Darbe nagrinejamas informuotas paciento sutikimas medicininio gydymo kontekste, sutikimui keliami reikalavimai, teisės aktų, susijusių su pacientų teisėmis normos. / The aim of this work was to answer the legal question whether rendering of the standard consent form to the patient and signing of it can be regarded as a proper informed consent.The growing availability of medical information sources, involvement of mass media and TV programs has enabled patients to get more information about medical care, so as a consequence, informed decision making became a central topic in doctor – patient communication.

Darbo tikslas. Įvertinti pacientų nuomonę apie konfidencialumo principo taikymą gydymo įstaigoje. Uždaviniai. Įvertinti pacientų informuotumą apie konfidencialumo principo taikymą sveikatos priežiūros įstaigoje. Išaiškinti pacientų požiūrį į konfidencialumo principo taikymą sveikatos priežiūros įstaigoje ir nustatyti ryšį su pacientų lytimi ir išsimokslinimu. Tyrimo metodika. N sveikatos priežiūros įstaigoje atlikta anoniminė anketinė 303 pacientų apklausa (atsako dažnis – 86,6 proc.) Duomenų analizei naudotas SPSS 13.0 statistinės analizės paketas. Diagramos ir lentelės parengtos Microsoft Excel 2007 programa. Rezultatai. 56,8 proc. tyrimo dalyvių teigė, jog perskaitė visas pasirašyti pateiktas formas, 28,7 proc. respondentų tvirtino, kad perskaitė kai kurias jiems pateiktas informavimo/sutiki-mo formas. 66,7 proc. respondentų teigė, kad prieš pasirašydami visiškai aiškiai žinojo dėl ko duoda sutikimą, 19,1 proc. respondentų prisipažino, jog kai kas buvo neaišku, ir 14,2 proc. respondentų nurodė, jog nesuprato su kuo sutinka, tačiau pasirašė, nes taip reikia. 52,5 proc. skaičiusių informavimo formas respondentų nurodė, jog pateiktoje informuoto sutikimo formoje buvo aiškūs visi teiginiai, 36,7 proc. respondentų dauguma teiginių buvo aiškūs. Mažiau nei pusė respondentų (45,9 proc.) manė, jog informacija apie ligą ir medicininius tyrimus yra įslaptinta, su šiuo teiginiu nesutiko 26,1 proc. respondentų. Nustatytas statistiškai reikšmingas ryšys tarp pacientų išsimokslinimo ir... [toliau žr. visą tekstą] / Aim of the study. To evaluate patients' opinion about the application of confidentiality principle in medical institution. Objectives. To evaluate patients' awareness about the application of confidentiality principle in health care institution. To find out patients‘ attitude towards the application of confidentiality principle in health care institution and to determine its relationship with patients‘ gender and education. Methods. An anonymous survey of 303 patients using questionnaires (response frequency – 86.6 %) ¬was carried out in the health care institution N. Data analysis used the SPSS 13.0 statistical analysis package. Charts and tables were prepared using Microsoft Excel 2007. Results. 56.8 % of the survey participants told that they had read all the forms presented to be signed, 28.7 % of the respondents claimed that they had read some of the forms of information/consent presented to be signed. 66.7 % of the respondents affirmed, that before signing they knew absolutely clearly why they had given their consent, 19.1 % of the respondents admitted that some things were unclear, and 14.2 % of the respondents told that they had not understood why they had given their consent; however, they had signed the form because it was necessary. 52.5 % of the respondents who had read the forms of information claimed that all the propositions of the form of informed consent were clear, 36.7 % of the respondents had understood most of the propositions. Less than half of the... [to full text]

The dissertation aims to analyse the problem of informed consent in clinical drug trials. Understanding of the provided information is one of the basic components of a person’s sound and informed decision to participate in a clinical trial. Our research evaluated informedness about clinical trials of patients participating in clinical drug trials in Lithuania, with emphasis on the informedness about key elements of clinical trial design (placebo-control, double-blindness, and randomisation). An anonymous survey of patients participating in clinical drug trials was conducted for the purposes of this study. The results of the study reveal that the legal framework sets the basis for adequate informedness about clinical trials of clinical trial participants, however, patients participating in placebo-controlled clinical trials are insufficiently informed about clinical trials. Patients participating in placebo-controlled clinical trials are better informed about the rights of clinical trial participants than about clinical trial design, however, informedness about design is a more important condition for overall informedness. The majority of placebo-controlled clinical trial participants do not understand at least one of the three key elements of clinical trials design and they tend to interpret the scientific methods used in clinical trials therapeutically. / Disertacijoje analizuojama informuoto asmens sutikimo įgyvendinimo klinikiniuose vaistinio preparato tyrimuose problema. Pateiktos informacijos supratimas yra viena svarbiausių asmens apsisprendimo dalyvauti klinikiniame tyrime sąlygų. Moksliname darbe vertinamas pacientų, dalyvaujančių placebu kontroliuojamuose klinikiniuose vaistinio preparato tyrimuose Lietuvoje (toliau – klinikinių tyrimų dalyviai), informuotumas apie klinikinius tyrimus, akcentuojant informuotumą apie klinikiniuose tyrimuose taikomus mokslinius metodus (placebo kontrolę, dvigubą aklumą, atsitiktinį tiriamųjų grupių sudarymą). Klinikinių tyrimų dalyvių informuotumas buvo tiriamas atliekant anoniminę apklausą. Mokslinio darbo rezultatai parodė, kad teisinis reglamentavimas sudaro prielaidas klinikinių tyrimų dalyvių informuotumui, tačiau jų informuotumas yra nepakankamas. Respondentai buvo geriau informuoti apie klinikinių tyrimų dalyvių teises nei apie klinikinių tyrimų metodologiją, tačiau informuotumas apie klinikinių tyrimų metodologiją yra svarbesnė prielaida bendram informuotumui. Dauguma klinikinių tyrimų dalyvių nesuprato vieno ar daugiau iš trijų pagrindinių klinikiniuose tyrimuose taikomų mokslinių metodų (placebo kontrolės, dvigubo aklumo, atsitiktinio tiriamųjų grupių sudarymo) ir buvo linkę suteikti jiems terapinę reikšmę. Tyrimo rezultatai sudaro prielaidas kryptingam klinikinių tyrimų dalyvių informuotumo gerinimui, informacijos apie klinikinius tyrimus viešinimui.

