XENOTRANSPLANTATION, CONSENT AND INTERNATIONAL JUSTICE

The risk posed to the community by possible xenozoonosis after xenotransplantation suggests that some form of 'community consent' is required before whole organ animal-to-human xenotransplantation should take place. I argue that this requirement places greater obstacles in the path of ethical xenotransplantation than has previously been recognised. The relevant community is global and there are no existing institutions with democratic credentials sufficient to establish this consent. The distribution of the risks and benefits from xenotransplantation also means that consent is unlikely to be forthcoming. Proceeding on the basis of hypothetical consent to a package of global health measures that includes xenotransplantation, as Rothblatt has recently advocated, is more problematic than she acknowledges. Given that it may place the lives of citizens of poor nations at risk to benefit the citizens of wealthy nations, xenotransplantation raises significant questions of international justice.     

ABORTION COUNSELLING AND THE INFORMED CONSENT DILEMMA

An obstacle to abortion exists in the form of abortion ‘counselling’ that discourages women from terminating their pregnancies. This counselling involves providing information about the procedure that tends to create feelings of guilt, anxiety and strong emotional reactions to the recognizable form of a human fetus. Instances of such counselling that involve false or misleading information are clearly unethical and do not prompt much philosophical reflection, but the prospect of truthful abortion counselling draws attention to a delicate issue for healthcare professionals seeking to respect patient autonomy. This is the fact that even accurate information about abortion procedures can have intimidating effects on women seeking to terminate a pregnancy. Consequently, a dilemma arises regarding the information that one ought to provide to patients considering an abortion: on the one hand, the mere offering of certain types of information can lead to intimidation; on the other hand, withholding information that some patients would consider relevant to their decision‐making is objectionably paternalistic on any standard account of the physician‐patient relationship. This is an unsettling conclusion for the possibility of setting fixed professional guidelines regarding the counselling offered to women who are considering abortion. Thus, abortion ought to be viewed as an illuminating example of a procedure for which the process of securing informed consent ought to be highly context‐sensitive and responsive to the needs of each individual patient. This result underscores the need for health care professionals to cultivate trusting relationships with patients and to develop finely tuned powers of practical judgment.     

UNINFORMED CONSENT: MASS SCREENING FOR PROSTATE CANCER

While medicine may agree in principle that cancer screening requires informed consent, such consent is not, in fact, common practice. In the case of prostate‐cancer screening this means that men in large numbers undergo PSA testing with little understanding of its liabilities – in particular, that it may or may not decrease mortality, often detects cancer of questionable significance, and may lead to unnecessary surgery. Given that prostate cancer is known to be overtreated and that family history is a risk factor, it follows that a man diagnosed with prostate cancer, even if it is of no clinical significance, automatically promotes his son into the high‐risk category; and given that those so categorized are subject to heightened medical surveillance and that the more diligently medicine searches for prostate cancer the more likely it is to find it, it follows that the sons of men diagnosed as a result of PSA testing are at risk of being overdiagnosed (and overtreated) precisely because their father was. Twenty years into the PSA revolution, its generational consequences have not been discussed in the medical literature.     

RECONSIDERING THE VALUE OF CONSENT IN BIOBANK RESEARCH

Biobanks for long‐term research pose challenges to the legal and ethical validity of consent to participate. Different models of consent have been proposed to answer some of these challenges. This paper contributes to this discussion by considering the meaning and value of consent to participants in biobanks. Empirical data from a qualitative study is used to provide a participant view of the consent process and to demonstrate that, despite limited understanding of the research, consent provides the research participants with some level of control and a form of self determination that they value. Participation is framed as a moral act of a responsible citizen providing reinforcement of self identity. Consent symbolizes the trust invested in researchers and research institutions to use the biobank for the public good. The paper argues that consent continues to play an important role in biobank participation and that a participant view should inform proposals to modify consent processes.     

CULTURE AND VOLUNTARY INFORMED CONSENT IN AFRICAN HEALTH CARE SYSTEMS

This paper discusses how to apply a collective decision model of the principle of voluntary informed consent in African communitarian culture, in a culturally sensitive way, in order to protect research candidates from potential exploitations and abuses. Dismissing cultural and ethical skepticism surrounding the global application of the principle of voluntary informed consent, the paper ultimately concludes that international collaboration on diagnostic and therapeutic medical research in Africa, especially HIV vaccine trials, is a moral imperative.     

