Studies
Introduction
This chapter aims to explore the differences in approaches used by research ethics
committees in the United Kingdom, United States of America and Australia. Utilising the legislation available to them and the current interpretations of that relevant legislation, the following chapters use a frame-work for the analysis of the case studies. The following research question will be examined in this chapter:
Has research governance affected research ethics?
With multi-national collaborations becoming more common, the question of how best to manage differing ethics requirements is a pertinent one. While this thesis does not examine the ethics of multi-national studies, the ability to compare studies from different jurisdictions is explored. This chapter will examine briefly the basis of the ethics requirements in three English-speaking countries – the United Kingdom, Australia and the United States of America. The differences in their ethical requirements are examined from a historical perspective to one of current day expectations and requirements.
Australia and the United Kingdom both have advisory approaches to ethics committees, in that; although there are statutory regulations with regard to how research can be carried out to receive funding, private research is not necessarily regulated. The United States of America has a more legislative and regulatory approach with the need for ethical review for all research which is mandated by federal legislation [17].
This chapter will consider research ethics committees and not clinical ethics committees. Research ethics committees (RECs) are more likely to be the committees that approve large scale public health studies, while clinical ethics committees are more concerned with ethical issues arising in clinical medicine [28]. For the purposes of the thesis, RECs will be taken as committees that are formed to evaluate the ethical and legal legitimacy of research
undertaken at a tertiary study institution (e.g. a University or teaching hospital). Clinical ethics committees (CECs) can be defined as predominately ad-hoc committees which
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evaluate treatment regimes in a clinical setting [26, 28]. Legally, both committees are perceived as having predominately advisory roles to researchers, clinicians or the organisations they are employed by. It is the context and structure of these research
committees, as well as the legitimacy of their standing with regards to advising on research that will be investigated in this chapter. The scope of RECs in this context is that of a
regulator/gatekeeper to research, not as an advisory body on clinical outcomes and treatments [223].
Certain aspects of the study of bioethics have a basis in regulatory law and literature. These areas, especially in genetics, end of life and reproductive technologies, have been legislated for and discussed due to the fact that they are areas for which the general public has a
perception that regulation and risk management are necessary [224]. This is primarily due to the debate that these topics generate through news reports and other media. While the public may be aware of these areas, the ethical debate about them is also shaped by the researchers and the investigations that they carry out.
Other areas that may have bioethical concern, such as university research, tend towards a more flexible interpretation with regards to legal liability and risk management. In both Australia and the United Kingdom, the imperative to present research for review by an ethics committee is not legally binding from a governmental or statutory point of view [225, 226]. In both of these countries, RECs have the job of review and oversight of research but do not in themselves have any legal standing. They do have a regulatory standing and provide ethical oversight within both the research and public communities [28, 32, 37]. The United States of America has a more legalistic, law-based system while still also having university- and research-based Ethics committees [17, 227].
Large-scale background monitoring via reporting of incidents by practitioners, which is used successfully in some aspects of public health (such as communicable diseases and disease outbreaks) is not necessarily feasible or practical with monitoring for areas such as nutrition or general health as noted by Susser [19]. From a public health perspective, and particularly from an epidemiological point of view, the current guidelines in both Australia and the United Kingdom, while adequate, can still be improved to take into account current advances in both techniques and law. These advances have included databanks, centralised reporting as well as utilisation of freely available information. As mentioned in Chapter one, many bodies and organisations supply funding with the caveat that an ethics committee approve the
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research. However, there is no requirement for self-funded research to be presented and discussed [8]. The United States, while operating under a different basis for its rules, has a more robust legal basis for the structure of its public health research [228]. While ethics committees are an accepted, and, in most cases, an integral part of the academic research process, there is no legal requirement for all research to be presented to a REC for discussion. While epidemiological work, especially in public health, may be presented to a committee for comment, it is not necessarily the type of research that raises red flags due to the fact this type of research generally uses databases and reported incidents, with the emphasis on non- invasive medical procedures. However, it is the results of those non-invasive medical procedures, and their potential to modify future research, which may generate concern in an ethics committee. It is this questioning of the outcomes and potential changes to
methodology that may result from the REC, which may affect both the implementation and interpretation of the work. This is particularly relevant where conclusions that may be reached by the REC prompt interventions that may be recommended. Changing
implementation and interpretation at the behest of RECs may change the ability to answer the questions asked.
Duty of Care
The duty of care of a researcher to a participant, whether in a clinical trial or a research study is the same. However, within a clinical trial the imperative of the researcher differs slightly. Various codes of conduct such as the EU Directive [229], or accepted best practice [230] are followed by clinicians during clinical trials. The National Cancer Institute [230] outlines very clearly when a trial should be stopped early. These instances include ―Significant and clear advantage of the tested treatment or clear evidence of no additional benefit to tested treatment.‖ While this is the case with clinical trials carried out in hospitals, participation by doctors in clinical trials of pharmaceuticals can change and influence prescribing patterns [231]. Sleight [232] notes that clinical trials have changed in both their scope and the attitude of researchers. He notes they have moved from very small sanctioned trials to large
randomised placebo control trials that may be multi-national in scope. While each country may have different requirements for a study to be undertaken, the imperative is always with the researcher to ensure the safety of the data or participants. Claudot notes that even if a study methodology is accepted in one country, it does not mean that it will be allowed in
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another due to differing expectations of research [233]. It is partially these differing expectations that will be explored in this thesis.