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PubMed1997

Institutional review board approval and publication of human research results.

OBJECTIVE: To determine if journals' instructions for authors require that manuscripts being considered for publication indicate that studies involving human subjects had appropriate institutional review board (IRB) approval. DESIGN: A descriptive study of the ethical guidelines published in the Instructions for Authors sections of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus. INTERVENTION: Literature review. MAIN OUTCOME MEASURE: Policy regarding IRB approval of studies that involve human subjects. RESULTS: Of the 102 journals surveyed, 48 (47%) require IRB approval of studies involving human subjects as a prerequisite for publication, and 25 (24%) do not present or refer the author to any information related to human research ethics. Of the remaining journals, 15 (15%) referred authors to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 3 (3%) to the Declaration of Helsinki, and 10 (10%) simply indicated that informed consent should be obtained. There was only 1 medical specialty (anesthesiology) in which all the representative journals presented the same ethical requirement. In the 48 journals that clearly required IRB approval of studies, 37 (77%) documented IRB approval with a statement in the manuscript, 7 (15%) required a separate signed statement from the author, and 4 (8%) did not mention a method of documentation. CONCLUSIONS: The results of this study suggest that about half of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus do not publish guidelines indicating that IRB approval of studies involving human research subjects is a requirement for publication. The manner in which publication requirements related to ethical standards are presented in biomedical research journals is extremely variable.

Codes of Ethics↗
PubMed2005

Compromised ethical principles in randomised clinical trials of distant, intercessory prayer.

The effects of distant, intercessory prayer on health outcomes have been studied in a range of randomised, blinded clinical trials. However, while seeking the evidentiary status accorded this 'gold standard' methodology, many prayer studies fall short of the requirements of the World Medical Association's Declaration of Helsinki for the ethical conduct of trials involving human subjects. Within a sample of 15 such studies published in the medical literature, many were found to have ignored or waived key ethical precepts, including adequate standards of care, patient confidentiality and informed consent. Prayer was considered in most studies to pose negligible or no risk to subjects, despite the fact that no clear mechanism of action nor any safety monitoring procedures were described. As a result, many studies did not meet basic ethical standards required of clinical trials of biophysical interventions, making application of their results ethically problematic. If investigators wish their data to adequately inform the use or rejection of intercessory prayer to improve health, these shortcomings should be addressed in future studies.

Conflict of Interest↗
PubMed2005

[Ethical implications of placebo-controlled clinical trials for psychotropic drugs].

The "note of clarification" of the World Medical Association to Article 29 of the Fifth Revision of the Declaration of Helsinki (Edinburgh 2000) intensified the controversial discussion of how methodologically compelling and ethically acceptable pure placebo controls are in clinical trials of new drugs if an effective standard therapy ("active control") is available. Pros and cons from this discussion are exposed and examined with regard to "minor" psychic disorders, depressions, and schizophrenia. Criteria are developed to facilitate the evaluation of each trial application. These criteria also seem to be necessary because normative authorities, which are responsible for licensing drugs such as FDA and EMEA, and legally relevant regulations such as the additional protocol for biomedical research of the European Council do not agree with regard to placebo controls. It is concluded that pure placebo-controlled clinical trials of new psychotropic drugs may be acceptable in minor psychic disorders, but in general -- at least in a pure form -- not in major disorders such as schizophrenia and major depression.

Controlled Clinical Trials as Topic↗
PubMed2003

The scientific establishment of a new therapeutic intervention for developmental conditions: practical and ethical principles.

