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PubMed2000

Revising the declaration of Helsinki: ethics vs economics or the fallacy of urgency.

Constant vigilance is required to ensure that the rights of volunteers in clinical trials are protected, particularly in developing countries. In this presentation to the XIII International AIDS Conference (abstract ThOrE651), Dirceu B Greco, of the Federal University of Minas Gerais in Brazil, describes the debate that has raged over the proposed changes to the Declaration of Helsinki, particularly with respect to access to medical care for trial volunteers and to the use of placebos in the control arms of the trials. The presentation argues: (1) that all trial volunteers should have access to the best diagnostic, preventive, and therapeutic methods, regardless of the standard of care in the countries where the trials are taking place; (2) that large efficacy trials of vaccines and drugs should be done first in countries where the best diagnostic, preventive, and therapeutic methods are available; and (3) that the costs of providing care and prevention services should be considered an integral part of the cost of the trials. The presentation explains how a partnership between activists, scientists, ethicists, and medical associations was effective in resisting pressures to lower the ethical standards for clinic trials. The presentation concludes that the gains made by this partnership constitute an important step in the struggle to provide universal access to education and health.

Acquired Immunodeficiency Syndrome↗
PubMed2000

The Declaration of Helsinki and research in vulnerable populations.

Mooted changes to the Declaration on the agenda of the World Medical Association have sparked a vigorous debate on international research issues. The medical, research and ethics communities in Australia need to participate more broadly in this debate.

Clinical Trials as Topic↗
PubMed2001

The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?

At a time when there was great attention and intense public controversy surrounding clinical (especially multinational) research, the 52nd general assembly of the World Medical Association (WMA) adopted the 5th revision of the Declaration of Helsinki (in October, 2000)-available at www.wma.net. These revisions are the most substantial adaptations since those adopted by the 29th WMA assembly in October, 1975. The commitment to revision of the declaration acknowledged that deficiencies and disagreements in interpretation needed to be corrected and that ethical standards evolve. Nevertheless, this revision process resulted in a controversial version of the declaration. Reports on the revisions have focused mainly on clinical trials that use placebos; but because of the role of the Declaration of Helsinki in the ethics of research, a more thorough examination is needed. Here, we analyse the process of revision and the major changes made to the declaration.

Ethics, Research↗
PubMed2001

The ethical use of placebo controls in clinical research: the Declaration of Helsinki.

Medical ethicists have questioned the use of no-treatment (placebo and sham procedure) controlled studies of new therapies when safe and effective standard therapies are available for use as an active or "equivalence" control. Current ethical principles of conduct for biomedical research specifically prohibit designs that withhold or deny "the best proven diagnostic and therapeutic" treatment to any participant in a clinical study, including those individuals who consent to randomization into a control group. Studies of psychophysiological therapies are often criticized on the grounds they lack a placebo or sham treatment control group. This paper briefly reviews the history of the problem and discusses the ethical standards that govern human research as derived from the Nuremberg Code and the Declaration of Helsinki. An examination of the problem with regard to research involving EEG biofeedback therapy for Attention-Deficit/Hyperactivity Disorder, Traumatic Brain Injury, and depression serves to highlight the issues. It is concluded that the active treatment control (treatment equivalence) design is most appropriate for those clinical studies examining disorders for which there is a known, effective treatment. Sham- or placebo-controlled studies are ethically acceptable for those disorders for which no effective treatment is available.

Biofeedback, Psychology↗
PubMed2004

Clinical trials in an emergency setting: implications from the fifth version of the Declaration of Helsinki.

Everybody agrees that research is crucial to improve the quality of emergency care. Consent of human subjects for participation in research requires that they fully understand their role and risk, not be coerced, and be allowed to withdraw at any time without penalty. In an emergency situation, informed consent is not always possible but the need for good research data is very high. Here is the ethical difficulty, and a real conflict of values: a population that might ultimately benefit from research cannot consent to the research and are thus excluded from the potential therapeutical advances. Patients at high risk of morbidity or death, with cardiac arrest, shock, head injury, or altered mental status, are evidently incapable of providing an adequate consent, but nevertheless are often in the greatest need of innovative therapy and might be willing to assume some risk for potential benefit. In an attempt to resolve this dilemma, the new version of the Declaration of Helsinki presents updated requirements for the waiver of informed consent and the protection of human subjects in emergency research.

Clinical Trials as Topic↗
PubMed2000

The ethics of placebo-controlled trials in developing countries to prevent mother-to-child transmission of HIV.

Placebo-trials on HIV-infected pregnant women in developing countries like Thailand and Uganda have provoked recent controversy. Such experiments aim to find a treatment that will cut the rate of vertical transmission more efficiently than existing treatments like zidovudine. This scenario is first stated as generally as possible, before three ethical principles found in the Belmont Report, itself a sharpening of the Helsinki Declaration, are stated. These three principles are the Principle of Utility, the Principle of Autonomy and the Principle of Justice. These are taken as voices of moral imperative. But although each has intuitive appeal, it can be shown that there are possible scenarios in which they give conflicting prescriptions. To achieve consistency, one must be subordinate to the others. The voice of utility is taken as subordinate to those of justice and autonomy and it is shown that given plausible assumptions about the level of poverty and education in the developing country targeted, the experiment is ruled morally wrong in the name of both justice and autonomy. Moreover, it is argued that no justification can be found for the inclusion of a placebo group, when strictly defined. By contrast, a 'no-treatment' control arm might be justified, but only when the demands of autonomy are satisfied, demands that are more stringent than they might appear. A utilitarian defence of the experiment is examined, namely that the would-be participants are in a no-loss situation, and it is shown that this defence is seriously flawed. Finally, it is concluded that there is no justification for amending the Declaration of Helsinki.

