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NHMRC

SECTION 1: VALUES AND PRINCIPLES OF ETHICAL CONDUCT

Introduction

The relationship between researchers and research participants is the ground on which human research is conducted. The values set out in this section – respect for human beings, research merit and integrity, justice, and beneficence – help to shape that relationship as one of trust, mutual responsibility and ethical equality. For this reason, the National Statement speaks of research ‘participants’ rather than ‘subjects’.

While these values have a long history, they are not the only values that could inform a document of this kind. Others include altruism, contributing to societal or community goals, and respect for cultural diversity, along with the values that inform Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (NHMRC 2003).

However, the values of respect, research merit and integrity, justice, and beneficence have become prominent in the ethics of human research in the past six decades, and they provide a substantial and flexible framework for principles to guide the design, review and conduct of such research. This National Statement is organised around these values, and the principles set out in paragraphs 1.1 to 1.13 give them practical expression.

Among these values, respect is central. It involves recognising that each human being has value in himself or herself, and that this value must inform all interaction between people. Such respect includes recognising the value of human autonomy – the capacity to determine one’s own life and make one’s own decisions. But respect goes further than this. It also involves providing for the protection of those with diminished or no autonomy, as well as empowering them where possible and protecting and helping people wherever it would be wrong not to do so.

Reference to these values throughout the National Statement serves as a constant reminder that, at all stages, human research requires ethical reflection that is informed by them. The order in which they are considered reflects the order in which ethical considerations commonly arise in human research.

Research merit and integrity are discussed first. Unless proposed research has merit, and the researchers who are to carry out the research have integrity, the involvement of human participants in the research cannot be ethically justifiable.

At a profound level, justice involves a regard for the human sameness that each person shares with every other. Human beings have a deep need to be treated in accordance with such justice, which includes distributive justice and procedural justice. In the research context, distributive justice will be expressed in the fair distribution of the benefits and burdens of research, and procedural justice in ‘fair treatment’ in the recruitment of participants and the review of research. While benefit to humankind is an important result of research, it also matters that benefits of research are achieved through just means, are distributed fairly, and involve no unjust burdens.

Researchers exercise beneficence in several ways: in assessing and taking account of the risks of harm and the potential benefits of research to participants and to the wider community; in being sensitive to the welfare and interests of people involved in their research; and in reflecting on the social and cultural implications of their work.

Respect for human beings is the common thread through all the discussions of ethical values. Turning to it as the final value is a reminder that it draws together all of the ethical deliberation that has preceded it.

The design, review and conduct of research must reflect each of these values.

Guidelines

 

Research merit and integrity

1.1 Research that has merit is:

  1. justifiable by its potential benefit, which may include its contribution to knowledge and understanding, to improved social welfare and individual wellbeing, and to the skill and expertise of researchers. What constitutes potential benefit and whether it justifies research may sometimes require consultation with the relevant communities;
  2. designed or developed using methods appropriate for achieving the aims of the proposal;
  3. based on a thorough study of the current literature, as well as previous studies. This does not exclude the possibility of novel research for which there is little or no literature available, or research requiring a quick response to an unforeseen situation;
  4. designed to ensure that respect for the participants is not compromised by the aims of the research, by the way it is carried out, or by the results;
  5. conducted or supervised by persons or teams with experience, qualifications and competence that are appropriate for the research; and
  6. conducted using facilities and resources appropriate for the research.

1.2 Where prior peer review has judged that a project has research merit, the question of its research merit is no longer subject to the judgement of those ethically reviewing the research.

1.3 Research that is conducted with integrity is carried out by researchers with a commitment to:

  1. searching for knowledge and understanding;
  2. following recognised principles of research conduct;
  3. conducting research honestly; and
  4. disseminating and communicating results, whether favourable or unfavourable, in ways that permit scrutiny and contribute to public knowledge and understanding.

Justice

1.4 In research that is just:

  1. taking into account the scope and objectives of the proposed research, the selection, exclusion and inclusion of categories of research participants is fair, and is accurately described in the results of the research;
  2. the process of recruiting participants is fair;
  3. there is no unfair burden of participation in research on particular groups;
  4. there is fair distribution of the benefits of participation in research;
  5. there is no exploitation of participants in the conduct of research; and
  6. there is fair access to the benefits of research.

1.5 Research outcomes should be made accessible to research participants in a way that is timely and clear.

Beneficence

1.6 The likely benefit of the research must justify any risks of harm or discomfort to participants. The likely benefit may be to the participants, to the wider community, or to both.

1.7 Researchers are responsible for:

  1. designing the research to minimise the risks of harm or discomfort to participants;
  2. clarifying for participants the potential benefits and risks of the research; and
  3. the welfare of the participants in the research context.

1.8 Where there are no likely benefits to participants, the risk to participants should be lower than would be ethically acceptable where there are such likely benefits.

1.9 Where the risks to participants are no longer justified by the potential benefits of the research, the research must be suspended to allow time to consider whether it should be discontinued or at least modified. This decision may require consultation between researchers, participants, the relevant ethical review body, and the institution. The review body must be notified promptly of such suspension, and of any decisions following it (see paragraphs 5.5.6 to 5.5.9).

Respect

1.10 Respect for human beings is a recognition of their intrinsic value. In human research, this recognition includes abiding by the values of research merit and integrity, justice and beneficence. Respect also requires having due regard for the welfare, beliefs, perceptions, customs and cultural heritage, both individual and collective, of those involved in research.

1.11 Researchers and their institutions should respect the privacy, confidentiality and cultural sensitivities of the participants and, where relevant, of their communities. Any specific agreements made with the participants or the community should be fulfilled.

1.12 Respect for human beings involves giving due scope, throughout the research process, to the capacity of human beings to make their own decisions.

1.13 Where participants are unable to make their own decisions or have diminished capacity to do so, respect for them involves empowering them where possible and providing for their protection as necessary.

Application of these values and principles

Research, like everyday life, often generates ethical dilemmas in which it may be impossible to find agreement on what is right or wrong. In such circumstances, it is important that all those involved in research and its review bring a heightened ethical awareness to their thinking and decision-making. The National Statement is intended to contribute to the development of such awareness.

This National Statement does not exhaust the ethical discussion of human research. There are, for example, many other specialised ethical guidelines and codes of practice for specific areas of research. Where these are consistent with this National Statement, they should be used to supplement it when this is necessary for the ethical review of a research proposal.

These ethical guidelines are not simply a set of rules. Their application should not be mechanical. It always requires, from each individual, deliberation on the values and principles, exercise of judgement, and an appreciation of context.