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Results for “Helsinki Declaration”

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PubMed1999

[Responsibilities of ethics committees].

Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.

Clinical Trials as Topic↗
PubMed1994

[Obstetric peridural anesthesia with sufentanil. Is it contraindicated?].

The advantages of the addition of low-dose sufentanil to local anaesthetics in epidural analgesia during labour (improvement of analgesia, reduction of total dose of local anaesthetic, reduction of rate of instrumental delivery outweigh) far the disadvantages (pruritus, sedation, potential maternal and neonatal respiratory depression). In over 8000 cases, the addition of incremental sufentanil (7.5 micrograms) up to 30 micrograms has not caused any negative effects on newborns, and hence, the addition of sufentanil is justified; it may even be indicated. Sufentanil has not yet been registered for epidural analgesia in Germany, in contrast to other countries. In considering whether this fact may prohibit its use, two aspects should be discussed: therapy and clinical experiments. The difference lies in the purpose rather than in the method of administration. Ethical and legal requirements for clinical tests are anchored in the declaration of Helsinki and the code of the medical profession. The legal background for therapy is represented in the proviso of the German Civil and Criminal Codes as well as the code of conduct on professional liability of the physician. Pain during labour is no absolute indication for the addition of sufentanil, but there are considerable arguments for its superiority in comparison to other standard procedures: the side effects and complications are very limited. Justification of this method is relatively easy in view of the fact that sufentanil has already been registered for peridural analgesia in obstetrics in many other countries. Last but not least, the patient must give informed consent before any procedure can be performed.

Adult↗
PubMed1998

[Study design in clinical radiologic research].

PURPOSE: To review important aspects of study design in clinical radiology and to introduce the reader to the requirements of Good Clinical Practice (GCP). METHODS: The European guidelines for GCP, the Declaration of Helsinki, the differentiation into study phases and the authors' own experience in open and sponsored clinical trials are the basis of this analysis. RESULTS: Guideline such as GCP do not limit scientific freedom in research but define high standards for the well-being of patients and volunteers as well as guaranteeing scientific honesty. The benefits of defined data monitoring and the necessity of a prospective statistical concept are frequently underestimated. CONCLUSION: Correct study design has to be expected in radiology too. High standards guarantee accuracy and honesty of scientific studies. Only this can warrant the value for the patient of radiological diagnostics and therapy.

Forecasting↗
PubMed2001

[Administration of MR contrast agents outside of approved indications (off-label use].

PURPOSE: The use of MRI contrast agents outside their labeled indications is routine in radiology. However, physicians feel frequently at unease. It is the aim of this paper to introduce the medical, juridicial and billing relevant issues in order to improve the knowledge on this topic. METHODS: The basis for off-label use is the physician's prerogative, which finds its basis in the "declaration of Helsinki". RESULTS: Off-label use is allowed under special conditions and might be even the medical state of the art. CONCLUSION: The necessity for off-label use will continue to increase for MR-contrast agents, as clinical trials for registration purpose are quite costly and manufactures continuously will concentrate on the essential indications.

Clinical Trials as Topic↗
PubMed2002

Improving the analysis of arteriovenous passage times.

PURPOSE: This study evaluated the effect of two techniques, time-based correction (TBC) and de-interlacing, on the quality of an image sequence from a scanning laser ophthalmoscope (SLO), and their impact on subsequent analysis for the determination of arteriovenous passage (AVP) times. METHODS: Fluorescein angiograms obtained from one patient participating in a concurrent study approved by an institutional review board (IRB) were analyzed before and after the serial connection of a TBC, and before and after de-interlacing of the images. Informed consent was obtained, and all tenets of the Declaration of Helsinki were followed. AVP times were determined and the variance in time per 100 frames was calculated. RESULTS: The average error in the determination of AVP times was significantly less after the application of these techniques ( p<0.05). Also, the coefficient of variance in the time elapsed per 100 frames was reduced after TBC and de-interlacing of the video sequence. CONCLUSION: The study showed that in addition to the subjective improvement in image quality after de-interlacing and TBC, quantitative parameters are improved. This leads to a more accurate analysis of the angiogram.

Arteries↗
PubMed2004

Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP).

