Marek Czarkowski

Cardinal Stefan Wyszyński University in Warsaw · Collegium Medicum

The paper reports results of the very first survey-based study on the prevalence, frequency and nature of ethical or other non-medical difficulties faced by Polish physicians in their everyday clinical practice. The study involved 521 physicians of various medical specialties, practicing mainly in inpatient healthcare. The study showed that the maj...

Clinical Ethics Consultations (CEC) are an important tool for physicians in solving difficult cases. They are extremely common in North America and to a lesser extent also present in Europe. However, there is little data on this practice in Poland. We present results of a survey of 521 physicians practising in Poland concerning their opinion on CEC...

INTRODUCTION In numerous countries legislation has been put in place allowing citizens to appoint persons authorized to make medical decisions on their behalf, should the principal lose such decision‑making capacity. OBJECTIVES The paper aimed to prepare a draft proposal of legal regulations introducing into Polish legislation the institution of th...

Problematyka podejmowania decyzji medycznych dotyczących pacjentów niezdolnych do samodzielnego podejmowania decyzji oraz tych, którzy na własne życzenie rezygnują z uzyskania informacji na temat własnego stanu zdrowia wymaga utworzenia stosownych uregulowań prawnych w tym zakresie. Polska Grupa Robocza ds. Problemów Etycznych Końca Życia proponuje...

Polish laws specify the parties responsible for lawful medical care in the availability of abortion differently than the Resolution of the Council of Europe. According to Polish regulations they include all Polish doctors while according to the Resolution, the state. Polish rules should not discriminate against anyone in connection with his religio...

According to UNESCO guidelines, one of the four forms of bioethics committees in medicine are the Hospital Ethics Committees (HECs). The purpose of this study was to evaluate how the above guidelines are implemented in real practice. There were 111 hospitals selected out of 176 Polish clinical hospitals and hospitals accredited by Center of Monitor...

Authors of the new version of The Helsinki Declaration reorganized the document, and for the first time, included the issue of compensation and treatment for participants who are harmed as a result of participating in research, they provided unified and better protection for vulnerable groups, and more precisely described requirements for post-stud...

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were...

Bioethics committees are along with ethic regulations and rules of law one of three main pillars in the system of protection of scientific biomedical research participants. Although principal directives for bioethics committees are established by international guidelines, detailed regulations may differ in particular states. The aim of this article...

Realizing scientific biomedical research conducted on human-beings demands obeying ample ethical rules. However, states keep independence in the means of implementing deontological guidelines to legislative acts. The aim of the article is to compare rules of law relative to protection of scientific biomedical research participants in two European U...

Publikacja w sposób interdyscyplinarny i kompleksowy omawia etyczne i prawne warunki dopuszczalności prowadzenia badan naukowych na człowieku w biomedycynie, w tym na ludzkim materiale biologicznym oraz ludzkich zarodkach. Książka umożliwia Czytelnikom zapoznanie się z fundamentalnymi problemami etycznymi, jakie rodzi dynamiczny rozwój nauk biomedy...

Till now Poland did not create an effective system which should protect rights of the research subjects. A research involving human subjects includes the observational and interventional studies. In Poland the interventional studies conducted by physicians or dentists must be submitted for an approval to bioethical committees only. There is no lega...

Despite more frequent use of the oscillometric method (OSC) for arterial blood pressure (BP) measurement, little is known about OSC's accuracy when used with hemodialysed patients. This study was undertaken to determine if hemodialysis (HD) and individual features in examined patients can affect the accuracy of OSC for BP measurement. In 54 hemodia...

The necessity of establishing hospital ethics committees (HEC) in Poland is obvious. Limitations of such initiatives are related with lack of standards, financial support, legal provisions and well trained and educated candidates on members of HECs. HECs should: protect patient's rights and their beneficience, facilitate ethics education for doctor...

The role, and even the necessity of hospital ethics committees, is not universally agreed upon. In the 2005, the UNESCO advised the establishment of four types of bioethics committees at different levels: policy-making and/or advisory bioethics committees/commissions/councils at national levels (PMAs), health-professional association (HPAs) bioethi...

Poland has no operational and ethical guidelines on research using human biological material (RHBM) although such recommendations are included in Declaration of Helsinki and Recommendation of the Council of Europe on RHBM. Polish Bioethics Committees have the right to assess projects of physicians and dentists only. RHMB might be carried by other s...

The accuracy of oscillometric blood pressure (BP) measuring devices determined in resting conditions may be distorted in those under hemodialysis (HD). The evaluation of accuracy of the Omron HEM-907 was performed in accordance with the International Protocol for validation of BP measuring devices (IP). Out of a group of 49 patients with end-stage...

Polish research ethics committees (REC) provide opinions on projects of medical research (A), object to participation of regional investigator or center in multicenter clinical trials (B) and provide opinions about amended protocols or documentation of investigated medicinal product, which might change safety of trials' participants (C). Model of s...

Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are "fit for purpose" by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting st...