BACKGROUND: Although the randomized controlled trial (RCT) is a major methodological breakthrough extending the limits of objectivity in clinical medical science, clinical trials of surgery have seldom included placebo surgery as a control, for ethical reasons. Especially in clinical studies intended eventually to establish a new intervention for developmental conditions, it has been recognized that there is huge examiner bias. In addition, the many miraculous cases that have been reported in nonsurgical open trials for developmental conditions and have eventually been evaluated as nonspecific positive outcomes in RCTs suggest that empirically promising interventions must be subjected to scientific scrutiny as soon as possible in the field of developmental conditions. APPLICATION TO PEDIATRIC NEUROSURGERY: Therefore, in childhood neurosurgery, clinical studies to establish a new therapeutic measure for developmental conditions should be designed as rigorously as possible using optimized scientific methods. The worldwide ethical guideline, the Declaration of Helsinki issued by the World Medical Association, can provide principles for the establishment of a new intervention in the treatment of a patient when proven therapeutic methods do not exist or methods used thus far have been ineffective. Physicians' discretion to use unproven or new therapeutic measures for such patients is approved in the presence of efforts of an ethical and scientific approach. Even if the measure is a very promising intervention, the research aspects must completely be demonstrated for informed consent and review by the ethical committee and the trial must be regarded as a clinical research. Especially when an RCT is not possible for ethical reasons, appropriate epidemiological data or animal experiments should suggest that the new measure is effective before a clinical trial. In a clinical setting, where neither epidemiological studies nor animal experimentation can be introduced, if necessary the researcher should collaborate with experts to obtain multidisciplinary justification for clinical testing.

Animals↗
PubMed2004

Placebo-controlled trials in major depression are necessary and ethically justifiable: how to improve the communication between researchers and ethical committees.

Despite numerous placebo-controlled clinical trials with antidepressants were conducted in humans and a large amount of data was already published in the last two decades, the members of the 4th European Expert Forum on Ethical Evaluation of Placebo-Controlled Studies in Depression were agreed that placebo-controlled trials with antidepressants also in the future are essential. Placebo-controlled studies measure the effect size in a reliable way and establish sensitivity and internal validity. They are scientifically sound and interpretable in terms of efficacy and are, therefore, clinically more relevant than non-placebo-controlled clinical trials. The "Note of Clarification" of the Declaration of Helsinki opens up where such trials are acceptable. This statement of the members of the 4th European Expert Forum is directed to academia, members of Ethic Committees, regulators, and industry to facilitate their decisions towards clinical studies with antidepressants. "Checklists" for the contents of patients information are given as well as for the investigator.Placebo-controlled clinical trials are scientifically necessary, ethical and feasible. The administration of the placebo is in itself a non-specific treatment and experts agree that there appears to be no increased suicidal risk in the placebo-group of carefully selected and monitored study patients.

Antidepressive Agents↗
PubMed2006

The protection of patients' rights in clinical trials.

The Helsinki Declaration is a very important document regarding the protection of patients' rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients' rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients' rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting.

Clinical Trials as Topic↗
PubMed1979

Problems with ethical aspects of psychotropic drug use.

1. Research is an important area within the purview of medical ethics. The Nuremberg Code and the Helsinki Declaration provide well established guidelines in this field. 2. Specific ethical issues still requiring clarification in psychopharmacological research are the informed consent, the benefit/risk ratio and the choice of placebo or standard. 3. Peer review committees, if well chosen for their objectivity, general competence and special expertise, are likely to be the best arbiters regarding such questions. 4. Legislation and other political interventions--unfortunately not always objective, competent or expert in the exercise of their powers--have recently developed into rampant paraethical problems that are plaguing medical treatment and research in many parts of the world and need to be dealt with urgently through internationally coordinated efforts. The WHO would appear to be the most appropriate agency for such action.

Ethics Committees, Clinical↗
PubMed2006

[Are SPA therapy and pulsed electromagnetic field therapy effective for chronic neck pain? Randomised clinical trial. Second part: medicoeconomic approach].

UNLABELLED: We report the results of a cost-effectiveness evaluation of pulsed electromagnetic field (PEMF) therapy and spa therapy (ST) versus usual care (control) for chronic neck pain. MATERIALS AND METHODS: Inclusion criteria were age 18 to 80 years with pain in the neck area of more than 3 months' duration and no contraindications for PEMF therapy and ST. Randomization to the ST (n=25) and PEMF groups (n=26) was blinded, as was collection of data. Non-included subjects (n=29) underwent usual care. The trial respected the Helsinki declaration, and informed consent was obtained from subjects. The analysis was intent to treat; the main outcome measure was increase in health dimension scores on the MOS SF-36 in terms of increase in French health care costs from 6 months preceding to 6 months after the start of the study. RESULTS: The increase in health care costs was less for the PEMF group (+68 euro+/-539 [95% confidence interval (CI)]: -145.0+281) than the ST and control groups. The increase tended to be less, but not significantly, for the ST group (+373+/-938 euro [95% CI, -14.0+76.0]) than for controls (+618+/-2715 euro [95% CI, -434.0+167.0]). The gain of one physical MOS SF-36 unit during one year cost 3400 euro [95% CI, -6759+13 100] for the PEMF group, 29,000 euro [95% CI, -1093+59 375] for the ST group and 95076 euro [95% CI, -66 769+256 923] for the control group, but the differences were not significant. COMMENTARY: These results suggest a potential cost-effectiveness for ST and particularly PEMF as compared to usual care in chronic cervical pain. Our results perhaps lack significance probably because of lack of statistical power and do not distinguish costs related or not to chronic cervical pain.

