Content
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Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked.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.
1. Principles of Ethical Conduct
The primary purpose of this Statement of ethical principles and associated guidelines for research involving humans is the protection of the welfare and rights of participants in research. The ethical and legal responsibilities which researchers have towards participants in research reflect basic ethical values of integrity, respect for persons, beneficence and justice. The responsibilities set out below accord with accepted moral and scientific principles set out in declarations, conventions and guidelines listed in Appendix 1 . The principles in NS 1. Principles of Ethical Conduct are intended to apply to the interpretation and the use of all subsequent parts of this Statement.
The ethical principles and values contained in NS 1.11.21 are applicable to all research involving humans. They are not replaced or superseded by any of the more specific paragraphs in the National Statement. Recourse to these generally applicable principles and values will often assist the resolution of dilemmas in the use of more specific paragraphs.
Integrity, respect for persons, beneficence and justice
The guiding value for researchers is integrity, which is expressed in a commitment to the search for knowledge, to recognised principles of research conduct and in the honest and ethical conduct of research and dissemination and communication of results.
The Joint NHMRC/AVCC Statement and Guidelines on Research Practice provides a concise summary of one of the essential elements of the basic ethical value of integrity, namely the standards for sound scientific research practice. In other respects, this paragraph refers to a value or a set of virtues of researchers with integrity. (See also the Research Ethics Collection, ' Ethical theory ', page 41).
In relation to each proposal presented to it, a Human Research Ethics Committee (HREC) should be satisfied that the researcher(s) responsible will conduct the research with integrity.
When conducting research involving humans, the guiding ethical principle for researchers is respect for persons which is expressed as regard for the welfare, rights, beliefs, perceptions, customs and cultural heritage, both individual and collective, of persons involved in research.
The purpose of this principle is to ensure that research participants are treated in ways that respect their dignity as persons. See also the Research Ethics Collection.
Points to consider
- Does the research respect the inherent dignity of all the participants?
- Are the welfare, rights, beliefs, perceptions, customs and cultural heritage of all participants respected in the research design?
- Where the research involves a collectivity or collectivities as participants, how are those components respected at the level of the collectivity?
- Does the research involve participants who are competent to decide for themselves?
- Does the research involve participants whose capacity for making informed choices is impaired or who otherwise have diminished autonomy?
- How is the research designed to respect participants capable of making informed choices and also those with diminished autonomy?
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In research involving humans, the ethical principle of beneficence is expressed in researchers' responsibility to minimise risks of harm or discomfort to participants in research projects.
As with respect for persons, beneficence embraces a range of related ideas. It includes avoiding harm to others as well as promoting their wellbeing. Within the context of research ethics, this is also often thought to include the idea of benefits to society as a whole flowing from the results of the research enterprise. However, the National Statement focuses on minimising the risks of harm and discomfort to research participants. Therefore, for Australian HRECs, beneficent concern is directed at the effects on individuals and communities of participation in, or exclusion from, research projects. This means that priority should be given to protecting research participants from harm. (See the Research Ethics Collection, ' Beneficence ', page E3.)
Points to consider
- What risks of harm arise in the proposed research?
- What is the magnitude of each of these risks?
- What is the probability of each of these risks?
- Has the researcher minimised these risks, either in the design or conduct of the research, to a satisfactory extent?
- Have all reasonable efforts been made to minimise each aspect of the risks involved in the research project?
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Each research protocol must be designed to ensure that respect for the dignity and wellbeing of the participants takes precedence over the expected benefits to knowledge.
This principle of respect for the dignity and welfare of research participants entails the rejection of research practices that sacrifice the welfare and lives of humans in the pursuit of knowledge. Research that involves deception is a clear example of research that infringes this principle, because generally it fails to respect the dignity of the participants involved.
The principle requires researchers and HRECs to give primary consideration to the effects of their participation on the dignity and welfare of participants. The expression 'dignity and welfare' has a wide meaning in order to include every aspect of participation.
The principle focuses on the dignity and welfare of people as participants. Respect for their dignity and welfare can be given precedence even in research that holds no promise of benefit to participants.
Points to consider
- Have the risks and benefits of the research proposal been identified and fully evaluated? Do the potential benefits justify any risks?
