by Elizabeth Grant AM
For decades ethical issues have been important factors in medical research. Over the past ten to fifteen years matters such as ethical values, privacy and confidentiality, free and informed consent, the ability of subjects to withdraw from research projects and the use of animals in research have been front page news and of great general interest. Along with the research community, the teaching institutions, and those who may or may not benefit from the research now or in the future, people in the wider community are also giving the ethical implications of research a high priority.
In 1981 research into repro-ductive technology was becoming increasingly important and was attracting considerable interest. The Medical Research Committee (MRC) of the National Health and Medical Research Council (NHMRC) set up a working party on ethics in medical research to recommend modifications to the Council's Statement on Human Experimentation in the light of recent statements both here and overseas.
As well, the group was to look at uniform requirements for Institutional Ethics Committees (IECs) in Australian research and teaching institutions and to reconsider and recommend changes to the Statement on Animal Experimentation and the functioning of Animal Experimen-tation Ethics Committees (AEECs). The working party also had a broad brief to examine and report to Council on any ethical considerations in relation to medical research using humans, human tissues or animals that might be referred to it.
In 1982 the Medical Research Ethics Committee (MREC) produced its first report, which amended the Statement on Human Experimentation, and included supplementary notes on the function and composition of IECs, research on children, the mentally ill and those in depen-dent relationships, the conduct of therapeutic trials, and in vitro fertilization and embryo transfer.
Subsequent guidelines and background papers have been produced on a number of topics including: Ethics in Epidemio-logical Research, Research involving the human fetus and fetal tissue, Guidelines on ethical matters in Aboriginal and Torres Strait Islander health research, Gene therapy, Genetic registers, and privacy where personal information is used in health research.
Work is now being carried out on social science research, such as psychological surveys, and the need for specific guidelines to assist investigators and IECs to protect those who are involved in such research whether as clients or practitioners.
Some 150 ethics committees from institutions all over Australia oversee ethical aspects of medical research involving humans. The composition of these committees is such that all 'shareholders' are represented in the core membership which must contain a male and female representative of the community, a lawyer, a minister of religion and a medical graduate with recent research experience.
These people are charged with examining proposals to ensure that the research is both scientifically valid and ethically acceptable. Proposals must include patient information and consent forms and indications that patients can withdraw from the research at any time without affecting their treatment. The rights of those in dependent relationships must be adequately protected and privacy and confidentiality issues must have been addressed. The researcher must be suitably qualified to carry out the project and IECs must monitor the research through regular reports to be assured that the original proposal has been adhered to.
Ethics committees are coming under increased pressure to approve projects, especially those which involve clinical trials of new drugs, or new forms or administration of marketed drugs. Drug companies are growing more aware of the requirements of the Therapeutic Drug Administration (TGA) for drug trials and are utilising the Clinical Trials Notification Scheme more frequently. This scheme places the responsibility more and more on IECs rather than on the Department of Health's TGA to monitor the conduct of such trials.
Three years ago the original MREC was replaced by the Australian Health Ethics Committee (AHEC) which has a broader agenda in that it looks at ethical issues over the whole of the health portfolio rather than just medical research. It requires annual reports on the composition of IECs and their use of the privacy guidelines which were drawn up following the Common-wealth Privacy legislation. There is no legislation to require institu-tions to maintain an IEC properly constituted in accordance with NHMRC requirements. However, sanctions can be invoked where an institution in receipt of NHMRC research funding is found to be in breach of Council guidelines on the composition and functioning of its IEC. Those sanctions may involve withholding or withdrawal of research funds from that institution.
It is interesting to note that research involving the use of animals is much more strictly monitored than that involving humans. This may seem strange at first but since animals cannot understand what will take place or give their consent, the rules pro-tecting them must contain strong safeguards and have the force of law. The concern of the general public in this area of research is, of course, evident in such organisations as the RSPCA and groups such as Animal Rights.
One of the first tasks undertaken by MREC in 1981 was to amend the Code of Practice for the use of animals in research. The task proved too difficult for a committee whose members were chosen for skills in looking at research involving humans. Subsequently a committee of experts from NHMRC, CSIRO and the Agricultural Council were brought together to complete the revision.
In 1984-85 an Animal Experimental Ethics Committee (AEEC) of the Medical Research Committee was set up to oversee the very large number of projects seeking Council funding for research using animals. This committee, later called the Animal Welfare Committee (AWC) was responsible for further reviews of the Code of Practice.
This Code, now the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, deals with the composition and functioning of AEECs, the responsibility of investigators, institutions and teachers, and the housing, care and breeding of animals used in research. It has been incor-porated in the legislation of most States and Territories, so the requirements of the Code are law.
Each year the Animal Welfare Committee examines the structure and the activities of each institutional AEEC and especially how it monitors its approved research, and oversees conditions in the animal house and how animals are transported. A very important aspect of each proposal received is the end point and the fate of the animals used.
The AWC may visit institutions where problems with animal research occur, and funds may be withheld if the provisions of the Code are not being fulfilled. The Committee is continually updating the Code and other documents to assist those conducting research involving animals. The animals range from rats and mice to dogs and cats, non-human primates and native animals.
In the early days some of the research community believed that an ethics committee which included non-scientific independent members could not and should not be able to approve or not approve good scientific research. This view has now largely disappeared and most of the research community appear happy to co-operate with the requirements of ethics committees.
The public is less suspicious and fearful of research knowing that there are independent committee members whose job is to protect the community from harm that might be caused through research. These committee members put in an enormous amount of usually unpaid time to serve on bodies monitoring research in the community. At a personal level the task is demanding, requiring understanding of the concepts and methods proposed and assessment of the outcomes of experiments, but it is also rewarding.
Australia leads the way in ethical guidelines. We were a long way ahead in drawing up rules regarding research in reproductive technology and IVF, and guidelines in other areas have also been at the forefront of advice to researchers. In animal research our practices are recognised all over the world.
Our system, so far, has led to less litigation, to better and safer research, and to a clearer understanding by the community of the ethical standards required by all who are involved in re-search using animals or humans.
There will always be differences of opinion regarding the value of research and the way it is carried out. At present we can be assured that each proposal for research involving humans or animals is well scrutinised by groups of very dedicated people.
Elizabeth Grant AM was a member of the MREC 1981-91 and a member of the AEEC and AWC from 1984 to the present. Her background is in pharmacy.