What is human research?
Research, like everyday life, often generates ethical dilemmas in which it may be impossible to find unanimous agreement on what is right or wrong.
In such circumstances, it is important that all people who are involved in research bring a heightened ethical awareness to their thinking and decision-making.
Ethical values and guidelines are not simply a set of rules: their application should not be undertaken simply to satisfy a list of documented requirements.
Ethically acceptable research should be developed through deliberation on values and principles, the exercise of sound judgment, and an appreciation of the context of the research.
Who is a ‘participant’ in human research?
A ‘human participant’ in research is any person who, for example:
- Provides research data, e.g. completes surveys
- Participates in interviews, discussions, a focus group, or observations
- Undergoes psychological, physiological or medical assessment that is not part of their clinical treatment
- Tests software or a device, or equipment
- Grants access to personal data or records, photographs, etc
- Provides human tissue, e.g. blood, urine, saliva, hair, etc
- Is identified in a record, e.g. employment record, medical record, education record, membership list, electoral roll
- Is identified in a databank, including unpublished human research data, e.g. an analysis of existing unpublished data collected by another researcher or collected for another research project
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What are the four key principles of human research?The ethical relationship between researchers and research participants is founded on four key values.
Respect for human beings
Respect is the common thread that binds the ethical consideration of human research.
Research merit and integrity
Unless the 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.
In the research context, justice should be expressed through the fair distribution of the benefits and burdens of research and in ‘fair treatment’ in the recruitment of participants.
Researchers act with beneficence by considering the risks of harm and the potential benefits of research to participants, and to the wider community; by considering the welfare and interests of people involved in their research; and by reflecting on the social and cultural implications of their work.
Based on the four key values, the relationship between researchers and research participants should be one of trust, mutual responsibility, and ethical equality. It is for this reason that the National Statement
prefers the term ‘research participants’ rather than ‘research subjects’.
Do not start your research without ethics approval
The University of Western Australia is responsible for establishing procedures for the ethical review of human research. A human research proposal must be assessed as ethically acceptable, and compliant with the requirements of the National Statement on Ethical Conduct in Human Research before research can begin.
Retrospective ethics approval for a research project cannot be granted. That is, ethics approval will not be granted for a project where recruitment of participants has already been undertaken, research data have already been collected, or where any other substantial research activity has already occurred. (Preliminary planning of the research project does not constitute commencement of the research project itself.)
It is the researcher’s responsibility to ensure that ethics approval has been obtained before commencing the research. Prudent researchers will allow sufficient time, and engage in appropriate planning, to ensure that the ethics review and approval process synchronises with other research funding and approval requirements.