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PubMed1996

Gastroenterology in the last decennia and initiatives in medical ethics: coincidence or linkage?

A quarter of a century ago ethics was an esoteric term, known to theologians and philosophers, but unknown as a discipline to the majority of doctors. Since then, however, ethics has become a substantial part of clinical medicine and health research. Ethics as an area of interest for Danish gastroenterologists appeared from several foci in the early days. One angle was an almost revival-like interest in research methodology and its ethical dimensions. Other angles were derived from Danish gastroenterologists' experiences transferred from other disciplines before the birth of Danish gastroenterology. From the time of these early incentives Danish gastroenterologists have constituted a platform for the implementation of the basic principles, lying behind medical ethics, now in collaboration with other parts of the medical profession. The topics are reflected in a number of publications and in the various practical diversions. An interest in information of patients appeared at an early stage. Publication ethics as a subdiscipline involved Danish gastroenterologists and has led to contributions within the framework of the International Group of Medical Journal Editors. Research ethics, a central topic throughout all years, has led to such important initiatives as the Second Helsinki Declaration and the establishment of a national control system for medical research in man. A further ramification of ethics is scientific dishonesty and good clinical practice. Here a recent initiative has led to the establishment of a national Committee on Scientific Dishonesty. Under the auspices of the OMGE (Organisation Mondiale de Gastroentérologie) Danish gastroenterologists have investigated transnational and transcultural differences in gastroenterologists' attitudes to information of patients and relatives and have unmasked considerable and important differences throughout the world. Medical ethics has, together with scientific methodology, to some extent reunited the sub-specialized fragments of the mother disciplines medicine and surgery and in this way has acted as partes pro toto.

Attitude of Health Personnel↗
PubMed1979

The pharmacist's role as a member of the institutional review board.

Since World War II, concern about the protection of human subjects in biomedical research has increased considerably. The Nuremberg Code and the Helsinki Declaration have been published. The United States Department of Health, Education, and Welfare (DHEW) has developed and published regulations that specify a review process which research institutions must follow in order to receive DHEW funds for research involving human subjects. Part of this process includes a review of research projects by an Institutional Review Board (IRB). Membership on the IRB must be varied and should include allied scientists. Because many of the projects include investigational drugs, the inclusion of a pharmacist as a member is logical. The pharmacist, if properly selected and prepared, can play a vital role in the review of research projects by assisting in the evaluation of the scientific merit of the plan, the appropriateness of the volunteer agreement, and the regulatory compliance of the project. The selected pharmacist should view the duty as another opportunity to practice clinical pharmacy.

Human Experimentation↗
PubMed1999

Hurtle tumour of the thyroid in a Mexican specialties hospital.

OBJECTIVES: To investigate the frequency of the Hurtle cell tumour in the hospital, best diagnostic method, best surgical management, and follow up. DESIGN: This was approved by the research and ethical committee under the protocol of the General Law on Health and the Helsinki Declaration. The study was retrospective and observational from January 1991 till January 1996. The patients included in the study were those operated on the neck whose clinical files contained histopathological results consistent with this type of tumour. Those whose histopathological reports were not Hurtle cell tumour of the thyroid were excluded. The histological slides of Hurtle cell tumour were reviewed by a consultant pathologist to reconfirm the diagnosis. The patients were then contacted by telephone or telegraph to come to the out patient department for a check up. SETTING: The clinical archives of the Specialties Hospital, the archives of the Pathology Department of La Raza Medical Centre as well as the library of the Specialties Hospital and the Information Service of the Specialties Hospital. SUBJECTS OR PARTICIPANTS: Were, at the end of the selection, nine patients who fulfilled the inclusion and exclusion criteria. RESULTS: These were three carcinomas, six adenomas, one tumour with cystic degeneration and one microfolicular with extension to the mediastinum. CONCLUSIONS: The frequency of this tumour is very low and the carcinoma even lower, it is a disease of the adult and predominantly female. It has a short evolution of the symptoms, with tumours of the neck as the main symptom. The fine needle aspiration cytology is the best diagnostic method and the total thyroidectomy is the goldstandard treatment of choice for both benign and malignant lesions. The follow up is very important at least five years for carcinoma and 10 years for adenoma, the Sestamibi Tc99 being very useful to detect early metastasis.

Adult↗
PubMed1999

Ultrastructural pathology of Golgi apparatus of nerve cells in human brain edema associated to brain congenital malformations, tumours and trauma.

The alterations induced by ischemia and anoxia upon smooth endoplasmic membranes are studied in 38 patients with congenital malformations, brain tumours and brain trauma. The effects of vasogenic and cytotoxic brain edema are examined in the Golgi apparatus of nerve and endothelial cells. Samples of cortical biopsies were conventionally processed for transmission electron microscopy. Cortical biopsies were performed according to the basic principles of Helsinki declaration. Slices of 2 to 5 mm were immediately fixed in the surgical room in 4% glutaraldehyde-0.1 M sodium phosphate buffer, pH 7.4 at 4 degrees C, and postfixed in 1% osmium tetroxide in similar buffer. The pathological alterations of the Golgi complex were studied in samples with moderate and severe brain edema. Moderate edema was mainly found in congenital malformations and severe edema in brain trauma and tumours. In some severely edematous neurons, observed in hydrocephalus associated to Arnold-Chiari malformation, small vesicular type Golgi complexes and atrophic ones were observed, characterized mainly by partial or total disappearance of stacked Golgi cisternae and presence of congregated vesicular profiles. In brain trauma and tumours the Golgi complex showed enlargement and fragmentation of the stacked cis- medial- and trans-Golgi cisternae and vacuolization of trans-Golgi network. In addition, an increased formation of Golgi and coated vesicles was observed in the cis- and trans-Golgi regions. Most Golgi and clathrin coated vesicles were observed throughout the cytoplasm suggesting an increased vesicular transport. In severe edema the nerve cell plasma membranes appeared fragmented, presumably due to an interference of the protein insertion process into the plasma membrane. In brain trauma, a hypertrophic Golgi complex was observed in some nerve cells and endothelial cells of cortical capillaries, with increased formation of Golgi and coated vesicles. The ischemia and anoxia associated to the vasogenic and cytotoxic brain edema induced enlargement, fragmentation and disappearance of stacked Golgi cisternae.

Adolescent↗
PubMed2001

[Complementary and alternative medicine--some ethical reflections].

CAM, Complementary and Alternative Medicine, exposes the clinician to a number of ethical challenges. While sound scientific evidence supporting clinical procedures is always recommendable, it is nevertheless acceptable to use CAM-procedures if they can reasonably be judged as harmless, and if conventional therapy offers little or no help. This is in line with the last revision of the Helsinki declaration. The physician must establish a close and trustful relationship with her patient and be open to the potential residing in CAM for a more profound understanding of clinical practice.

Complementary Therapies↗
PubMed2002

[Ethics committees bear a responsibility for patient information. Informed consent implies that the patient understands what he has consented to].

A cornerstone in health care is the duty to inform patients not only of their right to partake in decisions about their care but also of the various options for treatment. This applies particularly in clinical research, for which the Helsinki Declaration has defined patients' rights. Informed consent is of great importance both in routine care and in clinical research. Directives defining informed consent in relation to clinical trials have been issued by The EU Commission. The Department of Health and Social Security in England has also published several documents governing patient consent. Even if information is given to the patient it is not always comprehended. In one study of cancer treatment about one third of the patients had misunderstood the information in certain respects.

Clinical Trials as Topic↗
PubMed2003

Ethical issues related to the use of placebo in clinical trials.

Controversy exists regarding the ethics of using placebo control groups in clinical trials when effective treatments exist. The debate was fuelled by the announcement of the fifth revision of the Declaration of Helsinki in 2000. This study reviews the history and scientific background surrounding the controversy and investigates the prevailing attitudes of Hong Kong researchers regarding this issue. The controversy has centred on several issues. The first involves the methodological superiority of placebo-controlled trials in discerning treatment effects. Secondly, it is unclear whether the treatment effects encompass absolute treatment effects (including placebo effects) or are confined to treatment-specific effects (excluding placebo effects). Thirdly, there are concerns that subjects in the placebo group could be exposed to a high risk for developing serious adverse events. Fourthly, it is unclear whether the standard of best available treatment should be local or international. Preliminary research findings suggest that the opinions of Hong Kong researchers are divided on the use of placebo control groups in clinical trials when effective treatment exists. Further research on the topic is therefore warranted, and training and consensus meeting may be necessary to minimise the confusion related to this issue.

Clinical Trials as Topic↗
PubMedDate not supplied

[The Nazis, guide of the International Conference of Harmonization and ethics committees].

This article begins with the basic ethical principles in clinical research. The four moral principles of autonomy, beneficence, non-maleficence, and justice are reviewed. Likewise, a historical review of the participation of German physicians and the medical establishment that carried out the policies of the Third Reich is examined, and delineates several moral failures attributable to these physicians during the dark period of history known as the Holocaust. Medical ethics were completely ignored during that period, and thus, the Nuremberg Code was enacted for regulating human research by means of informed consent. A historical vision of the universal documents for ethics in clinical research has been reviewed from the Declaration of Helsinki in 1964 to the ICH Guideline (International Conference of Harmonisation) for Good Clinical Practice (GCP) in 1996. The ICH Guideline is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve participation of human subjects. The guide was developed with consideration of the current GCP of the European Union, Japan, and the U.S. Finally, we establish the composition, functions, and operations of the Ethic Committees that ensure the rights, safety, well-being, and confidentiality statement of subjects who participate in clinical research studies and document that protection by reviewing and approving/rejecting a study protocol, and evaluate research personnel, the research site, and materials and methods used for obtaining and recording informed consent protocol from subjects participating in the study.

Congresses as Topic↗
PubMed1992

[The effect of oxygen administration on serum concentration of potassium during exercise].

Recently, there have been many reports on the role of serum concentration of potassium as a potential limiting factor during exercise. K+ is known to induce muscle fatigue and to increase ventilation by direct stimulation of peripheral chemoreceptors. These two K(+)-mediated effects are considered to be the factors that limit exercise capacity. This effect seems to be exacerbated in hypoxemic states. The occurrence of hypoxemia in chronic pulmonary disease patients during exercise is believed to cause the excessive efflux of potassium to the extracellular space from skeletal muscles. The present study evaluated the relationship between the changes in arterial concentration of K+ and hypoxemia during exercise in 37 chronic pulmonary patients and 9 healthy controls. The study was carried out after obtaining formal and written consent of the patients in accordance with the stipulations of the Helsinki Declaration. Patients were divided into two groups according to PaO2 level at maximum exercise capacity; group I: PaO2 less than 55 torr, group II: PaO2 greater than or equal to 55 torr. The arterial concentration of K+ in group I patients tended to be higher than that in group II and controls. In group II, K+ concentration was significantly elevated (p less than 0.05) compared to controls. In group II, PaO2 values were inversely correlated with K+ (r = 0.3026; p less than 0.025), whereas in controls and group II they were unrelated. These results suggest that the augmented serum level of potassium in patients with chronic pulmonary disease is an important limiting factor during exercise.

Aged↗
PubMed2003

Intranuclear filamentous inclusion in human oedematous cerebellar Golgi cells.

The presence of intranuclear filamentous inclusions in cerebellar Golgi cells is reported in three patients with cerebellar tumours. Samples of cerebellar cortex were processed for conventional transmission electron microscopy. Cerebellar biopsies were performed according to the basic principles of Helsinki declaration. Intranuclear inclusions observed in oedematous Golgi cells, appeared as straight rodlets up to 3 microm in length and up to 0.4 microm in width, characterized by a periodic or crystalloid structure formed by dense bands, 9.2 nm thick separated by clear spaces, 5.4 nm in width. These structures are considered abnormal protein aggregates apparently induced by excitotoxicity, oxidative stress and impaired energy metabolism.

Cerebellar Neoplasms↗
PubMed2004

Medical ethics, clinical research, and special aspects in nuclear medicine.

Medical ethics is the science of survival. It studies the working out of judgments on right or wrong referred to the human being as a biological entity interacting with the whole ecosystem. Medical ethics in clinical research raises numerous moral and technical issues. Methodological aspects are essential for carrying out the aim of clinical research. Medical ethics documents are inspired by the Nuremberg Code and culminate in the recently updated Helsinki Declaration of 1964. In Italy 2 ministerial decrees in 1997 and 1998 laid the basis for the work of a medical ethics committee. They acknowledge the European Good Clinical Practice Guidelines and set professional needs within ethical committees. In clinical research the use of ionising radiation merits special consideration. In the recent past, serious human rights abuses in radiation experiments of the 1950s and 1960s have been found. As regards research in this field we can refer to the publication of the International Commission on Radiological Protection (ICRP) and to the report of the World Health Organisation (WHO). Legislative decree no. 187 of May 26, 2000, which transposed the 97/43/ EURATOM Directive represents the most comprehensive and recent normative reference to clinical research using ionising radiation. However, law no. 39 of March 1, 2002 is important for the partial modifications of previous decrees (art. 108 of L.D. no. 230 of March 17, 1995 and, art. 4 and attachment III of L.D. no. 187 of May 26). In this paper medical ethics, research, methodological issues and aspects of ionizing radiation are discussed.

Biomedical Research↗
PubMed2005

[The unreasonableness of prostate-cancer screening and the ethical problems pertaining to its investigation].

Since the early 1990s, screening with prostate-specific antigen (PSA) testing has increased the incidence of prostate cancer. Any decrease in mortality will not be seen for at least a decade, due to the long natural history of prostate cancer. Death due to prostate cancer is rare, while the prevalence oflocalised tumours is high. The prognosis of these early-detected localised tumours is uncertain, because most patients will die from other causes. Complications of prostate-cancer therapy are common, with high rates of impotence, incontinence and gastrointestinal problems after prostatectomy or radiotherapy. Randomised trials of prostate-cancer screening, notably the 'European randomised screening for prostate cancer' (ERSPC) trial, began with the consent of ethical committees. There is a real uncertainty regarding the benefits of prostate-cancer screening. However, it is clear that these benefits are limited, because prostate-cancer death is rare before the age of 75 years. There is no real uncertainty about the harms of prostate-cancer screening. High prevalence and high rates of treatment complications deduct many disease- and disability-free years from the eligible population (men aged 55-74 years). Therefore, there has been no real uncertainty over the balance of harms and benefits in prostate-cancer screening trials. Days may be added to old age, at the cost of months of disease- and disability-free living. It is not in the best interest of eligible men to participate in these trials. Randomised trials evaluating prostate-cancer screening violate in principle and practice the Helsinki Declaration of the rights of human subjects in medical research.

Aged↗
PubMed1999

Ethical genetic research on human subjects.

Since the Nuremberg trials and the Nazi doctors trial following World War II, international ethics protocols have emerged designed to protect human subjects from the atrocities of medical experimentation that were literally routine under the Nazis. Some of the apparent "lessons" from the Nazi period have been encapsulated in the Declaration of Helsinki, perhaps the leading medical ethics protocol. This paper argues that these protocols have not been notably conducive to human welfare or to the protection of human rights in the field of human genetics research. The paper proposes new protocols and a new approach to the ethics of research on human subjects.

Access to Information↗
PubMed1997

[Oral pefloxacin in the treatment of acute gastroenteritis].

