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PubMedDate not supplied

[Analysis of ethical aspects on human experimentation included in the instructions for the authors in 139 Brazilian scientific journals].

UNLABELLED: The concern with ethical standards during research in human subjects has been improving in Brazil during the last decade. Analysis of the ethical recommendations in instructions to authors may contribute to understand Brazilian Scientific Journals policies. OBJECTIVE: To evaluate the recommendations related to the ethics of investigation in human subjects in instructions to authors of Brazilian Scientific Journals. MATERIAL AND METHODS: Instructions to authors of 139 Brazilian Scientific Journals in medicine, biomedicine, nursery, odontology and general sciences were analysed. RESULTS: In one hundred ten (79.1%) of the 139 journals no recommendations related to ethics were found; 17 (12.2%) required previous approval by the institutional committee; 3 (2.1%) the procedures should be in accordance with the Declaration of Helsinki; 1 (0.7%) recommends the application of the informed consent; 5 (3.5%) recommend the use of Uniform requirements for manuscripts submitted to biomedical journals and 3 (2.1%) follow no specified rules. Twenty nine journals ask for references in ethics standards: in 15 (51.7%) the information must be included in the text; in 2 (6.8%) the authors must send a letter informing how the ethics standards were followed; in 1 (3.4%) a copy of the approval by the institutional committee must be included; in 1 (3.4%) believed the authors followed the standards and in 10 (34.4%) no specific reference was made. CONCLUSION: These results indicated that the majority of Brazilian Scientific Journals have little concern related to ethical aspects of research in human subjects included in instructions to authors. Even journals that make references to the ethical aspects the recommendations are quite different.

Brazil↗
PubMedDate not supplied

The cloning controversy.

Stem cell research has captured the imagination of many, including the scientific and medical community. But the medical community received a wake-up call early this year when a well-known researcher publicly confessed to deception. While the core question relates to honesty and integrity, it is equally necessary to examine the system that made such deception possible.

Cloning, Organism↗
PubMed2002

Ethics in exercise science research.

Ethical evaluation is a vital but sometimes neglected component of research policy in the exercise sciences. This article reviews some issues in human research, with particular reference to studies undertaken by the exercise scientist. The typical composition and functions of the research review committee are examined in the context of individual and institutional ethical norms. In multicentre trials, there are often problems in coordinating ethical approval between institutions. On-going monitoring of research may have value in the detection of fraud. A reduction in the secrecy of committee proceedings would allow a closer auditing of the research review process. Authors need to give more thought to developing appropriate research questions. Scarce resources may be wasted because of inappropriate study design or an inadequate statistical analysis of the results. The costs of any proposed investigation must be weighed carefully against possible benefits. Confidentiality is particularly important when collecting data at the worksite or over the internet. Informed consent should be based on a full disclosure of risks; the participant should be competent to understand the nature and magnitude of these risks, and undue pressure to participate in an experiment must be avoided. The opposition to placebo trials expressed in the Declaration of Helsinki requires careful consideration of the use of control groups, since regular exercise is known to benefit health. If research is conducted in under-developed societies, the standards of treatment of the participants should match those expected in developed societies. The publication of findings must be fair and well balanced; examples of fraud and misconduct continue to be reported. Some journals apparently still publish papers, even if they have not received an initial institutional review. Editors should restore meaning to the word 'author', avoid the bias to a publication of 'positive' results, limit the impact of commercial sponsorship on reporting and curtail the current trend to redundant presentations and publications. Development of academic courses in research ethics may help to avoid some of these abuses.

Canada↗
PubMed2026

Shielding the First 24 Postnatal Months of Life: A Proposal for a Prospective Cohort Study of Early-Life Electromagnetic Exposure and Autism Risk.

