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History of ethics and ethical review of human research in Australia

Ethical review of research involving humans has occured since the 1960s. Ethics review applies to medical, social and behavioural research. This link explores the development of ethical review and research involving humans.

Medical research

Australian activity in ethical review of human research began during the 1960s and was related closely to the federal funding of medical research. Through the passage of the Medical Research Endowment Fund Act 1937 , the Commonwealth Parliament had established the Medical Research Endowment Fund. Responsibility for the fund was vested in the Minister for Health, who could determine its use for medical research and in the training of persons in medical research, acting on the advice of the National Health and Medical Research Council, constituted in 1936.

In 1966, the Council issued the Statement on Human Experimentation that expressly drew on the Helsinki Declaration . In 1972, the Council appointed the Ethics in Clinical Research Subcommittee to examine the need to revise the Statement. Their report recommended peer group assessment of experiments involving human subjects and, in 1976, Supplementary Note 1 was added to the Statement, to make the requirement for review by an institutional ethics committee (IEC) explicit. The opening paragraphs were also amended to indicate that the Statement was applicable to all human subject research, encompassing medical, social and behavioural research.

In October 1982, the Council established the Medical Research Ethics Committee to assist the Council by keeping under review and making recommendations to Council on ethical principles in human experimentation and to facilitate, keep under review and report to the Council on the work of IECs, and respond to questions raised by them.

In November 1985, the Council adopted a recommendation that any institution that conducts research on humans must conform to Supplementary Note 1 in order to be eligible to receive funds for research from the Council. The risk of ineligibility to receive Council funds was an effective inducement for institutions to establish IECs. By 1990, it was estimated that there were over 100 IECs throughout Australia and in 2005, there are more than 220. (IECs are now known as Human Research Ethics Committees.)

The National Health and Medical Research Council Act 1992 establishes the Role of the CEO whose functions include the issue of "guidelines for the conduct of medical research involving humans". These guidelines must be issued precisely as developed by the principal committee of Council known as the Australian Health Ethics Committee (AHEC).

Social and behavioural research

Before the Council policy decision of 1985, ethical issues in social and behavioural research were recognised by Australian associations in sociology, psychology and anthropology, who offered guidance to their members on the ethical conduct of research. When the NHMRC extended the jurisdiction of IECs to include non-medical projects in 1986, the extension was achieved by defining planned experiments as ranging "from those undertaken as a part of patient care to those undertaken either on patients or on healthy subjects for the purpose of contributing to knowledge, and include investigations on human behaviour".

This extension of ethical review of research to include behavioural and social aspects of health reflected the shifting ground of health care delivery. Services dealing with drug and alcohol issues, health promotion and deinstitutionalised former mental hospital patients faced problems beyond the scope of traditional medical research. As research institutions began to implement the requirements for the review of behavioural health research, many extended the requirements of the NHMRC to other types of social and behavioural research. In addition, funding bodies began to require approval by an IEC as a condition for considering social science grant applications in areas related to health or health care.

The debate about HIV/AIDS policy further challenged the more orthodox thinking that a health problem should be considered only by medical experts. During the mid 1980s, after widespread debate about the ethical review of reproductive technologies, it was recognised that the issues raised were too broad to be considered only by IECs in hospitals or universities. At the national level, this resulted in the establishment of the National Bioethics Consultative Committee (NBCC) with representatives from social sciences and consumer organisations as well as clergy, lawyers and medical scientists. The NBCC published several issues and discussion papers about assisted reproductive technology before it and the Medical Research Ethics Committee were replaced by the Australian Health Ethics Committee (AHEC) in 1992.

National Statement on Ethical Conduct in Human Research

In 1994, the Commonwealth Minister for Human Services and Health commissioned a review of the role and functioning of Institutional Ethics Committees . In March 1996, the report of that review recommended that the existing guidelines be reviewed. Between 1996 and July 1999, AHEC developed the guidelines that were contained in the National Statement on Ethical Conduct in Research involving Humans (1999) (National Statement), issued by the NHMRC and endorsed by major research and academic institutions.

The NHMRC, the Australian Research Council and the Australian Vice-Chancellors Committee commenced a review of the National Statement in 2005. The review involved wide consultation with institutions and researchers in all disciplines and the community. In March 2007 after two rounds of public consultation the National Statement on Ethical Conduct in Human Research (2007) was released. This update provides more in-depth ethical guidance than the 1999 National Statement.

Archived information / completed projects

Values & Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (NHMRC 2003)

When developing the National Statement, the NHMRC accepted the need to revise the 1991 Interim Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (now rescinded).

