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PubMedDate not supplied

Ethics and children's rights: learning from past mistakes.

The primary aim of this article is to examine, within the context of recent controversial child health practice and research, the underlying philosophy of the aspect of the Nursing and Midwifery Council's Code of Professional Conduct which states that: 'You are personally accountable for ensuring that you promote and protect the interests and dignity of patients and clients, irrespective of gender, age, race, ability, sexuality, economic status, lifestyle, culture and religious or political belief.' A description of the Nuremberg Code, the Helsinki Declaration, the United Nations Convention on the Rights of the Child, and the Human Rights Act 1998 will form the backdrop to this article and a range of contemporary examples will be used to illuminate the ethical dilemmas facing children's nurses in their day-to-day work. Within this context the four major principles that underpin healthcare this will be investigated and the legacy of historical unethical practice and research acknowledged. The vulnerability of children and their families to potential coercion, and the role of local research ethics committees, will be discussed.

Age Factors↗
PubMed2001

Ethical acceptability, health policy and foods biotechnology based foods: is there a third way between the precaution principle and an overly enthusiastic dissemination of GMO?

The demand for consumer safety with regard to the food-processing industry is becoming, legitimately, more and more urgent. If ingested drugs can carry deleterious effects that exceed the beneficial effect that the research was initially undertaken for, then the same can only be the case for foods that stem from the same new biotechnologies, zero risk being non existent. There are two conflicting viewpoints about the possible risks linked to genetically modified organisms: a posteriori protection (based on vigilance once the product is on the market) and an a priori protection (at present usually supported by the precaution principle). We suggest a third way, which ensures consumer safety, but doesn't hinder scientific progress. Just as there are regulations for the protection of human subjects in biomedical research and regulations for the use of drugs after they are marketed, so should such regulations be introduced in the domains of food production that use biotechnologies. We therefore suggest that the scientific community and the food-processing industry develop evaluation protocols for new foods like the ones that exist for drugs. We thus offer thirteen regulations, based on the Helsinki declaration, in order to establish these protocols. These proposals, applied to food-processing research, would enable the industry to return confidence to consumers and thus avoid the random blocking of scientific progress, which is a source of health for the greater population.

Bioethics↗
PubMed2005

[From the Hippocratic Oath to the Declaration of Helsinki in times of budgets and DRG].

In the present healthcare system, the physician directly involved in patient care faces developments that are difficult to reconcile with his daily medical activity. He must face that the free choice of a doctor is undermined by access restriction and regulation. The focus of his activity shifts from classical medical examination to documentation and administration of the patients. His professional freedom of action is reduced by economic constraints. The thinning of the political responsibility has the consequence that he is left alone in communicating negative developments to the patients. The culture of clinical research is also increasingly under the pressure of economic constraints. While it must be demanded that physicians adapt to new developments, this must not completely undermine the basic principles of the medical profession.

Delivery of Health Care↗
PubMed1990

[Informed consent. Historical background and current problems].

At present, informed consent is essential before patients can participate in clinical trials. The fact that a doctor asks the patient for informed consent is an expression of respect for the patient's right to make decisions about his own body. The request is made in recognition of the fact that optimal treatment can only be ensured by means of clinically controlled trials. The need for regulation of research arose at the beginning of the present century when pharmacological development accelerated. The Nürenberg Declaration was elaborated after the second world war and, subsequently, the Helsinki Declarations I and II. In these, directives are established for clinical research and for the rights of participants. A number of conditions make it difficult to fulfill these intentions. It may be difficult to ensure that the patient has adequate basic knowledge. The patient may feel that he is in a state of dependence on the doctor which influences his possibility to choose freely. Confidence between doctor and patient may be undermined if the patient is requested to participate in randomization for choice of treatment. Doctors know too little about how valid information can be ensured.

Ethics, Medical↗
PubMedDate not supplied

[The concept and importance of medical law].

INTRODUCTION: Medical law is a scientific discipline which has not been affirmed in our country, but at law schools in many developed countries it has gained the status of a separate scientific discipline and today it is studied with multidisciplinary cooperation of Schools of Medicine, Schools of Dentistry and Schools of Pharmacy. Generally speaking, medical law concerns the rights and duties of the medical profession. ETHICS AND LEGAL QUESTIONS OF MEDICAL LAW: The progress of scientific research and of new technology used in diagnostics and treatment, opens new fields in terms of responsibility. Most European countries have legal institutions in the field of health care. These include laws and legal acts, as well as codification of professional norms. LAW CONCERNING PHYSISIANS: Apart from the national law, there is also an international law concerning physisians. The World Health Organization and the World Association of Medical Doctors brought the following declarations: Declaration on Promotion of Patients' Rights, the Revised Lisbon Declaration on Patients' Rights, the Revised Helsinki Declaration on Biomedical Research Involving Human Subjects and the Council of Europe's Convention on Human Rights and Biomedicine. CONCLUSION: There is no national order of physicians in Serbia and Montenegro, because chambers of physicians with legal authority and mandatory membership have not been formed. The foundation of Chambers of Physicians of Vojvodina and Montenegro is the first step to goal achieving.

Ethics, Medical↗
PubMed1999

Challenges to human subject protections in US medical research.