- Does the research project involve an unacceptably high degree of risk to participants in the light of the expected benefits of the research?
- Have participants been adequately advised of the risks and benefits involved in the project?
- Where the major potential benefit from the project will accrue to certain members of society in the future, rather than to the individuals actually taking part in the study, has this been made clear to potential research participants?
- Where a research project involves people capable of making an independent and considered decision about participation, to what extent may analysis of risks and benefits by an HREC be overly protective of participants?
- Where a research project involves vulnerable people as potential research participants, or those unable to make independent and considered decisions, have sufficient measures been included in the research proposal to protect these people from harm?
- Are there provisions in the research proposal for continuing review
and monitoring of data regarding efficacy and safety of the ongoing
research process.
The ethical value of justice requires that, within a population, there is a fair distribution of the benefits and burdens of participation in research and, for any research participant, a balance of burdens and benefits. Accordingly, a researcher must:
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avoid imposing on particular groups, who are likely to be subject to over researching, an unfair burden of participation in research;
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design research so that the selection, recruitment, exclusion and inclusion of research participants is fair; and
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not discriminate in the selection and recruitment of actual and future participants by including or excluding them on the grounds of race, age, sex, disability or religious or spiritual beliefs except where the exclusion or inclusion of particular groups is essential to the purpose of the research.
Justice can be understood variously to include fair treatment, equitable distribution of benefits and burdens within a society, or equal recognition and equal access to participation in society. Within the context of research practice, justice is generally understood to involve an obligation to share the benefits or burdens of research fairly throughout society. Justice as fairness (in which equality or restoration from unlucky burden is the primary concern), comparative justice (in which need is the primary distinction), and distributive justice, (in which need and socially distinguishing factors can be combined) can all be applied in assessing research proposals.
HRECs should scrutinise the proposed means of recruiting research participants in order to ensure that all groups within society are treated fairly with regard to participation in research. This involves protecting certain groups from unfairly bearing the burdens of research, while at the same time protecting other groups from unfair exclusion from the research process and, therefore, from the potential future benefits of that research.
Points to consider
- What is the justification for selecting certain people for recruitment and excluding others?
- Are these justifications based on the design of the research?
- Are potentially vulnerable people to be approached for recruitment? Why? How are these potential participants to be protected against exploitation?
- Is the recruitment process conducted in such a way that the privacy of potential participants is respected, and their right to refuse to participate acknowledged?
- Do recruitment methods, such as advertising, ensure that potential participants are given a clear account of the purpose of the researcher's approach?
- Are the participants representative of the population intended to
benefit from the research?
The proportion of burdens to benefits for any research participant will vary. In clinical research, where patient care is combined with an intent to contribute to knowledge, the risks of participation must be balanced by the possibility of intended benefits for the participants. In other research involving humans that is undertaken solely to contribute to knowledge, the absence of intended benefits to a participant should justly be balanced by the absence of all but minimal risk.
It is essential that a careful assessment is made of both burdens and benefits. Burdens of research include not only its risks but also the inconveniences or disruptions to participants' lives that may be caused by their participation. In order to determine whether the burdens of participation are justified, it is ethically acceptable to balance these burdens by the benefits for participants. Where there are no intended benefits to participants, it is unethical to accept anything more than a minimal level of burden to participants.
Points to consider
- Have the risks of the research proposal been identified and fully evaluated? Do the potential benefits for participants justify any risks?
- Have participants been adequately advised of the risks and benefits involved in the project?
- Where a research project involves vulnerable people as potential research participants (that is, those unable to make independent and considered decisions), have sufficient measures been included in the research proposal to protect these people from harm?
- Are there provisions in the research proposal for continuing review and monitoring of data regarding efficacy and safety of the ongoing research process?
- In research involving significantly more than minimal risk, is the consent process comprehensive and clear?
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Consent
Before research is undertaken, whether involving individuals or collectivities, the consent of the participants must be obtained, except in specific circumstances defined elsewhere in this Statement (see paragraphs 1.11, 6.9, 14.4, 15.8, 16.13).
The ethical and legal requirements of consent have two aspects: the provision of information and the capacity to make a voluntary choice. So as to conform with ethical and legal requirements, obtaining consent should involve:
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provision to participants, at their level of comprehension, of information about the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form of publication of research results); and
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the exercise of a voluntary choice to participate.
