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PubMed1995

[Ethics and research: ethical considerations in clinical research].

Two subjects are discussed: the use of placebo controls in clinical trials and informed consent. Particularly in trials of drugs for disorders for which there exist effective treatments, the use of placebo is still controversial, although anyhow in violation of the Declaration of Helsinki. Informed consent aims at giving a subject all the necessary information to allow him to decide, with full knowledge, whether to accept a particular treatment or experimental protocol. Its importance would seem, albeit essential, to be rather illusory.

Clinical Trials as Topic↗
PubMed1996

[Research in psychiatry and legislative restrictions].

Over the last few weeks decades research in psychiatry has undergone a considerable efflorescence. Experimental projects in fields as different as neurobiology or psychopathology, neuro-anatomy or epidemiology, or even cognitive psychology are of course subject to precise conditions which may derive from ethical guidelines as well as different legal systems. These legislative contexts therefore represent a parallel set of restrictions in the path of research activities and may in some cases curb their development. Restrictions of an ethical or deontological type are direct heirs of necessity. They emerged on the eve of the second world war when it became apparent that precisely defined conditions in which research could be conducted in humans were required, and derived for the most part from the recommendations of the Nuremberg Code on the one hand, and the Helsinki declaration on the other. The last version of the Code of Medical Deontology applicable to medical practice in France, and published by decree in September 1995, devoted an article to the question of experimentation. Each country has its own specific legislation which, in France, was explicitly formulated with the publication of the Loi Huriet in December 1988. The European Union is currently attempting to produce a homologous version of the various legislative documents and recommendations should soon be forthcoming which will be applicable to all member countries of the Community. Another area of limitation is less clearly formulated and involves the technical and occasionally methodological framework within research projects take place. Technical demands are highly variable depending on the field of investigation and chiefly revolve around a dogged hunt for statistically significant results (statistical significance sometimes seems to dispense with the need to determine the real meaning of results!); in some cases they too may curb inventiveness. This last type restriction is particularly apparent in drug trials where imperatives of industrial development as viewed by the sponsor may not always coincide with the investigators' desire to mark therapeutic progress. The increasing rigidity of strategies for assessing new substances which has become obvious over the last few years may in the end risk penalizing the discovery of innovative treatments. Promoting a return to clinical practice in the setting of these research projects would indisputably provide some novel solutions. Although many of the restrictions which currently stand in the way of psychiatric research are, so to speak, natural limitations and difficult to debate, excessive formalism in some areas should be spoken out against. Much thought has been given to this subject, a trend which is likely to inject some dynamism into psychiatric research at the dawn of the third millennium just around the corner.

Data Interpretation, Statistical↗
PubMed1997

[Ethics in tutorial publications].

On basis of scientific literature authors discuss general rules of ethics as the whole of moral rules and behaviour. They point out that compliance with ethical rules in scientific publications should be an integral part of scientific progress. They present the frequent breaches of ethical principles which include: changes or trickery in stating own study results to a priori accepted assumptions, their incorrect presentation or in a more positive mode, taking advantages from other authors publications not revealing its source, lack of sufficient knowledge of scientific literature, theft of foreign scientific ideas, plagiarism and auto plagiarism, unfair presentation of authors sequence in publication, omitting of some co-workers, not in conformity with Helsinki Declaration during human investigations, not in conformity with basic care concerning animals subjected to medical experiments.

Animal Welfare↗
PubMedDate not supplied

Concentration of copper and zinc in blood of psoriatic patients treated topically with ointment containing 2-chloroethyl-3-chloropropyl sulfide.

Copper and zinc concentration in plasma, erythrocytes and whole blood was determined in a group of psoriatic patients (n = 80 ) before and after treatment with an ointment (in accordance with recommendations of the Helsinki Declaration) in which 2-chloroethyl-3-chloropropyl sulfide (CLEPS) is an active compound and in a comparative group (n = 99) of clinically healthy volunteers. The performed examinations revealed a significantly lower (by 19.1%) plasma copper concentration in patients before treatment in comparison with the control group. After treatment (CLEPS) plasma copper concentration increased significantly (p < 0.001). In comparison with the control group, in erythrocytes of psoriatic patients copper concentration was higher both before and after treatment. Plasma zinc concentration in psoriatic patients was lower before treatment, whereas in erythrocytes, compared with the control group, it was higher both before and after treatment.

Administration, Topical↗
PubMed1998

[Ethic aspects of conducting physiological-hygienic and psychological studies on human subjects as applied to the activities in extreme environments].

