National Statement on Ethical
Conduct in Research Involving Humans
Preamble
Importance of ethics
Purpose of this Statement
Historical context
Statutory considerations
The meaning of ethics and of research
Ethics
Research
Structure and interpretation
Footnotes
Ethics and ethical principles extend to all spheres of human activity. They apply to our dealings with each other, with animals and the environment. They should govern our interactions not only in conducting research but also in commerce, employment and politics. Ethics serve to identify good, desirable or acceptable conduct and provide reasons for those conclusions.
The primary purpose of a statement of ethical principles and associated guidelines for research involving humans is the protection of the welfare and the rights of participants in research.
There is an important secondary purpose of a statement of ethical principles and accompanying guidelines, and that is to facilitate research that is or will be of benefit to the researcher's community or to humankind.
The purpose of this Statement is to provide a national reference point for ethical consideration relevant to all research involving humans. It is the product of wide consultation and builds on the NHMRC Statement on Human Experimentation and Supplementary Notes (1992).
This Statement identifies the ethical principles and values which should govern research involving humans. Throughout this Statement the term “involving” is used to mean not only those who are the principal focus of the research but also those on whom the research impacts. It provides guidance for researchers, ethics committees, institutions, organisations and the public on how such research should be designed and conducted so as to conform to those principles and reflect those values.
This Statement commences with statements of broad ethical principle, followed by short statements of considerations relevant in specific research contexts, arranged according to subject matter. This form offers guidance for rather than prescription of ethically sound research design and practice.
The development of modern codes of ethical principles related to all research involving humans is a comparatively recent phenomenon, although codes related to health and health related research commenced in the early part of this century. The awareness of the importance of respect for ethical codes in research involving human participants was accelerated in response to revelations of unethical practices, particularly during the Second World War. The judgement of the Nuremberg military tribunal on war crimes contained a set of principles and standards relating to permissible medical experiments. These have significantly influenced the subsequent development of codes of ethics.
Despite the emergence of these codes, incidents of unethical treatment of people in health research occurred. Most nations have published codes of ethical conduct in health research, often observing the 1964 Declaration of Helsinki published by the World Medical Association and a succession of international documents prepared during the last four decades (see Appendix 1). These documents demonstrate a trend towards making more explicit the ethical standards which must be met if research on human beings is to be ethically acceptable. Continuing revision of standards for and systems of review of research involving humans is necessary.
Australia has followed these trends. The Statement on Human Experimentation, a set of applied ethical standards about medical research involving human subjects, closely followed the Declaration of Helsinki (which had been ratified by Australia in 1964). The Statement on Human Experimentation was first published by the National Health and Medical Research Council (NHMRC) in 1966. In succeeding years, Supplementary Notes were developed providing guidance on ethical issues in relation to distinct kinds of research or categories of research subjects and participants. The Statement on Human Experimentation became a widely used standard for the ethical review, by institutional ethics committees, of research involving humans, particularly medical research, but increasingly of social and behavioural research as well. In November 1985, the NHMRC resolved that observance by institutions of the standards and procedures set out in the Statement on Human Experimentation and Supplementary Notes for the approval of research would be mandatory for continuing eligibility for NHMRC research funds.
It is now widely accepted that all kinds of research involving or impacting upon humans should conform to the highest standards of academic integrity and ethical practice. The Australian Research Council (ARC), which is the major Australian funding body for research outside the fields of clinical medicine and dentistry, has recently been concerned to develop a code of ethics that will be applicable to all forms of research which either involve humans directly or impact upon them directly or indirectly. The term 'impacting' refers to research which requires interaction with humans with special interests in the research (other than the community of professional colleagues), either as individuals, groups or collectivities, in the course of conducting the research or communicating the results of research.
The original Statement on Human Experimentation has undergone several revisions in the light of international ethical and scientific developments. During 1996-98 the ARC also endorsed a code of ethics for human research, parts of which have been incorporated into the present document, after discussions by a Working Party with representation from the NHMRC, ARC, AVCC (Australian Vice-Chancellors' Committee) and the four Learned Academies of Science, Humanities, Social Sciences and Engineering and Technological Sciences. In the report of a review of the system of institutional ethics committees in Australia in 1996, Footnote 1 a review of the Statement on Human Experimentation and Supplementary Notes (1992) was recommended and has been conducted. This National Statement on Ethical Conduct in Research Involving Humans is the outcome of that review and the deliberations of the Working Party.