Between 2000 and 2003, AHEC developed the guidelines now contained in Values & Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (Values & Ethics Guidelines). An account of their historical context appears in the document at pages 1-5 and the process of development is described in Appendix 1.

Assisted Reproductive Technology (ART)

The continued development of new technologies in assisted reproductive technology (ART) means that ART remains a complex area, scientifically and ethically, for both clinical practice and research.

Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (NHMRC 2007)

The Ethical guidelines on the use of assisted reproductive technology in clinical practice and research 2007 were endorsed for public release in September 2004. These guidelines replace the previous Ethical guidelines on assisted reproductive technology 2004 .

The role of the ART ethical guidelines in the regulation of ART

The Ethical guidelines on the use of assisted reproductive technology in clinical practice and research 2004 underpin the regulation of ART practice within Australia. Accreditation of ART treatment centres by the Reproductive Technology Accreditation Committee (RTAC) is the basis of a nationally consistent approach for overseeing ART clinical practice. RTAC’s accreditation requirements include compliance with the guidelines in order to gain accreditation. RTAC was established by the Fertility Society of Australia.

The Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002

The Ethical guidelines on the use of assisted reproductive technology in clinical practice and research 2004 are consistent with the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 . The Guidelines are also prescribed in the regulations under the Research Involving Human Embryos Act 2002.

The NHMRC Licensing Committee oversees the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning Act 2002.

Information on stem cell research and fetal tissue research

With regard to stem cell research and fetal tissue research, the information below remains in force:

Fetal tissue use in research

Research involving the fetus and fetal tissue requires special consideration. The National Statement on Ethical Conduct in Human Research (2007) is used as a guide on ethical matters for research involving the human fetus or human fetal tissue.

Overview

The use of human fetal tissue in research is regulated through State and Territory legislation, underpinned by guidelines issued by the NHMRC.

Prior to undertaking work involving the use of human fetal tissue, a researcher must first obtain approval from an appropriately constituted institutional Human Research Ethics Committee (HREC). This includes ensuring that the work complies with relevant State or Territory legislation and the NHMRC's National Statement on Ethical Conduct in Human Research (2007). Once the research project has HREC approval, the researcher must then obtain consent from the tissue donor(s) before any work can be undertaken.

The use of fetal tissue in research was considered during the review of the Ethical guidelines on assisted reproductive technology 1996 (replaced with the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (2004). In light of the special issues surrounding fetal tissue and the use of fetal tissue in research, AHEC decided that a separate process was necessary in order to appropriately deal with these issues. For this reason, the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (2004) do not address issues around the use of fetal tissue in research .

See related information on Assisted reproductive technology.

Animal to human transplantation research (Xenotransplantation)

Ethical and Practical Issues Concerning Ashed Bones from the Commonwealth of Australia's Strontium 90 Program, 1957-1978

As part of Australia's program of testing for Strontium 90, between 1957 and 1978, samples of bones taken at autopsy were sent to be ashed and the assayed for the the radioisotope, sr90. The Australian Health Ethics Committee has written a report on matters relating to the stored samples of ashed bones.

AHEC report

This document was revoked in 2008. It is kept here for archival and reference purposes only.

In October 2001, the Federal Minister for Health and Aged Care, the Hon Dr Michael Wooldridge, asked the Australian Health Ethics Committee (AHEC) to advise him on matters pertaining to currently stored samples of ashed bones from the Commonwealth of Australia's program of testing for Strontium 90 between 1957 and 1978. The report, approved for release by Senator the Hon. Kay Patterson in March 2002, contained a number of recommendations covering responsibilities of institutions such as in disseminating information, dealing with requests from next of kin and disposal of remaining bone ash.

Australian Radiation Protection and Nuclear Safety Agency (ARPANSA)

The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) has issued a media release about this report.

Organs Retained at Autopsy - Ethical and Practical Issues

This document was revoked in 2008. It is kept here for archival and reference purposes only.

This document was issued following cases which came to light in the United Kingdom and in Australia, where organs had been removed from people during routine autopsy procedures but had been retained for research purposes without the permission of the next of kin.

The report Organs Retained at Autopsy - Ethical and Practical Issues was issued in August 2001. It contains advice and recommendations on what should be done about tissues and organs currently held by Australian institutions without permission as a result of autopsies. Recommendations address issues such as the need for audit of organs and records, providing information and support to next-of-kin, disposal of organs and further research on unclaimed organs.

Page reviewed: 6 July, 2011