The paper deals with ethic concerns of biomedical research involving human subjects aimed at mitigating risks for and raising the effectiveness of humans in extreme environments. Cited are the main principles of the Nuremberg Code, Helsinki Declaration, Convention of the European Council on Bioethics and other international and national documents regulating ethic implementation of research with participation of human subjects. The 6-year experience of the Bioethics Commission convened at SRC RF--IBMP is summarised.

Environmental Exposure↗
PubMedDate not supplied

The role of generics in transplantation: TM-MMF versus Cellcept in healthy volunteers.

Because several studies having revealed a relation between early graft rejection and long-term graft survival, potential benefits have been attributed to MMF. The cost of the drug is, however, prohibitive, which renders its long-term use in countries with limited income. We thus compared the pharmacokinetic profiles of a new MMF generic formulation (MM-Cept developed by Ivax CR) with those of Cellcept (Hoffman La Roche) in healthy volunteers. This open label, balanced randomized, two-treatment, two-period, two-sequence, single-dose, crossover, comparative oral bioavailability study was conducted in non-smoking adult male healthy volunteers between the ages of 18 and 45 years. The study was performed in accordance with the basic principles defined in the US 21 CFR Part 312.20 and the principles enunciated in the Declaration of Helsinki (World Medical Association Declaration of Helsinki). The subjects were given a single oral 1 g dose with a washout period of 10 days. Pharmacokinetic profiles included blood levels at 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 10, 12, 16, 20, 24, 30, 36, and 48 hours following each dose. The formulations were MMCept 500 mg tablets and Cellcept 500 mg tablets. Subjects were fasted overnight and for 4 hours postdosing. Mycophenolic acid (MPA) concentrations were determined using HPLC. Physical examinations, hematology, urinalysis, and serum chemistry tests including liver enzymes were performed at screening and at the end of the study. Subjects were monitored for safety and adverse events throughout the study. Both products showed similar bioavailability. The LSM were within the limits for FDA approval (80 to 125), suggesting that the two products are equivalent and switchable.

Adult↗
PubMed2004

The standard of care debate: against the myth of an "international consensus opinion".

It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki's traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by this author, it will be demonstrated in this paper that there is not such a thing as an international consensus opinion, and that the authorities used by Lie et al as evidence in support of their claim should not be relied upon as authorities or final arbiters in this debate. Furthermore, it will be shown that arguments advanced substantively to show that lower standards of care are ethically acceptable in the developing world, conflate scientific with economic reasons, and ultimately fail to bolster the case they are designed to support.

Clinical Trials as Topic↗
PubMed1983

Legal aspects of clinical trials in Israel.

Clinical trials were mainly the concern of medical ethics until the first code on this subject was laid down in a judgment given by a military tribunal in Nuremberg in 1947. In 1964 the World Medical Association adopted the Declaration of Helsinki, which was revised in 1975, regarding clinical trials and research. The Declaration of Helsinki and the developments in the pharmacological and pharmaceutical sciences led to legislation regarding clinical trials and human experimentation. In Israel it is forbidden to use any drug that is not registered. In order to register a drug, evidence of quality, safety and efficacy is necessary, and the means by which these factors are proved is the clinical trial, which demands appropriate legislation. Developments in various medical fields, as well as new treatment techniques, brought about the need for more comprehensive legislation on experimentation on human beings and embryos. In Israel, this field is covered by two enactments, the first on drugs and the second on any other experimentation on human beings. However, these enactments are frame laws, which lay down the rule that no clinical trial may be carried out without the prior approval of the Ministry of Health. They also state the minimum conditions to be met, and provide the Ministry with the authority to add any conditions at any time, as well as the right to stop the trial. The Declaration of Helsinki serves as the minimal legal basis for clinical trials. Some legal problems relating to the clinical trial remain unsolved and are left to the discretion of the Ministry of Health. The author makes some observations and suggestions with regard to matters of consent, incompetents as subjects, the right of withdrawal, and the power of the Ministry.

Clinical Trials as Topic↗
PubMed2003

Ethical aspects of placebo in migraine research.

Randomized placebo-controlled clinical trials have been the 'golden standard' during the last decades in the development of new drug therapies. This scientifically valid approach has recently been questioned in the fifth revised version of the Declaration of Helsinki, which states that the use of placebo-controlled clinical trials is only acceptable when no proven treatment exists for the studied disease. The World Medical Association further claims that no national ethical, legal or regulatory requirements should be allowed to reduce or eliminate any of the statements in the declaration. In spite of this, the document is not generally accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations. In the evaluation process for a drug to be approved in many countries today, clinical investigators at the hospitals and researchers at the pharmaceutical companies are obliged to use study protocols that would be rejected if the new declaration were to be fully adopted. Adherence to the clinical trial guidelines of the International Headache Society could also mean violation of the new Helsinki declaration of ethics. Some ethics committees have already adopted the new declaration, which has caused concern among clinical investigators, who find this document to be vastly out of the line with common practice. At the moment, the situation is unclear and debated with increasing polarity concerning the scientific and ethical issues regarding the use of placebo in clinical trials.

