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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.

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PubMed1998

Anticipatory planning for research participants with psychotic disorders like schizophrenia.

Current and coincident biomedical advances make this an opportune time to encourage research with individuals who have fluctuating periods of incapacity caused by psychotic disorders like schizophrenia. Effecting research with this heterogeneous population who may have impaired decision-making capacity that diminishes their autonomy, while honoring their liberty and safeguarding their well-being, may be difficult to achieve. Federal regulations and guidelines in regard to research with this population are insufficient and cause additional obstacles. Use of research advance directives that allow for the appointment of a surrogate decision maker, the designation of a research monitor, and delineation of specific safeguards for the research participants also may provide protection for investigators and foster and improve community trust in medical research.

Advance Directives↗
PubMed2002

Protecting clinical research and human participants: considerations for domestic and foreign clinical trials.

In recent years there has been a shift in focus from national and international "Ethics Influentials" related to the approval of life-saving therapies to a national and international reassessment of the conduct of clinical trials and human subject protection. Due to intense and ongoing pressure from several groups (including the media, patients and families, tort lawyers, patient advocacy groups, ethicists, and government advisory bodies), there are several initiatives underway to revise ethical standards for the conduct of clinical trials. This article discusses the need for an integrated approach to improving the ethical conduct of clinical trials as well as the need to promote the equally important ethical consideration of efficient approval of safe and effective life-saving medical therapies.

Advisory Committees↗
PubMed2003

Efficacy and safety of a combination of metformin and rosiglitaone in patients with type 2 diabetes mellitus--a postmarketing study.

The efficacy and safety of combined metformin and rosiglitazone therapy in type 2 diabetes has been evaluated in an open-label, phase IV, prospective, multicentre study conducted in India over a period of 3 months in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. The superiority of the combination therapy in its effects on glycaemic parameters and lipid profile has been observed. A discussion of the same with brief review of literature has been presented here.

Adult↗
PubMed2003

[Reduced pain from osteoarthritis in hip joint or knee joint during treatment with calcium ascorbate. A randomized, placebo-controlled cross-over trial in general practice].

INTRODUCTION: Although vitamin C is essential for the formation of collagen and proteoglycan and has been shown to minimise surgically induced arthritis in guinea pigs, no controlled trial has examined its effect on human osteoarthritis. MATERIAL AND METHODS: The trial was a multicenter, double-blind, randomised, placebo-controlled, crossover-trial performed by ten general practitioners. The Declaration of Helsinki and the European guidelines for good clinical practice were strictly followed. One hundred and thirty-three patients with radiographically verified symptomatic osteoarthritis of the hip joints and/or the knee joints were treated with one gram of calcium ascorbate or identically looking placebo tablets. The calcium ascorbate tablets and the placebo tablets should be swallowed daily for 14 +/- 3 days respectively, separated by 7 +/- 3 days wash out. The main outcome measure was difference on the 100 mm visual analog scale (VAS) score for pain in a preselected joint. The secondary outcomes were Lequesne score for function and patient preference. RESULTS: Calculated on an intention-to-treat principle, calcium ascorbate reduced pain significantly compared to placebo (p = 0.0078 by analysis of variance between groups (ANOVA) for difference in VAS, mean difference 4.6 mm (95% CI 1.2-8.0). Similar superiority was found for Lequesne index (p = 0.036, difference 0.56 (95% CI 0.04-1.08) and for patient preference (p = 0.012). DISCUSSION: The demonstrated effect is less than half as pronounced as commonly reported for NSAID etc. If the finding can be reproduced with a smaller, acceptable intake of vitamin C this would be of importance considering the large prevalence of osteoarthrosis.

Adult↗
PubMed2003

[Is it still ethical to conduct clinical trials against a placebo? A review of the ethical and methodological controversy].

UNLABELLED: A DEVELOPING CONTROVERSY: The marketing authorization for new drugs from the regulatory authorities'and ethical point of view, is only possible following convincing proof of their efficacy and safety. Between the drug registration authorities, who underline the necessity of early assessment against a placebo, on the one hand, and the ethical and consumer committees that disapprove of the use, the controversy has developed. FOR METHODOLOGISTS: Comparisons with reference drugs provide less credible results that comparisons versus a placebo. This is why their exclusive use may have deleterious effects on the reliable assessment of products to be launched on the market, in terms of efficacy and safety. Equivalence trials do not provide the expected solution since their internal validation requires a placebo arm. RETICENCE BUT NO PROHIBITION: The fifth revision of the declaration of Helsinki by the World medical association in the year 2000, which led to violent controversy regarding the drawing-up of section 29 and its clarification note, does not really help the debate progress: the authors of the texts confirm their reticence to the use of a placebo, but do not prohibit it. They have chosen a "middle of the road" solution. IN PRACTICE: The decision to conduct or not a placebo-controlled study should take into account the aims of the study (within the context or not of a marketing authorization submittal by an industrial), the early stage of the development of the drug or not and, above all, the level of efficacy and safety of the drugs already available versus the anticipated effects of the new product.

