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Surgical innovation involves practices, such as new devices, technologies, procedures, or applications, which are novel and untested. Although innovative practices are believed to offer an improvement on the standard surgical approach, they may prove to be inefficacious or even dangerous. This article considers how surgeons considering innovation should reason in the conditions of uncertainty that characterize innovative surgery. What attitude to the unknown risks of innovative surgery should they take? The answer to this question involves value judgments about the acceptability of risk taking when satisfactory scientific information is not available. This question has been confronted in legal contexts, where risk aversion in the form of the precautionary principle has become increasingly influential as a regulatory response to innovative technologies that pose uncertain future hazards. This article considers whether it is appropriate to apply a precautionary approach when making decisions about innovative surgery.

Demands for access to experimental therapies are frequently framed in the language of rights. This article examines the justifiability of such demands in the specific context of surgical innovations, these being promising but non-validated and potentially risky departures from standard surgical practices. I argue that there is a right to access innovative surgery, drawing analogies with other generally accepted rights in medicine, such as the right not to be forcibly treated, to buy contraceptives, and to choose to have an abortion, including a post-viability abortion where the mother's life or health is threatened by the pregnancy. I argue that we accept these rights because we believe that people are entitled to try to preserve their lives and health and to make choices of an important and intensely personal kind, and I suggest that a person's choice of medical treatment should be seen in the same light. However, since few rights are absolute, I also consider the circumstances in which it may be justifiable to limit the right to access innovative surgery. In discussing this question, I apply the human rights standard of proportionality, comparing the importance of the reasons for limiting the right with the severity of the invasion on liberty.

This article considers the issue of expanded access to innovative treatments in the context of recent legislative initiatives in the United Kingdom and the United States. In the United Kingdom, the supporters of legislative change argued that the common law principles governing medical negligence are a barrier to innovation. In an attempt to remove this perceived impediment, two bills proposed that innovating doctors sued for negligence should be able to rely in their defence on the fact that their decision to innovate was "responsible." A decision to innovate would be regarded as responsible if it followed a specified process. Although these changes to the law of medical negligence were not passed, this article argues that the idea of a process-based approach was sound. In the United States, a number of states have passed "Right to Try" laws that permit doctors to prescribe and companies to provide investigational products without the need for FDA approval. These laws do not purport to and nor are they able to alter the obligations of individuals and companies under federal law. They are consequently unlikely to achieve their stated aim of expanding access to investigational products. This article argues that they nevertheless have a cogent rationale in so far as they highlight the need for rights-based reform to federal regulations governing access.

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This article considers procedural justice in the law, with specific reference to the adjudicative context of governmental officials applying legal standards to particular cases. We critically survey the three main accounts of procedural justice in the literature: utilitarian, outcome-based, and dignitarian. Utilitarian and outcome-based theories share the instrumental view that the only purpose of procedures is to lead to accurate legal outcomes. However, the former are willing to trade off the benefits of accuracy against its costs, whereas the latter hold that procedural rights are necessary to guard against the injustice caused when individuals' legal rights are mistakenly denied.Dignitarian theories maintain that process matters apart from outcomes, because procedures should show respect for individuals' dignity in the Kantian sense of rational agency. We present a new perspective, drawing on relational theory. Relational theory holds that we are social creatures whose self-identities and sense of self-respect are bound up with the quality of our relationships with other individuals, groups, and institutions. Our relational account is informed by empirical research in social psychology which has found that people's evaluation of procedures is substantially influenced by relational concerns.

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