Adult↗
PubMed2006

Research audit and publication.

The ethics of research, audit and publication have developed mainly within the last fifty years. The Declaration of Helsinki is the universally accepted code of conduct for researchers worldwide. All research has to be approved by an ethics committee, all of which are governed by a centralised structure which is the Central Office for Research Ethics Committees (COREC) in the UK. This standardised system has been developed to oversee all research activity across the whole of Europe and every European county will have an equivalent organisation. The committees concern themselves with research but the differences between audit and research are difficult to discern in many places. If there is any doubt then the advice of the local research ethics committee should be sought. Only the individual him/herself can give consent. This may produce difficulties in cases of certain groups especially unconscious patients and children. The outcome of every study should be published whatever the results and the ongoing development of centralised (national) research trial databases will promote this philosophy. Publication of results thought to be of lesser importance may prove difficult, however, and so there is a temptation to falsify or modify data to make it more attractive. This, together with other activities such as the fabrication of data, plagiarism, dual publication, salami publication, conflicts of interest and irregularities in authorship, have given Editors of journals a number of problems. Many of these issues around publication ethics may prove difficult to detect but the fear of sanctions from employers and professional organisations is a useful deterrent.

Authorship↗
PubMed2000

Influence of seat characteristics on occupant motion in low-speed rear impacts.

To analyze the effect of the seat characteristics on dummy motions and human volunteer motions, sled tests simulating low-speed rear impacts were conducted with some seats which had different characteristics. Volunteer's cervical vertebral motions were photographed with an X-ray cineradiographic system at a speed of 90 frames/s as well as the visible motions of dummy's and volunteer's were recorded. Although the tests were conducted under limited conditions, the results indicated the relationship between the occupant's visible motions, which are assumed to be closely related to the whiplash injury mechanism, and seat characteristics. It should be noted that the volunteer sled tests were discussed and approved by the Tsukuba University Ethics Committee and the volunteer submitted his informed consent in writing in line with the Helsinki Declaration.

Acceleration↗
PubMed2003

Activation of a residual cortical network during painful stimulation in long-term postanoxic vegetative state: a 15O-H2O PET study.

Survivors of prolonged cerebral anoxia often remain in the persistent vegetative state (PVS). In this study, long-term PVS patients were investigated by 15O-H(2)O PET to analyze their central processing of pain. The study was approved by the local Ethics Committee, the experiments were performed in accordance with the Helsinki Declaration of 2000. Seven patients remaining in PVS of anoxic origin for a mean of 1.6 years (range 0.25-4 years) were investigated. We performed functional PET of the brain using 15O-labelled water during electrical nociceptive stimulation. Additionally, a brain metabolism study using 18F-fluorodeoxyglucose (FDG) PET and multi-sequence MRI (including a 3-D data set) were acquired in all patients. PET data were analyzed by means of Statistical Parametric Mapping (SPM99) and coregistered to a study-specific brain template. MRI and FDG PET showed severe cortical impairment at the structural and the functional level, that is, general atrophy of various degrees and a widespread significant hypometabolism, respectively. Pain-induced activation (hyperperfusion) was found in the posterior insula/secondary somatosensory cortex (SII), postcentral gyrus/primary somatosensory cortex (SI), and the cingulate cortex contralateral to the stimulus and in the posterior insula ipsilateral to the stimulus (P<0.05, small-volume-corrected). No additional areas of the complex pain-processing matrix were significantly activated. In conclusion, the regional activity found at the cortical level indicates that a residual pain-related cerebral network remains active in long-term PVS patients.

Adult↗
PubMed1997

Molecular mimicry as a therapeutic approach for an autoimmune disease: oral treatment of uveitis-patients with an MHC-peptide crossreactive with autoantigen--first results.