Where a participant lacks competence to consent, a person with lawful authority to decide for that participant must be provided with that information and exercise that choice.
The importance of informed decision-making
This paragraph identifies three essential components of an effective consent, namely, that it be based on information, that it be voluntary and that it be made by a person competent to make that choice.
Information
The paragraph identifies the type of information that needs to be provided to participants and then reminds researchers that the manner and form of provision of the information needs to be carefully considered.
Voluntariness
In general terms, it may be acceptable to use people as a 'means' to gaining knowledge for the future if these people are also treated as 'ends in themselves', in particular, they are able to make a free and informed decision to participate. If individuals are free to do so, and if they understand the aims of the research, the risks, burdens and potential future benefits, then inviting them to participate will generally not constitute exploitation by the researcher. (See the Research Ethics Collection, ' Consent ', page E29; see also the Research Law Collection , page L7, for a discussion of the legal aspects of consent.)
Competence
People are competent to give consent if they are adults or 'mature minors' and are able to understand what the procedure involves and to consent to it. Clearly, competence may be difficult to assess in certain situations. (See Research Law Collection page L13, for further discussion of this issue.)
Complexity and legality
Informed consent is an unavoidably complex ethical issue. Questions may be raised about what constitutes sufficiently informed consent; whether research participants are sufficiently able to appreciate the significance of risks, 'randomisation', and other scientific concepts; [Footnote 1] whether decisions to participate in research are ever 'free'; [Footnote 2] and whether fully informed consent is always necessary. [Footnote 3]
Points to consider
- Do the recruitment and decision-making processes included in the research proposal ensure adequate protection of the freedom of participants to decide whether or not to participate in the project?
- Do the recruitment processes included in the research proposal provide for a disclosure of the types of information listed in this paragraph?
- Do the recruitment processes included in the research proposal provide for a manner and form for disclosure of that information appropriate to the research participants?
- Are all participants likely to be competent to decide whether or not to participate? If not, how is this addressed in the research proposal?
- If the researcher plans not to seek consent from potential research participants, is this justified?
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A person may refuse to participate in a research project and need give no reasons nor justification for that decision.
Informed agreement to participate is one possible result of the informed choice process, an informed decision not to do so is the other possible result. An individual's choice not to participate in research should be respected, whether the individual has reasons or not. HRECs need to be satisfied that the freedom to decide not to participate is clearly presented.
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Where consent to participate is required, research must be so designed that each participant's consent is clearly established, whether by a signed form, return of a survey, recorded agreement for interview or other sufficient means.
There are some contexts where written evidence of a person's consent to participate may not be necessary, or may pose a more significant threat to participants than the protection that written evidence of consent is meant to provide. For example, in research involving anonymous surveys into illegal or socially stigmatised activities, requiring written evidence of consent may identify participants and so put them at risk of social harm or legal prosecution. Although consent is still required in these situations, the completion of consent forms that identify participants is likely to be inappropriate. Such situations require the researcher and the HREC to identify clearly the process of consent that will be followed and how the fact of that consent will be evidenced.
Points to consider
- Is written evidence of consent to be sought from participants? If not, why not?
- Are there special features of the context that make written consent inappropriate?
- Is the process by which participants can consent to participate clearly described?
- How will the fact of consent be evidenced?
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The consent of a person to participate in research must not be subject to any coercion, or to any inducement or influence which could impair its voluntary character.
HRECs need to assess whether there are any inducements offered to potential participants that would limit the voluntariness of their choice to participate or to refuse to do so. Any payment to participants should not be so great as to constitute an inducement to take part in the project. [Footnote 4] Inducements may invalidate consent by making it more difficult for participants to assess the risks and benefits of research, encouraging them to expose themselves to risk of harm. [Footnote 5] See the Research Ethics Collection, ' Consent ', page E29.
Points to consider
- Have participants been subject to any type of coercion, whether actual or perceived?
- Is there potential for misuse of participants' trust, for example in their physician if she or he is inviting them to participate in research?
- Does the recruitment or selection process incorporate payments or
rewards of any sort? If so:
- What is the type and level of payment or reward?
- Are they necessary? If so, why?
