Informed consent in embryonic stem cell research: are we following basic principles?

• Published in: Canadian Medical Association journal (CMAJ) 2007-06, Vol.176 (12), p.1722-1725
• Main Authors: Caulfield, Timothy, Ogbogu, Ubaka, Isasi, Rosario M
• Format: Article
• Language: English
• Subjects: Analysis; Bioethics; Blood & organ donations; Canada; Consent; Embryo Research - ethics; Embryo Research - legislation & jurisprudence; Embryology, Experimental; Embryonic Stem Cells; Ethical aspects; Ethics Committees, Research; Guidelines as Topic; Humans; Informed consent (Medical law); Informed Consent - ethics; Informed Consent - legislation & jurisprudence; Laws, regulations and rules; Patient Rights; Regulation; Research methodology; Stem cell research; Stem cells; Tissue Donors - ethics; Tissue Donors - legislation & jurisprudence
• ISSN: 0820-3946; 1488-2329
• DOI: 10.1503/cmaj.061675

Despite this tradition, many policies about research on embryonic stem cells limit the right to withdraw consent to a specific time during the research process, usually to any time before a stem cell line is created (Table 2). One can certainly see why, from the perspective of researchers, it is desirable to have a clear cut-off for when consent can be withdrawn. Allowing research participants to withdraw their consent after a cell line has been created could create unique and profound problems for researchers. Indeed, a stem cell line could end up in hundreds of laboratories throughout the world. However, this logistical reality needs to be explicitly balanced and reconciled with the general principle that the goals of research do not supersede individual rights.21,22 Likewise, in analogous situations, such as biobanking projects, most policy documents explicitly note the existence of the right to withdraw consent.27,28 Of course, if a stem cell line is made truly anonymous, withdrawal of consent will not be possible. In such circumstances, donors should be made aware of this during the consent process. However, in the current environment, it seems unlikely that a stem cell line could be made truly anonymous. There are currently so few stem cell lines in Canada that anonymity could never be fully achieved. In addition, this may not be a desirable course of action. Having continuing access to the health status of the donor may be necessary if, for instance, a cell line is to be used for clinical trials. Traceability of stem cell lines is an internationally accepted ethical and scientific standard for stem cell research, and this requirement has been incorporated into a number of national policies.11,30 It has recently been suggested that, in the context of stem cell research, "donor contact information should be kept current to facilitate rescreening."31 It seems self-evident that, if linkage and recontact is required, the right to withdraw consent, at some level, should endure. Although consent policies are always evolving, the rationales that underlie the existing consent norms should not be ignored. We need to be sure that the hype and social controversies that have surrounded this area of research do not lead us to overemphasize either the benefits or the risks.33"34 We should avoid overly protectionist assumptions that would have us alter the usual approach to obtaining consent, including allowing clinicians to obtain the necessary consent. Likewise,