In the rat model of experimental autoimmune uveitis (EAU) we have demonstrated that a peptide from the sequence of human disease-associated MHC-class I antigens can induce uveitis upon immunization. Moreover, oral administration of this MHC-peptide tolerized Lewis rats to the disease induced with two different retinal autoantigens, retinal S-antigen (S-Ag) and IRBP. In uveitis patients T cells responding to S-Ag peptide also respond to the MHC-peptide, which shows crossreactivity with the major epitope from S-Ag due to some shared discontinuous amino acid homologies. The 14-mer peptide B27PD is derived from the sequence of all HLA-B antigens that are statistically associated with uveitis (including HLA-B27). Patients with long-lasting endogenous uveitis, suffering from side effects of conventional immuno-suppressive therapy or being therapy-refractive, were orally tolerized with peptide B27PD in this first open therapeutic trial. Patients received peptide three times a week over a 12 weeks period, while only low dose steroids were allowed as concomitant medication. The aims were (1) to investigate whether immunosuppressive therapy could be discontinued and steroids reduced while relapses of ocular inflammation reside and (2) to search for side effects. The Helsinki Declaration was strictly observed and the study design approved by the local ethical committee. The first patients orally tolerized with the HLA-peptide (two had stopped azathioprine immediately prior to onset of oral peptide treatment) could discontinue their steroids because of reduced intraocular inflammation. No side effects of therapy were observed. Oral tolerance induction with a peptide derived from the patients' own HLA-antigens and crossreactive with the organ-specific autoantigen seems to be a potent therapeutic approach.

Administration, Oral↗
PubMed2001

Monotherapy trials in antiepileptic drugs: are modified "presurgical studies" a way out of the dilemma?

Monotherapy trials in epilepsy are confronted with a dilemma: either they are in conflict with ethical requirements, or they are scientifically not meaningful. Monotherapy trials, which are performed as controlled studies randomizing patients to ineffective (pseudo)placebo treatment, are incompatible with the Helsinki Declaration. On the other hand, equivalence or noninferiority studies using an active-control design do not permit valid conclusions on the efficacy of the test drug. Therefore, they do not fulfill scientific requirements for trials on new drugs. As an alternative approach, a monotherapy trial design for epilepsy patients undergoing presurgical evaluation was outlined. During presurgical evaluation, antiepileptic drugs are routinely tapered down for seizure recording. This situation is used for a placebo-controlled short-term monotherapy trial. Four trials according to this design have been completed so far. Recently, several points of concern have been raised against this design, especially for matters of ethics and external validity. In the present article, these objections are outlined and discussed. In the proposed modification the randomization and the titration of the test drug or control begins prior to the presurgical investigations. The advantages are: the test drug does not have to be titrated quickly, pure monotherapy conditions are achieved, and the subjects do not have to experience more seizures than are required for the presurgical evaluation.

Anticonvulsants↗
PubMed2001

Palliative care research.

Most of the research in palliative medicine is of a descriptive nature. Clinical practice is based upon clinical experience rather than upon research. The level of appropriate research reduces the chance for improvement of palliative care. Ethical and methodological obstacles seem to be prominent in palliative care research. The Declaration of Helsinki is generally accepted as an ethical code of practice for clinical research and it also applies to palliative care. In order to obtain reliable data, standardisation of data collection is needed. Improvement of quality of life is the primary endpoint in most studies in palliative care. The existing validated quality of life instruments such as the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QLQ)-C30 can be used until the patient is too sick to complete the questionnaire. New approaches are needed and must be developed for the dying patients. Palliative care research needs proper funding; specific programmes supporting research on a European level are needed. The European Association for Palliative Care (EAPC) is capable of conducting and coordinating collaborative research in palliative care on a European level.

Europe↗
PubMedDate not supplied

[Quality standards and their assurance for study centers in the competence network malignant lymphoma].

