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Results for “Helsinki Declaration”

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PubMed2000

Ethical requirements that must be met before the introduction of new procedures.

For orthopaedic care of patients to continue to improve, new approaches, both diagnostic and therapeutic, must be continually developed. To verify that a new approach actually provides improved outcomes, these innovations must be subjected to rigorous scientific study. However, because outcomes of clinical interventions only can be studied in human subjects, these studies must not only meet scientific criteria, they also must meet strict ethical criteria. The Declaration of Helsinki, a document prepared by the World Medical Association that originally was written in 1964, revised substantially in 1975, and most recently revised in 1996, provides guidelines for such studies. In addition to satisfying ethical requirements, clinical investigators also face various complex issues that must be dealt with in the performance of clinical research studies. One of the most difficult issues is the conflict between a physician's concern for the well-being of his or her patients and the need for protocol driven trials. No matter how enthusiastic surgeons may be about a new therapeutic approach, they must recognize that they are responsible to scientifically validate their innovative approach with a well controlled clinical trial using valid functional outcome measures.

Biomedical Technology↗
PubMed2003

The Study on Cognition and Prognosis in the Elderly (SCOPE): principal results of a randomized double-blind intervention trial.

BACKGROUND: The prognostic benefits of blood pressure lowering treatment in elderly hypertensive patients were established more than a decade ago, but are less clear in those with mildly to moderately elevated blood pressure. OBJECTIVE: To assess whether candesartan-based antihypertensive treatment in elderly patients with mildly to moderately elevated blood pressure confers a reduction in cardiovascular events, cognitive decline and dementia. DESIGN: Prospective, double-blind, randomized, parallel-group study conducted in 1997-2002. SETTING AND PARTICIPANTS: The study was of 4964 patients aged 70-89 years, with systolic blood pressure 160-179 mmHg, and/or diastolic blood pressure 90-99 mmHg, and a Mini Mental State Examination (MMSE) test score >or= 24. A total of 527 centres in 15 countries participated in the study. INTERVENTION: Patients were assigned randomly to receive the angiotensin receptor blocker candesartan or placebo, with open-label active antihypertensive therapy added as needed. As a consequence, active antihypertensive therapy was extensively used in the control group (84% of patients). Mean follow-up was 3.7 years. MAIN OUTCOME MEASURES: The primary outcome measure was major cardiovascular events, a composite of cardiovascular death, non-fatal stroke and non-fatal myocardial infarction. Secondary outcome measures included cardiovascular death, non-fatal and fatal stroke and myocardial infarction, cognitive function measured by the MMSE and dementia. RESULTS: Blood pressure fell by 21.7/10.8 mmHg in the candesartan group and by 18.5/9.2 mmHg in the control group. A first major cardiovascular event occurred in 242 candesartan patients and in 268 control patients; risk reduction with candesartan was 10.9% [95% confidence interval (CI), -6.0 to 25.1, P = 0.19]. Candesartan-based treatment reduced non-fatal stroke by 27.8% (95% CI, 1.3 to 47.2, P = 0.04), and all stroke by 23.6% (95% CI, -0.7 to 42.1, P = 0.056). There were no significant differences in myocardial infarction and cardiovascular mortality. Mean MMSE score fell from 28.5 to 28.0 in the candesartan group and from 28.5 to 27.9 in the control group (P = 0.20). The proportions of patients who had a significant cognitive decline or developed dementia were not different in the two treatment groups. CONCLUSIONS: In elderly hypertensive patients, a slightly more effective blood pressure reduction during candesartan-based therapy, compared with control therapy, was associated with a modest, statistically non-significant, reduction in major cardiovascular events and with a marked reduction in non-fatal stroke. Cognitive function was well maintained in both treatment groups in the presence of substantial blood pressure reductions. Both treatment regimens were generally well tolerated.

Aged↗
PubMed2003

Research in children.

The importance of medical research to the diagnosis and treatment of human diseases is well recognized. The use of human subjects, however, presents complex legal and ethical challenges for the scientific community and for society. The history of research performed on children reveals an especially vulnerable population needing special protection against violation of individual rights and exposure to undue risk. The development of guidelines and policies to protect children as research subjects is reviewed. Special focus is given to the present federal regulations that are intended to provide an ethical context for the performance of pediatric research, including the distinction between therapeutic and nontherapeutic studies. In part, these guidelines represent a return of the pendulum to a more moderate position, after an era of restrictive regulations in reaction to past abuses of children as research subjects. As a result, federal and professional initiatives are bringing renewed focus on the need for rigorous study of childhood development and disease within an appropriate ethical framework.

Child↗
PubMed2004

Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive.

PURPOSE OF THE REVIEW: The new European legislation on good clinical practice in the conduct of clinical trials on drugs has raised serious concern that potentially lifesaving studies cannot be carried out in critically ill patients in Europe anymore after May 2004. The requirement of nominating a legal representative for obtaining informed consent before inclusion will deprive current and future patients of participation in research. The new legislation does not differentiate between patients who are incompetent because of a psychiatric illness or dementia and patients who are incapacitated owing to an emergency situation. All those patients may be enrolled in a clinical trial only after informed consent has been granted by a legal representative. RELEVANT FINDINGS: Recent publications regarding the new European legislation manifest an outcry by intensive care specialists, emergency medicine specialists, traumatologists, and specialists of other related disciplines concerned about the proposed active withholding of potentially beneficial therapies for this very unfortunate group of patients. Many authors, although acknowledging the ethical principle of autonomy, express that in the field of emergency medicine not all criteria of autonomy may be met. The Declaration of Helsinki requires that even the best prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research. There is agreement among the authors that critically ill patients should not be deprived from the benefits of research. SUMMARY: Many groundbreaking therapies will not be scientifically evaluated anymore, and thus beneficial treatments in fatal diseases will be prevented. The European legislation is asked to adapt the Directive to promote research in critically ill patients.

Clinical Trials as Topic↗
PubMed2004

Prebiotics promote good health: the basis, the potential, and the emerging evidence.

BACKGROUND: The prebiotics concept, which was launched in 1995, concerns nondigested and selectively fermented carbohydrate food ingredients. It was thought that their effect in the colon could reduce risk for disease. The prebiotic concept is revisited and possible mechanisms are proposed. The physiologic consequences of prebiotic consumption are evaluated in terms of potential to reduce risk for disease. This is a compilation of several research papers, each of which complied with the World Medical Association Declaration of Helsinki. METHODS: For human dietary intervention trials, the aim was to perform double-blind, placebo-controlled, cross-over studies. A parallel design was used only for long-term studies. Most research has been done with beta(2-1) fructans, so they are used as an example of prebiotics here. RESULTS: The results are relevant to the fields of gut function, lipid metabolism, mineral absorption, bone formation, immunology, and cancer. CONCLUSION: It is observed that modification of intestinal flora by inherently selectively fermented prebiotics is central in determining their nutritional properties. They interact positively through the large intestinal surface with various physiologic processes and are thought to improve health status by reducing risk for disease (markers).

Animals↗
PubMed2005

Good clinical practice: historical background and key aspects.

Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver-Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.

Clinical Trials as Topic↗
PubMed2005

Accurate dosimetry: an essential step towards good clinical practice in nuclear medicine.

In nuclear medicine, an increasing number of radiolabelled agents are under investigation for future use in diagnostic imaging and for applications in radionuclide therapy. All these studies require large amounts of human data to allow for statistical comparisons with existing and well established diagnostic or therapeutic methodologies. In the framework of a good clinical practice environment, clinical trials should be carried out according to international guidelines and regulations as described in the Declaration of Helsinki. Studies involving ionizing radiation, as is the case in nuclear medicine, require special consideration to comply with the ALARA (as low as reasonably achievable) principle. Special publications of the International Commission of Radiological Protection and the World Health Organization deal with this topic in medical research. From the legislation point of view, the 97/43/EURATOM Directive represents the reference to clinical research using ionizing radiation within the European Union. In order to keep the radiation dose of (healthy) volunteers as low as possible, predictive dosimetry studies based on in-vivo animal biokinetics are essential. On the other hand, patients included in dose-escalation radionuclide therapy trials should be monitored individually with respect to dosimetry of the tumour and the critical organs. In this paper the importance and methodology of contemporary patient dosimetry in diagnostic and therapeutic nuclear medicine research are reviewed. It is concluded that reliable dosimetry is essential in performing scientific clinical studies according to the principle of good clinical practice.

Biomedical Research↗
PubMed2000

International research ethics.

This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non-therapeutic research should be upheld; 2) the questions of whether currently demanded best proven diagnostic and therapeutic methods of treatment for all research subjects is feasible both in developed and in developing countries, and whether it should be upheld; 3) the questions of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely.

AIDS Vaccines↗
PubMed2001

Is 'best proven' a useless criterion?

In this article, I examine some proposals for modification of ethical documents regulating research, particularly, the problems that introducing certain economic clauses may pose. I evaluate suggestions that reject the notion of providing the 'best proven diagnostic and therapeutic method' in favor of 'the highest attainable therapeutic method' or 'the proven effective prophylactic, diagnostic and therapeutic methods.' I analyze the plausibility and problems of introducing a double standard and the consequences it may have in developing countries. Finally I highlight the impact these changes may imply for these countries.

Clinical Trials as Topic↗
PubMed2001

Other issues.

Explore the source record for details and available documents.

Bioethical Issues↗
PubMed1995

Research ethics--a widening of the scope and extrapolation into the future.

Until recently, the concept of research ethics covered only the safety of, and the respect for, the research subject, i.e. the trial patient and the healthy volunteer. The reason was obviously that human research subjects are the most vulnerable of all key persons involved in biomedical research, and the fact that this vulnerability was made tragically visible through the atrocities of World War II. Not in any way to detract importance from this part of research ethics these years experience a widening of the conceptual scope, involving not only the researcher and his or her honesty but also society as a whole, not just duties and rights considered unilaterally but bilaterally. And further, including perspectives as science freedom and a given generation's responsibility for its global fellow-men and for future generations.

Ethics, Medical↗
PubMed2006

Xenotransplantation--ethics and regulation.

Healthcare workers, researchers, and policy makers find themselves in challenging times, being required to make (often prompt) decisions in the face of novel ethical dilemmas. Moral theory may assist with decision-making in complex areas of medicine such as the xenotransplantation of insulin-producing cells to reverse diabetes. Moral theory attempts to capture intuitions about whether an action is right or wrong and it may gives us a deeper understanding of moral claims as it gives us an account as to why an action is good or bad. We may opt to choose different ethical frameworks such as consequentialism, principlism or a duty-based approach, to assist with deciding a certain action in a particular scenario. The xenotransplantation of porcine insulin-producing cells is a potential solution to the shortage of human tissue. It is crucial for the advancement of xenotransplantation that the benefits to society outweigh the risks and whilst there is enormous potential to assist mankind, there are unique bioethical challenges and dilemmas. New treatment strategies should be regulated appropriately to minimize risks to patients, their relatives and the wider community. There are specific regulations (such as those developed by the FDA) that provide a robust framework for the safe implementation of xenotransplantation and more generally applicable ones such as the Declaration of Helsinki. Xenotransplantation is either morally acceptable or not to an individual. Patients must ultimately decide as to whether they would accept a certain form of treatment or not, a decision which would take into account their religious beliefs and categorical objections. There is no point in developing a treatment option unless there is good patient support. To that end, a study was conducted to ascertain the acceptance of tissue from different animal sources, by diabetic patients in England and Australia. Interviews were conducted to ensure that patients' views were reflected in their answers. There were 316 English and 195 Australian questionnaire respondents and the vast majority would accept human (85%, 94%), porcine (68%, 85%) or non-human primate (67%, 82%) tissue, respectively. This study suggests that a large proportion of diabetic patients may accept a xenotransplantation product.

Animals↗
PubMed2005

Module one: introduction to research ethics.

This module will introduce you to the ethical concepts underlying applied ethical decision-making in the area of research involving human participants. We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an understanding of historical and legal context makes arguably little sense. It is for this reason that this module will begin with a brief history of research ethics and ends with a brief overview of the relevant national and international guidelines pertaining to ethical issues in research involving human participants.

Clinical Trials as Topic↗