Ethics Issues in Stem Cell Research

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Science  21 Apr 2006:
Vol. 312, Issue 5772, pp. 366-367
DOI: 10.1126/science.312.5772.366

The International Stem Cell Forum (ISCF) supports research on all stem cell types, including adult stem cells, embryonic stem cells, and stem cells from umbilical cord blood (1). The Ethics Working Party (EWP) of the ISCF has 19 participants from 17 (2) countries. In 2004, the EWP defined its mission as (i) clarification of ethical issues and, where possible, the international harmonization of ethical standards; (ii) the sharing of stem cell lines; and (iii) an agreement on standards for the characterization and registration of lines. As it pursued this mission, by conducting ongoing study of regulatory approaches to human embryonic stem cell research in 50 countries, the EWP identified certain international trends, effective practices, and emerging issues that require further discussion and clarification.

International trends include the following. A small number of countries prohibit all embryonic stem cell research (3). Most other countries either permit in vitro research with embryos with no mention of stem cells, limit the creation of stem cell lines to surplus in vitro fertilization (IVF) embryos under certain conditions (such as governance, accreditation, ethics review, and restrictions on research objectives), or limit research to imported cell lines. Seven countries (4) explicitly permit the creation of embryos for research purposes, but it must be shown that the research cannot be achieved with the use of other stem cell lines (such as IVF embryos or adult cell lines). All 50 countries studied prohibit or strongly discourage human reproductive cloning (through laws or guidelines). In most countries that allow human embryonic stem cell derivation from human embryos, there are shared principles as well as professional norms and substantive and procedural conditions that further constrain this work. Currently, common principles and procedures include respect for human dignity (5); respect for life (limiting growth to 14 days, at which time the primitive streak forms); autonomy (requirement for informed donor consent); donor and/or patient privacy and confidentiality; noncommercialization (prohibiting the buying and selling of embryos); avoidance and declaration of conflicts of interest; limitation to therapeutic purposes (in contrast to reproductive cloning); ethics review before commencement of study; and the traceability of cell lines with respect to their sources.

In the absence of a more formal international ethics framework specific to stem cell research, some countries have added more stringent and effective practices. Licensing requirements ensure the competence of personnel and the quality and safety of stem lines and verify the informed consent of participants. Equivalence requirements ensure that the importation or exportation of stem cell lines is limited to countries that meet the ethical requirements of the host country and are lawful in the importing country. Sunset clauses (6) in guidelines or laws ensure continual review of changing scientific and socioeconomic norms. Additional requirements include monitoring the research using the established lines in stem cell banks.

Recent evidence of scientific fraud and unacceptable egg donor procurement practices in South Korea (7) highlights the importance of regulation as an emerging issue in this field. Scientific responsibility and integrity must be promoted with attention to possible economic and political influences that might negatively affect researchers. Incentives for open exchange, registration, and validation of results need to be identified. The conditions (such as financial gain, informed consent, protections of confidentiality, and privacy of the donor) for egg donation for IVF treatment should be distinguished from the conditions surrounding egg donation for research purposes, and potential egg donors should be informed clearly as to the intended uses of their eggs. The failure to follow good ethical practices in egg donation could result in a loss of trust and reluctance to donate among prospective donors. The scarcity of human ova available for research makes human-animal chimeras more attractive, but the application of chimeras to stem cell research requires conceptual clarification and attention to its ethical dimensions. Finally, transparency on the powers and the composition of the necessary oversight bodies is a sine qua non for all stem cell research irrespective of a country's position.

International Stem Cell Forum Ethics Working Party

ISCF EWP, Centre de Recherche en Droit Public, Université de Montréal, Montreal, QC H3C 3J7, Canada. The members of the ISCF EWP are B. M. Knoppers (Chair) (Université de Montreal), G. Richardson (King's College London School of Law), E. H. Lee (National University of Singapore), J. Kure (Masaryk University, Czech Republic), G. de Wert (University of Maastricht, Netherlands), J. C. Ameisen (French Institute of Health and Medical Research), L. Lötjönen (National Advisory Board on Research Ethics, Finland), K. Breen (National Health and Medical Research Council, Australia), R. Isasi (Université de Montreal), A. Mauron (University of Geneva), T. Murray (The Hastings Center, New York), and J. Wahlström (University of Gothenburg, Sweden).

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