Adolescent↗
PubMed2004

Placebo: its action and place in health research today.

The place for the placebo in human clinical research is addressed in this paper. The World Medical Association which is comprised of some 80 National Medical Associations uses much of its resources to address medical ethics and human rights issues. It adopted the Declaration of Helsinki in June 1964 which addressed the protection of individuals in clinical trials. The use of placebos assumes an important role in this document. Five Revisions of the Declaration of Helsinki have occurred and the most recent was adopted in October 2000. The provisions on placebo are now in Paragraph 29 which reads as follows: "The benefit, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic methods exists." The reactions to the newly revised version of the Declaration of Helsinki were numerous and rapid, not the least of which was the paragraph I quoted above. At the direction of the WMA Council, a small group of experts together with the WMA workgroup studied the Paragraph 29 to ensure that no ethically sound research was being restricted by the revision. The outcome was approved by the Council and later the WMA General Assembly in October 2000. This gives a note of clarification as to the appropriate use of placebos. Numerous papers and statements over the last several years have described positions very much in line with the Note of Clarification cited above.

Clinical Trials as Topic↗
PubMed2004

Ethical principles and standards for the conduct of human and animal biological rhythm research.

Most research papers published in Chronobiology International report the findings of investigations conducted on laboratory animals and human beings. The Journal, its editors and the publication committee endorse the compliance of investigators to the principles of the Declaration of Helsinki of the World Medical Association relating to the conduct of ethical research on human beings and the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council relating to the conduct of ethical research on laboratory and other animals. Chronobiology International requires that submitted manuscripts reporting the findings of human and animal research conform to the respective policy and mandates of the Declaration of Helsinki and the Guide for the Care and Use of Laboratory Animals. The peer review of manuscripts will thus include judgment of whether or not the involved research methods conform to the standards of good research practice. This article outlines the basic expectations for the methods of human and animal biological rhythm research, both from the perspective of the fundamental criteria necessary for quality chronobiology investigation and from the perspective of humane and ethical research on human beings and animals.

Animals↗
PubMed2003

Review of procedures for protecting human subjects in recent clinical studies of pesticides.

Arguments have been made for and against the regulatory use of data from human subjects on both scientific and ethical grounds. One argument against the use of data from human clinical studies involving pesticides asserts that such data are obtained from studies that do not follow the Common Rule (40 CFR 26), which provides procedures for protecting human subjects in studies funded by federal agencies, including the U.S. Environmental Protection Agency (U.S. EPA). Although privately conducted studies using human subjects are not legally subject to or required to comply with the Common Rule, the protections of the Declaration of Helsinki and the International Conference on Harmonisation (ICH) Good Clinical Practice are commonly followed. We sought to answer the question of whether recent human clinical studies with insecticides performed according to Good Clinical Practice provided volunteers with the same protections as the Common Rule. All three sets of guidance have in common the intent to protect volunteer human subjects by providing standards for the conduct of studies in which they participate. This analysis compares the elements of the Common Rule with comparable elements from the Declaration of Helsinki and Good Clinical Practice to evaluate similarities and differences in procedural requirements. It then evaluates the documentation from 15 recent human studies of twelve insecticides conducted at four clinical laboratories in order to determine whether the conduct of those studies is consistent with the protections of the Common Rule. There were some cases for which we could not verify compliance with certain Common Rule elements; however, based on our evaluation it is apparent that the studies we reviewed were conducted in a manner substantially consistent with the fundamental protections of the Common Rule-voluntary participation, informed consent, and review by an ethical committee or institutional review board.

Clinical Trials as Topic↗
PubMed2002

Who is my brother's keeper?

