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. However, they confront such difficulties less frequently than their foreign peers. Moreover, Polish doctors indicate different circumstances as a source of the experienced problems. The difficulties most often reported relate to (i) patients (or their proxies) requests for medically non-indicated interventions; (ii) problems with communication with patients (or their proxies) due to the patients' negative attitude, unwillingness to cooperate, or aggression; and (iii) various difficulties with obtaining informed consent. Polish physicians report difficulties associated with disagreements among care givers or scarcity of resources less frequently than doctors from other countries. The study's findings provide support for the thesis that a significant portion of Polish physicians still follow a traditional, paternalistic, and hierarchical model of healthcare practice. Instead of promoting patient's empowerment, engagement, and rights, they often consider these ideas as a threat to physicians' professional authority and autonomy. The study leads to the conclusion that due to insufficient training in medical ethics, communication skills, and medical law, many Polish physicians lack the knowledge and competence necessary to adequately respond to challenges posed by modern healthcare practice.

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. The study was conducted by the survey method. There were 56 (50%) hospitals that responded to the survey. The number of HECs members fluctuated between 3 and 16 members, where usually 5 (22% of HECs) members were part of the board committee. The composition of the HECs for professions other than physicians was diverse and non-standardized (nurses-in 86% of HECs, clergy-42%, lawyers-38%, psychologists-28%, hospital management-23%, rehab staff-7 %, patient representatives-3%, ethicists-2%). Only 55% of HECs had a professional set of standards. 98% of HECs had specific tasks. 62% of HECs were asked for their expertise, and 55% prepared <6.88% of the opinions were related to interpersonal relations between hospital personnel, patients and their families with emphasis on the interactions between superiors and their inferiors or hospital staff and patients and their families. Only 12% of the opinions were reported by the respondents as related to ethical dilemmas. In conclusion, few Polish hospitals have HECs, and the structure, services and workload are not always adequate. To ensure a reliable operation of HECs requires the development of relevant legislation, standard operating procedures and well trained members.

[Abortion and conscientious objection]. / Aborcja a klauzula sumienia.

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. The number of lawful abortion in Poland does not exceed 1000 per year and can be carried out by only a few specialists contracted by the National Health Fund. Sufficient information and assistance should be provided to all pregnant women by the National Health Fund. The participation of all physicians in the informing process is not necessary, as evidenced by the lack of complaints to provide information on where in vitro fertilization treatment can be found - until recently only available when paid for by the individual and performed in much larger numbers than abortion. Entities performing this paid procedure made sure to provide information on their own. The rejection of the right to the conscientious objection clause by negating the right to refuse information may lead some to give up the profession or cause the termination of certain professionals on the basis of the professed worldview. Meanwhile, doctors are not allowed to be discriminated against on the basis of their conscience or religion.

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.

[Helsinki Declaration--next version]. / Kolejna nowelizacja Deklaracj Helsinskiej.

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. Anonymisation is not an ethically neutral procedure. Moreover, the Helsinki Declaration does not explain the meaning of the term "anonymisation," which means that the criteria for the procedure might be provided by local stakeholders and because of this, these criteria may push into ethically unacceptable ranges.

[The role of bioethics committees in the systems protecting scientific biomedical research participants in France and in Poland]. / Komisje bioetyczne jako element systemu ochrony uczestników naukowych badan biomedycznych we Francji i w Polsce.

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. Historical beginnings of the bioethics committees system in France and in Poland are briefly mentioned, Subsequently, the networks of bioethics committees in both countries are compared. Although the number of bioethics committees (Research Ethic Committees) in both countries is comparable, the procedure of their establishment varies. French committees are based on administrative division of the country and divide on regional and interregional committees. In Poland, bioethics committees are established by medical universities, medical research and development units or regional chambers of physicians and dentists. In France there is no equivalent of Appeal Bioethics Committee, however one could appeal from the negative bioethics committee's opinion. The composition of French bioethics committees is more diverse and half of the members are not related to medical professions. Members of French committees are named on indefinite term by headmaster of Regional Health Agency after having been chosen in competition for the post. In Poland members are called on three-year-term but the rotation of members is not overwhelming since there is no limit of terms for one member. French legal solutions seems more secure for scientific bioethics research participants. For this reason, a detailed research on legislation in other countries is necessary before introducing any new regulations in Polish law.

[The system of protection of scientific biomedical research participants in France and in Poland]. / System ochrony uczestników naukowych badan biomedycznych we Francji i Polsce--porównanie przepisów prawa.

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. French regulations cover more types of scientific biomedical research than those in Poland. In France almost all types of interventional scientific biomedical research including research on human biological samples and research on cosmetics are covered by the rules of law. Polish regulations are limited to interventional research conducted by doctors and dentists. In both states projects of clinical trials of medicinal products demands double acceptance - from bioethics committee and from competent state authority. In protection of scientific biomedical research participants the role of state authority competent for personal data is more vital in France than it is in Poland. In France there is also National Ethics Advisory Committee whereas in Poland there is no such institution. The systems protecting scientific biomedical research participants differs therefore in both states in many vital aspects and French measures cover more types of scientific biomedical research, hence the level of participants protection in various types of research is more equitable.

[Research ethics committees: one size fits all?]. / Komisje etyczne do spraw badan na ludziach: 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. There is no legal obligation to obtain an approval of the independent research ethics committee for all observational studies or the interventional studies conducted by investigators others than physicians. Moreover, the existing system does not demand a further monitoring of the ongoing studies with an exception of the clinical trials. The system of bioethics committees for the assessment of interventional studies conducted by physicians or dentists should be complemented by two types of research ethics committees: committees which would evaluate projects of medical studies conducted by the other medical specialists (for example: nurses) and committees which would evaluate projects of biomedical studies conducted by the non-medical specialists (psychologists, sociologists). The new regulations should not restrain a progress of the science. Thus legislators should take into the consideration that the projects may differ in the degree of the complexity of ethical issues and the scientific validity. The different methods of the assessment of the biomedical research projects should be available.

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). RESULTS: No difference was found in systolic BP measured before and after HD (SBP before HD: REF -147.3 ± 27.3, OSC -147.5 ± 25.0 mmHg, p>0.05, SBP after HD: REF-141.1 ± 33.9, OSC-141.2 ± 31.5 mmHg, p>0.05, respectively), but diastolic BP (DBP) was significantly higher both before and after HD during REF measurement in comparison with OSC (DBP before HD: REF -79.0 ± 17.0, OSC -76.7 ± 15.0 mmHg, DBP after HD: REF -78.6 ± 18.8, OSC -76.7 ± 16.7 mmHg, p<0.001, respectively). No significant correlation between loss of body weight caused by HD and differences in BP measured by REF and OSC after HD was indicated (Pearson's correlation coefficients: for SBP -0.041, for DBP 0.030). However, a significant correlation between differences in BP measured by REF and OSC before HD and differences in BP measured by REF and OSC after HD was observed (Spearman's rank correlation coefficients: for SBP 0.502 and for DBP 0.557, p<0.000001). CONCLUSIONS: Our study found that individual features, not HD, determine the accuracy of OSC for BP measurement in hemodialysed patients.

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. We present results of a survey of 521 physicians practising in Poland concerning their opinion on CECs and related practices. We analysed the data looking at such issues as CECs' perceived availability, use of CECs, and perceived usefulness of such support. Physicians in our study generally encounter hard ethics cases, even-surprisingly-those who do not work in hospitals. Most physicians have no CEC access, and those that do still do not employ CECs. However, physicians perceive this form of support as useful-even more so among actual users of CECs. We compared these findings with similar studies from other European countries and the North America. We point out peculiarities of our results as compared to those in other countries, with some possible explanations. We hope the results may encourage regulatory debate on the need to formally introduce CECs into the Polish healthcare system.

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. Scientists should have a fundamental role in this process, their duty being to immediately, upon identification, report research with dual use potential. An important entity in the identification system of dual use research should also be the Central Register of Biological and Biomedical Research, which gathers information about all biological and biomedical research being conducted in a given country. Publishers, editors, and review committees of journals and other scientific publications should be involved in evaluating results of clinical trials. The National Council of Biosecurity should be the governmental institution responsible for developing a system of dual use research threat prevention. Its role would be to develop codes of conduct, form counsel of expertise, and monitor the problem at national level, while the Dual Use Research Committee would be responsible for individual cases. In Poland, current actions aiming to provide biological safety were based on developing and passing an act about genetically modified organisms (GMO's) and creating a GMO Committee. Considering experiences of other nations, one should view these actions as fragmentary, and thus insufficient protection against dual use research threats.

[How can we establish hospital ethics committees?]. / Jak zakladac szpitalne komisje etyczne?

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. Members of HECs should present a broad range of disciplines and backgrounds. They should provide a comprehensive and reliable opinion in which all medical, legal and ethical aspects should be mentioned. All members should have a basic knowledge of medical ethics, related legal provisions and Medical Code of Ethics. Different models of ethics support should be provided. Ethical consultation of single specialist and committee or subcommittee debates are possible choices. It is necessary to prepare operating procedures for HECs which will provide standard and unified formalities for all referred cases. Hospital management who is interested in establishing HEC should provide adequate financial support. Members of HECs should be encouraged to upgrade their skills and knowledge.

[Are the hospital ethics committees necessary in Poland?]. / Zasadnosc powolywania szpitalnych komisji etycznych w Polsce.

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. The article discusses the necessity of establishing HECs nationwide. So far, only two bodies of this kind exist in two large, academic paediatric hospitals. In some other academic centers, institutional RECs try to act as HECs, but it is only a temporary solution. A nationwide discussion, and formal establishment of HECs will be necessary.

[Will Polish investigators have access to the research ethics committees?]. / Czy wszyscy polscy lekarze badacze beda mieli miel zapewniony dostep do komisji bioetycznych?

