Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

Czarkowski, Marek; Różanowski, K.

doi:10.1007/s11948-009-9113-x

Cited by 11 publications

(10 citation statements)

References 6 publications

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“…Fourteen out of the 15 non-uRECs evaluated less than six initial studies each year. Czarkowski and Rozanowski12 have evaluated the function of ethics committees in Poland and reported an increase in the number of ethics committees that evaluate <20 studies per year, which they considered alarming. The Central Committee on Research Involving Human Subjects (CCMO) of the Netherlands has stated that to get accredited an REC has to assess at least 10 protocols per year 10.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the work of hospital districts’ research ethics committees in Finland: Table 1

Halila

2014

J Med Ethics

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The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area.

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Section: Discussionmentioning

confidence: 99%

Evaluation of the work of hospital districts’ research ethics committees in Finland: Table 1

Halila

2014

J Med Ethics

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“…The experiments were conducted in a group of volunteers (N=25) in controlled series of measurements conducted in three different types of conditions. The experiments were conducted in line with the methodology approved by the Bioethics Committee and developed in line with EU guidelines [15].…”

Section: B Methods For Determination Of Psychological Profile Parametersmentioning

confidence: 99%

First approach for design of an autonomous measurement system to aid determination of the psychological profile of soldiers

Różanowski

Sondej

Lewandowski

2015

2015 22nd International Conference Mixed Design of Integrated Circuits &Amp; Systems (MIXDES)

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The article presents the first attempt for design of an autonomous measurement system to aid assessment and to determine the psychological profile of soldiers. A method for ascertaining the psychological profile is presented including the physiological signals being generated by the monitored subject as an important element thereof. The measurement system used in the preliminary experiments and the design of a new, extendedfunctionality system, are presented. The new version of the measurement system facilitates determination of physiological parameters, environmental conditions and physical activity. In addition, it allows introduction of data on the psychological profile of the soldier to determine the degree of a soldier's adaptation to task-related situation at given point in time. The main element of the measurement system has been designed using an application-specific integrated circuit.

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“…Their mean age was 27 ± 0.4 years. Each study participant was informed about the study design and provided an informed consent [19]. On the day of experiment, participants abstained from caffeine intake of any form for at least 4 hours before the test and for the entire duration of the test.…”

Section: Study Subjectsmentioning

confidence: 99%

Rheological model of dynamic pupillary reflex in the assessment of the level of autonomic nervous system activation

Różanowski¹,

Truszczyński²,

Lewandowski³

et al. 2016

WIT Transactions on Engineering Sciences

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The aim of this publication was to adapt a rheological model of Kelvin-Voigt in the description of the dynamic pupillary reflex. The pupillary reflex presents the results of physiological adaptation mechanisms in the human eye, i.e. response of the iris to the changing intensity of light falling on the retina under the condition of sensory deprivation. Pupillary light reflex (PLR) is a closed loop nerve reflex.The new approach to PLR evaluation presented by the authors consists of adapting the Kelvin-Voigt model to the description of this phenomenon. The authors, for their tests of correct implementation of the model, used data from pilot studies. Research was performed on a group of 10 volunteers in a laboratory environment, at night. The mean age of the study participants was 27 ± 0.4 years. For PLR registration, the F²D Fit-For-Duty system was used .The system provides useful data for shift work or for personnel in high-risk careers.The PLR measurements were taken for both eyes, which were exposed to a series of five flashes at 30-second intervals. The whole measurement of both eyes was conducted with patients wearing goggles, in order to maintain the same measurement conditions, mostly with regard to accommodation.Owing to proper implementation of the model, we managed to attain a high level of its adaptation to real data (>90%). The results show their strong correlation, and the model shows high sensitivity to changes in the shape of the reflex curve, caused by sleep deprivation introduced in the experiment.

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Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

Cited by 11 publications

References 6 publications

Evaluation of the work of hospital districts’ research ethics committees in Finland: Table 1

Evaluation of the work of hospital districts’ research ethics committees in Finland: Table 1

First approach for design of an autonomous measurement system to aid determination of the psychological profile of soldiers

Rheological model of dynamic pupillary reflex in the assessment of the level of autonomic nervous system activation

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