The legal grounds regarding clinical trial in Turkey.

The first mention of clinical trials in a legal document occurred in Turkey many years before the Helsinki Declaration or Belmont report; issued in 1926, the Code of Pharmaceutical Products and Preparations No. 1262 law carries the statement: "Experimental drugs can be used in a patient only by his/her permission". Then the other regulation is the Regulation on Medical Deontology, dated 1960, and still in force. Article 10 and 11 of this Regulation address physicians and dentists who are conducting research. After periods of misconducted and ill-designed studies, the modern era of clinical trials began in 1993 with the introduction of the "Drug Research Bylaw". This document was directly influenced by the initial drafts of ICH-GCP Guidelines, and some parts were very similar. This became the main document that regulates the conduct of clinical trials in Turkey. A good clinical practice (GCP) guidelines document was added in 1995. On the other hand, an amendment made to Article 90 of the New Turkish Penal Code No. 5237 of 26 September 2004, which will come into force on 1st April 2005, envisages that in conflicts between international treaties concerning basic rights and freedoms and national laws, priority will be given to the international treaties. Therefore, in Turkish law, international treaties concerning basic rights and freedoms are given precedence as compared with national laws and other regulations. The Article stipulates the conduct of research on conditions such as not violating human well-being and dignity.

Healthcare Personnel's Knowledge and Management of Frequently Encountered Forensic Cases in Emergency Departments in Turkey.

BACKGROUND: Emergency department (ED) personnel frequently encounter incidents related to crime, violence, and suspicious injuries. The aim of this descriptive study was to determine the knowledge levels of ED healthcare personnel in their handling of frequently encountered forensic cases. METHODS: A cross-sectional descriptive study composed of ED healthcare personnel at all state, education and research, and university hospitals with EDs, located in Ankara, Turkey, was completed. Participants at the 15 hospitals in question were interviewed via a questionnaire developed by the researchers. RESULTS: Three hundred fifty healthcare personnel who worked agreed to participate in the study. The results show that ED healthcare personnel have less knowledge than expected of the right way to handle frequently encountered forensic cases. Very few of the healthcare professionals who participated in the study had received any training or education in the field of forensic nursing. Among participants, postgraduates, health professionals educated in forensic nursing, and healthcare staff who used additional resources to understand forensic cases, and those who had evaluated cases that presented to the ED as forensic cases, had significantly higher levels of knowledge. IMPLICATIONS: This study supports the need for professional development in forensic nursing, such as in-service training, and curriculum development for a certificate in forensic nursing to enhance the practical training of healthcare professionals who work in EDs.

[The effect of firearms in inducing stress in high school students in the city of Düzce (Turkey)]. / Atesli Silahlarin Adolesans Döneminde Stres Yapici Faktör Olarak Etkisi.

OBJECTIVE: This study aimed to examine the behaviors of high school students exposed to firearms and firearms- related violence, which they had perpetrated or witnessed, and whether or not these events were related to stress. METHOD: The study was conducted in Düzce province, which is characterised by the widespread use of firearms. A questionnaire was prepared to ascertain students' attitudes and behaviors towards owning firearms, their thoughts about firearms- related violence, and whether or not they had been a victim or witness to firearms- related violence. After a stress level scale was added to the questionnaire, it was administered to 791 students randomly chosen from the 8304 students that were attending all high schools in Düzce. The results were evaluated with using SPSS v.11.0 software. RESULTS: The level of stress in students that had contact with firearms, whether or not they were faced with a violent act, may be reached the adaptation difficulty level. Aggressive behaviors like hectoring occurred between coequal groups and brothers/sisters, affectedstress levels. Exposure to and witnessing violent acts had important roles on level of stress. Gender, income level, and lack of a private room at home for adolescents affected stress levels. Contrary to expectations, the presence of firearms at home or in their surroundings did not have an effect on stress levels. Hearing the sound of gunfire was one of the most important factors related to stress levels. CONCLUSION: Because of its ability to induce stress in adolescents, they must be protected form exposure firearms and their use, which is widespread in Düzce.

The Knowledge Level of Dentists in Turkey About Their Potential Role on the Disaster Victims Identification (DVI) Team.

OBJECTIVE: Although dentists are valuable assets in identification teams during disaster events, forensic dentistry is not used effectively in the identification studies conducted in Turkey, and the importance of dental data is ignored. The aim of this study was to determine the level of knowledge of dentists regarding their duties and responsibilities during major disasters. METHODS: This descriptive study was conducted between December 2015 and June 2016. Registered dentists (n=20.280) of the Turkish Dental Association were invited to complete the organization's online survey. A total of 539 dentists participated in the volunteer workshop. Data were analyzed using SPSS, version 22.0 (IBM Corp, Armonk, NY). The chi-square analysis was used to evaluate the knowledge level of dentists by group regarding disaster victim identification (DVI) - the process and procedure of recovering and identifying victims of major disasters (eg, earthquake, terrorist attack). RESULTS: The dentists included in the study consisted of 320 (59.4%) females and 219 (40.6%) males with a mean age of 37.4±12.6 years. The number of specialists and general dentists were 249 (45.6%) and 297 (54.4%), respectively; 249 (69.71%) dentists who had knowledge about forensic dentistry stated that they received this information during their formal training. The percentage of dentists who were aware of the existence of an organization of a disaster response operation in Turkey was 74.2%, but only 20.5% (n=110) had knowledge about DVI. We found that 92.9% (n=104) of these dentists believed that dentists should be included in the team for the identification of disaster victims. On the other hand, only half (52.3%) of the dentists with knowledge of DVI wanted to work on the identification teams. The majority (99.1%) considered DNA analysis to be the safest method for identification. CONCLUSION: Our findings show that, although dentists know about the identification process, they do not have enough relevant knowledge. (Disaster Med Public Health Preparedness. 2019;13:533-538).

Obstetric and gynecologic malpractice in Turkey: incidence, impact, causes and prevention.

The Forensic Medicine Association was established in Turkey by law number 2659 for the purpose of providing expertise in legal cases. In this study the opinions given by the lawcourts and public defenders in the Forensic Medicine Association's First, Second, Third, and Fifth Specialization Divisions between the years 1990 and 2000 (approximately 680,000 files) were examined retrospectively. It was determined from these that there were 636 cases of medical malpractice. In examining the distribution of cases based on specialty branch, it was established that 16.82% (n=107) were in the area of obstetrics and gynecology, 10.69% (n=68) in general surgery, 10.53% in neurology and neurosurgery, and the remaining areas were found to be at lower percentages. It also showed that in recent years there has been an increase in the number of cases claiming medical malpractice in the area of obstetrics and gynecology, and that 58% of the cases (n=62) from 1998 to 2000 were in this area. 96% of the 107 cases that claimed malpractice in the area of obstetrics and gynecology were found to be related to obstetrics and 3.8% (n=4) to gynecology and surgical procedures. In 31% (n=33) of the 107 cases fault was found; all of the cases where medical malpractice was found were in the area of obstetrics and none of the cases related to gynecology were found to have an element of error. Cases that had an element of error were evaluated from the aspect of profession of the health care personnel at fault, areas of fault, places where fault occurred, situations that resulted in death, cause of death, whether or not an autopsy was done, injury that resulted from fault, intervention that was done, and obstetric and gynecologic risk factors that set the stage for claims. Care standards and breach of standards were examined.

Medicolegal evaluation of vascular injuries of limbs in Turkey.

This study evaluated 372 cases of post-traumatic extremity vessel lesions, for which the Forensic Medicine Council, Istanbul, Turkey prepared medicolegal evaluation reports between 1998 and 2000. The study group (n = 372) comprised of 346 men (93.0%) and 26 women (6.9%), and their ages ranged between 6 and 73 years (30.18 +/- 6.13). There were 378 artery (74.5%), and 131 vein injuries (25.5%) out of a total of 509 limb vascular injuries. The most frequently injured arteries and veins were the femoral artery (n = 73), and the deep femoral vein (n = 41), respectively. The causes of injuries were as follows: cutting and stabbing complements, in 160 cases (43.0%); gunshots in 136 cases (36.6%); traffic accidents in 52 cases (14%); work accidents in 23 cases (6.2%); and blunt trauma in one case (0.3%). These injuries were accompanied by local nerve lesions (27.1%), local bone lesions (37.1%), and injuries to other organs (11.0%). The medicolegal assessments by the Forensic Medicine Council showed that there were risk of death in 371 cases. Additionally, there was 'organ dysfunction' in 37 (9.9%) and 'organ loss' in 53 (14.2%) cases. The results of this study suggested that the main causes of severe vascular injuries (i.e. those accompanied by bone and nerve lesions) had serious consequences such as amputation, permanent disorders or loss of function and were caused by gunshot and traffic accidents.

[Clinical drug research from medical ethics and legal perspectives]. / Tip etigi ve tip hukuku açisindan klinik ilaç arastirmalari.

