Stem cell research ethics: consensus statement on emerging issues.

This article is a consensus statement by an international interdisciplinary group of academic experts and Canadian policy-makers on emerging ethical, legal and social issues in human embryonic stem cells (hESC) research in Canada. The process of researching consensus included consultations with key stakeholders in hESC research (regulations, stem cell researchers, and research ethics experts), preparation and distribution of background papers, and an international workshop held in Montreal in February 2007 to discuss the papers and debate recommendations. The recommendations provided in the consensus statement focus on issues of immediate relevance to Canadian policy-makers, including informed consent to hESC research, the use of fresh embryos in research, management of conflicts of interest, and the relevance of public opinion research to policy-making.

Children and medical research.

A considerable proportion of medical treatments for children are based on estimates and assumptions rather than clinical evidence. Clinical research on children provokes intensive discussion internationally. While children are protected from the risks of clinical trials, they are hindered from receiving the benefits of pharmaceutical innovations obtained by adults. The recruitment of children into research trials is more complicated than that of adults for several reasons: 1) the physical size and relative water content of the body differs not just compared to adults but also amongst subgroups of children making the group of potential participants relatively small; 2) diseases common among adults may be rare among children and vice versa; 3) children's ability to understand the significance of a study varies and depends on the age and developmental stage of the child; and 4) depending on the level of understanding, differing views have been given on the degree of respect that should be paid to a child's right to consent, assent, or refuse to participate in a trial. We suggest that: 1) the number of children recruited in research trials should be kept as small as possible, but large enough to enable scientifically valid results; 2) special training should be made mandatory for researchers who study diseases of children; 3) children or adolescents should participate in decision-making that concerns them whenever possible; and 4) in minor procedures, the consent of just one parent is sufficient.

Law, ethics and professional guidelines in medical research.

The volume of law and other regulation in medical research has expanded enormously within the last five years. Researchers need an awareness of how these legal instruments are hierarchically related, so they know which regulation to apply where there is a conflict of norms. They also express concern on whether there is any space left for ethical and professional guidelines in the light of all this formal regulation. This paper addresses these two issues. It is argued that when drafting new legislation or guidelines, room must be left for responsible individual decision-making.

Medical research on minors in Finland.

This article concerns the legal regulation of medical research on children in Finland. The topic is covered by the Medical Research Act of 1999 and by the Recommendations issued by the Working group on medical research on children in 2003. The Decisions of the Parliamentary Ombudsman also play an important role in this area in Finland. The article focuses on two specific issues: involvement of guardians in decision-making for the child, and the expansion of the right to self-determination of minors. Two case examples on these topics are also discussed. Overall, the author comes to the conclusion that the Finnish legislation, policy-makers, investigators and the industry have succeeded well in taking into account international legislation in this area, although there is also room for improvement.

Medical research on patients with dementia--the role of advance directives in European legal instruments.

Current international legal instruments recognise the use of advance directives to carry on the will of the dementing research participant beyond the boundaries of her present legal capacity. Advance directives are gaining greater recognition in patient care than in medical research, where their legal status is still somewhat unclear. In particular, the three major international documents on medical research - the Council of Europe Convention on Biomedicine and Human Rights (ETS 164), its Additional Protocol on Biomedical Research (ETS 195), and Directive 2001/20/EC on Clinical Trials on Medicinal Products--give conflicting messages on the legal status of advance directives in medical research. This article examines the provisions in these documents and their national applications in Finland and the United Kingdom.