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 +/- 31.7 (range: 0-131) projects of clinical trials and 71...

Double-application research is research whose results can become a source of knowledge, products, or technologies that are potentially useful to persons who intend to create threats to public health, agriculture, plants, animals, the environment, or inanimate matter. The great majority of double-application research has to do with genetic materials...

Different stakeholders involved in clinical trials are exposed to hazards related with this biomedical research. Beside clinical trials participants other important stakeholders are: investigators, sponsors, centers and clinical research organizations. Hazard prevention needs effective methods of hazard disclosure and analysis. A reduction of risks...

Investigators and other stakeholders involved in clinical trials are not aware about all possible harms, hazards and risks related to this activity. Different categories of harms may occur during clinical trials like: physical (injury, illness, pain, suffering, or discomfort), psychological, social, economic, legal, dignitary and relational. Clinic...

Biological research with legitimate scientific purpose that may be misused to pose a biological threat to public health and/or national security is termed dual use. In Poland there are adequate conditions for conducting experiments that could be qualified as dual use research, and therefore, a risk of attack on Poland or other countries exists. Opt...

A decrease in blood pressure (BP) values observed over consecutive measurements may lead to significant discrepancies, affecting individual diagnostic and therapeutic decision making. The goal of the study was to assess whether it was possible to limit or eliminate the tendency for BP values to decline in successive measurements. In a group of 148...

SPIS TREŚCI Podziękowania Słowo od autorów Wprowadzenie 1. Istota i rodzaje eksperymentów medycznych 2. Świadoma zgoda jako warunek dopuszczalności prowadzenia eksperymentów medycznych na ludziach 2.1. Świadoma zgoda jako wymóg etyczny 2.2. Świadoma zgoda jako przedmiot regulacji międzynarodowych i europejskich 2.3. Świadoma zgoda w prawie p...

Each year more than 400 new clinical studies are registered in Poland. They gather above 50.000 of study participants. Social opinion on clinical trials is an important factor. The paper presents the review of actual opinions on clinical research in Poland. It provides the description of standards of protection of study participants, benefits and r...

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emerg...

57-year-old woman with a history of ischaemic heart disease, arterial hypertension and after myocardial infarction was admitted to the university hospital because of progressive hearing loss and fever of unknown origin. Shortly before hospitalization she developed cough, hemoptysis and conjunctivitis. On the basis of clinical presentation Wegener's...

Few publications report the possibility of "torsade de pointes" (TdP) type tachycardia and ventricular fibrillation occurring in patients with prolonged QT syndrome in the course of hypothyroidism. The authors present the case of a 51 year-old woman with Hashimoto disease and hypothyroidism, inadequately supplemented with L-thyroxine. This patient...

Few publications report the possibility of "torsade de pointes" (TdP) type tachycardia and ventricular fibrillation occurring in patients with prolonged QT syndrome in the course of hypothyroidism. The authors present the case of a 51-year-old woman with Hashimoto disease and hypothyroidism, inadequately supplemented with L-thyroxine. This patient...

Coexistence of the goitre, proptosis and palpitations was observed in XIX century for the first time. Sinus tachyarytmias and atrial fibrillation are typical cardiac symptoms of hyperthyroidism. Atrial fibrillation occurs more often in patients with toxic goiter than in young patients with Grave's disease. These findings suggest that causes of atri...

Polish ethic committees should have to work together in order to maintain and develop high quality standards in the protection of human subjects. Exchanging knowledge, know-how and information polish ethic committees should have to implement standard operating procedures. Procedures should improve quality and proficiency of all types of ethic commi...

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 th...

Hypercalcemia is one of the most common paraneoplastic syndromes, where it may result from the presence of osteolytic metastases or from humoral effect of factors produced by tumor cells. One of such factors is the parathyroid hormone-related protein (PTH-rP). This protein is usually produced by solid tumors, especially by squamous cell carcinomas....

Transient character of laboratory abnormalities is usually explained as a false result of estimation. Spontaneous disappearance of laboratory abnormalities could be recognized as non-important and contradicting serious disease. Presented case of multiple endocrine neoplasia type 1 (MEN 1) denies these assumptions. Sixty-nine-years old woma was admi...

Thyrotoxicosis leads to profound changes in the cardiovascular system. Using a new non-invasive ultrasonic system VED elaborated by Powałowski et al., we aimed to assess whether arterial blood flow is related to the intensity of thyrotoxicosis in patients with Graves' disease. We compared two groups: hyperthyroid (Graves' group n=25, mean age=31+/-...

Longitudinal arterial resistance (RL) originates during blood flow in large conduit arteries while peripheral resistance (RP) reflects the tension of arterioles. Using a new noninvasive ultrasonic system of assessment of mechanical properties of arterial walls, we aimed to discover whether both RL and RP are affected by excess of thyroid hormones (...

Introduction: According to previous studies, blood pressure (BP) tends to lower during consecutive measurements. Nevertheless it has not been reviewed whether this trend is influenced by a short break during series of measurements. Aim of study: Our aim was to analyze the results of blood pressure measurements performed in two series of consecutive...

