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National Statement on Ethical Conduct in Research Involving Humans

The National Statement on Ethical Conduct in Research involving Humans ('the statement') was issued by the National Health and Medical Research Council (NHMRC) in accordance with the NHMRC Act 1992 (Cth). The primary purpose of this statement is the protection of the welfare and the rights of participants in research and to facilitate research that is or will be of benefit to the researcher's community or to humankind. 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 statement refers to the following responsibilities on the part of researchers:

1. 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.
2. Consent; before research is undertaken, whether involving individuals or collectivities, the consent of the participants must be obtained, except in specific circumstances, for example in the use of de-identified data in epidemiological research, observational research in public places, or the use of anonymous surveys.
3. Research Merit and Surveys; 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.
4. Ethical Review and Conduct of Research; research projects involving humans must be reviewed by a Human Research Ethics Committee and must not be undertaken or funded unless and until approval has been granted.

Human Research Ethics Committees - Composition

The minimum membership of an HREC is seven members, being men and women, comprising:

1. a chairperson,
2. at least two members who are lay people, one man and one woman, who have no affiliation with the institution or organisation, are not currently involved in medical, scientific or legal work, and who are preferably from the community in which the institution or organisation is located,
3. at least one member with knowledge of, and current experience in the areas of research that are regularly considered by the HREC (eg. health, medical, social, psychological, epidemiological, as appropriate),
4. at least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people (eg. medical practitioner, clinical psychologist, social worker, nurse, as appropriate),
5. at least one member who is a minister of religion, or a person who performs a similar role in a community such as an Aboriginal elder, and
6. at least one member who is a lawyer.

Appointment of Members

The institution or organisation may recruit members for an HREC in such a manner and shall appoint them for such a period and on such terms and conditions as it determines. Members are to be appointed for their expertise and not in a representative capacity.

Procedures

Institutions and organisations and their HRECs must establish working procedures concerning:

• frequency of meetings
• preparation of agendas and minutes
• distribution of papers prior to meetings
• presentation of research protocols
• timely consideration and review of research proposals
• methods of decision making
• prompt notification of decisions
• reporting of adverse occurrences
• appropriate monitoring
• receiving complaints
• advising institution(s) or organisation(s) to discontinue a research project
• fees, if any, to be charged
• confidentiality of the content of protocols and of committee proceedings.

Advocates and Interpreters

An HREC must consider whether an advocate for any participant or group of participants should be invited to the HREC meeting to ensure informed decision making and understanding by these participants.

Where research involves the participation of persons unfamiliar with the English language (or the language in which the research is to be undertaken), an HREC must ensure that the participant information statement has been translated into the participants language, and that an interpreter is present during discussions with the participants about the project.

Monitoring and Complaints

An institution or organisation and its HREC have the responsibility to ensure that the conduct of all research approved by the HREC is monitored by procedures and/or by utilising existing mechanisms within the institution which will ensure the achievement of the goals for monitoring as determined by the institution or organisation and the HREC.

An institution with an HREC shall establish mechanisms for receiving and promptly handling complaints or concerns about the conduct of an approved research project. An HREC must nominate a person to whom complaints from research participants, researchers, or other interested persons may be made in the first instance.

All principal investigators, co-investigators and supervisors are required to read this document. The National Statement can be found at the National Health and Medical Research Council website.

For more information contact the Executive Officer to the Committee: