Each institution is responsible for ensuring that adequate resources are made available to its IEC for the assessment and ongoing monitoring of approved research protocols. Recommendation 8.1
An institution should not establish an IEC unless the institution can assure AHEC that there are adequate means for resourcing the committee. Recommendation 8.3
5. To Researchers
The UK, MRC distinction between innovative therapy/treatment and research should be adopted by AHEC and the Statement on Human Experimentationmodified to reflect that the systematic use of an innovative treatment or therapy be considered as research and consequently be subject to assessment by an IEC.
(a) Where a particular experimental treatment/intervention is expected to benefit an individual patient it may be considered as innovative practice rather than research. Where this is the case, the treatment should be governed by doctor/patient ethics considerations.
(b) Where any innovative therapy/intervention undergoes systematic investigation (i.e., is trialed on a number of patients) it should be subject to the same ethical assessment as any research protocol. Recommendation 5.2.1 Researchers should endeavour to simplify all Consent Forms for research subjects and should aim to achieve a form of words which is understandable by a student with Grade 8 schooling. Recommendation 6.4.2
6. Further Recommendations
Funded positions should be created in each State for an “area liaison” officer whose duties will involve coordination of liaison between AHEC and IECs and fostering communication/networking between IECs.
Recommendation 8.4
Schedule 2
Academy of Technological Sciences and Engineering also gave the National Statementits support, as did the Ministers for Health and Aged Care, Industry, Science and Resources, and Education and Youth Affairs.
The significance of this level of support for the National Statementshould not be underestimated, as it will ensure a very high standard of protection for participants in all areas of research. All research involving human participants conducted in Australian universities, funded by NHMRC or the Australian Research Council, or involving the learned academies, will now have to be conducted in accordance with these guidelines.
National Workshops
In August 1999, the National Statementwas the focus of a series of workshops convened in the capital cities of each State and Territory, and including Alice Springs. These workshops were designed to facilitate the use and understanding of the National Statementby those directly responsible for the maintenance of ethical standards of research in Australia. They were attended collectively by approximately 1,000 representatives of Human Research Ethics Committees from around the country.
Human Genetics
A further major achievement for AHEC has been the finalisation of two guidelines in the field of genetics:
Guidelines for Genetic Registers and Associated Genetic Material and Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies.
Guidelines for Genetic Registers and Associated Genetic Material covers all aspects of register operation and provides guidelines in such difficult areas as gathering, using and releasing register data and associated genetic material; recruiting people to genetic registers and obtaining their consent; and security and storage of genetic material. The revised document has a wider focus than the original guidelines.
Human somatic cell gene therapy remains experimental. Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies provides guidance to Human Research Ethics Committees that are asked to review and approve research proposals involving somatic cell gene therapy, and assists researchers to prepare their submissions for ethical review. The document identifies bodies other than Human Research Ethics Committees from which approval may need to be obtained. An information paper on human somatic cell gene therapy, that provides background information to the Guidelines, is included with the Guidelines.
A third genetics document is expected to be finalised early in 2000. Ethical Aspects of Human Genetic Testing— an information paper addresses issues of equity, access and resource allocation; commercialisation;
geneticisation; counselling; and genetic testing of children. Although not formal guidelines, this information paper has been the subject of wide consultation— a feature which has strengthened the document.
Genetics is an ever-changing field of research and the guidance and guidelines developed by AHEC will play a crucial role in protecting individuals whilst encouraging a high standard of research.
Human Research Ethics Committees
Compliance by Human Research Ethics Committees with NHMRC ethics guidelines is reported annually to the Research Committee and NHMRC. This process ensures consistent application of the guidelines as well as providing an auditing mechanism to support quality research.
In 1999, AHEC continued to provide support to Human Research Ethics Committees by acting as a focal point for queries and concerns as well as preparing guidelines on issues that are likely to be raised during the conduct of research. A major thrust to this end was the 1999 Workshop series which introduced the new National Statementand gave representatives from the research, academic and HREC sectors an opportunity to discuss issues of concern.
AHEC is developing an operating manual for Human Research Ethics Committees, which is expected to be
providing procedural advice on the application of the National Statement on Ethical Conduct in Research Involving Humans.
Section 95 Privacy Guidelines
Stage two of the public consultation process for the privacy guidelines was conducted in 1999. The Privacy Act 1988 (Commonwealth) authorises the NHMRC to issue guidelines for the protection of privacy in the conduct of medical research. The Federal Privacy Commissioner is also involved in this process. The existing guidelines, Aspects of Privacy in Medical Research, were issued in 1995.
The revision of these guidelines is a result of a number of changes in the environment in which the guide-lines operate, namely the introduction of the NHMRC Act 1992 and the National Statement on Ethical Conduct in Research Involving Humans,and developments in privacy regulation.
The guidelines provide a framework in which medical research involving personal information obtained from Commonwealth agencies should be conducted, to ensure that such information is protected against unauthorised collection or disclosure.
The revised Guidelines under Section 95 of the Privacy Actwere developed in collaboration with the Federal Privacy Commissioner. Two stages of public consultation were conducted as required by the NHMRC Act, and AHEC endorsed the revised guidelines at its November 1999 meeting. They will be tabled at Council and in the Federal Parliament in early 2000.
Aboriginal and Torres Strait Islander Guidelines
AHEC has reaffirmed its commitment to the protection of Indigenous Australians participating in research by planning a revision of the ‘Interim guidelines for ethical matters in Aboriginal and Torres Strait Islander health research.’ Recognising that the revision must be a transparent and inclusive process, AHEC is committed to full consultation.
Ethical, Legal and Social Implications Program
AHEC organised the Ethical, Legal and Social Implications (ELSI) program of the Human Genome Organisation’s 1999 meeting. The meeting was a vehicle by which AHEC was able to showcase its own work, as well as contribute to the national and international debate on ethical issues.
The ELSI program included a debate, chaired by the Hon. Justice Michael Kirby, that “Too much is expected of human genetics research and the human genome project.” It was judged a great success by participants.
Three workshops were chaired by AHEC members and were part of the ELSI program. These were:
‘Commercialisation and benefit-sharing’; ‘Religious and cultural perspectives in contemporary genetics’; and
‘Genetic susceptibility testing.’
The financial and intellectual contributions made by the Australian Health Ethics Committee were duly acknowledged. The ELSI program was highly praised by participants and the President of HUGO, and was considered to be one of the best prepared and attended.
Conclusion
This is the third year of the triennium and, in doing my report, I would like to pay tribute to the dedicated and hard-working members of AHEC who have given unstintingly of their time. The Committee’s success is due to the combined efforts of members.
It has been my pleasure to chair this Committee for a second triennium. The challenges for AHEC in the future are increasing, especially as a result of the increased use of technology and the improvements in health care testing and information collection.
Professor Donald Chalmers Chairman