Disertacijoje analizuojama informuoto asmens sutikimo įgyvendinimo klinikiniuose vaistinio preparato tyrimuose problema. Pateiktos informacijos supratimas yra viena svarbiausių asmens apsisprendimo dalyvauti klinikiniame tyrime sąlygų. Moksliname darbe vertinamas pacientų, dalyvaujančių placebu kontroliuojamuose klinikiniuose vaistinio preparato tyrimuose Lietuvoje (toliau – klinikinių tyrimų dalyviai), informuotumas apie klinikinius tyrimus, akcentuojant informuotumą apie klinikiniuose tyrimuose taikomus mokslinius metodus (placebo kontrolę, dvigubą aklumą, atsitiktinį tiriamųjų grupių sudarymą). Klinikinių tyrimų dalyvių informuotumas buvo tiriamas atliekant anoniminę apklausą. Mokslinio darbo rezultatai parodė, kad teisinis reglamentavimas sudaro prielaidas klinikinių tyrimų dalyvių informuotumui, tačiau jų informuotumas yra nepakankamas. Respondentai buvo geriau informuoti apie klinikinių tyrimų dalyvių teises nei apie klinikinių tyrimų metodologiją, tačiau informuotumas apie klinikinių tyrimų metodologiją yra svarbesnė prielaida bendram informuotumui. Dauguma klinikinių tyrimų dalyvių nesuprato vieno ar daugiau iš trijų pagrindinių klinikiniuose tyrimuose taikomų mokslinių metodų (placebo kontrolės, dvigubo aklumo, atsitiktinio tiriamųjų grupių sudarymo) ir buvo linkę suteikti jiems terapinę reikšmę. Tyrimo rezultatai sudaro prielaidas kryptingam klinikinių tyrimų dalyvių informuotumo gerinimui, informacijos apie klinikinius tyrimus viešinimui. / The dissertation aims to analyse the problem of informed consent in clinical drug trials. Understanding of the provided information is one of the basic components of a person’s sound and informed decision to participate in a clinical trial. Our research evaluated informedness about clinical trials of patients participating in clinical drug trials in Lithuania, with emphasis on the informedness about key elements of clinical trial design (placebo-control, double-blindness, and randomisation). An anonymous survey of patients participating in clinical drug trials was conducted for the purposes of this study. The results of the study reveal that the legal framework sets the basis for adequate informedness about clinical trials of clinical trial participants, however, patients participating in placebo-controlled clinical trials are insufficiently informed about clinical trials. Patients participating in placebo-controlled clinical trials are better informed about the rights of clinical trial participants than about clinical trial design, however, informedness about design is a more important condition for overall informedness. The majority of placebo-controlled clinical trial participants do not understand at least one of the three key elements of clinical trials design and they tend to interpret the scientific methods used in clinical trials therapeutically.

Purpose: Patients’ perspectives of informed consent for chiropractic care have not been investigated. This study explored how patients of chiropractors perceived the exchange of risk information during informed consent. Methods: Interviews were conducted with 26 participants, recruited from chiropractic clinics. Interview transcripts were analyzed using a constant comparative method of analysis. Findings: Participants experienced informed consent as an on-going process where risk perceptions were shaped throughout four distinct stages. In the first stage information acquired prior to arriving at the clinic for treatment shaped perceptions of risk. In the second stage participants assessed the perceived competence of the practitioners. Participants then signed the consent form and discussed the risks with t heir practitioner. Finally, they communicated with their practitioners during treatment to ensure their pain threshold was not crossed. Conclusion: These findings suggest that patients perceive informed consent as a social process involving on-going communication with their practitioners.

The purpose of this writing is to analyses the doctrine of informed consent. Person exercises his autonomy by making informed and reasonable decisions. The writing attempts to disclose a theoretical and practical role of the informed consent institute and its influence on physician’s civil liability. This work consists of five parts. First of all is given ethical importance of informed consent doctrine. In the following parts of the work it is analyzed national and international regulations on informed consent. There is short Lithuanian case law on informed consent overview. At the end it is concluded that there are some gaps in Lithuanian law concerned with informed consent.

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

Probabilities, an essential dimension of risk communication, can be presented in various formats including frequencies (e.g., 1 in 10), percentages (e.g., 10%), or verbal phrases (e.g., unlikely); the literature is mixed concerning which format best supports comprehension. Additionally, it is not well understood how people who vary in their level of numeracy understand those probabilities. The goal of the present three-phase within-participant study was to understand how the factors of format and numeracy influence comprehension and mental representations of probabilities for younger and older adults. Overall, the results of this research clearly indicated that comprehension and mental representation of health risk probabilities are influenced by format, age, and numeracy. To best support comprehension and comparison of health risk probabilities for younger adults and healthy older adults with varying numeracy, percent format should be used.

Univ., Diss.--Düsseldorf, 2005. / Literaturverz. S. [387] - 423.

Thesis (Ph.D.)--Ohio University, June, 2008. / Title from PDF t.p. Includes bibliographical references.