Medical ethics and law in clinical drug research are the two main points that have been discussed in public and medical circles. Conducting drug research on "easily affected and vulnerable groups", such as psychiatric patients, has always been a controversial issue in medicine. How should human subjects be protected, especially psychiatric patients, who are defined as "vulnerable subjects and groups"; what are the ethically and legally justifiable reasons for basing drug research on psychiatric patients; and what can be said about responsibilities in the context of medical ethics and law? Patients who are in the mentioned groups can not be informed clearly about the characteristics of research which they would be involved in. In recent years psychiatric, geriatric, anesthesiology and pediatric patients are defined as "patients who do not have the ability for consent". In this article answers will be given to questions such as why medical ethics is interested in clinical drug research, and what kind of roles should ethics play in drug research. The situation worldwide will be analyzed from a historical approach with regard to laws and regulations concerning drug research. The legal rights of human subjects who have the ability to give informed consent and of those who do not will be discussed and the place of psychiatric patients as human subjects in drug research will be addressed. Some unethical examples and their consequences will be considered and discussed. In this context, a critical evaluation will be made of the situation in Turkey.

Comparison of the three age estimation methods: which is more reliable for Turkish children?

BACKGROUND: Three atlases-the GOK, the Greulich-Pyle (GP), and the Tanner-Whitehouse (TW3)-are used frequently for age determination in Turkey. The purpose of this study was to evaluate the applicability of these three methods related to the skeletal age assessment for Turkish adolescents. MATERIALS AND METHODS: The conventional roentgenograms of the left hands and wrists, elbows, shoulders, and pelvises of 333 healthy Caucasian children (164 females, 169 males) who fit the study and the criteria of each atlas were obtained. The mean differences (+/- standard deviation [S.D.] in years) between the chronologic age (CA) and the skeletal age (BA), which were obtained by using each age estimation method, were calculated and tested using t-test. RESULTS: For girls, the most accurate method was the TW3 (mean differences (d): -0.21 (p<0.05)), following by the GP (d: 0.66 (p<0.001), and the GOK (d: 2.99 (p<0.001)). For boys, the most accurate method was the GP (d: -0.02 (p>0.05)), followed by the TW3 (d: -0.18 (p<0.05)) and GOK (d: 1.05 (p<0.001)). DISCUSSION AND CONCLUSIONS: Results show that the TW3 (for girls) and the GP (for boys) methods are more appropriate than the GOK atlas for estimating the BA. GOK could be used for boys aged 11-14 years but it should not be used for girls.

Establishment of interdisciplinary child protection teams in Turkey 2002-2006: identifying the strongest link can make a difference!

OBJECTIVES: The University of Iowa Child Protection Program collaborated with Turkish professionals to develop a training program on child abuse and neglect during 2002-2006 with the goals of increasing professional awareness and number of multidisciplinary teams (MDT), regional collaborations, and assessed cases. This paper summarizes the 5-year outcome. METHODS: A team of instructors evaluated needs and held training activities in Turkey annually, and provided consultation when needed. Descriptive analysis was done via Excel and SPSS software. RESULTS: Eighteen training activities were held with 3,570 attendees. Over the study period, the number of MDTs increased from 4 to 14. The MDTs got involved in organizing training activities in their institutions and communities. The number of medical curriculum lectures taught by MDTs to medical students/residents, conferences organized by the MDTs, and lectures to non-medical professional audiences increased significantly (R(2)=91.4%, 83.8%, and 69.2%, respectively). The number of abuse cases assessed by the MDTs increased by five times compared to pre-training period. CONCLUSIONS: A culturally competent training program had a positive impact on professional attitudes and behaviors toward recognition and management of child abuse and neglect in Turkey. The need to partner with policy makers to revise current law in favor of a greater human services orientation became clear. PRACTICE IMPLICATIONS: Pioneers in developing countries may benefit from collaborating with culturally competent instructors from countries with more developed child protection systems to develop training programs so that professional development can improve recognition and management of child abuse and neglect.

Is the assessment of bone age by the Greulich-Pyle method reliable at forensic age estimation for Turkish children?

