How to deal ethically with the use and disposal of human tissue samples isone of the difficult issues to be tackled by the Irish Council for Bioethics, launched yesterday by the Tánaiste, Mary Harney. The council's scientific director talks to Dick Ahlstrom
Revelations about the retention by hospitals of human organs and tissue samples have caused shock and deep public disquiet. This concern highlights the need for an organisation to monitor research activity, in human health and the wider area of genetic research.
The Tánaiste, Mary Harney yesterday officially launched just such a body to ensure that ethical standards are applied in Irish laboratories. The Irish Council for Bioethics has a wide remit to devise an acceptable ethical framework that will be applied in a range of research areas.
The council's official launch took place in Dublin at the Royal Irish Academy (RIA), where it has been working for some time - it held its first meeting last May.
Harney mooted the creation of a broadly based advisory body on ethics last Monday during her keynote address on Government science policy. She did not clarify whether it should be an existing body such as the new council or a completely new body, for example modelled on the UK's Royal Society or the US National Academy of Sciences.
The council now has a three-year remit to develop ethical standards for research. She applauded the RIA for creating the council, following a request from her Department. She also said that with State investment in scientific research reaching unprecedented levels, "the time has come for us to consider whether an advisory body should be introduced to advise the Government on related ethical issues".
Another body with a similar mandate, the Commission on Assisted Human Reproduction, has been working for two years to develop recommendations for Government on issues such as in vitro fertilisation, human embryo and stem cell research and related contentious subjects. It is due to report later this year.
The Bioethics Council is initially concentrating on three areas, according to its scientific director, Dr Siobhan O'Sullivan. These include the handling, storage and disposal of human biological samples; genetically modified organisms (GMOs) including food products; and defining what bodies and organisations should have ethical committees overseeing their activities. "It is an independent body set up to look at ethical and moral implications of biological research," O'Sullivan explains.
An interdepartmental report in 2000 suggested the creation of a bioethics body. As constituted, the council has 21 permanent members, with a number of working groups that include co-opted specialists. All those involved in the permanent council and working groups contribute their time free of charge.
The council working groups build a consensus on a given issue, which is then considered and agreed upon by council. Its findings include guidelines for the best international practice to be applied here, she explains. The Government and representative bodies, as well as the researchers themselves, want these ethical guidelines, she believes.
"We want to make it possible to do good ethical research in this country that people will want to take part in," she says. The council members "are not there to represent any organisation, they are there to contribute in their areas of expertise".
Nor will the council be laying down the law on any issue. "Anything that comes out of here isn't going to be the 'word of God'. We are not here to tell people what they should think about cloning. It is up to society as a whole to decide how they want to live. We will present the issues and stimulate public debate, an informed public debate."
Presentation of information to the public is an important part of the council's role," she says. "One of our central roles is to stimulate this debate. People have to be informed because there are tough decisions to make and they'll have to make these decisions. The ramifications of all of these issues are huge for society."
She also acknowledges that the retention of tissue samples - in many cases without patient or family consent - caused huge disquiet about research practices. "There were no guidelines for people working in the field. I thought the biological samples collected would have been straightforward but for the problems that have arisen over the past few years."
The first working group is "looking at all the issues surrounding the collection of biological samples, their use and storage and ethical issues, including what they are used for and how they are disposed of. We hope to put together guidelines to help practitioners use the best practice for handling these samples," she says.
"If people knew what they were getting into, you can explain quite easily to people," she believes. "If you would tell people that, they would be quite happy to supply samples." People are usually quite willing to support medical research if they have all the information.
Surprisingly, the GMO issue is more contentious, she believes. "From a public perspective, GMO is the most sensitive area. Everyone eats food, so it affects everyone. People have real concerns. Is it food you are prepared to feed your baby? "We are looking at the technical issues such as whether they are safe, the environmental issues and the whole area of who controls our food."
The third working group is looking at existing ethical committees, for example, within hospitals and research centres and whether more organisations need such an overseeing group. "We have no guidelines for the Irish situation. What is best practice for an ethical committee? We act as a reference body for those groups," she says.
The council does not yet have a working group looking at cloning, embryo research and related areas, although she expects to have one by the end of the year. It will take on board the recommendations put forward by the Commission on Assisted Human Reproduction, she says.
She also expects the council to have a lifespan longer than its initially planned three years. "Bioethics issues are not going to stop in three years and who knows what is going to come next," she says.