- Is there a risk that inducements may cause potential participants, or researchers, to overlook possible harms involved in the research project?
- Does the recruitment process protect people from being coerced or unduly influenced to participate?
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It is ethically acceptable to conduct certain types of research without obtaining consent from participants in some circumstances, for example, the use of de-identified data in epidemiological research, observational research in public places, or the use of anonymous surveys. (See 14. ' Epidemiological research ' and 17. ' Research involving deception of participants, concealment or covert operation '.)
Some research may be justifiable even though consent, or written consent, is not sought from participants. However, the risks of participation should be minimal and the research process should not involve any intrusion into the participant's daily activities.
This paragraph recognises such limited exceptions to the requirement for participant consent. It does not exempt that research from ethical review, which, in appropriate circumstances may be suitable for expedited review, for which see N.S. 2.272.29.
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A participant must be free at any time to withdraw consent to further involvement in the research. If any consequences may arise from such withdrawal, advice must be given to participants about these before consent to involvement in the research is obtained.
HRECs need to be satisfied that, at the time participants are asked to consent to participate, they are fully informed of the consequences of exercising their right to withdraw from the research, including withdrawal of information or material.
Points to consider
- Will research participants be able to have their samples or data withdrawn from the research project if they wish to do so?
- Has this been made clear in information documentation and consent forms?
- Does the research design place any restriction on retrieval of data or samples? If so, is this restriction made clear to potential participants? Is it in written form?
- If there are any restrictions on withdrawal of samples or data, does the HREC consider this to be justifiable?
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Research merit and safety
Every research proposal must demonstrate that the research is justifiable in terms of its potential contribution to knowledge and is based on a thorough study of current literature as well as prior observation, approved previous studies, and where relevant, laboratory and animal studies.
All research involving humans needs to have both value and validity. That is, the research must demonstrate that, because of prior research, it is justifiable to seek the information to which the research is directed. Second, the research needs to be so designed that it is likely to lead to the discovery of new knowledge. HRECs need to be satisfied that these conditions are met, and may need to draw on expertise outside their membership for advice. (See NS 2.19.)
Points to consider
- Is there a clear hypothesis?
- Is the research likely to yield new knowledge, enhance understanding or clarify existing uncertainty?
- Has this, or similar, research been carried out before in the same, or similar, contexts?
- Could a systematic review of the literature demonstrate the importance of the research question?
- Do the researchers have the necessary expertise to analyse and interpret the results of the research project?
- Has a statistician been involved in the preparation of the research proposal? If not, should a statistician be consulted?
- Has the research project been designed to account for, or avoid, biases in participant selection, data collection, data analysis and data interpretation?
See ' Research question, statement of ', page E149 in the Research Ethics Collection.
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All research proposals must be so designed as to ensure that any risks of discomfort or harm to participants are balanced by the likely benefit to be gained.
The ethical difficulty with analysing risks and benefits in relation to research practice is that the risks are not often borne by the people for whom the possible benefits will accrue. Given this, potential benefits are unlikely to outweigh the risks for individual research participants. However, researchers and HRECs need to be satisfied that such risks as participants are exposed to are justified by the benefits expected from the research. To reach this decision, HRECs must carefully assess and quantify the magnitude and probability of the risks to participants and the expected benefits to participants and to others.
Points to consider
- Have the risks to participants and the benefits to participants and others been clearly identified and quantified?
- Where the major potential benefit from the project will accrue to certain members of society in the future, rather than to the individuals actually taking part in the study, has this been made clear to potential research participants?
- Where a research project involves vulnerable people as potential research participants, or those unable to make independent and considered decisions, have sufficient measures been included in the research proposal to protect these people from harm?
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Research must be conducted or supervised only by persons or teams with experience, qualifications and competence appropriate to the research. Research must only be conducted using facilities appropriate for the research and where there are appropriate skills and resources for dealing with any contingencies that may affect participants.
Researchers and HRECs should assess the relevant experience, qualifications and competence of researchers to conduct the proposed research. This should involve identifying who, among teams of researchers, will conduct each phase of the research process, including recruitment of participants. Facilities need to be appropriate for the scientific needs of the research. The HREC will need to be satisfied that appropriate facilities are available in the institution(s) in which the research is to be conducted. These will need to include facilities to meet any physical, emotional or other needs of participants that result from their participation.
