Striving for balance between participation and protection in research involving prison populations

Introduction

Research involving prisoners has been the subject of considerable controversy over the last century, and its existence dates back to the Roman Empire. Researchers have cited prisons as almost ideal environments to conduct research with relatively stable captive populations a fact that serves to minimise many of the challenges faced by research teams in the general community. The well-known atrocities carried out by the Nazi physicians on prisoners were pivotal to changing behaviour in Europe in the mid-20th century, but extensive prisoner experimentation continued to occur in the United States for many years. On the background of increasing global public scrutiny and outrage at the treatment of prisoners, the ethical landscape has been the subject of substantial evolution over recent years. The need to protect the vulnerable in society, including those in custody, is currently viewed with paramount importance, and while such protection is fundamental, there is a risk that the most marginalised in our communities become increasingly invisible with their lack of participation in research leading others to make decisions that directly impact them, without their own voice being heard (Daley, 2015). As every person’s autonomy is valued more and more by our global society is it time that we seriously consider supporting the most vulnerable in our communities to participate in research with the same fervour that we have dedicated to protecting them of late?

The evolution of the ethical landscape

One of the fundamental codes of conduct for human research in general was born out of the acts committed by Nazi physicians against prisoners of war, the Nuremberg Code 1949. The Code is a set of 10 principles that were included in the judgment of the Nuremberg Military Tribunal with the respect for the dignity of all held has a central feature and the exclusion of incapacitated subjects, which has been viewed by many researchers and scholars latterly as too restrictive.

The Nuremberg Code served as a great starting point for the global discussion of ethical conduct in research, and in 1964, the World Medical Association adopted the Declaration of Helsinki, a broader set of guidelines drawn up by physicians with multiple subsequent revisions. This Declaration made way for the possible inclusion of individuals with decision-making difficulties, with the crucial caveat that appropriate safeguards must be adopted.

Internationally, individual countries have further explored the ethical principles to underpin research, and in Australia, the National Statement serves to provide overarching guidance to institutions, researchers, Human Research Ethics Committees and others exploring the ethics of proposed research initiatives. The first principle of the National Statement is to consider whether the research proposed has merit and once that is demonstrated the principles of respect, beneficence and justice are explored.

The ethical landscape has evolved so much over the last century, it is almost unrecognizable, and there is no desire to revisit the inhumane actions of the last century. Despite considerable ongoing efforts to provide clear guidance nuances remain, and there is no definitive correct way to conduct ethical research with vulnerable populations. The current national and international frameworks provide direction, but there are areas open to interpretation and possibilities for the tension between protecting the vulnerable in our society and supporting their participation to be further explored.

Progressive individualism, towards responsive communitarianism

Principlism is the ethical framework that has been dominant internationally over recent years with its four principles of beneficence, non-maleficence, distributive justice and autonomy providing an approach adopted by many to examine the relationship between researchers and their subjects (Cheyette, 2011). Gillon (2003) has long since argued that the principle of autonomy is the most important of the four principles, that is thinking for oneself, making decisions based on that thinking and then acting on these decisions. He justifies this position explaining that when contemplating beneficence and non-maleficence respect for autonomy is central, with individuals uniquely defining their perceptions of benefits and in turn of harms (Gillon, 2003). The final principle of justice includes the challenging discussion about the allocation of finite health resources, the crucial role that moral legislation plays and the fundamental concept of the human rights of all.

Over recent years, the importance of the rights of those most vulnerable in society have been strengthened with the Convention on the Rights of Persons with Disabilities ratified by Australia in 2008. One of the fundamental principles of the Convention is the respect of the autonomy of all, which is regardless of any disability individuals should be empowered to make decisions about their own lives. In line with this approach, there have been a number of legislative changes across the globe including the enactment of the Mental Capacity Act 2005 which seeks to empower and protect vulnerable individuals in England and Wales and the adoption of capacity based mental health legislation in a number of states across Australia.

It is on this background that an argument can be made that capacitous prisoners should be allowed to make decisions about whether they participate in research and that Human Research Ethics Committees should move away from a paternalistic protective approach and steps should be taken to enhance individuals’ capacity to make such decisions (Daley, 2015). Daley (2015) further highlights the risk of an over emphasis on the possible benefits and harms of participation without due consideration of the potential benefits and harms of not participating.

Prisoners are internationally recognised as a vulnerable group, not only because of the deprivation of their liberty and inherent reduction in autonomy, but they have high levels of mental illness and substance misuse, high levels of infectious diseases and chronic conditions, they are from lower socio-economic communities and from ethnic minority groups. Health inequity is well-recognised, even within developed countries and the World Health Organization Commission on the Social Determinants of Health challenges us to address this inequity. In order to rise to this challenge and tackle health inequity, we need to conduct ethical research involving those most disadvantaged, including those in prison. We need to empower the vulnerable to participate in research not only seeking to quantify the level of inequity, but to evaluate changes to policy and practice in an attempt to effectively tackle the inequity.

The principlist approach provides a much-needed foundation when navigating the ethical challenges faced when exploring research with vulnerable populations. The focus on individual autonomy is internationally respected and increasingly the emphasis is on the responsibility of health professionals and researchers alike to change their practice in order to maximise a vulnerable individuals’ ability to make their own decisions. The principles of non-maleficence and beneficence are intimately connected and while historically these crucial aspects have been considered in terms of an individual becoming involved in research perhaps a shift towards the additional consideration of the potential harms and benefits of an individual not participating should be adopted. In addition, the possible positive and negative outcomes should be considered not only for the vulnerable on an individual basis but recognising their important role as a representative of their community. Finally, the principle of justice highlights the need to distribute the burden and rewards of research fairly, but with the current global imperative to address the social determinants of health and reduce inequity caution needs to be taken not to exclude those who could make a significant contribution.

There is evidence that high-quality ethically conducted research in prison systems can have positive outcomes for individuals detained, staff and the wider community (Shaw and Elger, 2015). Despite this to conduct any project in a correctional setting in NSW involves seeking the approval of multiple Human Research Ethics Committees often with different interpretations of the available guidance and working within a variety of ethical frameworks. With the knowledge that increased bureaucracy is known to dissuade researchers from participating in valuable projects (Bessant, 2006) is there an unmet duty to facilitate this process and cease the inadvertent silencing of some of the most vulnerable in our community under the guise of protecting them?

Conclusion

Taking into consideration the atrocious treatment of prisoners in the name of research over the last century, the arrival at the current ethical position of research on the vulnerable only being allowed if it avoids all harm, is totally understandable. However, there is an argument that born out of a desire to protect the most marginalised in our society they have unwittingly become even less visible and their views about their treatment even less likely to be heard. While it is essential that those entrusted with the role of assessing research proposals within an ethical framework explore in depth the potential harms that an individual could be subject to as a result of participation in a project, it is crucial that this assessment is measured and is balanced against the potential harm to the person involved of not participating, both at an individual level and as a member of their broader community.

As we are called to rise to the challenge of health inequity across the globe with an emphasis on taking action to look at the social determinants of health and addressing the inequities by adopting new policies and practices and subsequently evaluating these, it is time to facilitate the participation of those most vulnerable in ethical research so that those traditionally excluded from society are central to the change process and the improvement of their circumstances. The addition of concern for the common good, as a core value when considering the ethical dilemmas presented by research proposals could assist in redressing the balance between the protection of the vulnerable at all costs and ensuring that those most oppressed are supported to participate in ethical research, as we strive to reduce health inequity for all. Only when we achieve the visibility of all sections of our society, by ensuring that no group is too difficult to access or is over protected, will we truly succeed in fulfilling the fundamental ethical principle of justice.