Adult↗
PubMedDate not supplied

[Qualitative analysis of the perception of people who participate in a clinical trial, Navarra].

BACKGROUND: The objective of this study is to explore the perception that participants in a clinical trial have about the information disclosured by the physician, during patient recruitment and along the study as a preliminary stage for drafting a questionnaire. METHODS: Qualitative study by means of quasi-structure interviews to subjects of different features taken from a patients list obtained by randomized selection of participants in clinical trials approved within the 1998-1999 period. For conducting the interviews, a guide was prepared based on the recommendations of the Helsinki Declaration. RESULTS: Six (6) interviews were held with 7 individuals, as one married couple was interviewed. Most of the categories encountered belonged to the Helsinki Declaration. In addition, others being related to the fulfillment of expectations and to the balance of the risks/benefits done by the individuals for deciding to take part in the study. CONCLUSIONS: The patients were acceptably informed of the most points dealt with under the Helsinki Declaration. The existence of lacking areas having a major impact on the fulfillment of their expectations however having been revealed.

Adult↗
PubMedDate not supplied

Declaration of Helsinki.

Recommendations guiding physicians in biomedical research involving human subjects.

Codes of Ethics↗
PubMed2000

Starting clinical trials of xenotransplantation--reflections on the ethics of the early phase.

What kind of patients may be recruited to early clinical trials of xenotransplantation? This is discussed under the assumption that the risk of viral infection to the public is non-negligible. Furthermore, the conditions imposed by the Helsinki declaration are analysed. The conclusion is that only patients at risk of dying and with no alternative treatment available should be recruited to xenotransplantation trials in the early phase. For some of the less dangerous cell or islet cell xenotransplantation other categories might be recruited. The risk of cell and islet cell xenotransplantation should, however, be weighted against the development of other technologies. In order to safeguard the public, the opt-out clause in the Helsinki declaration should not be fully applied. Legally binding rules on obligatory monitoring and restrictions should be imposed--before clinical trials start.

Animals↗
PubMed1999

[Information provided in writing for "informed consent" in clinical trials].

The Helsinki Declaration contains recommendations guiding physicians who conduct clinical trials. One is that the requirement for informed consent is essential for approval of a trial. An important component of the informed consent doctrine is that all data required for the participant's decision must be provided. We analyze data of a therapeutic trial, and define 12 data components outlined in, or directly derived from the Helsinki Declaration. 61 instances of informed consent for therapeutic clinical trials from various fields of medicine, from 1994 to 1997, were analyzed. In each the presence of the 12 components was evaluated. The data demonstrated that there were only 5 components cited in most cases of informed consent: trial objectives, methods, treatment plan, risks, and the option of withdrawing. Benefit to the participant was mentioned in half the cases, while only limited information was provided about other components such as life-threatening and unpredictable risks, and alternative treatment. Examples of informed consent from 1997 showed statistical improvement since 1994 in the data concerning trial objectives, methods, risks and alternative therapy. Informed consent documents of international multicenter trials compared with local trials showed statistical improvement in the data components of the trial objectives, methods, and risks, including those of potentially life-threatening and unpredictable risks, and alternative therapy. Analysis of informed consent showed that not all components required for a comprehensive decision regarding participation in a clinical trial are included. These data emphasize the need to design a structured informed consent protocol in which all the required data components are specifically outlined for potential participants.

Clinical Trials as Topic↗
PubMed1997

[Ethical problems in the biomedical research projects, presented to the Ethical Committee of the Medical School at the Pontificia Universidad Católica of Chile].

BACKGROUND: The higher methodological complexity of either diagnostic or therapeutic procedures has raised concern about the ethical principles that should underlie the conduct of biomedical research involving humans. AIM: To evaluate ethical problems of research proposals submitted to an ethics committee. MATERIAL AND METHODS: All research proposals involving humans, submitted within a two years period to the ethics committee of the School of Medicine of the Catholic University, were retrospectively reviewed. "Ethical problem" was defined as any explicit disagreement with the ethical principles and guidelines for the protection of human subjects involved in biomedical research, according to the Helsinki declaration. RESULTS: In 20 of 44 reviewed projects, an ethical problem was identified. The most common problems were the absence or inadequacy of the informed consent, the justification of the use of placebo and problems related to the methodological aspects of the research, particularly the lack of an adequate control group when the potential benefits of a new drug were evaluated. CONCLUSIONS: According to the Nüremberg code, the Helsinki declaration and the International Principle of Ethics in Biomedical Research, we analyse ethical problems and suggest judgement elements for them.

Chile↗