the actors are liable... (shrink)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs, 1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process. 2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV (...) as well as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the... (shrink)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs,1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process.2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV as well (...) as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the difficulty of even engaging with community members in oppressive settings, where authorities severely restrict civil liberties of PWID so that even discussing issues related to drug use and enforcement may place individuals at risk. To overcome such limitations, he appropriately suggests interviewing confidentially those who have previously been detained in closed settings as part of the community engagement process. Similarly, Wolfe observes that critical issues can be overlooked with a narrow focus on study procedures if contextual factors before, during or after a study are ignored. For example, he cites the risk of overdose for study participants who have been abstinent during a study and subsequently resume injecting when the study concludes. These kinds of risks may not be obvious …. (shrink)

Those researching HIV prevention measures for people who inject drugs face a dilemma. Regions where baseline HIV prevalence and onward transmission via injecting is sufficiently high to power HIV prevention trials are also those where repressive laws, policies and practices raise concerns about the ethics of research subject protection. Dawson et al, outlining criteria to address ethical challenges in HIV prevention research among PWID, recommend that all trial participants be offered sterile injecting equipment and urge additional strategies to limit research (...) and background risks.1 In light of ethical questions opened by recent clinical trials involving PWID, including several the authors cite favourably, these cautions are timely. Dawson et al urge weighing of costs and benefits of PWID participation in research trials as an essential part of the ethical calculus. Overdose is a particular risk in any trial that uses abstinence from opioids as a precondition for participation or as an outcome of interest, and a risk that institutional review boards and researchers frequently ignore. Given the increased likelihood of fatal overdose for those who return to injection following a period of abstinence, provision to all trial participants of naloxone—the overdose antidote …. (shrink)

In many countries around the world, people who inject drugs remain at high risk of HIV acquisition not because effective forms of prevention are unknown, nor because they find effective prevention undesirable, but because those in charge, mainly politicians but also bureaucrats, find evidence-based practice politically unacceptable. The evidence for preventive efficacy of harm reduction strategies, most prominently needle and syringe programmes but also treatment programmes such as opiate substitution, is irrefutable.1 However, political responses to drug use issues are varied (...) and complex, so the will to implement appropriate harm reduction programmes in the interests of public health remains lacking in too many jurisdictions. As a consequence, the discussion of how best, in the context of research, to reduce HIV incidence in populations of people who inject drugs but are not offered comprehensive access to known prevention strategies is—tragically—an important one. Dawson et al 2 focus on access to sterile injecting equipment and recognise that this should remain the ‘default’ standard of prevention for HIV prevention trials involving people for whom injecting drug use is the primary risk factor for HIV acquisition. ‘Standard of prevention’ means the background or minimal HIV risk reduction interventions offered to all participants in a trial, regardless of what other investigational interventions they are assigned to receive. The standard of prevention concept is grounded in the ethical principle of beneficence—that researchers and sponsors are obliged to maximise benefits and minimise risks to participants in research studies.3 …. (shrink)