Clinical and research practices designed by developed countries are often implemented in host nations of the Third World. In recent years, a number of papers have presented a diversity of arguments to justify these practices which include the defence of research with placebos even though best proven treatments exist; the distribution of drugs unapproved in their country of origin; withholding of existing therapy in order to observe the natural course of infection and disease; redefinition of equipoise to a more bland version, and denial of post-trial benefits to research subjects. These practices have all been prohibited in developed, sponsoring countries, even though they invariably have pockets of poverty where conditions comparable to the Third World prevail. Furthermore, the latest update of the Declaration of Helsinki clearly decries double ethical standards in research protocols. Under these circumstances, it does not seem appropriate that First World scholars should propose and defend research and clinical practices with less stringent ethical standards than those mandatory in their own countries. Recent years have witnessed frequent reports of less stringent ethical standards being applied to both clinical and research medical practices, for the most part in the field of drug trials and drug marketing, initiated by developed countries in poorer nations. Still more unsettling, a number of articles have endorsed the policy of employing ethical norms in these host countries, which would be unacceptable to both the legislations and the moral standards of the sponsor nations. Also, these reformulations often contravene the Declaration of Helsinki or one of its updates. This paper is not so much concerned with the actual practices, which have been subjected to frequent scrutiny and publicly decried when gross misconduct occurred. Rather, my concern relates to the approval and support such practices have found in the literature on bioethics from authors who might be expected to use their energy and scholarship to explore and endorse the universalisability of ethics rather than to develop ad hoc arguments that would allow exceptions and variations from accepted moral standards. To this purpose, issue will be taken with arguments in three fields: medical and pharmaceutical practices, research strategies, and local application of research results.

Bioethics↗
PubMed2005

Orthodontic Clinical Trials III: reporting of ethical issues associated with clinical trials published in three orthodontic journals between 1989 and 1998.

AIMS: The aims of this study were to assess whether reports of orthodontic clinical trials complied with the requirements of the Declaration of Helsinki. DESIGN: A retrospective observational study. SETTING: The American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Journal of Orthodontics (formerly and up until 1999 known as the British Journal of Orthodontics, BJO) and European Journal of Orthodontics (EJO). DATA SOURCE: Clinical trials published between 1989 and 1998. METHODS: A hand search was performed to identify all clinical trials. Each trial report was assessed for inclusion of a statement that ethical approval and/or informed consent had been obtained. RESULTS: One-hundred-and-fifty-five papers were identified, of which 85 (54.8%) were reports of randomized controlled trials (RCTs) and 70 (45.2%) of controlled clinical trials (CCTs). 16.1% (25/155), of the trial reports stated that ethical approval had been obtained and a quarter (39/155, 25.1%) indicated that informed consent had been obtained. CONCLUSIONS: Most orthodontic clinical trial reports failed to state whether ethical approval and/or informed consent had been obtained. The reporting of the ethical issues associated with orthodontic clinical trials could be improved further not only by the instructions to authors in orthodontic journals stating the need for studies to comply with the Declaration of Helsinki, but also by Journal editors refusing to publish trials that do not comply.

Clinical Trials as Topic↗
PubMed2001

Institutional Review Board approval for prospective experimental studies on infants and children.

BACKGROUND/PURPOSE: The Declaration of Helsinki requires Institutional Review Board (IRB) approval for experimental studies on human subjects. The authors questioned whether published prospective surgical experimental studies document IRB approval for infants and children. METHODS: Prospective studies were identified in 5 surgical and 2 major pediatric journals from 1997 through 1999. Documentation of IRB approval was recorded. Results were analyzed using Pearson chi(2) tests and a multivariate regression model. Statistical significance was defined as P less than .05. RESULTS: A total of 149 prospective experimental studies on pediatric subjects were evaluated; the majority being interventional or therapeutic studies (105 of 149). More than 75% were from academic medical centers (125 of 149), grant-supported (110 of 149), and appeared in surgical journals (110 of 149). Slightly less than 25% of studies (40 of 149) documented IRB approval. Observational studies, grant support, and publication in nonsurgical journals all correlated positively with IRB approval and were statistically significant variables (P<.001, P<.001, P<.001, respectively). Interventional or therapeutic, institutionally or privately-funded studies found in surgical journals were most likely to avoid IRB documentation (P<.001). CONCLUSIONS: The majority of prospective pediatric studies in the surgical journals omit IRB documentation. Strict requirements for specific IRB approval and documentation in compliance with the Declaration of Helsinki would allow higher ethical standards for the clinical investigation of infants and children.

Chi-Square Distribution↗
PubMed2003

Update on unethical use of placebos in randomised trials.

The most recent (Fifth) revision of the Declaration of Helsinki, adopted in October 2000 by the World Medical Association (WMA), reinforces the longstanding prohibition against offering placebo instead of effective therapy. The WMA left no doubt that if a beneficial treatment for a condition has already been recognised, it is unethical to offer placebo in place of such treatment to anyone in a study of the same condition. We have previously drawn attention to the discrepancy between the spirit of the Declaration and the common practice of using placebo controls in randomised trials even if effective treatment exists. Despite the mandates of the Declaration of Helsinki and concern from ethicists and scientists, the US Food and Drug Administration (FDA) continues to demand and defend placebo-controlled evidence of efficacy and safety for the development of many new pharmaceuticals, even if effective therapy exists. We suggest that the FDA's arguments defending their practice are insufficient to justify medical research that violates the Declaration of Helsinki.

Government Regulation↗