BACKGROUND: The aim of most of the trials of the Competence Network Malignant Lymphoma is to optimize the standard treatment of lymphoma using only registered drugs in the case of medicinal therapies (quality assurance protocols). In contrast to regulatory trials, special regulations for quality assurance protocols are not given by the legislature. However, there is agreement that also for this type of studies the declaration of Helsinki and the Guidelines of the International Conference on Harmonisation (ICH) are relevant. The ICH Guidelines must be formulated to take into account the specific situation of quality assurance protocols and to ensure at the same time efficiency and transparency of these studies. This is the aim of the quality management of the study groups in the Competence Network Malignant Lymphoma. METHOD: The quality assurance measures already established in the study groups are being expanded to a comprehensive quality management concept in agreement with the ICH Guidelines and allowing for the situation of quality assurance protocols. To this end, a working group for quality management (AG-QM) has been set up to define and establish general quality standards for all aspects of planning, executing and evaluating quality assurance protocols in study centers. RESULTS: The AG-QM has developed a system of Standard Operating Procedures (SOPs) reflecting all working procedures of the study centers. Furthermore, evaluation parameters for the quality of trial execution have been identified and the harmonisation of documentation parameters has been initiated. Term definitions are collected and their harmonisation coordinated. CONCLUSIONS: Development of quality standards is the first step of quality management. To ensure the realisation of these standards in practice, the AG-QM will establish quality assurance measures including continuous reevaluation of quality criteria and actualization of quality standards if necessary.

Helsinki Declaration↗
PubMed2006

Ethics, standards, and procedures of animal and human chronobiology research.

The majority of research papers published in Chronobiology International report the findings of investigations conducted on laboratory animals and human beings. The editors and the readers of the journal expect the authors of submitted manuscripts to have made an important contribution to biological rhythm and related research through the ethical conduct of investigations and unbiased and accurate reporting of findings. Authors of scientific papers are required to disclose any potential conflict of interest. The journal accepts only papers that are original work, no part of which has been submitted for publication elsewhere, except as brief abstracts. The journal and its editors endorse the compliance of investigators to the principles of the Declaration of Helsinki of the World Medical Association, which relate 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, which relate to the conduct of ethical research on laboratory and other animals. The peer review of manuscripts by Chronobiology International thus includes judgment as to whether or not the investigative methods conform to the standards of good research practice. This article updates the ethical policies, standards, and procedures for manuscripts submitted to Chronobiology International that involve human and animal biological rhythm research, both from the perspective of the criteria of quality chronobiology investigation and from the perspective of humane and ethical research on human beings and animals.

Animal Experimentation↗
PubMedDate not supplied

Children as guinea pigs: historical perspective.

Experimentation involving children is not a new phenomenon. Children have been used as research subjects in a diverse set of experiments, including the trials of new vaccines and sera, in efforts to understand normal pediatric anatomy and physiology and in the development of new drugs and procedures. Concern about child participants in research is also not a new development. For more than a century, critics of medical research have called attention to the fact that children and other vulnerable populations--pregnant women, prisoners, the mentally ill--have too often served as the unwitting and unwilling subjects of medical experiments. This paper looks at several early cases in which children participated, including the first trial of cowpox vaccine, the first human trial of rabies vaccine, and the first treatment of Listerian wound antisepsis. The history of concern for children, especially institutionalized children, in medical research is considered along with the development of regulations or guidelines, including the Declaration of Helsinki (1964).

Child↗
PubMedDate not supplied

Requirements for pharmacokinetic evaluation of antibiotics in phase I studies.

Initial pharmacokinetic studies usually include healthy volunteers to minimize variation generated by diseases. Ethical aspects of initial studies are paramount. The guidelines of the Helsinki Declaration should be followed or even extended. Thorough toxicologic screening in animals is a prerequisite. The use of radioisotopes for pharmacokinetic studies should be limited. The basic design of studies includes cross-over administration of intravenous and oral doses of several sizes. Bioavailability, total area under the serum concentration curve, serum half-life, amount eliminated in urine as active drug, and metabolism are the most important data. The fate of the parent compound and of its possible metabolites in both healthy persons and ill individuals (including those with renal or hepatic dysfunction) should be monitored. Diet may have consequences with regard to recommended dosage schedules. When possible, tissue penetration of antibiotics should be assessed, preferably through the analysis of peripheral human lymph and of suction-blister and peritoneal fluids. Theoretical dosage schedules based on pharmacokinetic assessments in healthy persons should be tested in patients with infectious disease, particularly in those with reduced renal and/or hepatic function.

Administration, Oral↗