IT would be easier to conduct genetic engineering research on humans than on animals, given the limits of Irish regulations.
A range of specific controls are applied to animal experimentation that do not apply to human studies, and most controls on human studies are voluntary and not based on EU or Irish law.
Policing of the controls is devolved to several State bodies depending on the type of research or study. For example, drug trials are licensed by the Irish Medicines Board while any genetic engineering is overseen by the Environmental Protection Agency. Animal tests and research are authorised by the Department of Health under animal cruelty Acts dating back to the last century.
The Medical Council has a well-defined policy on medical ethics and all physicians involved in treatments or research and registered by the council must agree to its terms, explained the chairman of the Council's ethics committee, Dr James Clinch. Doctors had an ethical obligation to preserve and improve life and were precluded from doing anything that invaded bodily integrity without the patient's consent, he said.
Research activity can only be conducted when a physician has the consent of the donor of a tissue sample or the recipient of the treatment. Doctors comply voluntarily with the ethical guidelines, he said, but there were no laws that forced compliance.
The EPA regulates research on and any possible release of genetically modified organisms (GMOs). This would extend at least in principle to human genetic engineering, according to Dr Tom McLoughlin, a scientific officer with the EPA. It oversees laboratories conducting research on GMOs and must issue a licence before any intentional release of a GMO, he says.
Its powers are derived from Irish legislation arising from two EU directives. Human genetic research could be carried out in a laboratory controlled by these regulations, he said, but he was not aware of any such research.
The use of gene therapy, where GMOs are used to treat conditions such as cystic fibrosis, present problems however. "The EPA would be responsible for the [GMO] organism," he said, but the Irish Medical Board would be controlling the medical trial.
Irish legislation for drug trials is "harmonised on a European level" said Dr Vincent Irwin of the IMB. It controls drug trials under the Clinical Trials Act and no trial can be undertaken without a licence, he said. "To the best of my knowledge there is no clinical trial using GMOs taking place in Ireland," he said. But research on human genetic engineering could be undertaken, as there are no laws restricting human research, according to a spokeswoman from the Department of Health.
In contrast, there are extensive controls on any animal research. They exist in two Cruelty to Animals Acts, the more recent derived from EU directives. Any laboratory conducting animal research must have a licence and is open to regular inspection, according to a specialist in animal research based in the university sector.
Proposals for animal studies must come from students at graduate level or higher and must be vetted and authorised by senior academic staff before a licence can be applied for to the Department of Health. Researchers must show there is no alternative to the research and studies are classed according to any discomfort that might be caused to the animal.
Unacceptable levels of discomfort will automatically disqualify any research, and unauthorised research can be prosecuted under the Acts.
