Tough Clinical Decisions: Experiences of Polish Physicians.

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 majority of Polish physicians encounter ethical and other non-medical difficulties in making clinical decisions.

Clinical Ethics Consultations in the Opinion of Polish Physicians.

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.

Institution of the health care agent in Polish legislation: position of the Polish Working Group on End-of-Life Ethics.

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 the health care agent. PATIENTS AND METHODS The draft proposal has been grounded in 6 expertise workshops, in conjunction with several online debates.

[Abortion and conscientious objection].

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 religion or belief, even more so because the issue of abortion is an example of an unresolved ethical dispute.

Hospital Ethics Committees in Poland.

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 Monitoring Quality in Health System.

[Helsinki Declaration--next version].

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-study arrangements and the use of placebos. Despite this, more consideration should be taken regarding research on human biological material and data, because the new version of The Helsinki Declaration still does not provide an acceptable level of protection for the rights and interests of donors of human biological materials. Although the new version of The Helsinki Declaration confirmed that when using identifiable human materials and data in medical research, informed consent must be obtained for its use and reuse, the obligation for the assessment of each project of medical research using human biological materials (identifiable and unidentifiable) by Research Ethics Committees was not implemented.

[The role of bioethics committees in the systems protecting scientific biomedical research participants in France and in Poland].

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 was to compare two bioethic committees systems: French and Polish one.

[The system of protection of scientific biomedical research participants in France and in Poland].

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 Union member states--France and Poland.

Consensus standards for introductory e-learning courses in human participants research ethics.

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 drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders.

[Research ethics committees: one size fits all?].

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.

Limitations of the of the oscillometric method for blood pressure measurements in dialyzed patients.

Background: 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.

Material/methods: In 54 hemodialysed patients (57 ± 15 years), during 2 sessions (before and after HD), 3 pairs of BP measurements each were performed on arms, alternately employing OSC and auscultatory method, with mercury manometers by 2 observers (REF).

[How can we establish hospital ethics committees?].

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 doctors and other health professionals and provide ethics advice in individual cases.

[Are the hospital ethics committees necessary in Poland?].

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) bioethics committees, health care/hospital ethics committees (HECs), and research ethics committees (RECs). Until recently in Poland, only RECs existed.

[Guidelines on research on human biological materials].

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 scientists than physicians and dentists.

[Will Polish investigators have access to the research ethics committees?].

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 self-financing of REC is in force in Poland. Charges collected for opinions should cover incurred costs of REC.

[How to prevent hazards and to reduce risk in clinical trials?].

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.

Polish Research Ethics Committees in the European Union system of assessing medical experiments.

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.

[Hazard, risk and harm in clinical trials].

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. Clinical trial participants are not the only one stakeholder exposed to different types of hazards.

Repeated ventricular.

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 was admitted to the ward with symptoms of hypometabolic crisis.

The dilemma of dual use biological research: Polish perspective.

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. Optimal solutions for limiting such threats are required, and the national system of biosecurity should enable early, reliable, and complete identification of this type of research.

[Social aspect of clinical research in Poland].

Each year more than 400 new clinical studies are registered in Poland. They gather above 50.000 of study participants.

Can the pressor response accompanying blood pressure measurement be limited in young, normotensive women?

Background: 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.

Methods: In a group of 148 normotensive women aged 21.

[Progressive hearing loss as the leading sign of Wegener's granulomatosis].

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 granulomatosis was suspected.

Emergency research without consent under Polish law.

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 emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials.