1 Development of Medical EthicsCommittees After World War II Nazi doctors were being judged at Nuremberg trials for carrying out all sorts of research on prisoners in concentration camps in any way they wanted it. At that point it became obvious that doctors and their research should be monitored. The Nuremberg panel of judges suggested 10 principles of research in healthcare, also known as the Nuremberg Code ( 1 ), which defined the moral principles of medical research, prohibited any sort of violence related to research and introduced the concept of informed
The study of the legal framework regulating the activities of the Ethics Committees in the Member States of the European Union outlines several key factors forming the basis of the activity of the Ethics Committees. Compliance with the ethical principles of behaviour by physicians, patients, patients relatives, patient organizations and by the society as a whole requires professionals dealing with medical ethics and law to form, defend and bring to the knowledge and implementation an ethical code of behaviour of all participants in clinical trials as well as in the provision of medical services in general. The modern legal framework in Bulgaria, regulating the nature, functions and powers of the ethics committees, is complex and multi-layered, including both constitutional law and a number of acts at the law and bylaw level. Ethical committees set up in medical establishments aim to help physicians and other medical and non-medical specialists in the hospital, patients and their families coping with the ethical and legal dilemmas they face in everyday life. The results of a survey conducted among 149 medical specialists and 269 patients working and being treated in three different medical establishments in the country show that there is a low level of awareness of the types of ethical committees and their functions. 51% of the questioned medical specialists and 62.5% of the questioned patients replied that they were not aware when issues could be referred to the ethics committees in the country. The analysis of the regulation of the activities of ethics committees in the healthcare systems within the EU and in the health system in Bulgaria shows that there is a need to optimize the activity of the ethics committees operating on the territory of the country.
/ICH/2711/99). Available at: http://www.emea.europa.eu/pdfs/human/ich/271199EN.pdf ALRAVILLA, A. - MANFREDI, C. - BAIARDI, P. et al.: Impact of the new European paediatric regulatory framework on ethicscommittees: overview and perspectives. Acta Paediatr, 2012, 101, No. 1, p. e27-32. (Epub 2011 Jul 23). ICH E11, p. 5 - 6. ICH E11, p. 5 - 6. ICH E11, p. 6 - 7. ICH E11, p. 11 - 13. Ethical Considerations for Clinical Trials on Medicinal Products Conducted with Paediatric Population. Recommendations of the ad hoc group for the development of implementing guidelines for
intravenously or epidurally, for the maintenance of analgesia with marked reduction in morphine, buprenorphine and sufentanil associated PONV. [ 13 , 14 , 15 , 16 ] But no similar studies on epidural fentanyl have been found till date. Hence, this study was formulated to assess the effectiveness of epidural naloxone in attenuating PONV in patients receiving epidural fentanyl for pain relief after lower limb orthopaedic procedures. MATERIALS AND METHODS After procuring Institutional EthicsCommittee approval and written informed consent, 46 patients, between 18–80 years, of
approved by the Republic of Slovenia National Medical EthicsCommittee ( http://www.kme-nmec.si/ ) and patients signed a written consent form prior to study inclusion. It included patients who were less than 35 years old and with body mass index (BMI) between 17 and 26 kg/m 2 . They attended the IVF program because of tubal factor infertility. The spermiograms of their partners were normal, according to the World Health Organization (WHO) criteria. As our previous study did not expose any differences in CC gene expression between patients who were treated with either
compliance with the regulations of the Ministry of Health, Iran and were approved by the Medical EthicsCommittee of Urmia University for Animal Studies (approval No. 1432, October 16, 2015). Subcutaneous challenge of the animals in all groups with 50 μL PBS suspension containing 1 X 10 4 viable tumor cells was considered as the onset of the experiment. The animals were observed for the development of palpable tumors and were equally distributed in 4 groups of 10 following confirmation of tumor development, including a control group, and 3 treatment groups each receiving
Aim/objective: Since 2007, companies in the EU must submit paediatric investigation plans (PIPs) for new drugs, unless the PIP is waived and the review article investigated if that improve the child healthcare. Methods: We analysed the EU Paediatric Regulation (EUPR), PIP decisions, PIP decision patterns, EU key documents on "better medicines for children" and examined PIP studies versus the epidemiology described in the reference literature. We examined how PIPs translate into studies by checking www. clinicaltrials.gov and www.clinicaltrialsregister.org. We also investigated the medical sense of PIP-demanded clinical studies in adolescents. Results: The EUPR in Art. 2 (1) defines “paediatric population” as those between birth and 18 years. It lists challenges in dosing and safety of drugs in neonates and infants as if these challenges apply to anybody < 18 years. PIPs demand studies in adolescents although this group needs separate dose finding and efficacy studies only in exceptional cases, if at all. Most PIP studies in rare diseases are unfeasible: too many studies for too few patients in general. Two questionable PIP studies were discontinued in 2016, in one of them several patients died. Conclusions: Neonates and infants have immature organs, with resulting potential for drug over/underdosing. PIPs equalize the legal definition of childhood with a biological limit. The resulting automatism leads to a worldwide threat to children. Most PIP-demanded studies are medically senseless, some even worse. Ethics committees should reject questionable PIP studies and suspend such ongoing studies immediately.
Background: Rotational thrombelastometry (ROTEM) is a real-time clotting test that provides insight into clotting factors, the fibrinolytic system and platelet function. We obtained the longitudinal values on ROTEM in normal pregnancy and in puerperium.
Material and Methods: After ethics committee approval and subject informed consent, citrated blood was sampled from healthy pregnants four times during pregnancy and one time postpartum. As controls we used nonpregnant women undergoing voluntary blood donation. Extem and Intem tests and basic coagulation test were carried out.
Results: We included 112 women in our study, 55 non-pregnant women (controls) and 57 healthy pregnants with 5 samplings. The values of maximum clot firmness (MCF - in EXTEM and INTEM) were significantly higher up to 34th-36th week of pregnancy than those in non-pregnant subjects. MCF in 6th-7th week after delivery was significantly higher in both tests. Clotting time (CT) in pregnant women was significantly shorter (EXTEM) compared to non-pregnant subjects. We also found a very strong correlation between MCF and platelet count in all gestational weeks.'
Conclusions: Rotation thromboelastometry clearly demonstrates the hypercoagulability in pregnancy and can reflect the higher risk of venous thromboembolism in both pregnancy and puerperium. Strong correlation between MCF and platelet count can suggest role of platelets in hypercoagulability in pregnant women. This study provides a better knowledge about physiological changes in ROTEM measurement during pregnancy and postpartum.
Introduction: Atrial fibrillation (AF) is the most frequent cardiac rhythm disorder, considered until recently benign. Due to its major complications (cardio-embolic episodes) patients need to be anticoagulated. Aim: To assess the quality of life (QOL) in patients with new oral anticoagulants (NOAC) versus those using classical anticoagulants (VKA). Methods: A total of 483 patients admitted consecutively in our clinic were evaluated during hospitalization and after discharge. Follow-up visits were conducted: at baseline, 6, 12, 18 and 24 months; the quality of life (QoL) was measured by a specific questionnaire (EQ-5D-3L), and the results were assessed. Patients were divided in two groups considering their anticoagulant use: NOAC or VKA. Baseline characteristics, clinical outcomes as well as QoL indices were compared between the two groups The current research has been conducted in accordance with the ethical prin ciples set out in the Helsinki Declaration and Good Clinical Practice Recommendations and was approved by our hospital Ethics Committee. Results: The mean age of our studied group (374 eligible patients) was 64.7 ± 8.2 years (p=0.220); 116 patients (31.01%) used NOAC. Patients with NOAC obtained better results in all domains: physical (57.0±8.9 vs. 51.1±12.5 vs. 42.0±6.2; p<0.001), social (62.6±19.8 vs. 52.5±20.0 vs. 45.7±16.0; p=0.019) and environmental (62.9±12.7 vs. 52.7±7.6 vs. 60.7±3.6; p =0.018). Compared to VKAs, NOACs were more commonly prescribed in patients with a history of stroke or with a higher thromboembolic risk (p<0.001). EQ-5D-3L total score: 75.6 ± 20.9; visual analogue scale: 63.1 ± 20.6. Conclusion(s): Satisfaction and QoL with oral anticoagulants were high, although they were both better with NOACs. A worse QoL was associated with comorbidities, polypragmasy, and previous treatment with VKA. Patients strongly expressed their desire to improve their QoL.
Background and Aims. Atrial fibrillation (AF) is the most common arrhythmia seen clinically. Due to the lack of literature and guidelines on maternal AF as a postoperative complication following cesarean delivery (CD), we undertook a study to characterize parturients who developed AF following CD and to evaluate arrhythmia management and outcomes in this patient population. Methods. After receiving ethics committee approval, a retrospective chart review was performed to determine the incidence, possible risk factors, treatment, and outcome of women who developed AF following CD performed between 2003 and 2012 at New York Methodist Hospital in Brooklyn, New York. Results. A total of 17,039 CDs were performed at New York Methodist Hospital from 2003 to 2012. Of these, seven parturients developed AF after CD. The incidence of AF following CD in this patient population was 1:2,434 (0.04%). The age range was 26-41 years, with a median of 33 years. All 7 parturients were at term or postterm. Two deliveries were elective and five were emergent. Two of the seven parturients had prior history of paroxysmal AF. One patient was identified as having mitral regurgitation. All seven had low levels of serum magnesium postoperatively. Out of the seven, two parturients had spontaneous conversion to normal sinus rhythm, one required electrical cardioversion and four required pharmacologic cardioversion. Conclusions. Postoperative AF (POAF) exists as a rare complication in women who undergo CD with an incidence of 0.04% in our patient population. All parturients in our study were noted to have hypomagnesemia in the postoperative period. Occurrence of AF increased length of hospital stay and utilization of hospital resources.