Should Gamete Donors be Allowed to Withdraw Consent from Embryo Research?

89 Should Gamete Donors be Allowed to Withdraw Consent from Embryo Research? J O N AT H A N M A C K E N N E Y In many parts of the world, including both the UK and Singapore, it is legally permissible to create embryos from donated gametes for research purposes. In these countries, specific guidelines and legislation include provisos that acknowledge a donor’s right to withdraw consent, necessitating removal of donated cells from research projects. However, most national guidelines on embryo research state that consent can only be withdrawn up to the point that an embryo is actually used for the purpose of any project or research. In apparent contrast, the Declaration of Helsinki (2008) provides, in principle, an unqualified right for a research participant to withdraw consent from involvement in a project at any time.1 The seeming inconsistency in consent procedure between universal ethical principles and specific guidance for embryonic research has led some to question if the limitations imposed on withdrawing consent are valid. Curtailing the right to withdraw consent has been justified on consequentialist grounds, including practical considerations of expense and inconvenience following withdrawal when research is already underway. Using Roger Brownsword’s concept of consent as a form of control over “person, property and privacy”,2 I take a rights-based position that withdrawal of consent is beyond the authority of the gamete donor once an embryo has been formed. According to this position, the apparent conflict between the Declaration of Helsinki and national guidelines can be resolved without altering policy at national levels. Apparent Inconsistencies in Policy Stem cell research is one of the most discussed modalities of research on human embryos at present. Many countries have specific laws and guidelines for creation Asian Bioethics Review June 2009 Volume 1, Issue 2 89–107 A R T I C L E S S h o u l d G a m e t e D o n o r s b e A l l o w e d t o Wi t h d r a w C o n s e n t ? J o n a t h a n M a c K e n n e y A s i a n B i o e t h i c s R e v i e w J u n e 2 0 0 9 Vo l u m e 1 , I s s u e 2 90 and use of human embryos in this context, some of which contain edicts on consent and its withdrawal. Singapore’s Bioethics Advisory Committee (BAC) recommends that scientists preferentially use pre-existing embryonic stem cell lines, or “spare” embryos created for assisted reproductive technology3 before they create new embryos. In the UK, the Human Fertilisation and Embryology Act (2008) also permits the creation of human embryos for research purposes.4 In order to create such an entity, human donors are required. Traditionally, these have been male and female gamete donors, although newer technologies such as cloning may change this prerequisite somewhat. In order to protect human participants in research projects, the World Medical Association published the Declaration of Helsinki. Now in its eighth revision, it continues to enshrine a code of “Ethical Principles for Medical Research Involving Human Subjects” that claims to be impervious to any other “national or international ethical, legal or regulatory requirement.”5 Although it carries no binding authority in national or international law, the document remains fundamental in policy formation worldwide. In its latest revision in 2008, withdrawal of consent continues to be unequivocally protected under principle 24: “The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.”6 A similar assertion can be found in article 14 of the Council of Europe’s “Additional Protocol to the Convention on Human Rights in Biomedicine, Concerning Biomedical Research”: “consent may be freely withdrawn … at any phase of the research.”7 Principle 1 of the Declaration of Helsinki states that its ambit includes “identifiable human material or data”8 and as Caulfield, Ogbogu and Isasi note, Canadian policy on...