BACKGROUND: Estimation of age is an important task for forensic experts especially in developing countries where birth records are often not well maintained. In this study, we investigated whether or not the Greulich-Pyle (G-P) method is sufficient at forensic age estimation for Turkish children. METHODS: Plain radiographies of left hands and wrists of 492 (241 (49.0%) female, 251 (51.0%) male) healthy children between 11 and 18 years of age for girls and 11 and 19 years of age for boys were taken. Mean chronological ages (CA) were compared with mean skeletal ages according to G-P atlas for each gender and in the second step the differences those for each age group were determined. The children were Caucasian and had a low-middle socioeconomic status in this study population. The paired sample t test was used to indicate the difference between G-P (mean skeletal age according to G-P atlas) and CA (mean chronological age). In order to indicate the relation Pearson correlation coefficient was used. Modeling the relationship between G-P and CA linear regression was used. The analyses were done under SPSS 11.5. RESULTS: The G-P compared to their CA. The CA was 14.52+/-2.18 S.D. years, S.E.: 0.14 (median: 14.47, range: 11.07-18.92 years) whereas G-P was 15.06+/-2.31 S.D. years, S.E.: 0.15 (median: 15.00, range: 10-18 years) for girls. The difference between the two parameters was statistically significant (p<0.001). The CA was 15.28+/-2.41 S.D. years, S.E.: 0.15 (median: 15.09, S.E. range 11.13-19.94 years) and G-P was 15.41+/-2.92 S.D. years, S.E.: 0.18 (median: 15.60, range 9-19 years) for boys. The difference was not statistically significant (p>0.05). There was a high correlation (Pearson r=0.882, p<0.001) for girls and (Pearson r=0.900, p<0.001) for boys. The determination coefficient (R2) is equal to 0.778 for girls and 0.81 for boys. The regression model also tested by ANOVA and it is found significant (p<0.01) for both genders. According to age groups G-P was advanced (0.17-1.1 year) almost for all ages and differences were significant at 11, 12, 14, 16 ages for girls. G-P was delayed at 11-14 ages (0.01-0.58 year) but not significant except for 13 years and G-P were significantly advanced in 15-17 ages (0.88-0.98 years) but then delayed in 18-19 years of age (0.02-0.48) for boys. The difference's standard deviation at 12, 13, 15, 16 years of ages for girls and between 12 and 16 and 18 years of ages for boys were more than 1 year. CONCLUSION: When the results of the previous study and this study are compared, the test method could be used technically by pediatricians and other clinicians, but it is even more important for ethically unacceptable errors to disappear, especially in cases involving the possible criminal liability of the supposed minor. So standard deviation at 12, 15 years of ages for girls and 12, 15, 18 years of ages for boys were more than 1 year. But it is not known that the other methods whether more useful or not than this method. For the time being unless any other methods will be proved more useful, we have to use this method cautiously for possible criminal liability cases in forensic age diagnosis.

Statutory disclosure in article 280 of the Turkish Penal Code.

A new Turkish Penal Code came into effect on 1 June 2005. Article 280 concerns health care workers' failure to report a crime. This article removes the responsibility from health care workers to maintain confidentiality, but also removes patients' right to confidentiality. It provides for up to one year of imprisonment for a health care worker who, while on duty, finds an indication that a crime might have been committed by a patient and who does not inform the responsible authorities about it. This forces the health care worker to divulge the patient's confidential information. A patient who thinks he or she may be accused of a crime may therefore not seek medical help, which is the universal right of every person. The article is therefore contrary to medical ethics, oaths taken by physicians and nurses, and the understanding of patient confidentiality.

The legal and ethical aspects of medical malpractice in Turkey.

The issue of patients' rights is relatively unknown in our country but it is often recalled when an incident of death or disability is suspected as being caused by a physician's error. However patients' rights are being violated thousands of times every day in our country. More than these patients' rights' violations, the essential point is the lack of a mechanism to claim those rights and to complain about the practices which violate them. In our country, patients and their relatives are uninformed, powerless and unprotected against physicians and health organizations, and they typically accept whatever happens to them without complaint. Some of the reasons for this are, presumably, an underdeveloped consciousness of patients' rights, an absence of patient organizations, and insufficient ethical and legal regulations on patients' rights. These deficiencies were diminished somewhat by the "Regulation on Patients' Rights," which was prepared by the Ministry of Health in 1998. Another legal draft law referred to as "Responsibilities Due to Malpractice in Medical Services" has been prepared and is in the process of becoming law. This draft law and the general conditions of the country on this subject are evaluated in this article.

Emerging health sector problems affecting patient rights in Turkey.

It is accepted throughout the world today that a new approach is needed to health care, one that brings to the forefront the role of economic development. This situation has also increased the importance of the health care sector and health data have begun to take a significant place in countries' development indicators. Health care services as a basic indicator of social and economic development in Turkey, as in the rest of the world, continue to gain in importance. However, there is a significant difference between health indicators for Turkey, which is a candidate for full membership of the European Union, and European Union countries.