BACKGROUND: Autism Spectrum Disorder (ASD) involves Mirror Neuron System (MNS) dysfunction, driving core social and imitative impairments. Systemic physiological alterations such as autonomic dysregulation, mitochondrial dysfunction and neuroinflammation are known to impair synchronization and plasticity of neuronal clusters. A less-evident environmental cofactor, coinciding with rising ASD prevalence, is the considerable world-wide increase in electromagnetic radiation (EMR) overall exposure among children. Experimental evidence shows how low-intensity EMR influences cellular processes, via voltage-gated calcium channels (VGCCs), oxidative stress, and mitochondrial metabolism. The Resonant Convergence framework, allow to predict how chronic EMR exposure during the first 24 postnatal months of life can act as a factor in ASD pathogenesis. The best candidate mechanism is chronic Ion Cyclotron Resonance (ICR) detuning the Ca2+-calmodulin pathway, thus disrupting MNS synchronization. METHODS AND ANALYSIS: A prospective observational pilot cohort study (24-month follow-up) proposes to enroll 1000 full-term newborns into two arms: an EMR-reduced cohort (n = 500, rest and sleep-phase Faraday shielding) and a standard exposure cohort (n = 500). Exposure is quantified via radiofrequency (RF)/extremely low frequency(ELF) measurements, proximity analysis, device inventories and wearable dosimetry. The primary endpoint is a continuous neurodevelopmental trajectory score (joint attention, language, electroencephalogram (EEG) mu-rhythm); binary ASD diagnosis (Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Autism Diagnostic Interview-Revised (ADI-R)) is a secondary, exploratory endpoint. Moreover, an optional genomic screening will evaluate gene-environment interactions within extremely low-frequency electromagnetic field (ELF-EMF) vulnerable pathways, including ASD-associated genes upregulated by RF via bromodomain and extraterminal protein (BET)-mediated epigenetic mechanisms. Analyses will employ risk ratios, Fisher's exact tests and logistic regression adjusted for confounders; mixed-effects and Bayesian modeling will evaluate longitudinal outcomes and exposure reduction effects. Given a 2-3% baseline prevalence, approximately 20-30 ASD cases are expected. The study is therefore powered for exploratory signal detection rather than definitive causal inference, providing the critical baseline data required to justify and design future confirmatory trials. Sex-stratified modeling will address the 4:1 male-to-female prevalence ratio. ETHICS AND DISSEMINATION: Ethics committee approval is not yet sought; full protocol review and approval will be obtained prior to the study initiation, in strict accordance with the Declaration of Helsinki. Written parental informed consent will be mandatory for all participants prior to enrollment. Study findings and methodological milestones will be disseminated through peer-reviewed international scientific publications. This protocol provides a structured methodological framework for the first prospective investigation of sleep-phase EMR reduction as a potential modulator of ASD incidence during early neurodevelopment. Results will inform adequately powered confirmatory trials in electromagnetic neurodevelopmental epidemiology.

autism spectrum disorder↗
PubMed1986

Auranofin versus penicillamine in rheumatoid arthritis. One-year results from a prospective clinical investigation.

Forty patients with definite or classical active rheumatoid arthritis were stratified by the minimization procedure to auranofin (6 mg/day) or penicillamine (go slow and low regime). This investigation is a prospective planned 3 year patient and 'doctor-open' as well as 'doctor-blind' clinical trial. This article describes the results after 12 months. Both drugs decreased disease activity and improved the functional capacity in a similar way. Two patients in the auranofin group and 5 in the penicillamine group stopped treatment due to major side effects. Four other patients in the auranofin group left treatment: 2 due to death from unrelated cause and 2 according to the Helsinki II Declaration. After one year a further patient in the auranofin group and 2 in the penicillamine group stopped treatment due to lack of clinical effect. Side effects due to auranofin were statistically more frequent distal in the gastrointestinal tract (loose stools/diarrhoea) than with penicillamine. In contrast, penicillamine produced significantly more side effects in the oral cavity (mainly taste disturbances) than auranofin. Other side effects were about equal in the two groups, but 2 cases of severe proteinuria and one with obstructive lung disease were observed in the penicillamine group. Only 3 patients did not complain of any untoward effect during the 12-month period. We conclude that on the basis of this one year investigation it is an open question whether one should select auranofin or penicillamine for the treatment of clinical active rheumatoid arthritis.

Acute Disease↗
PubMedDate not supplied

Referral of patients with cancer for participation in randomized clinical trials: ethical considerations.

Physicians with patients with cancer may be faced with two conflicting ethical obligations. One is to contribute to the advancement of scientific knowledge. Among the ways available to respond to this duty is to refer patients for participation in RCTs. The second obligation is to serve the health interests of the individual patient. When these two duties conflict, the latter obligation to the individual takes priority. In the words of the Declaration of Helsinki, "Concern for the interests of the subject (patient) must always prevail over the interests of science and society." Quite often there is no conflict. The patient can pursue his or her health interests most effectively by enrollment in an RCT. In such cases, the referring physician can contribute to the success of the patient's participation in the RCT by explaining what the patient can expect to experience as a patient-subject. It is usually important to explain that referral does not necessarily entail severing the original doctor-patient relationship.