Legislation has been primarily concerned with health and medical research. Since the last review of the Statement on Human Experimentation, the Commonwealth Parliament enacted the National Health and Medical Research Council Act 1992. The object of that Act is to make provision for a national body to pursue activities designed to foster medical and public health research and the consideration of ethical issues relating to health. The Act establishes the NHMRC as a statutory entity and sets out its functions, powers and obligations. One of the functions of the NHMRC is to inquire into, issue guidelines on and advise the community on ethical issues relating to health. In the exercise of that function, the NHMRC is specifically required to issue guidelines for the conduct of medical research involving humans precisely as developed by the Australian Health Ethics Committee (AHEC). AHEC was established by the NHMRC Act as a principal committee of the NHMRC.
In issuing this Statement, the NHMRC fulfils its specific obligation to issue guidelines on medical research as well as its function to provide guidelines on ethical matters relating to health. The NHMRC requires all institutions or organisations that receive NHMRC funding for research to establish a Human Research Ethics Committee (HREC) and to subject all research involving humans, whether relating to health or not and whether funded by the NHMRC or not, to ethical review by that committee. The NHMRC expects this Statement to be used as the standard for that review. It has drawn on internationally accepted principles in developing this Statement by reference to which the ethical acceptability of any research involving humans, whether related to health or not, can be determined. Accordingly, this Statement is recommended for use by any individual, institution or organisation conducting research involving humans as an inclusive, reliable and informative guide to the ethical considerations relevant to the review of that research. This would include any research involving humans undertaken by industry.
The meaning of ethics and of research
These expressions have contested meanings. The following indicates the approach taken to their use in this Statement.
Some basic ethical principles
Among the essential values for research is that of the integrity of researchers. This includes the commitment to research questions that are designed to contribute to knowledge, a commitment to the pursuit and protection of truth, a commitment to reliance on research methods appropriate to the discipline and honesty. A convenient statement of these values is contained in the Joint NHMRC AVCC Statement and Guidelines on Research Practice (1997).
In one of the early reflective documents on research ethics, the authors of the Belmont Report Footnote 2 identify three basic ethical principles: those general judgments that serve as a basic justification for particular ethical prescriptions and evaluations of human action. The first of these is respect for persons, that is, that individuals should be treated as autonomous agents and that persons with diminished autonomy are entitled to protection. If respect for persons is equivalent to treating others as autonomous agents then we cannot show respect for those whose autonomy we recognise to be diminished. But we clearly can show such respect. That respect is for the inherent dignity and the rights of persons and is, at the same time, a commitment not to use a person only as a means to an end.
The second is beneficence, that is, the obligations to maximise possible benefits and minimise possible harms. (The obligation to do no harm is referred to separately as non-maleficence.) Harm, in this context, extends beyond physical harm to a wide range of psychological or emotional distress, discomfort and economic or social disadvantage. Researchers exercise beneficence in assessing the risks of harm and potential benefits to participants, in being sensitive to the rights and interests of people involved in their research and in reflecting on the social and cultural implications of their work.
The third principle is justice, addressing the resolution of the question of who ought to receive the benefits of research and bear its burdens. In the early twentieth century, it was recognised as unjust that, while the burdens of serving as medical research subjects fell largely on public patients, the benefits of improved medical care flowed largely to private patients. In contemporary times, researchers and HRECs should recognise the potential for injustice where some groups are regularly selected as research subjects because of convenience and without regard to the frequency of research with those populations or to whom the benefits of the research flow. Questions of justice can also arise in relation to the use of public funds for research.
The detailed and applied provisions of this Statement find their origin and justification in these principles. Other important principles apply to research involving humans. These include the preservation of the integrity of scholarship and research, the integrity of the individual researcher or research team, the promotion of the integrity of institutions and organisations responsible for research, and the accountability of researchers both to the general community and to specific groups or collectivities (see8. Research Involving Collectivities) who have a defined interest in the research.
