Bulletin of the World Health Organization

International perspectives on the ethics and regulation of human cell and tissue transplantation

Annette Schulz-Baldes, Nikola Biller-Andorno, Alexander Morgan Capron

Volume 85, Number 12, December 2007, 941-948

Table 1. Eight of the central ethical issues in the regulation of human cell (HC) and human tissue (HT) transplantation

Issue Agreement Disagreement
Consent for HC/HT removal • No HC/HT removal without consent• Informed consent for donation from living donors• Disclosure of possible limitations to withdrawing consent • Informed versus presumed consent in deceased donation?• Role of the next of kin (“family veto”) in deceased donation?° Obligation to inform about possible profit-making, international circulation or cosmetic applications?
Confidentiality of donor data • Confidentiality of donor data (with exceptions)
Unpaid HC/HT donation • Unpaid donation• Removal of financial disincentives for donation° Only not-for-profit institutions in donation discussions and the promotion of donation
Fair HC/HT procurement • Fair criteria for donor identification and selection ° Binding priority of organ over HC/HT recovery?
Stewardship for donated HC/HT • Obligation to honour and realize donor intent• Option to veto HC/HT use for research or education• No discriminatory restrictions of HC/HT use° Stewardship, effectiveness, accountability, fair pricing, responsiveness to local and/or national needs and fair allocation are more important than institutional for-profit/not-for-profit structure ° Option to veto HC/HT use abroad or for cosmetic applications?
Quality and safety management • Necessity of quality and safety management• Long-term follow-up of donors and recipients • Balance between quality, safety and HC/HT availability in resource-poor settings?
Fair distribution of processed HC/HT • Need for allocation criteria and prioritization rules despite limited scarcity° General priority of HC/HT use for life-saving over life-enhancing and cosmetic purposes° General priority of local and/or national self-sufficiency ° Scope of allocation criteria and prioritization rules: institutional, national, subregional?° Institutional reciprocity as an allocation criterion?° For-profit organizations in HC/HT distribution?° General priority of subregional self-sufficiency?° International HC/HT circulation to subsidize public health care?
Consent for HC/HT transplantation • No HC/HT transplantation without voluntary and informed consent ° Obligation to inform recipients about profit-making and international circulation?° Limits of consent for medically contested uses?

• normative agreement or disagreement was analogous to that for organ transplantation;° normative agreement or disagreement was specific for HC/HT transplantation.

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