Clinical Trials as Topic↗
PubMed1992

[Written patient information. Analysis of Danish biomedical research programs].

All patients involved in biomedical research must, according to the Helsinki II declaration, receive complete verbal and written information about the project. Valid consent must be based on adequate information. This study analyses all of the 225 written patient information sheets submitted for approval to the regional research ethical committee covering the three southernmost counties in Jutland (Denmark) during the years 1989 and 1990. Linguistic analysis shows that the information is written in a difficult style with a median readability index of 48.2. It is generally recommended that information directed to the general public should have a readability index below 40 (approximately the level of the popular press). Analysis of information content shows that several important pieces of information are often missing: for instance, information about the name of the leader of the research and about the fact that the relationship with the institution will not be adversely affected by a refusal to participate in the research programme.

Denmark↗
PubMedDate not supplied

[Informed consent in clinical practice and medical research].

The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats). However, it is important to recognize the limitations of these formats when used outside the context of a continuous communication process with the patient. For this reason, ultimate instrumentation is through continuous dialogue between patient and physician. Finally, Informed Consent might help improve the patient-physician relationship which, in the end, might be the best way to counteract the influence of the establishment of health management services.

Biomedical Research↗
PubMedDate not supplied

[Medicine: conflicts of interest in research].

A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (patient's welfare, research integrity, ethics, education) tends to be influenced by a secondary interest. Among secondary interests are intellectual conflicts of interest that include the desire for faculty advancement, competition for sponsored research funding, to win prestigious research prizes, as well as financial conflicts of interest that arise when medical investigators own equity in a company that sponsors the study they conduct or when they serve as consultants to companies or are members of the company's advisory boards. Ethical conflicts of interest predominate in undeveloped countries. Known consequences of conflicts of interests include compromising health, death, minimization of adverse reactions, lower research quality, the probability to favor the sponsor's product, and delayed publication when results obtained are not the expected. Medical consciousness should be corrected to avoid moral duality that could harm both patients and medical ethics.

Biomedical Research↗
PubMed2003

Ethical issues and problems in clinical research.

In the paper some documents on clinical research have been presented. Declaration of Helsinki WHO documents are suggested as a basic papers in this field. Some "delicate" problems are pointed and discussed in question about placebo and "moral obligations".

Biomedical Research↗
PubMed2003

[Doctor-initiated clinical trials and the revised pharmaceutical affairs law].

In Japan, clinical trials aiming at application for approval of new drugs take a long time and a lot of money, and their quality thought to be poor. Japanese pharmaceutical companies tend to conduct more clinical studies in the United States and/or Europe than in Japan. The Ministry of Health, Labour and Welfare (MHLW) announced a three-year plan to facilitate clinical trials in Japan; the establishment of a large-scale clinical trial network, the improvement of the clinical research infrastructure, and the utilization of doctor-initiated clinical trials. The revised Pharmaceutical Affairs Law enables doctors and medical institutions to perform clinical trials using unapproved products spontaneously without any corporate sponsorship. Drugs needed by some patients but unapproved because they are unprofitable for companies are expected to be approved under this system. MHLW stipulated the ethical and scientific quality standard of doctor-initiated clinical trials, which is consistent with the principles of the Declaration of Helsinki, and Good Clinical Practice (GCP). To establish a system that allows expedited approval of safer and more effective products, the integration of the functions of the current review bodies, such as the Organization for Pharmaceutical Safety and Research (OPSR) and the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), into an independent administrative agency is scheduled.

Clinical Trials as Topic↗
PubMed1992

[Quality assurance in clinical trials. Problems related to patient information].

In connection with a phase-III study of cholesterol lowering agents, a questionnaire survey was carried out on information to patients' during clinical trials. The survey included 124 patients and nine team members with different professional backgrounds. The results show that, in spite of the fact that the patients had received information in accordance with the guidelines, only 47% of them had perceived that conventional treatment would be offered to those who dropped out of the study. A test of the extent of the patients' understanding about the drugs they were taking showed that only 39% knew how the drug acted and the reasons for the chosen dosing schedule. 23% of the patients would like to have received more information, but 9% of these had problems in formulating questions to the health personnel. Anxiety was a problem for 16% of patients, especially in the early phase of the clinical study. Only half of the team-members were aware of this. 45% of the patients felt that they would disappoint the team if they expressed a wish to drop out of the study. Most of the team-members would have tried to motivate the patients to continue to participate in the trial. Based on the results of the survey, we suggest some main elements of standard procedures for providing information to patients in connection with clinical trials.

Adult↗
PubMed2004

Revisiting Helsinki.

Explore the source record for details and available documents.

Attitude of Health Personnel↗
PubMed2004

Revisiting Helsinki.

Explore the source record for details and available documents.

Attitude of Health Personnel↗