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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Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked.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.
Beneficence
The focus of NS 1.3 is on the reduction of harm. However, the principles of beneficence can include other ideas, particularly the idea of benefits to society as a whole flowing from the results of the research enterprise. [Footnote 1] The inclusiveness of this view has been challenged.
In many of the codes of ethics for research, there is an assumption that the interests of science coincide with the interests of society. However, the assumption is open to question. Hans Jonas, an early philosopher to write on the ethics of human experimentation, challenged the view that 'science benefits society' implicit is an assumption that the benefits of research are experienced by the whole of society whereas the burdens are suffered by individual subjects. It is not society as a whole, but some individuals who may benefit from research into particular diseases. The issue then is the conflict between the search for potential benefits for individual sufferers of a disease as against the potential harms, or the risk of harm, to individual subjects of research. [Footnote 2]
While ethics committees need to engage in an assessment of the risks of harm associated with research proposals, there may be some difficulty in establishing exactly what these are. 'Harm' has been defined as the defeating of an interest, where an individual's interests are understood to be the range of things in which that individual has a stake. [Footnote 3] Understanding 'harm' in this way means that a person can be harmed not only by direct damage to their wellbeing, such as a physical wound, but also, for example, by loss of access to needed social services. Therefore, although 'harm' is most frequently understood in physical terms, it can also include psychological distress, discomfort, social disadvantage, invasion of privacy and infringement of rights (See NS Preamble p.4 and 1.14, 1.19 and 1.20). See ' Risk ' in this Collection, page E155, for a detailed discussion of defining and assessing risks to research participants.
The term 'risk' refers to both the probability of a harm occurring and the magnitude or severity of that harm. Assessments of the risks associated with a research project frequently incorporate the combined probabilities and magnitudes of several potential harms. Many kinds of possible harms need to be taken into account when considering risks to participants:
- physical harms, such as pain, discomfort, injury or side-effects of drugs;
- psychological harms, such as depression, anxiety, confusion, stress, guilt, embarrassment and loss of self-esteem;
- harms associated with infringements of privacy and breaches of confidentiality;
- social harms, such as 'labelling', stigmatisation or discrimination in employment; and
- economic harms, such as actual financial costs of participation.
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How can risks be minimised?
Given that it is not possible to remove all risks from the research process, the task for ethics committees is to:
- consider whether a risk to participants is reasonable in relation to the potential for the particular research project to benefit relevant others in the future;
- be satisfied that risks to participants are minimised where possible;
- consider rejecting, or requesting amendment of, those proposals that appear to involve an unacceptably high degree of risk to participants; and
- be satisfied that those who volunteer to take part in research clearly understand the nature of the risks involved.
Researchers may adopt, and HRECs may require that researchers adopt, risk minimisation strategies. Such strategies may include:
- frequent monitoring of participants;
- the presence of trained personnel who can respond to emergencies;
- coding of data to protect confidentiality;
- 'debriefing' for participants;
- continuing review and monitoring of data to ensure that the study does not continue after the emergence of reliable evidence of reduced efficacy and/or safety, or actual harm to participants;
- exclusion of vulnerable individuals or groups from participating in research where necessary and justified; and
- consideration of whether alternative means for answering the research question are available, and whether participation by humans is really necessary.
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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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