Individuals and communities
The basic principles recognised by the authors of the Belmont Report reflect the high value that the dominant Western tradition places on individual autonomy. It is important for researchers to recognise that this is not the only way in which human interaction and responsibilities are conceptualised. In many non-Western societies, and in some communities within Western societies also, the rights and autonomy of the individual are complicated and constrained, to a greater or lesser extent, by those of related individuals and groups with specific authority over that individual. Thus researchers need to be aware of individuals' rights within specific local and national socio-cultural contexts.
It is also the case that non-Western traditions as well as more recent developments in social research practice have often emphasised the importance of community values. Members of societies see value in collective activities well beyond the value of each person's individual share of the benefits. The cultural diversity in Australian society means that there may be a range of views on the relative weight of individual and collective values. A constant awareness of this variety will be necessary to ensure that the application of the ethical values by which research is assessed continues to respect that variety of opinion. Research has a significant value to the community as a whole, and all members of the Australian community share in the responsibility to foster and maintain this valuable social institution.
Ethics and science in research
Ethical considerations are as germane to good research as are scientific considerations. Ethical inadequacies in a research proposal are as significant as scientific inadequacies. But scientific inadequacies also have ethical implications. Projects without scientific merit are wasteful of resources and needlessly subject participants to risks. Accordingly, an essential condition of the ethical acceptability of research is the determination that the scientific quality of a proposal and the skill and experience of the researchers are such that the objectives of the proposal can reasonably be expected to be achieved.
Ethics and law in research
Research involving human participation is subject to a variety of legal regulation, at Federal, State and Territory levels. Commonwealth laws regulate registration, use of, and certain research on pharmaceutical drugs and medical devices, the protection of privacy and intellectual property. State and Territory laws regulate access to and use of health information held by authorities, consumer protection and professional conduct. Researchers need to conform to relevant legal requirements and HRECs need to be satisfied that the conduct of research that they approve is lawful.
In the event that both a legal requirement and an ethical guideline apply, the legal requirement will prevail (although they will normally be consistent). Ethical guidelines have the objective of defining standards of behaviour to which researchers should adhere. Where the guidelines prescribe a standard that exceeds that required by the law, then researchers should apply this higher standard.
Defining research
The Statement is addressed to research involving or impacting upon humans. Understanding the scope of research involving humans requires knowledge of what research includes and what involving humans includes.
There are many definitions of research. These include systematic investigation to establish facts, principles or knowledge and a study of some matter with the objective of obtaining or confirming knowledge. A defining feature of research is the validity of its results. The knowledge that is generated by research is valid in the sense that what is discovered about the particular facts investigated can be justifiably claimed to be true for all like facts. However, it remains difficult to find an agreed definition of research.
An alternative approach to finding a definition of research is to list examples
of what constitutes research, such as:
- systematic prospective collection of information to test an hypothesis;
- a planned study of existing practices with a view to changing/improving practice in light of the study's findings and/or to increase understanding; or
- the administration and analysis of data in response to surveys or questionnaires, interviews or opinion polling.
However, such lists risk including activity that would not normally be included, like quality assurance activities or audits and excluding activity that probably should be included, such as research conducted as part of a course of education. Further, such lists risk omitting newly emerged genres of research, of which various kinds of multi-disciplinary research are examples.
The involvement of humans is no more easily defined. This includes the
use and/or collection of personal, collective or cultural data from participants or
from their records, which may include their oral testimony or observed
cultural activities, the testing of responses to conditions devised by researchers
or invasive testing of new therapies.
In some contexts, another way of clarifying the nature of involvement of
humans is the distinction between therapeutic and non-therapeutic research. The
former is research conducted with the intent of providing a direct benefit to
the participants, while the latter is research conducted with the intent to
derive knowledge and not to be of direct benefit to participants (although it may be
so). The distinction can be used in the ethical assessment of an
acceptable balance, for research participants, between the benefits and the risks of research.
