3 - Regulating experimental procedures and medical research

Summary

Involving humans in experimental procedures or medical research involves possible benefit and risk, and in regulating such activities three interests are usually involved: the recipient's, the professional's, and advancing medicine and science. With xenotransplantation the public interest is also engaged. When regulating any biotechnology these interests must be recognised and regulation usually takes two forms: the general regulatory framework applying to any experimental procedure and medical research, and any additional systems governing specific biotechnologies. The latter is considered in Chapter 4; here I explore how experimental procedures and medical research are defined, regulated and into which category genetically engineered solid organ xenotransplants fall. The regulatory schemes in England are used as an example of the problems which may be encountered when trying to regulate a developing biotechnology. I also draw on Australian, Canadian, New Zealand and the US schemes where relevant, and consider whether the current regimes are appropriate given the risks of xenotransplantation. To what extent is xenotransplantation on the general ‘regulatory radar’?

Knowing how an activity is classified is important as this affects the regulatory scheme to be followed and how and which recipients can be selected. I explore the legal provisions and ethical guidance on selecting recipients, and whether these offer appropriate parameters for experimenters/researchers and potential recipients. Can and should a competent, desperately or terminally ill patient with little or ‘no other hope’ be able to receive the first genetically engineered solid organ xenotransplant, as has been suggested? The risk is that desperately ill patients with no other hope will be used as research tools because of their understandable willingness to rely on remote chances of benefit. I consider the protection offered to potential xeno-recipients, and introduce some of the issues explored further in Chapter 5 relating to the principle of autonomy. Should people be allowed to sacrifice themselves in the (limited) hope of gaining some benefit for themselves, but with the more likely outcome being providing information for future generations, especially when the risks go beyond the potential beneficiary? Who receives a genetically engineered solid organ xenotransplant is important as there is a consensus that the risks necessitate recipients, and others, to agree to and comply with surveillance regimes, and if recipients are unable or unwilling to comply with these requirements public health may be jeopardised.