United States regulations governing federally supported research with human subjects derive in part from 2 international codes, the Nuremberg Code and the Declaration of Helsinki. The Declaration of Helsinki states that "concern for the interests of the subject must always prevail over the interests of science and society." The concept of minimal risk and the principle of informed consent are the key means by which US federal regulations seek to protect the rights and welfare of the individual in the research setting. Current trends in medical research-including increased funding, ever-greater capabilities of computers, development of new clinical tools that can also be used in research, and new research tools developed through research itself are creating greater demand for human subjects, for easier recruitment and conscription of these subjects, and for unimpeded access to patient medical records and human biological materials. Nationally and internationally, there are new pressures to subordinate the interests of the subject to those of science and society. The National Bioethics Advisory Commission, which is about to undertake a comprehensive review of the US system of human subject protections, faces a daunting task.

Advisory Committees↗
PubMed2004

The necessity and the value of placebo.

The use of placebo in clinical trials has been repeatedly challenged as being unacceptable from an ethical point of view. The present paper responds to this criticism by taking up the issue in the light of the pertinent provisions of the Helsinki Declaration. Examples from different therapeutic areas are given that highlight the importance of placebo in situations in which its use is acceptable according to the Declaration. Particular emphasis is given to the question of active control trials, which, under conditions of low assay sensitivity, may become an ethically less acceptable approach than the use of a placebo control.

Biological Assay↗
PubMed1996

[Is the placebo still ethically acceptable and scientifically useful in clinical drug experimentation?].

Here, the authors address the question whether the administration of placebo, in clinical trials of drugs to be registered or already registered, is ethically acceptable and/or scientifically useful. An important issue, particularly in view of the different opinions emerging in the international scientific community. Since many diseases are already treatable with established therapies and drugs, clinical trials should be performed mainly with placebo containing the appropriate active compound, in agreement with the Helsinki declaration. Active placebo should be employed when slightly modified compounds are tested and when trials are in phase 2/b, 3 or 4. The use of active placebo in these settings would be more correct from a scientific, ethical and economical point of view.

Clinical Trials as Topic↗
PubMed2005

[Clinical trials: vulnerability and ethical relativism].

Research in human beings is an important chapter of medical ethics. In recent years, investigation has been taken over by profit driven corporations that must guarantee the medical and commercial application of results. This new model of investigation has generated conflicts of interest in doctor-patient, researcher-subject relationship. The inevitable debate and media reaction has led. These trials of controversial design to regions of the globe where the vulnerability of the populations continues to allow their undertaking. This article includes a historical perspective on experimentation in human beings and the conditions that led to its regulation: the Nuremberg CODE, followed by the Helsinky Declaration in its different versions, and the Belmont Report, that defend the subject according to the ethic of principles used in western medicine. There is then a review of the attempts to change international regulation to reintroduce clinical trials with placebo--which since 1996 is only permitted where there are no therapeutic or diagnostic methods--on populations that would otherwise have no access to treatment. This then leads on to the issue of double standards in medical investigation defended by many investigators and some official entities. The article concludes that it may be prudent to allow local ethical commissions to approve deviation from the established norm if such is necessary to resolve urgent questions of health in the country, but it is unacceptable that any such emergency is used as a reason to reduce the ethical prerequisites, in clinical trials. It also concludes that true urgency is in making available to all who need it the effective products already in existence. Furthermore, that the acceptance of ethical relativism can result in the exploitation of vulnerable third world populations for research programmes that cannot be undertaken in their sponsoring countries due to the ethical restrictions in place.

Clinical Trials as Topic↗
PubMedDate not supplied

[Argentina, Brazil and Mexico. Biomedical research and the defense of a single standard of attention in developing countries].

In the Helsinki Declaration, which established the ethical principles for research with human subjects, article 5 states, "...concern about the well-being of human beings should always come before the interests of science and of society..." Research proposals should include this commitment, both in developed and developing countries. In countries like Argentina, Brazil and Mexico, much of the population experience situations of great injustice, including a lack of equal access to health care. In some cases, sectors of the pharmaceutical industry may see these deficiencies as offering opportunities for carrying out research and achieving economic profits, something which carries the risk of perpetuating and even intensifying the unjust situations and violations of human rights--these population groups already suffer from. This situation implies the need for commitment to and ethical reflection upon human rights related to health. Agreements are needed between the actors involved in health research: sources of funding, researchers, public policy makers, and the study subjects themselves, in order to protect the latter's rights, including continuity of medical treatment for research subjects, when necessary.

Adolescent↗
PubMed2004

[Research ethics and the use of placebo: status of the debate in Canada].

The question of the use of the placebo is one of the most controversial in the field of the ethics of research today. The use of the placebo remains the standard practice of biomedical research in spite of the fact that various revisions of the Helsinki Declaration have sought to limit its use. In Canada, the Tri-council policy statement: Ethical conduct for research involving humans adopted a very restrictive position with respect to the use of placebos, precisely defining the situations in which its use would meet the demands of ethical research. The positions taken by the various ethical decision-making bodies are, however, hardly shared by regulatory bodies such as the Food and drug administration (FDA), the Council for international organization of medical sciences (CIOMS) or the European agency for the evaluation of medicinal products (EMEA). This divergence of opinions reveals two quite different conceptions of what constitutes the ethical. In the case of decision-making bodies in the ethical field, it is clearly medicine's Hippocratic Oath which explains their reluctance to use placebos. The first responsibility of the doctor is to "do no harm" to his or her patient. This duty is inherent to the medical profession and as such is not grounded in the view of medicine as a contract for care. In the case of regulatory bodies, it is the vision of "medicine as contract" which is in view; and it is this notion that justifies the use of placebos once free and informed consent has been obtained. It is also worth noting that these regulatory bodies make frequent use of arguments based on utilitarian ends. In an unprecedented move, the World medical association published in October 2001 a clarification note about the use of placebos. An analysis of this text raises the question about its real meaning: clarification or concession?

Biomedical Research↗