Clinical Trials as Topic↗
PubMed2000

Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues.

In recent years, several authors have argued that placebo-controlled trials are invariably unethical when known effective therapy is available for the condition being studied, regardless of the condition or the consequences of deferring treatment. Some have also disputed the value of placebo-controlled trials in such a setting, asserting that the comparison of new treatment with old treatment is sufficient to establish efficacy and is all that should be of interest. This article considers the ethical concerns about use of placebo controls and describes the limited ability of active-control equivalence (also known as noninferiority) trials to establish efficacy of new therapies in many medical contexts. The authors conclude that placebo-controlled trials are not uniformly unethical when known effective therapies are available; rather, their acceptability is determined by whether the patient will be harmed by deferral of therapy. If patients are not harmed, such trials can ethically be carried out. Furthermore, active-control trials, although valuable, informative, and appropriate in many circumstances, often cannot provide reliable evidence of the effectiveness of a new therapy.

Controlled Clinical Trials as Topic↗
PubMedDate not supplied

Risk, Helsinki 2000 and the use of placebo in medical research.

There has been vigorous debate over the use of placebo controls in clinical trials in human subjects where active treatments are already in widespread use. The debate has extended from the use of placebo controls in trials of products for AIDS in developing countries to the use of placebos in trials in conditions such as mild hypertension, asthma, depression, chronic stable angina etc. Some have argued that placebos can never be justified where an active treatment exists. By contrast, we believe that minor levels of risk are justified in healthcare research under defined conditions provided there is full information and consent. The opportunities for altruism in research should neither be exploited nor prevented.

Acquired Immunodeficiency Syndrome↗
PubMed1999

[Informed well-considered consent ('informed consent'): an end or a means?].

Since World War II, all sorts of protective measures have been taken for people who receive medical care or who are involved in scientific research. More and more, informed consent has become the standard. In the field of experimental therapeutical research, informed consent is still a controversial subject; the individual person's interests versus general interests. But informed consent appears to have become such an absolute prerequisite for all types of observational research that the future of epidemiological research based on existing data is threatened. According to both the Declaration of Helsinki and the Dutch Law for Protection of Persons, it is possible to omit asking individual informed consent under certain circumstances. Permission for research could then be given by a supervisory board or a medical-ethical commission. After all, informed consent was never meant to be a goal of its own, but a means for self-protection and securing the right to autonomy. In situations where this right is curbed for other reasons, it appears that insisting on informed consent misses its target completely.

Epidemiology↗
PubMed2000

[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.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

[Epidemiological study of Chlamydia trachomatis infection in a sample of women requesting voluntary termination of pregnancy, treated with rokitamycin].

BACKGROUND: Infection with Chlamydia trachomatis usually involves the cervix uteri, causing no symptoms, and may easily be unrecognised and untreated until troublesome symptoms arise, such as pelvic inflammatory disease, which can affect fertility and reproductive life. Therapies include the macrolide antibiotics, and in this class rokitamycin offers marked lipophilia, excellent intracellular penetration, and bactericidal activity at concentrations close to the MIC. The present study was therefore designed to establish the frequency of intracervical infection with Chlamydia trachomatis in women applying for termination of pregnancy, and to assess the efficacy and safety of this drug in this indication. METHODS: Women aged 18-40 years were admitted for termination of pregnancy, with a positive cervical swab for Chlamydia trachomatis. The study was conducted in accordance with the Declaration of Helsinki and amendments. Patients were given one oral tablet of 400 mg rokitamycin in the morning, and one in the evening, for two weeks. Treatment started ten days before the termination, within 48 h of taking the swab. Partners were to receive the same treatment. RESULTS: 292 women requiring termination of pregnancy, on average at the 9th week of pregnancy, were assessed. Of these, 24 (8.2%), mean (+/- SD) age 27.1 +/- 6.1 years, range 18-39, with a positive cervical swab for Chlamydia trachomatis, were treated with rokitamycin; 22 of their partners were treated too. Forty days after the start of treatment 22 patients (92%) gave negative results; these were all the cases whose partners had received treatment. No adverse events were reported and the acceptability of the treatment was considered good or excellent in 91% and fair in 9% of the cases. CONCLUSIONS: The findings confirm that rokitamycin is one of the most useful and effective macrolides for the treatment of infections caused by intracellular microorganisms; it is extremely well tolerated and has marked microbiological efficacy.

Abortion, Therapeutic↗