Ethical considerations in toxicology

Since most of the research necessary for the safety evaluation of chemicals requires the killing of laboratory animals, toxicologists are faced with an ethical conflict between their professional duties and the interests of the animals. In the past, the protection of consumers against chemical injury was considered to be of the greatest importance, and society approved of all efforts to detect even the slightest hazards from man-made and environmental chemicals. In recent years, toxicologists have become aware of their ethical responsibilities not only for the safety of the human population but also for the welfare of the animals. They have begun to review the classical toxicological procedures critically and now require that the maximum amount of relevant information is obtained from the smallest number of laboratory animals. Toxicologists have also become aware of the alternative methods that permit the investigation of toxicological responses in unicellular organisms and cell cultures. The problem of testing chemicals for irritant properties on skin and mucous membranes is an excellent example of how concern for animals has generated a range of original and imaginative research leading not only to a reduction in the use of animals but also to a more efficient and scientific approach to an important health problem.     

Ethical considerations in research with children

The author discusses the nature of research in a therapeutic context, the documentation required by a review committee, the problem of proxy consent for children and other 'incompetent' individuals, the balance of risk-to-benefit, and the protection owed by society to its most vulnerable members. Opposing views are presented regarding the ethics of involving children in research. The difficulty of assessing risks and benefits is acknowledged while upholding the right of parents and guardians to receive full disclosure of information upon which to base consent. There is a role for serious ethical inquiry in the search for agreement on what is right. Life implies relationships and mutual obligations. Research involving children raises ethical questions for the physician-researcher, the parents, other hospital personnel and society at large.     

Ethical considerations on the beginning of life

This article was prepared by a working group of paediatricians and gynaecologists belonging to the Association of Medicine and the Person as a proposal to be discussed at the Bioethical Commission of the National Federation of Italian Chambers of Physicians which took place in Ferrara on 24–25 October 2008. The document addressed four key aspects of the bioethics of the beginning of life: (1) a responsible sexuality under the aspect of prevention and contraception with particular attention to the crucial aspects of adolescence and emergency contraception; (2) medically assisted procreation starting from scientific studies and the evaluation of risks/benefits for individuals born from this practice, with special attention to genetic diagnosis prior to implant, in view of the substantial negative effects on the embryo and on the introduction of eugenic selection; (3) a responsible procreation, the protection of maternity and the voluntary interruption of pregnancy: what significance does each of these elements carry? What is the role of doctors in all this? What are the proposals to protect motherhood nowadays? What is the role of the doctors in pre-natal diagnosis and what information is provided to parents on the actual usefulness of these tests? (4) the decision not to resuscitate extremely premature babies, which has been discussed by the Italian Scientific Society of Neonatology, by the Italian National Commission of Bioethics and by the Italian High Council of Health Services. Some positions still emerge in regards to assistance of prematures which are at variance with the position of the three above mentioned organisations and of a great part of the scientific world.     

Ethical considerations in clinical pharmacogenomics research

In recent years there have been unprecedented advances in our understanding of the involvement of genetic polymorphisms in the response to drug therapies. Polymorphisms have been identified that lead to variable patient responses to several medications including cardiovascular, psychiatric, anti-infective and analgesic therapies. The potential for the development of customized, genotype-based therapies is scientifically and clinically attractive. However, these developments, although bearing scientific promise, raise ethical concerns for the conduct of research with human subjects, particularly with respect to confidentiality, risk-benefit analysis, DNA-banking and pharmacoeconomic issues. This article discusses some of the ethical considerations that are related to the use of pharmacogenomics in clinical research protocols.     

Ethical considerations in human experimentation.

An accepted practice in medical research has been the subordination of individual rights to the benefit of mankind. The Nazi experiments, and other recent abuses, have focused increased attention on the dignity and rights of human research subjects and have led to new regulations to control human experimentation. Central to establishing what constitutes permissible human experimentation are the issues of risk-benefit ratio and informed consent. Evaluating the risk-benefit ratio requires consideration of the nature of the experiment, the likelihood of its success, and the type of subjects to be utilized. Participation in a study requires voluntary "educated" informed consent. Certain categories of subjects, such as children and the mentally handicapped, require special protection in this regard. Finally, formal education in medical ethics and prohibiting publication of unethical studies are likely to prove more effective in curbing unethical experimentation than increasing government regulation.     

Ethical considerations on pharmacogenomics.

Pharmacogenetics offers the prospect of an era of safer and more effective drugs, as well as more individualized use of drug therapies. The effect of human genetic variance on responses to therapy will influence drug-development clinical trials and the use of products in clinical practice. It also promises to raise new ethical challenges, in particular in the fields of research and therapy. Last but not least, pharmacogenetics is likely to fulfil the old dream of an individualised medicine, but in a totally unexpected way.     