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. Legitimacy of collection of charges for proceedings B and C is questioned due to the dimness of Polish provisions. At the same time the number of submitted to REC projects of medical research decreases but the number of proceedings B and C increases. REC should have and office and secretary. The duty to provide opinions B and C and lack of A proceedings might cause financial collapse of REC. Shortage of assets might deprive investigators of an access to REC. Provisions regulating financing model of Polish REC should be amended.

[Guidelines on research on human biological materials]. / Zasady prowadzenia badan na ludzkim materiale biologicznym.

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. Who and how should evaluate projects of RHBM conducted by non-doctors is not defined yet. RHBM should normally seek informed consent. RHBM might be carried on identifiable or anonymised biological material. Recommendations might differ accordingly to the categories of human biological material: identifiable or anonymised. It is appropriate to develop guidance on sampling and collecting human biological material for research and on conducting RHBM. Genetic research is a special type of RHBM in which broad categories of harms (like: physical, psychological or social) may occur.

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 21.6+/-1.5 years, two series (S1, S2) consisting of three brachial BP measurements each (I, II, and III) were performed, using an Omron 907 oscillometric manometer. RESULTS: Systolic blood pressure (SBP) (mmHg) was higher in measurement I than in II and III, in both S1 and S2: S1-I: 114.9+/-10.5 vs. S1-II: 112.6+/-9.9, P<0.00003, vs. S1-III: 111.0+/-9.6, P<0.000001; S2-I: 111.5+/-9.8 vs. S2-II: 110.1+/-9.1 P<0.007, vs. S2-III: 110.1+/-9.2, P<0.0008. Furthermore, measurement II was higher than III in S1 (P<0.002). Similarly, diastolic blood pressure (mmHg) was higher in measurement I than in II and III, in both S1 and S2: S1-I: 68.3+/-8.4 vs. S1-II: 67.3+/-8.7, P<0.008, vs. S1-III: 65.7+/-8.7, P<0.000001; S2-I: 66.6+/-8.3 vs. S2-II: 65.8+/-8.2, P<0.04, vs. S2-III: 65.7+/-8.7, P<0.02. Measurement II was again higher than III in S1 (P<0.00003). CONCLUSIONS: The common alerting reaction to BP measurements cannot be avoided in young, normotensive women, but it can be limited, as demonstrated by the results of BP measurements in S2. The simple procedure of automatic cuff inflation and noninvasive, oscillometric BP measurement may carry an independent pressor effect, which corrupts the accuracy of BP measurements.

[How to prevent hazards and to reduce risk in clinical trials?]. / Jak zapobiegac zagroeniom i ograniczac ryzyko w badaniach klinicznych?

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 related with clinical trials is possible due to education, training, inspections, research discipline and penalties. Effective ways of hazard elimination or hazard reduction should be developed as well. Education and training should be offered to all stakeholders but their forms and contents should be adapted to different types of stakeholders. Direct control of the clinical trials should be held by stakeholders conducting clinical trials and outside inspections should be done by other institutions like clinical research organizations, research ethics committees and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Serious oversight is an absence of any independent inspection during a phase of publication of clinical trial results. We should not accept any exception from the golden rule that results of all clinical trials must be published. Indemnity for damages is a popular way of compensation for clinical trials participants. Investigators, sponsors and centers should have valid liability insurance. Drastic measures for reduction of risks in clinical trials are different kinds of penalties. They should prevent participation of unreliable stakeholders and promote those who respect regulations and high ethical standards.

[Hazard, risk and harm in clinical trials]. / Zagrozenie, ryzyko i szkoda w badaniach klinicznych.

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. Among others the most important are: investigators, sponsors, centers (where clinical trials are conducted), contract research organizations and bioethics committees. Regardless of multiple hazards, substantial harms are discovered relatively rare. This situation could be explained by a small number of high risk potential clinical trials and low social awareness about different types of possible harms. Proper education should ameliorate our knowledge about hazards, risks and harms in clinical trials.

[Social aspect of clinical research in Poland]. / Spoleczne aspekty prowadzenia badan klinicznych w Polsce.

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 risks related to the participation in clinical research and the role of media in creating and influencing of the social perception of clinical trials. Results of conducted questionnaire studies imply that Poles correctly identify and assess the risk of participation in clinical experiments. The primary reason for the participation seams to be the possibility to help other patients, contribution to the progress of science and standards of medical care and potential benefits for other sufferers. The need of testing the safety and efficacy of the new medication in man is generally well recognized. At the same time a substantial part of the society is concerned with the possible corruption of investigators and unethical behaviour of sponsors. The social perception of clinical research in Poland is in majority of analyzed parameters not substantially different from opinions in other member states of EU. However, the medical society should be more active in influencing and changing some negative impressions.

[Standard operating procedures in ethic committees]. / Standaryzacja procedur w komisjach bioetycznych.

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 committee's activities. Standard operating procedures should cover as important problems as conflict of interest, trial's insurance or elections of ethic committees. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. Governmental initiatives and creation of forum for polish ethic committees are essential in the effective standardisation, coordination and implementation of procedures in regional ethic committees. These projects need support via public funding from our authorities.