Human ethics/bioethics
How are human ethics considered in New Zealand?
Ethical approval is required for a range of biotechnological (and other) procedures. These involve the collection of cell or tissue samples from humans, the conducting of clinical trials, and some reproductive research or technologies. In addition, the Environmental Risk Management Authority may also have to consider ethical issues in its decision making, and the New Zealand Bioethics Council is an advisory body that considers ethical implications of biotechnology. The National Ethics Advisory Committee is also responsible for providing advice to the Minister of Health on ethical issues of national significance. Further information on these are provided below.
Collection of cell and tissue samples
Collection of tissue samples from people for research requires assessment by a human ethics committee. The Human Tissue Act 1964 regulates collection and use of tissue samples from deceased individuals. This Act is currently being reviewed, and new legislation is expected to be introduced in the second half of 2006. Note that if cells or tissues have been obtained from a culture collection rather than directly from a donor then ethics approval may not be required. Check with your ethics committee. The Ministry of Health is drafting Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines For Research. When finalised, the guidelines will provide a framework for scientists and ethics committees when considering importing and using established human embryonic stem cell lines.
The organisation of ethics committees was changed in 2004, following a review of the system of ethical review of health and disability research. Health and disability ethics committees assess applications for research in their region, while the Multi-region Ethics Committee assesses applications that involve several regions. The New Zealand Health and Disability Ethics Committee webpage has more information for ethics committee members, study participants and researchers.
The HRC Ethics Committee has responsibility for providing guidelines for ethical research [53 pages, 365Kb, PDF] and accrediting health and disability ethics committees. The HRC has also produced guidelines on ethical considerations relating to research in human genetics [12 pages, 45Kb, PDF].
Ethical review of clinical trials
Clinical trials are to test the safety and efficacy of medicines. Ethical review of clinical trials by a health and disability ethics committee considers whether the trial meets ethical guidelines, such as how people are selected for the trial and whether they are provided with enough information to be able to make an informed decision. Further information on the types of clinical trials is provided in the Glossary. Researchers may wish to consult the guidelines from the Ministry of Health's Operational Standard for Ethics Committees, as well as the HRC's ethical guidelines.
Ethics associated with reproductive procedures and research
In 2004 the Human Assisted Reproductive Technology Act 2004 (the HART Act) was enacted. This Act establishes what are prohibited reproductive procedures and areas of research, and sets out the process for seeking ethical approval for non-prohibited procedures that are not considered established assisted human reproductive procedures. An example of a procedure that is not currently considered established is the use of a surrogate mother in conjunction with an assisted reproductive procedure. An example of a prohibited procedure is the cloning of humans for reproductive purposes.
Ethical oversight under the HART Act includes a Ministerial advisory council (ACART) and an ethics committee (ECART).
The Advisory Committee on Assisted Reproductive Technology (ACART) (of 8 - 12 members) provides advice on assisted reproductive procedures and human reproductive research to the Minister of Health, issue guidelines to the ethics committee, and monitor developments in assisted reproductive procedures and human reproductive research. The advisory committee is required to consult on the guidelines that it proposes to issue.
The Ethics Committee on Assisted Reproductive Technology (ECART) considers applications for non-established procedures or human reproductive research in line with the guidelines and advice issued by the advisory committee. The ethics committee is able to cancel previous approvals when it becomes aware of serious risk to human health and safety. Those people carrying out research must provide progress reports to the ethics committee and a final report upon completion of the research.
An assisted reproductive procedure can be declared an established procedure by Order in Council. Established procedures do not require ethical approval, although ACART will monitor established procedures and may declare an established procedure prohibited (or require an ethical approval) if unanticipated problems arise. In recommending that a procedure become an established procedure, ACART must make an assessment of known risks and benefits, an assessment of whether the risks are acceptable, and an ethical analysis. Contact the Ministry of Health for more information.
Procedures that are not covered by guidelines or advice from the advisory committee cannot be approved by the ethics committee.
Prohibited Human Assisted Reproductive Procedures
The HART Act lists prohibited actions. These include genetic modification of gametes and embryos for reproductive purposes, and the use of gametes from foetuses for reproductive purposes. Selection of an embryo on the basis of sex is only permitted to prevent or treat a genetic disorder or disease. Schedule 1 of the HART Act contains a list of prohibited actions.
Environmental Risk Management Authority
Some applications made under the Hazardous Substances and New Organisms Act can raise ethical issues. ERMA has established an Ethics Advisory Panel and is developing a framework for dealing with HSNO applications raising ethical and cultural issues so that it has a more explicit process for identifying and recognising ethical considerations. See ERMA's website for more information on how it considers ethical issues.
Bioethics Council
Toi te Taio - the Bioethics Council - is an advisory body that was established to look at ethical, cultural and spiritual issues arising from biotechnologies of an overarching nature. There is no formal or legislative relationship between Bioethics Council and regulatory agencies such as ERMA NZ. However, some of the applications that ERMA receives raise ethical, cultural and spiritual issues of general interest and or concern that the Council may want to investigate.
The Council has recently investigated the ethics of using human genes in other organisms, and their report is available on their website. In 2005 they are investigating xenotransplantation (animal to human organ transplantation).