A similar distinction used by the Council for International Organisations of Medical Sciences (CIOMS)Footnote 3 is that between clinical research and non-clinical research. The former is defined as that undertaken in combination with patient care with one or more of its components designed to confer diagnostic, prophylactic or therapeutic benefits on the individuals involved in addition to the development of new health knowledge. Non-clinical research is that undertaken on patients or other subjects or with data pertaining to them, with the sole intention of contributing to knowledge. All would be within the meaning of research involving humans as that expression is used in this Statement. However, the Statement is designed to also include research involving humans that may not be categorised as therapeutic, non-therapeutic, clinical or non-clinical.
The ARC distinguishes between "pure" and "applied" research.Footnote 4 Pure research is defined as experimental and theoretical work undertaken to acquire new knowledge without looking for long-term benefits other than the advancement of knowledge. Applied research is defined as original work undertaken primarily to acquire new knowledge with a specific application in view.Footnote 5
It is not possible to define all kinds of research involving humans by using a distinction between therapeutic and non-therapeutic research. Some research, particularly outside the health and medical fields, is not performed directly on human subjects but rather involves their informed cooperation in the researcher's investigation of some human behaviour or some local knowledge base in, for example, the social, cultural, biological or physical environment. This kind of research involves the exchange of knowledge between the researcher and those with whom he or she interacts.
Defining participants
The definition of participants in this Statement includes not only those humans who are the principal focus of the research endeavour but also those upon whom the research impacts, whether concurrently or retrospectively. Two examples of research that impacts on humans are studies of human remains that are linked to identifiable living humans or fieldwork in which a researcher requires access to community-controlled resources. Research involving (and impacting on) humans may occur in a wide range of disciplinary fields.
What a Human Research Ethics Committee should review
The difficulty faced in providing a suitable definition of research involving humans suggests that a more appropriate focus is to seek to define that which needs to be considered and approved by an HREC. Where activity involves human participation or definable human involvement and has a purpose of establishing facts, principles or knowledge or of obtaining or confirming knowledge, the features of human involvement will be the focus of deciding whether it is research and so subject to review by an HREC.
Where that involvement has a potential for infringing basic ethical principles, at least respect for humans, beneficence and justice, review by an HREC is warranted. Such a potential arises: where that involvement could cause harm to the well-being of participants, whether physically, psychologically, spiritually or emotionally; or in the exploitation of cultural knowledge and/or property, where their involvement, or the use of their personal or community-based information, has a potential for infringement of their privacy or of the confidentiality or ownership that attaches to that information; or where their involvement imposes burdens with little benefit.
Researchers, regulators, funding bodies, institutions, organisations and HRECs will need to address these issues with deliberate care and caution and arrive at provisional descriptions of what constitutes research that merits ethical review. In this process, a sustained awareness of the characteristics of the evolving research environment and practice will be important.
Institutions and organisations and boundaries between research and practice
The adoption of such an approach to deciding whether an activity ought to be subject to review by an HREC (and be thereby classified as research requiring HREC review) provides guidance rather than prescription to institutions and organisations in which such activities and research are conducted. The range of activities undertaken by and within an institution or organisation will be affected by its capacity, its resources and its mission. It is the responsibility of each institution and organisation to develop criteria to classify which of its activities are reviewable by its HREC and which are not. This Statement should form the basis and source for those criteria. Accordingly, variation in the classification of activities between and among institutions and organisations may occur, so long as it can be justified by reference to this Statement.
The research environment
The experience of humans involved in research ranges from that of passive subject to active co-researcher. Although this Statement tends to use the expression “participants”, mere changes of titles may not reflect the reality of experience. Further, such changes in names may lead to significant changes in expectation among those involved: to be called a participant may lead to expectations to be involved in the design, conduct and reporting of research in ways that may compete with more conventional perceptions of research held by some researchers. Where research moves beyond well established paradigms and contexts, HRECs will need to recognise the tension between, and the ethical implications of, changing perceptions and expectations of those conducting and those involved in research.
