From Hippocrates to paternalism to autonomy : the new hegemony -- From autonomy to consent -- Consent, autonomy, and the law -- Autonomy at the end of life -- Autonomy and pregnancy -- Autonomy and genetic information -- Autonomy and organ transplantation -- Autonomy, consent, and the law.

Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant (...) may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)

A new culture of care -- Maximising capacity -- Assessing capacity -- Advocacy and empowerment -- Advance care planning -- Best interests -- Liberty and choice.

Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading (...) cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)

In this article Mr Tam Dalyell mp uses extracts from the speech1 he made in the House of Commons on 11 December 1974 to reiterate his reasons for persisting in his attempts to have formulated in law the right of hospitals to take such organs from a dead person as might be useful unless before death potential donors (all of us) had stated that they did not consent. Details of those objecting would be registered on a central computer.

We explore two special challenges indigenous peoples pose to the idea of sovereigns as trustees for humanity. The first challenge is rooted in a colonial history during which a trusteeship model of sovereignty served as an enabler of paternalistic colonial policies. The challenge is to show that the trusteeship model is not irreparably colonial in nature. The second challenge, which emerges from the first, is to specify the scope and nature of indigenous peoples’ sovereignty within the trusteeship model. Whereas the (...) interaction between states and foreign nationals is the locus of cosmopolitan law, the relationship between states and indigenous peoples is distinctive. In the ordinary cosmopolitan case, foreign nationals do not purport to possess legal authority. Indigenous peoples often do make such a claim, pitting their claim to authority against the state’s. We discuss how international law has attempted to come to grips with indigenous sovereignty by requiring states to include indigenous peoples in decision-making processes that affect their historical lands and rights. A crucial fault line in the jurisprudence, however, separates a duty to consult indigenous peoples from a duty to acquire their free, prior and informed consent. The latter but not the former recognizes that indigenous peoples possess a veto over state projects on their lands, in effect recognizing in them a limited co-legislative power. We focus on recent jurisprudence from the Inter-American Court of Human Rights, and consider whether either the duty to consult or FPIC are enough to dispel the shadow of the trusteeship model’s colonial past. We suggest that they are a move in the right direction, and that implicitly they represent international law’s recognition that states are no longer the sole bearers of sovereignty at international law. In limited circumstances, international law recognizes indigenous peoples as sovereign actors. (shrink)

Biobanks are proliferating rapidly worldwide because they are powerful tools and organisational structures for undertaking medical research. By linking samples to data on the health of individuals, it is anticipated that biobanks will be used to explore the relationship between genes, environment and lifestyle for many diseases, as well as the potential of individually-tailored drug treatments based on genetic predisposition. However, they also raise considerable challenges for existing legal frameworks and research governance structures. This book critically examines the current governance (...) structures in place for biobanks in England and Wales. It shows that the technologies, techniques and practices involved in biobanking do not always conform neatly to existing legal principles and frameworks that apply to other areas of medical research. Using a socio-legal approach, including interview data gathered from the scientific community, this book provides unique insights and makes recommendations about appropriate governance mechanisms for biobanking in the future. It also explores the issues around the secondary use of information, such as consent and how to protect privacy, when biobanks are accessed by a number of different third parties. These issues have relevance both within England and Wales and to a wide international audience, as well as for other areas where large datasets are used.--Back cover. (shrink)

A difficult task for politicians who want to fight injustice without doing wrong themselves is identifying where it is permissible to vote for and/or promote so-called “imperfect laws” which somewhat improve existing unjust legal situations but leave closely related injustices intact. One approach is to seek a “selective ban” on some injustices which are politically preventable. This approach is acceptable at least in principle, unlike the approach of “regulation”—i.e., permitting or instructing others to do, or prepare to do, the unjust (...) act in specified ways. The latter necessarily involves us in formal cooperation with evil: wrongly intending that others choose wrongly; for example, that abortion doctors deliberately prepare for abortion, albeit in ways that make an abortion less risky or less likely. In relation to parental consent or parental notification, and to pregnancy counselling and provision of information to pregnant women, while there may be ways of requiring these without complicity in others’ wrongful choices, this is at least more difficult than is often recognised. There can also be problems of principle in seeking consensus with fellow-legislators who may positively intend and even promote the continuation of remaining injustices even as they collaborate with more consistent reformers in passing laws which mitigate injustice overall. (shrink)