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Please note:
The Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked. This information is kept here for archival purposes only. For the current guidelines, Human Research Ethics Committees should refer to the National Statement on Ethical Conduct in Human Research 2007.
Ethical Theory
HREC members could adopt a number of approaches to assessing the ethical aspects of research proposals. They might rely on their intuitions about whether or not a proposal is morally acceptable or they might apply specific moral theories to this assessment. Such theories include 'utilitarianism', 'virtue ethics' and 'rights-based' moral theory. Several ethical frameworks have been applied to ethical issues in research practice and these are discussed in detail in the relevant literature. [Footnote 28]
According to utilitarian moral theories, it is the outcomes or consequences of actions or policies that denote whether or not an action or policy is ethically acceptable. Actions or policies that promote positive outcomes, understood in terms of improving welfare and increasing happiness or the satisfaction of preferences, are ethically acceptable. Those that are likely to lead to negative consequences, understood in terms of causing harm and increasing suffering or frustrating preferences, are not. Utilitarian moral theories focus on the 'greatest good for the greatest number' and do not recognise individual rights as the primary ethical concern.
Those who adopt a virtue-based ethic focus on the development and exercise of sound moral character. Here, virtuous character traits, such as generosity, goodness, kindness, sympathy and care for others are valued and encouraged.
Rights-based moral theories focus on the identification of the moral rights relevant to a particular course of action, such as the right to life, the right to self-determination, the right to privacy, or the right to health care. Rights-based theories require an assessment of actions and states of affairs in terms of the identification of conflicting rights, the potential for rights violation and the protection of the individual's rights.
An HREC member who chooses to assess research proposals in terms of moral theory would face the constant challenge of having to resolve the central conflict between utilitarian and rights-based theories. That is, the conflict would be between the 'greatest good for the greatest number' and the primacy of individual rights.
Another possible approach to the assessment of research proposals involves applying a set of moral principles to the circumstances of the specific proposal and assessing whether or not it is consistent with those principles. Ethical 'principlism', which has been central in the development of the bioethical literature, and the literature concerning research ethics in particular, seeks to avoid some of the problems associated with the application of abstract moral theories to practical ethical questions. At the same time, 'principlism' draws together ethical considerations grounded in different moral theories, such as concern with individual rights to autonomy, respect for persons and the promotion of social welfare and the avoidance of harm.
The National Statement refers to three key ethical principles (see NS 1.21.5)
- respect for persons: 'individuals should be treated as autonomous agents and that persons with diminished autonomy are entitled to protection';
- beneficence: 'the obligation to maximise possible benefits and minimise possible harms. (The obligation to do no harm is referred to separately as non-maleficence.)'; and
- justice: 'addressing the resolution of the question of who ought to receive the benefits of research and bear its burdens.'
These principles are generally relevant to the evaluation of research ethics, no matter what ethical theory or framework an HREC member adopts. Some principles may simply carry greater weight depending on the individual committee member's ethical position. However, it should also be pointed out that this approach could, on occasion, lead to differing recommendations.
For example, an emphasis on respect for persons, understood as respect for participants' autonomy or self-determination, can conflict with concern for beneficence or wellbeing. For instance, providing a participant with information about the outcome of tests undertaken as part of the research process might have harmful consequences for that participant.
Another example is a research project that involves taking blood samples from several members of a family. The results of the blood test might demonstrate that a particular child could not have been fathered by the man whom the participant has always accepted as her or his biological father. It could be argued, on the basis of respect for persons, that participants ought to be told of the finding, even though they might be badly affected by the news. However, it could also be argued, on the basis of beneficence, that revealing this information would be harmful to a participant and so should be withheld. In addition, this particular example is complicated by the fact that several members of the same family are involved, and so revealing this information to the participant could well affect other family members. It is the significance (or salience) of each principle in a particular context that is the key to the resolution of such conflicts.
However, regardless of the ethical position an HREC member adopts, it is essential that committee members identify and evaluate the relevant issues. This section of this Collection suggests an approach to ethics committee review that focuses on the process of identifying, assessing and balancing relevant ethical aspects of specific research projects.
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Handbook TOC
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Abbreviations
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Commentary on the National Statement
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A Research Ethics Collection
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A Research Law Collection
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Bibliography
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Appendices
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