Parents or guardians should always be asked for their written consent before their child's organs or other biological material are used in scientific experiments, a major report to be launched by the Minister for Health today will recommend.
The report from the Irish Council for Bioethics, which is chaired by former attorney general Dermot Gleeson, also says genuine attempts should be made to contact individuals, or the families and next of kin of individuals,whose "archived" biological material may have been taken without consent.
If this is not successful, the matter should be referred to a research ethics committee, which would use a range of criteria to decide whether this material should be exempt from a requirement for consent.
The report also rules out support for a market for human biological material, but acknowledges the increasing commercial potential of human biological material. It says financial remuneration, other than expenses, should never be offered to research participants in exchange for the donation of human biological material.
The report recommends that researchers and sponsors of research should also consider sharing the commercial benefits of this research.This could be done by returning a percentage of the profits among the wider community from which the research participants were drawn.
Consent forms relating to the future use, storage and disposal of their biological material should also be developed.Such material should be stored in a secure manner.
The recommendations of the council have no statutory basis, but are intended to serve as a guide for the scientific and medical community here.
It says that where research on human biological material is used for commercial exploitation, "full and frank disclosure" of such commercial use, as well as the interests of the researchers involved, should be made to prospective research participants and to research ethics committees.
If research participants or their next of kin express a wish for biological material to be returned for burial this should be facilitated. Records of disposal should be maintained for inspection.
Researchers should always discuss with participants the potential commercial uses of their biological material.
"The human body and its parts shall not, as such, give rise to financial gain. Researchers may not sell for profit . . . biological material that they have collected for research purposes." The report says individuals should be allowed to refuse to take part in, or withdraw from, a research project without having to justify their decision.
"Evidence of free and informed consent should ordinarily be obtained in writing. In cases where it is not possible to obtain consent in writing, procedures used to seek and document informed consent shall be recorded, documented and maintained."
The Irish Council for Bioethics was set up in 2002 to consider ethical issues raised by advances in science and medicine.
Human biological material report: key proposals
Individuals should be entitled to refuse to take part in or withdraw from a study at any time. In the case of anonymous material, it should be made clear to research participants that it will not be possible to withdraw their sample once it is no longer identifiable.
Consent to a child's participation must be obtained from the parents/legal guardians and the child whenever he or she has sufficient competence to make this decision.
Evidence of free and informed consent should usually be obtained in writing.
Where possible, efforts should be made to contact individuals, or their families or next of kin, whose "archived" biological material may have been taken without their consent. Failing this, the matter should be referred to a research ethics committee for a decision.
Research ethics committees should satisfy themselves that the consent of persons in dependent or unequal relations - such as prisoners, students or terminally-ill patients - has been adequately and voluntarily obtained.
Consent for the removal of biological material during diagnosis or treatment should be explicitly separated from the consent to use any surplus material for research.
Research participants should never be offered any financial or material inducement to donate biological material for research other than reasonable expenses.
Researchers and sponsors of research should consider sharing the commercial benefits of any research.