Ethical Principles

Based on a review of key internationally accepted bioethics documents, the BAC formulated five guiding principles, reflecting their local application. The five principles endorsed by the BAC are as follows:

Respect for persons

Individuals are to be respected as human beings and treated accordingly. This includes respecting their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC refers to as autonomy. Their welfare and interests are to be protected, especially when their autonomy is impaired or lacking. This principle mandates the need for informed consent to participation in research, respect for privacy, safeguarding confidentiality, and minimising harm to research participants. It also requires a proper regard for religious and cultural diversity.

This principle integrates with many other aspects of life in societies that could be described as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical). Ideals such as all citizens being equal under the law, or having rights to privacy and the management of their affairs, to the enjoyment of security and public health and safety, with rights over their own bodies, and many others, all, in the last analysis, come down to the principle that individuals should be accorded certain basic rights or entitlements arising from their existence in society. These entitlements exist notwithstanding individual differences in endowment of race, character, gender or talent, and without requirement that individuals justify them. However, an individual’s autonomy can be curtailed under certain circumstances, for public good, such as when quarantined in disease epidemics.

Solidarity

The BAC earlier advocated a principle of reciprocity between the individual and wider society, as a way to capture the well-established idea that there is some measure of mutual obligation that regulates the relationship between the two. However, the underlying principle is perhaps better expressed as solidarity. The essential principle is not one of individual exchange, but of a wider vision in which common interest is invoked as a reason for the subordination of individual interest to that of a group in specified circumstances. Solidarity reflects the importance of general altruism as a basis for participation in biomedical research.

In biomedical research, agreed social benefits – considered as a public good – carry an implication that, if accepted, they inherently reflect an in-principle willingness to consider participation in research of the kind yielding the accepted benefits. This means that there is a balance to be struck between the interests of the public and the rights of individual participants; and that incompatible and irreconcilable ethical perspectives should be resolved with some regard to the public interest. The BAC is therefore of the view that respect for individuals can be subordinate to the public interest, but only in certain minimal risk research, typically public health and epidemiological research, based on the principle of solidarity.

Justice

The concept of justice as applied to research includes the general principle of fairness and equality under the law. This implies that access to the benefits of research, and the burden of supporting it, should be equitably shared in society. It should not, for example, be considered ethical to exempt a class of otherwise suitable patients from participation in research by virtue of economic status. The concept of justice also implies that researchers and their institutions incur some responsibility for the welfare of participants and their compensation and treatment in the event of adverse outcomes arising directly from their participation. It mandates careful consideration of the arrangements in place for ancillary care or follow-up in the case of research participants located in regions that may be resource-poor relative to the initiating country. Moreover, in the event research yields an immediate benefit that could apply to one of the participants in the research, justice would dictate that the benefit be offered.

Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any society, both justifying and implementing a specific conception of justice is difficult, since research may entail compromises between competing interests. What different parties in a disagreement see as fair may depend upon widely different assumptions.

Proportionality

The regulation of research should be in proportion to the possible threats to autonomy, individual welfare, or public good. Proportionality is fundamental to the administration of any system of regulation or governance, not just in bioethics or research, and has legal standing as such. A robust formulation of the principle is that interference with individuals should not exceed what is needed to achieve necessary regulation. It appeals to moderation and good sense in the determination of prohibited actions and the avoidance of micro-management and over-determination. The risk in any acceptable programme of research, and the strictness of its regulation, should not be disproportional to any anticipated benefits. Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical decisions, which is in any case often impracticable in multicultural contexts.

Sustainability

The research process should be sustainable, in the sense that it should not jeopardise or prejudice the welfare of later generations. For example, research leading to permanent change to the human genome might not be considered ethical, even if immediately beneficial, on the grounds that the long term implications are unforeseeable and could possibly be harmful.

The wider idea of sustainability has become an important aspect of contemporary thinking with increasing realisation of the finite nature of the earth and consequent need for thought regarding its sustainability and general viability. There may be debates over such things as the nature or extent of global climate change and the reserves of natural resources, but few would deny the need to consider these issues in terms of a responsibility to the future. The principle may be taken narrowly as relating to the welfare of humans in the future, which is the sense in which it is perhaps most relevant to biomedical research, but it can also be taken broadly in the field of bioethics, where it supports arguments for the conservation of nature and the minimisation of resource depletion for the good of the planet as a whole.

Other considerations

Beneficence

It may be noted that beneficence is not listed explicitly among the BAC’s principles, though it is mentioned in some jurisdictions.This is because beneficence (together with non-maleficence or the principle of ‘do no harm’) finds its main expression in medical treatment, deriving from the Hippocratic Oath. It expresses the first duty of the physician – to treat the patient. In research, however, the participants may not be patients, and even if they are, there is often no direct benefit for the patient from participation in the research. Indeed, it is necessary to ensure patients participating in research are not victims of therapeutic mis-estimation – the fallacy of overestimating the benefits they may gain from participating in the research. Research is a process designed to yield a general contribution to knowledge, which is practically useful or theoretically important, and is therefore a public good. This is not the same as beneficence. Indeed, many researchers would argue that a spirit of intellectual curiosity often impels valid research that is difficult to evaluate in any practical way. The importance of respect for persons seems to us to capture better the essential aspects of beneficence and non-maleficence insofar as these concepts apply to research participants, and we have thus framed the principle of respect for persons as, in effect, incorporating them.

Research Integrity

Research integrity is the term used to refer to the integrity or validity of the research process. Anything which undermines the objectivity of the research and the validity of the results can be regarded as a threat to research integrity, for example if there is plagiarism, selectivity in the publication of results, or if the independence of scientists is undermined by their obligations to their employers or to the funders of their research.

The BAC’s view is that research integrity is essential. It is not a simple concept, but to some extent, the presumptive integrity of research and of researchers is already implicit in adherence to the BAC’s general ethical principles outlined above, and its importance is made explicit wherever appropriate in these Guidelines. Further guidance is available in the Singapore Statement on Research Integrity, developed by the 2nd World Conference on Research Integrity, which was the first international effort to encourage the development of unified policies, guidelines and codes of conduct, with the long-range goal of fostering greater integrity in research.

The BAC is also of the view that research institutions have a responsibility to ensure that the requirements of research integrity are observed, and IRBs have a responsibility to check that research integrity, as well as research merit, has been considered.