Background: Validation procedures of automated blood pressure measuring devices are carried out at rest only. Design: We aimed to determine whether venous blood redistribution affects the accuracy of the OMRON HEM-705CP (Osc). Lower body negative pressure stimulus (−40 mmHg) (LBNP) was used to simulate changes of body position. Methods: Fifty-four...

Validation procedures of automated blood pressure measuring devices are carried out at rest only. We aimed to determine whether venous blood redistribution affects the accuracy of the OMRON HEM-705CP (Osc). Lower body negative pressure stimulus (-40 mmHg) (LBNP) was used to simulate changes of body position. Fifty-four young healthy volunteers had...

Validation protocols that have been introduced for automated blood pressure (BP) measuring devices recommend procedures carried out at rest only. We aimed to determine whether venous blood redistribution affects the accuracy of the oscillometric method of BP measurement. For this purpose, we chose a popular oscillometric ambulatory BP monitor--the...

Introduction: In clinical practice BP measurements are increasingly being taken by automatic devices, most of which use the oscillometric method (B). Varied international recommendations were introduced to minimalize discrepancies between BP taken by mercury sphygmomanometers (A) and automatic devices (B). Though, it still remains unknown whether r...

Thyroid hormone excess is accompanied by many cardiovascular symptoms. We hypothesised that mechanical properties of the large arteries are also involved in hyperthyroidism-induced cardiovascular changes and set out to investigate this further. We compared 2 groups: one composed of hospitalized patients with newly diagnosed, non-treated Graves' dis...

We present the patient with 1-month history of mild hypertension, who was admitted to our department with suspicion of coronary heart disease. He had family history of hypertension and coronary heart disease, hyperlipidaemia and he has been smoker for several years. During the diagnostic exertion test chest pain together with an unusual high blood...

Introduction: Changes in the mechanical properties of the arterial wall observed in patients with essential hypertension (EH) may reflect either a primary defect due to genetic factors predisposing to EH or a secondary effect of elevated blood pressure on the arterial wall. Aim of study: We investigated the elastic behaviour of the big artery in di...

Introduction: Divergent results of the assessment of the left ventricular diastolic function in patients with clinically evident hyperthyroidism (increased left ventricular diastolic performance) and subclinical hyperthyroidism (decreased left ventricular diastolic performance) clearly indicates the necessity of the further evaluation of this topic...

Blood pressure was measured in two groups of young males-group S-55 men with positive family history of essential hypertension (EH) and group K-11 men with negative family history of EH (mean age 24.5 +/- 3.3 and 23.5 +/- 4.7 years). Two methods of blood pressure measurement--traditional blood pressure measurement (method A) and automatic ambulator...

An exaggerated pressor reaction to the isometric exercise and cold pressor test (CPT) is found to be a predictor or future hypertension. In the two groups of young males: 51 men with positive family history of essential hypertension (EH) (mean age: 24.3 +/- 3.3 years, group S) and 11 men with negative history of EH (mean age: 23.5 +/- 3.7 years, gr...

Non-invasive automatic 24-h indirect monitoring of blood pressure was performed in two groups of young males - group S - 55 men with positive family history of essential hypertension (EH) (mean age 24.6 +/- 3.6 years) and group K - 11 men with negative family history of EH (23.5 +/- 3.7 years). Circadian blood pressure variations were studied in tw...

Serum adrenaline (AD) and noradrenaline (NA) were measured by RIA method in two groups of young males: group S (n = 54) with positive family history of essential hypertension (EH) and group K (n = 9) with negative family history of EH (mean age: 24.6 +/- 3.3 i 23.6 +/- 3.6 years respectively). AD and NA concentrations were estimated in basic condit...

Digoxin-like immunoreactivity (DLS) and erythrocyte sodium-potassium pump (PSP) activity were measured in a group of 16 patients with chronic renal failure (CRF) before and just after haemodialysis and in a group of 9 healthy persons. Before haemodialysis DLS was present in the blood of most CRF patients, at the mean concentration of 0,14 +/- 0,13...

In 8 non-dialysed patients with chronic renal failure (PNN) and hypertension (NT)-(PNNT group) sodium-potassium pump activity (PSP) and intra-erythrocyte sodium (NaE) and potassium (KE) concentration were measured. No differences were found in PSP, NaE and KE between group PNNT and healthy volunteers (Z). These results do not support an importance...

Two subgroups of patients were selected out of those dialysed for chronic renal failure. Group A included patients without arterial hypertension before dialysis, and group B patients with arterial hypertension before dialysis. Blood endogenous digoxin-like substance (DLS) has been assayed. Its blood levels were not increased in hypertensive patient...

Atrial natriuretic peptide (ANP) may be involved in the regulation of blood volume and in the modulation of blood pressure (BP). In chronic renal failure (CRF) sodium and water retention may lead to augmented blood volume and the development of arterial hypertension. The present study was undertaken to investigate the relationship between circulati...