Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Helsinki Declaration”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 523 records · Page 29Linked to original sources
PubMed2003

[Clinical trials in "developing" countries: is there a special "Third World" ethic?].

With increasing frequency, clinical trials are carried through in countries of the "third world". In particular, recent studies aimed at establishing the efficacy of new AIDS therapies, or AIDS vaccines, applied lower ethical standards than those formulated by the Declaration of Helsinki of the World Medical Association, and accepted in the US and internationally,--although American researchers and institutions were involved in these studies. The paper reconstructs the controversies following the publication of these studies, and analyses the conditions for the existence of such double standards of research ethics. Particular attention is given to the concept of informed consent and the difficulties to put it into practice in different cultural contexts.

AIDS Vaccines↗
PubMed2004

[Placebo-controlled trials in schizophrenia].

BACKGROUND: Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. PURPOSE: The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. METHODS: Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. DISCUSSION: Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. CONCLUSIONS: We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow-up procedures for the study as determined by the local Helsinki Committee; and appointment of a supervisory mechanism by the administration of the medical institution where the study is being performed.

Clinical Trials as Topic↗
PubMed2004

The legal protection of test subjects in clinical trials of medicinal products for human use in the European Union.

On the international as well as on the level of the European Union a legal framework has been developed on the protection of test subjects has been developed. In 2000, the Declaration of Helsinki, issued by the World Medical Association, was revised and the previous distinction between therapeutic and non-therapeutic trial situations has been eliminated. Non-therapeutic trials that only aim at the progress of scientific knowledge and do not benefit the patient are now admissible. This is not to the benefit of the position of the test subject and most certainly not when the test subject should be given special protection. The question arises what this recent revision means for the group of incompetent adult patients in clinical trials on medicinal products (hereinafter called drugs) in the European Union (EU). This group needs special protection. Also relevant are national and international legal frameworks and the protection offered by informed consent procedures and screening by ethics committees and member states' competent authorities.

Adult↗
PubMed2004

Impact of the European Clinical Trials Directive on academic clinical research.

With the adoption of the Clinical Trials Directive it was Europe's intention to make the performance of multi-national clinical trials in Europe easier through the harmonization of the regulatory procedures. As the Directive was mainly conceived to facilitate the performance of multi-national clinical trials to develop new drugs, it is to be determined to what extent academic clinical trials will be concerned by the Directive and more importantly what will be its impact on daily academic clinical research. Contrary to several national regulations the scope of the Directive is very large only excluding non-interventional trials. This implies that most of the academic clinical trials will be concerned by the Directive. Besides the handling of the regulatory procedures in the different countries, issues related to insurance, labeling requirements and provision of the investigational medical products will expose the academic sponsor to additional administrative and financial challenges that will have to be handled appropriately, as the academic sponsors will be controlled by Inspectors regarding their compliance with the new regulations to come.

Academic Medical Centers↗
PubMed2003

Informed consent in clinical research: policies and practices in Singapore.

The policies and practices for obtaining informed consent from research subjects in clinical research play a vital role in determining a nation's success as a center for clinical research. The difficulty lies in the fact that while on the one hand, informed consent is a necessary pre-condition for ethical clinical research, a scrupulous observance of the guidelines for informed consent could, on the other hand, cripple medical research. Crippling of ethical medical research can be adverse to public interest, and consequently, unethical. Hence, a fine balance must be struck in the application of the guidelines for obtaining informed consent. This, in turn, would depend on the constitution and skill of research ethics committees who are appointed to consider and approve clinical research proposals. The discussion below addresses the above difficulty with recommendations that could further enhance Singapore's image as a regional clinical trial hub.

Clinical Trials as Topic↗
PubMedDate not supplied

[Recognition of international ethics codes by physicians and biomedical investigators. Are we prepared for the 21st century challenges?].

International oaths and declarations (IOD) represent the essence of proposals or promises on a relevant global issue for which a social group stands for. Their appropriate spread is essential in order for them to have a significant impact. The purpose of this study was to determine the frequency of recognition of several medical practice and clinical research related IOD, among medical personnel differentiated by level of clinical experience and closeness to biomedical research. Five groups were surveyed: 35 undergraduate interns, 50 internal medicine residents, 19 graduate (masters and doctoral degrees) students at the outset of courses, 18 veteran graduate students and 70 biomedical investigators. Performance in the recognition of the 6 probed IOD was uniformly poor. Barely just an average of about one declaration per subject was adequately identified. The Declaration of Helsinki was recognized by more than 50% of those belonging to the groups in which theory and practice of medical research joined together. No other IOD was recognized beyond a 40% level in any group. Comparison of university of origin showed no substantial differences. The lack of knowledge of IOD as a framework in the analysis of ethical conflicts arising along medical practice or clinical research is a worrisome issue. Medical schools seem to neglect their role in divulging them. Institutional review boards should also contribute to divulge IOD. The optimal incorporation of the IOD message comes from its acquisition through a process that links theory and practice.

Codes of Ethics↗