The research environment in Australia is marked by an increase in the quantity and diversity of research that is being conducted and in the sources of funding for that research. Not only have there been major developments in traditional research fields during the last century, but new fields are continually opening up in a great many disciplines. Within research related to health, the continuous advance in knowledge of the predictors of health status increases the avenues of further research. The field of genetics is currently a clear example. In this changing context, the NHMRC regards the development and promulgation of an inclusive, relevant and reliable set of guidelines for the ethical design and conduct of all research involving humans as essential. Such guidelines become more important as the sources of funding and number of researchers multiply. Clarity in published national standards is the basis for consistency in the ethical conduct of research.
Categories of personal information
In this Statement and particularly in 14. Epidemiological Research, 15. Use of Human Tissue Samples and 16. Human Genetic Research, distinctions are made between three types of personal information or material. Distinctions are made between identified, potentially identifiable (coded or re-identifiable) and de-identified (not re-identifiable, anonymous). There are genuine public concerns about privacy and the storage of information of a personal nature. This Statement distinguishes between the responsibilities of researchers in respect to each category; greater care is required where the research involves identifiable or potentially identifiable information.
The three types of personal data are as follows:
Identified
Data that allow the identification of a specific individual are referred to as “identified data”. Examples of identifiers may include the individual's name, date of birth or address. In particularly small sets of data even information such as a postcode may be an identifier.
Potentially identifiable (coded, re-identifiable)
Data may have identifiers removed and replaced by a code. In such cases it is possible to use the code to re-identify the person to whom the data relate so that the process of de-identification is reversible. In these cases the data are referred to as “potentially identifiable”.
De-identified, (not re-identifiable, anonymous).
The process of de-identification can be irreversible if the identifiers have been removed permanently or if the data have never been identified. These data are referred to as "de-identified". It should be recognised that the term "de-identified" is used frequently, in documents other than this Statement, to refer to sets of data from which only names have been removed. Such data may remain “potentially identifiable”.
The benefits of research
The conduct and outcomes of research involving humans has had and will continue to have benefits for society. Such research, in seeking new knowledge about the conditions for social wellbeing including the causes of social dysfunction, the origins and progress of disease or the efficacy of treatment or health care, plays an essential part in the beneficial future of Australian society. Further, the opportunity that such research provides for the education of Australian students and researchers should not be underestimated. In the assessment of the ethical acceptability of any research project, a committee should pay regard to the importance and the benefits of research and assess and balance these against the burdens undertaken by those participating in research.
1. Principles of Ethical Conduct sets out ethical principles and values to which all research that involves humans and to which the Statement applies must conform. 2. Human Research Ethics Committees (HRECs) sets out the procedures for consideration and approval of all such research by an HREC.
In addition, more detailed guidance is provided on how different types of research should be designed and conducted so as to conform to the ethical principles and values in 1. Principles of Ethical Conduct and so as to be suitable for approval by an HREC under 2. Human Research Ethics Committees. Accordingly the general principles in 1. Principles of Ethical Conduct are intended to apply to the interpretation and the use of all subsequent parts of this Statement.
A glossary of terms and expressions used throughout the Statement appears as an appendix to this Statement.
Footnotes
1 Report of the Review of the Role and Functioning of Institutional Ethics Committees, A Report to the Minister for Health and Family Services, March 1996, Commonwealth of Australia, Canberra.
2 The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, Department of Health, Education and Welfare Publication No (OS) 78-0012, US Government Printing Office, Washington, 1978
3 Council for International Organizations of Medical Sciences(CIOMS) in collaboration with the World Health Organization (WHO), International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS, Geneva, 1993, p.11.
4 Department of Education, Training and Youth Affairs, Large Research Grants Scheme: Guidelines for Year 2000 Grants, Australian Research Council, 1999, p.4.
5 The Australian Taxation Office also has definitions related to research. See Income Tax Assessment Act 1936 (Cth) Section 73B (1AB).
[Preamble] [Part 1] [Part 2] [Part 3] [Part 4] [Part 5] [Part 6]
[Part 7] [Part 8] [Part 9] [Part 10] [Part 11] [Part 12] [Part 13]
[Part 14] [Part 15] [Part 16] [Part 17] [Part 18] [Part 19]
[Appendix 1] [Appendix 2] [Appendix 3]