The tail suspension test: Ethical considerations

Conclusion The above analysis of haemodynamic, behavioral, physiological and pharmacological factors concord in suggesting that the Tail Suspension Test is considerably less stressful to experimental animals than the traditional behavioral despair test. It should always be borne in mind, however, that any attempt to model depression in animals by definition does not render them happy. The aim is therefore to reduce the animal's discomfort to a minimum which is still compatible with the research goal, the discovery of new antidepressant agents. This important ethical consideration, together with the greater pharmacological sensitivity of the procedure, suggests that the Tail Suspension Test is a useful addition to the battery of behavioral tests available for evaluating antidepressant activity in animals.     

Ethical considerations in psychopharmacological research involving children and adolescents

Rationale Increased community utilization of psychotropic medications among children has brought attention to pediatric psychopharmacology research and associated ethical issues. Objectives To discuss ethical aspects of child participation in psychopharmacology protocols. Methods Selective review of relevant scientific and regulatory literature. Results Efficacy and safety of psychotropics in children cannot be entirely inferred from adult data and direct participation of children in research is necessary. Child research must follow special regulations that are in addition to those common to all human research. For research with prospect of direct benefit, a critical factor is whether the risk/benefit ratio is favorable to the participating child. For research without such a prospect, the concepts of minimal risk and minor increase over minimal risk apply. However, the interpretation and application of these principles to specific protocols vary across settings and among ethics committees. Thus far, little empirical investigation has been conducted on children and parents' motivation for research participation, effectiveness of the informed consent and assent procedures, possibility of persistent consequences of exposure to experimental treatments and placebo, and validation of the concepts of minimal risk and minor increase over minimal risk. Conclusions Research on human subject issues relevant to child participation is a promising approach to improving ethical methods and procedures of pediatric psychopharmacology. The opinions and assertions contained in this paper are the private views of the author and are not to be construed as official or as reflecting the views of the National Institute of Mental Health or the Department of Health and Human Services     

临床试验中对受试者疼痛管理的伦理考虑

论述《临床试验中对受试者疼痛管理的伦理考虑》的起草背景、制定依据和适用范围,以及临床试验中疼痛的主要来源,临床试验中对受试者疼痛管理的伦理一般考虑和临床试验中试验操作程序引起的受试者疼痛等负担的伦理考虑等,以期从伦理角度对临床试验中受试者疼痛管理提出指导意见.适用于伦理审查中对于受试者疼痛管理的伦理考虑,以及研究者制定...     

Pharmacoeconomic considerations in anaesthetic use

Healthcare costs are rising in all areas of medicine, especially in high technology specialities such as anaesthesia. Therefore, cost containment and reduction have become major goals in many hospitals and anaesthesia departments. One area that has received substantial attention is the cost of pharmaceutical products, in particular the cost of newer, shorter-acting inhaled and intravenous anaesthetics, analgesics and neuromuscular blocking agents. Numerous pharmacoeconomic studies have been published on the theoretical analysis of anaesthetic drug costs and the potential benefit of various anaesthesia techniques. However, the results are not conclusive and anaesthesia departments continue to seek ways to reduce costs. In this review, we intend to discuss cost terminology, common areas of cost containment in anaesthesia and the relationship of anaesthesia care costs to total perioperative costs.     

Pharmacoeconomic considerations in anaesthetic use

Healthcare costs are rising in all areas of medicine, especially in high technology specialities such as anaesthesia. Therefore, cost containment and reduction have become major goals in many hospitals and anaesthesia departments. One area that has received substantial attention is the cost of pharmaceutical products, in particular the cost of newer, shorter-acting inhaled and intravenous anaesthetics, analgesics and neuromuscular blocking agents. Numerous pharmacoeconomic studies have been published on the theoretical analysis of anaesthetic drug costs and the potential benefit of various anaesthesia techniques. However, the results are not conclusive and anaesthesia departments continue to seek ways to reduce costs. In this review, we intend to discuss cost terminology, common areas of cost containment in anaesthesia and the relationship of anaesthesia care costs to total perioperative costs.     

Ethical issues in substance use intervention

This essay offers an overview of some of the ethical questions raised by governmental and medical interventions into drug use. With respect to the former, it begins with the liberal assumption that constraints on free action are to be justified by reference to its deleterious impact on others, but then qualifies that assumption by noting the social requisites of free action. With respect to medical interventions, it focuses on the codes that have been developed for treatment providers and their clients, and explores the ethical underpinnings of several of their central provisions--informed consent, privacy, confidentiality, nondiscrimination, professionalism, and accountability.