A child has the full right of protection of his/her life by provision of optional medical care. There is a need in paediatrics for better evidence based practice founded on quality research into efficacy and safety of children's medications. To protect the best interests of the child one must balance the ethical demand to do clinical studies with the necessity to avoid doing harm. To achieve this end good clinical practice in paediatric research demands that studies comply with the Declaration of Helsinki, ICH topic E11, EU Directives and other relevant international guidelines. Evident differences in physiology, pharmacology, pharmacokinetics and pharmacodynamics between children of differing ages and between children and adults demand properly constructed and conducted studies that respect the special somatic, emotional and mental needs of children. To justify any research project one must balance the benefit/risk ratio, provide experienced, competent personnel and infracture, obtain adequate informed consent/assent, and have the study evaluated and approved by an ethics committee containing expertise on the rights and needs of children.

Adolescent↗
PubMed2002

Conflicts of interest in science and medicine: the physician's perspective.

The various statements and declarations of the World Medical Association that address conflicts of interest on the part of physicians as (1) researchers, and (2) practitioners, are examined, with particular reference to the October 2000 revision of the Declaration of Helsinki. Recent contributions to the literature, notably on conflicts of interest in medical research, are noted. Finally, key provisions of the American Medical Association's Code of Medical Ethics (2000-2001 Edition) that address the various forms of conflict of interest that can arise in the practice of medicine are outlined.

American Medical Association↗
PubMed2004

Clinical trials: active control vs placebo--what is ethical?

The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs, superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of micro (the difference between a tested drug and comparator) < or = 0 against micro > 0; the latter tests the null hypothesis of micro < or = - delta against, micro > - delta, where delta is the clinical difference from the comparator. In a superiority trial, a new drug is tested against a placebo; in a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with placebo to a non-inferiority trial with an active-control--following the latest revision of Declaration of Helsinki--is in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical: to violate patients' rights or to produce results without scientific value. All presented considerations lead to the conclusion that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation of patients, and the ancient quest for effective medicines. In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is fruitless.

Controlled Clinical Trials as Topic↗
PubMed2004

Placebo in the investigation of psychotropic drugs, especially antidepressants.

The paper presents major ethical, legal and methodological problems related to the use of placebo in mental disorders, especially in depression. It is pointed out that although authoritative groups of experts and numerous publications in the field of psychopharmacology indicate advisability of the double blind design with placebo in clinical trials of antidepressants, in recent years there have been more and more voices questioning legitimacy of this method. Objections of an ethical nature are raised, and reliability of this approach is put into doubt from the methodological viewpoint. These issues are discussed in more detail in the paper. Available alternative solutions should be implemented in psychotropic drug studies. The author shares these objections and doubts of an ethical nature, and believes that the placebo procedure is not a necessity in clinical trials of antidepressants.

Antidepressive Agents↗
PubMed2004

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis.

UNLABELLED: The placebo drug reactions from controlled trials were studied for the first time systematically for efficacy and the safety in drug data pooled from randomized, placebo-controlled, multicentre studies. RESULTS: The efficacy of placebo on clinical symptoms and outcome varied between the therapeutic indications. However, no placebo effects on laboratory values, as e.g. blood glucose or Hb1c in diabetics, were noted. The frequency and type of placebo-induced adverse reactions also varied between indication groups. The placebo side effect profile was largely similar to the side effect profile of the active treatment. The mechanisms of placebo effects are many fold and varied (e.g. endorphin release, conditioning), much lacks explanation. CONCLUSION: Since the prescription of non-evidence based medicines (= pseudoplacebos) may clearly also result in serious adverse effects, such practice may not only be non-beneficial but may even be harmful. In clinical research, the judicious use of placebo remains essential to establish the efficacy and safety, safeguarding that patients receiving placebo will not be subject to harm and are fully informed.

Guidelines as Topic↗
PubMed2005

The ethics activities of the World Medical Association.

Since its formation in 1947, the World Medical Association (WMA) has been a leading voice in international medical ethics. The WMA's principal ethics activity over the years has been policy development on a wide variety of issues in medical research, medical practice and health care delivery. With the establishment of a dedicated Ethics Unit in 2003, the WMA's ethics activities have intensified in the areas of liaison, outreach and product development. Initial priorities for the Ethics Unit have been the review of paragraph 30 of the Declaration of Helsinki, the expansion of the Ethics Unit section of the WMA website and the development of an ethics manual for medical students everywhere.

Ethics, Medical↗