Points to consider
- Does the research protocol make clear who will conduct each phase of the research?
- Is there satisfactory evidence of the experience, qualifications and competence of each of the researchers?
- Are there appropriate facilities for the conduct of the research?
- Are there appropriate facilities for the needs of participants?
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Ethical review and conduct of research
Research projects involving humans must be reviewed by a Human Research Ethics Committee (HREC) and must not be undertaken or funded unless and until approval has been granted.
Ethical approval should be gained prior to research being funded or undertaken. Institutions need to ensure that their research approval processes make this clear to researchers and provide clear unequivocal evidence of approval. Where conditions are required to be met before commencement, procedures should provide clear evidence that they have been met.
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A researcher must suspend or modify any research in which the risks to participants are found to be disproportionate to the benefits and stop any involvement of any participant if continuation of the research may be harmful to that person.
HRECs should be satisfied that researchers are aware of an obligation to suspend or modify research and, by NS 2.37, will require notification of such situations. There are two situations in which research is to be modified or suspended: first, where risks to participants are disproportionate to benefits (of research) and, second, where a participant may suffer harm.
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The results of research (whether publicly or privately funded) and the methods used should normally be published in ways which permit scrutiny and contribute to public knowledge. Normally, research results should be made available to research participants.
There is limited social, ethical or scientific value in carrying out research if the results are not published or otherwise disseminated, since the research thereby fails to contribute to the advancement of knowledge, research practice or policy. [Footnote 6] Publication of research results may also serve to minimise misconduct by researchers, such as plagiarism and scientific fraud. [Footnote 7]
HRECs should be satisfied that researchers have considered appropriate ways in which research findings can be disseminated.
In the past, publication in professional journals was considered adequate dissemination of research results. However, there is an increasing expectation from research bodies, research participants and consumer groups that participants be informed of the results of research they have participated in, or that may have implications for their ongoing wellbeing. [Footnote 8] Nevertheless, the communication of research results raises some difficult ethical issues. These are discussed in the Research Ethics Collection see under ' Research, communication of results ', page E141.
Points to consider
- Will participants be advised of research results? If not, why not?
- Have the researchers declared their intention to submit the results of their research for publication or other means of dissemination? If not, why not?
- Is the planned method of feedback of information to participants appropriate to the type of research being undertaken?
- Is the HREC satisfied that the researcher has considered the importance of peer review of research findings prior to public release?
- Is the HREC satisfied that the researcher has justified any limitations imposed by 'commercial-in-confidence' considerations?
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Where personal information about research participants or a collectivity is collected, stored, accessed, used, or disposed of, a researcher must strive to ensure that the privacy, confidentiality and cultural sensitivities of the participants and/or the collectivity are respected. Any specific agreements made with the participants or the collectivity are to be fulfilled.
HRECs need to assess carefully the processes of collection, storage, access to and use of personal information, and determine whether those processes will in fact achieve the degree of protection that is promised to participants.
Mere assurances in participant information sheets that information will be kept confidential should not be accepted as adequate unless the research design will achieve that result.
For further discussion of legal aspects of confidentiality and privacy, consult the Research Law Collection under ' Confidentiality ' page L7 and ' Privacy ' page L43.
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Where the records and results of research contain information of clinical significance it is the responsibility of both the researcher and the institution or organisation to maintain the security and storage of records and results so as to enable any necessary follow-up studies to be carried out.
The obligations of researchers and institutions are directed to the minimisation of risks of harm to participants.
HRECs need to assess whether such information is likely to be generated from the research and be satisfied that arrangements are in place to secure that availability.
Separate consent for any follow-up studies should normally be obtained.
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Where research is conducted in an overseas country under the aegis of an Australian institution or organisation, the research must comply with the requirements of this Statement as well as the laws and guidelines of that country.
This paragraph is intended to establish, as a minimum standard for ethical conduct of research involving humans undertaken by an Australian institution, the requirements of the National Statement. Those standards and none lower are to apply to such research wherever conducted. Compliance with the laws and guidelines relevant to the conduct of research of the country in which the research is conducted is also required but in addition to those of the National Statement.
For a further discussion related to this paragraph, see the Research Ethics Collection under ' International research ', page E105.
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