ANOTHER LOOK AT THE PRESUMED-VERSUS-INFORMED CONSENT DICHOTOMY IN POSTMORTEM ORGAN PROCUREMENT

In this paper I problematise quite a simple assertion: that the two major frameworks used in assessing consent to post‐mortem organ donation, presumed consent and informed consent, are procedurally similar in that both are ‘default rules.’ Because of their procedural common characteristic, both rules do exclude marginalized groups from consent schemes. Yet this connection is often overlooked. Contract theory on default rules, better than bioethical arguments, can assist in choosing between these two rules. Applying contract theory to the question of post‐mortem organ donation suggests that the default rule should be one that goes against the wishes of the stronger party in consent decisions.     

PROCESS FOR OBTAINING INFORMED CONSENT: WOMEN’S OPINIONS

In Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96. 1 Consent must be obtained through a specific structured process. Objective: To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods. Subjects and Methods: Eight focus groups were conducted, involving a total of 51 women living in the metropolitan region of Campinas. The women involved in the study were either participating in a clinical trial in the area of women’s health or had participated in such a trial in the previous 12 months. A thematic guide was used to conduct the focus group discussions; the discussions were recorded, transcribed and a thematic analysis performed. Results: In general, the person who invites a woman to participate in a study should be a member of the research team but not the principal investigator. Information relating to the study should be given orally and in writing, both individually and in the group setting. Study volunteers should be informed about, among other things, the risks, possible side effects and discomforts, including long‐term effects. The use of audiovisual aids to provide information was suggested. Conclusion: The process for obtaining informed consent was seen as a means of establishing a relationship between the volunteers and the investigator/research team. The information that the study participants expected to be given coincides with the requirements established under Resolution 196/96. The use of audiovisual aids would improve understanding of the information provided.     

THE WORLD WAR II PLUTONIUM EXPERIMENTS: CONTESTED STORIES AND THEIR LESSONS FOR MEDICAL RESEARCH AND INFORMED CONSENT

During the Second World War medical researchers around the USAinjected 18 hospital patients with radioactive plutonium in orderto learn its effects on the body. Two documents, a newspaperaccount and a university committee report, tell divergent storiesof the scientists and patients involved in that experiment. Thisarticle uses those documents – plutonium narratives– as a catalyst for exploring the problematicrepresentation of past human experimentation, assumptions of moralprogress in medical research, and the nature of informed consenttoday. Informed consent is shown to be an evolving process anddiscursive practice that cannot be understood apart from itshistorical and cultural embeddedness.     

TRUSTED CONSENT AND RESEARCH BIOBANKS: TOWARDS A ‘NEW ALLIANCE’ BETWEEN RESEARCHERS AND DONORS

We argue that, in the case of research biobanks, there is a need to replace the currently used informed consent with trusted consent. Accordingly, we introduce a proposal for the structure of the latter. Further, we discuss some of the issues that can be addressed effectively through our proposal. In particular, we illustrate: i) which research should be authorized by donors; ii) how to regulate access to information; iii) the fundamental role played by a Third Party Authority in assuring compliance with the reciprocal expectations and obligations of donors and scientists. Finally, we briefly analyse two issues that might represent important elements of a ‘new alliance’ between researchers and donors to which the trusted consent could pave the way: i) the correlations between needs and rights of the two parties, and ii) possible economic transactions.     

ATOPIC DERMATITIS DUE TO SENSITIVITY TO POLLEN

Observation of 100 patients with atopic dermatitis due to hypersensitivity to pollen over a period of 12 years emphasized certain important diagnostic and therapeutic features. The incidence was higher in females than in males and higher in middle and old age than in the earlier years.Pollen dermatitis may be the sole or major manifestation of allergy; 43 patients gave no history of other allergic symptoms. It may involve any or all areas of the body. The site or the distribution of lesions or the nature of the lesions gave no clue as to the diagnosis of pollen sensitivity.The character of the eruption varied widely from patient to patient and in given patients from week to week at times.Atopic dermatitis due to pollen sensitivity may be purely seasonal, perennial with seasonal exacerbations or perennial without seasonal variation.Reactions to skin testing with pollens suspected as allergens may be positive, equivocal or negative. In 58 patients there were positive correlative skin reactions to pollens.The diagnosis of atopic dermatitis due to pollen sensitivity, and the composition of the desensitizing antigen or antigens, must be based primarily on the clinical history and the area of residence.Most patients could tolerate only very weak dilutions at the beginning of desensitization therapy. Strong dilutions caused exacerbation of the dermatitis.Good or excellent results were obtained with perennial pollen desensitization therapy administered over long periods. In 13 patients good results took four to eight years of desensitization therapy. Fifty required less than two years. Tolerance of the patient for a given dose of antigen should determine the maximum dilution used in therapy.     

学名索引

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