UNLABELLED: In the case of travellers' diarrhoea, in order to reduce to a minimum the period of sickness and temporary invalidity, suitable therapy needs to be undertaken, involving the reintegration of fluids and electrolytes, as well as antibiotic treatment whose spectrum of action covers the most commonly isolated microorganisms. The aim of the study was to verify the rapidity of the antibacterial action of pefloxacin in the treatment of this type of gastrointestinal infection. MATERIALS AND METHODS: The patients enrolled were treated for 5 days with pefloxacin in tablets containing 400 mg of the active agent, given orally. Treatment involved a first dose of 800 mg (2 tablets in a single administration), followed by 400 mg twice a day (1 tablet every 12 hours). Administration was carried out prevalently at mealtimes. At the end of treatment a two-week follow-up period was scheduled. At the beginning of the study, and after 5 days' treatment, a coproculture was carried out, with identification of the germ responsible for the infection. The study was carried out in accordance with the principles of the Helsinki declaration and its revisions, in particular each patient gave his/her informed consent to participate in the trial. RESULTS: Thirty patients enrolled in the study (16 males, 14 females), of mean age 48.2 years (18-82 min-max), mean weight of 66.3 kg (46-88 min-max), suffering from acute gastroenteritis. The coproculture carried out at the baseline for all patients led to the isolation in 10 patients, of 10 pefloxacin-sensitive GRAM-negative bacterial strains: Salmonella spp. in 6 cases, Shigella spp. in 2, Escherichia coli in 1 and Yersinia enterocolitica in 1. At the end of treatment and follow-up the coproculture indicated that all the germs isolated initially had been eradicated and no cases of superinfection or reinfection occurred. The number of daily evacuations gradually decreased from a mean of 6.8 at the baseline to 1.1 on the fifth day (p<0.0001). The consistency of faeces had increased in a significant fashion by the third day and at the end of treatment 93.3% of patients had well-formed faeces. In the course of treatment abdominal pain, nausea and vomiting decreased progressively and body temperature returned within normal limits by the third day. Safety was excellent in 93.3% of patients, with one case of nausea and one of erythema, which resolved spontaneously in the course of treatment. At the end of treatment with pefloxacin, the physician expressed his final judgment of efficacy, which was excellent in 86.7% of cases (26/30) and good in 13.3% (4/30), in accordance with the clinical evaluation of recovery in 93.3% of cases (28/30) and of improvement in 6.7% (2/30). CONCLUSIONS: In forms of acute gastroenteritis in which coproculture shows the presence of germs sensitive to pefloxacin, the use of this quinolone guarantees a high percentage of success with a short course of treatment.

English Abstract↗
PubMed1990

[Verbal information in clinical trials at an oncology department].

Prior to participation in clinical trials, patients must give their consent on the basis of information from the doctor. The content of the information is defined in the Helsinki Declaration. Information given in an oncological department was investigated and the patients were interviewed about the information obtained. The problems associated with the informative interviews with the patients were that these were frequently unstructured, that the patients were more concerned with their illness and treatment and that doctors had done too little to ensure that the patients had understood the information. It was most difficult for the doctors to provide thorough information about side-effects and disadvantages. Patients had greatest difficulty in understanding the principle of randomization. The patients' main reason for participation in the trial was the hope for therapeutic benefit. In departments where clinical research is undertaken, constant attention is required for how information on clinical trials is best given.

Aged↗
PubMedDate not supplied

[Codes of ethics for nursing research].

This article is a review of codes of ethics for research on human subjects with emphasis on the Code of Nuremberg and the Declaration of Helsinki which constitute the guidelines for health science researchers. The need for function of ethical committees is discussed and a framework of ethics in nursing research is pointing out since the subject of nursing research is mainly the human being healthy or sick.

Ethics, Nursing↗
PubMedDate not supplied

Superoxide dismutase and catalase activity in psoriatic patients treated topically with ointment containing 2-chloroethyl-3-chloropropyl sulfide.

The purpose of this study was to determine dismutase and catalase activities in erythrocytes of psoriatic patients with psoriasis vulgaris topically treated with an ointment (in accordance with recommendations of the Helsinki Declaration), in which 2-chloroethyl-3-chloropropyl sulfide (CLEPS) is an active compound. SOD activity in hemolysates was determined according to the method of Misra and Fridovich [12] and calculated as units per g of hemoglobin. CAT activity in hemolysates was determined by Beers and Sizer method [2] and expressed in U/g Hb. SOD activity in the control group was 1.61 +/- 0.48 U/g Hb x 10(3). However, the activity of CAT was 5.72 +/- 1.17 U/g Hb x 10(4). Before treatment SOD activity was decreased by ca. 22.5% (1.25 +/- 0.53 U/g Hb x 10(3)) while that of CAT by about 7% (5.30 +/- 1.41 U/g Hb x 10(4)), in comparison with the normal control. After treatment with the ointment, activity of both enzymes increased by about 18% to 1.55 x 10(3) U/g Hb and by about 16.5% to 6.25 x 10(4) U/g Hb, respectively. The results of our investigations showed that the ointment (containing mustard gas derivative) applied on psoriatic skin, causes increased of SOD and CAT activity in erythrocytes after regression of psoriatic lesions and treatment termination.

Administration, Topical↗