Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| CLINICAL STUDIES and ETHICAL COMMITTEES | - | Spring Semester | 3+0 | 3 | 7 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | Third Cycle (Doctorate Degree) |
| Course Type | Elective |
| Course Coordinator | Prof.Dr. Fulya İlçin GÖNENÇ |
| Name of Lecturer(s) | Prof.Dr. Fulya İlçin GÖNENÇ |
| Assistant(s) | Res. Assist. Sinem Taştekin |
| Aim | The primary function of the course is to discuss the relationship between the law and the practise of modern developments in the latter. During the course, in the context of medical law and ethics with explaining fundamental concepts, basic issues of clinical trials and research ethics committees will be explained in accordance with current international declarations and medical ethic. |
| Course Content | This course contains; A brief history of clinical trials and medical research,Basic concepts and definitions and ethical norms,Context and purpose of clinical researches,Codes, declerations and other ethical guidance of research with humans,Transparency of clinical trials,Phases of drug clinical trials (Phase 1,2,3,4),Protecting Study Subjects, Insurance, Consenting to Research, and Responsibility,Selection of subjects; research with healty volunteers, Research involving women, children, those at risk of impared desion making capacity,Legal and ethical standarts of informed consent in research,Privacy and confidentialy, justice in research,Organization, duties, and operating guidelines and procedures of research ethics committees,Composition, membership, standard operating procedures of Ethics Committees,Case studies.,General assessment.. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| -Analyzes the basic legal and ethical conflicts which arise in the practise of clinical trials. | 10, 14, 16, 9 | A, E |
| -Understand such concepts as personhood, transparency and autonomy will be able to evaluate the importance and limitations of consent to clinical trials. | 13, 14, 9 | A, E |
| -At the end of this course students will also acquire an appreciation of what research is and of how it is regulated. | 10, 9 | A, E |
| -Have knowledge about national and international legal regulations on clinical research. | 10, 9 | A, E |
| -Have knowledge about how clinical research is conducted in an ethical framework. | 10, 9 | A, E |
| Teaching Methods: | 10: Discussion Method, 13: Case Study Method, 14: Self Study Method, 16: Question - Answer Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam, E: Homework |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | A brief history of clinical trials and medical research | lecturer's notes on the course |
| 2 | Basic concepts and definitions and ethical norms | lecturer's notes on the course |
| 3 | Context and purpose of clinical researches | lecturer's notes on the course |
| 4 | Codes, declerations and other ethical guidance of research with humans | lecturer's notes on the course |
| 5 | Transparency of clinical trials | lecturer's notes on the course |
| 6 | Phases of drug clinical trials (Phase 1,2,3,4) | lecturer's notes on the course |
| 7 | Protecting Study Subjects, Insurance, Consenting to Research, and Responsibility | lecturer's notes on the course |
| 8 | Selection of subjects; research with healty volunteers, Research involving women, children, those at risk of impared desion making capacity | lecturer's notes on the course |
| 9 | Legal and ethical standarts of informed consent in research | lecturer's notes on the course |
| 10 | Privacy and confidentialy, justice in research | lecturer's notes on the course |
| 11 | Organization, duties, and operating guidelines and procedures of research ethics committees | lecturer's notes on the course |
| 12 | Composition, membership, standard operating procedures of Ethics Committees | lecturer's notes on the course |
| 13 | Case studies. | lecturer's notes on the course |
| 14 | General assessment. | lecturer's notes on the course |
| Resources |
| Power point presentations, study texts that relevant with subject. |
| Course notes, articles, books or electronic resources. |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PY1) In light of the current developments in the field of health law, develop and deepen the knowledge about the main sources, legislation and jurisprudence which related to the health law. | X | |||||
| 2 | PY2) With understanding relationships among concept, institution and method that related to disciplines of health law, come up with original solutions by using knowledge requiring proficiency on analysis, synthesis and assessment of new and complex ideas | X | |||||
| 3 | PY3) Evaluate and use new information within the health law in a systematic approach | X | |||||
| 4 | PY4) Evaluate innovative aproach an already known knowledge about health law or research and implement an original subject. | X | |||||
| 5 | PY5) Solve the problems encountered in the legal theory and practice by using research methods that specific to field of law. | X | |||||
| 6 | PY6) Evaluate innovative aproach an already known knowledge about public law or carry out an independent study which needs expertise in the field of health law and its sub-disciplines. | X | |||||
| 7 | PY7) Develop different perspectives and take responsibility to solve complex issues which require expertise and encountered in the field of health law and its sub-disciplines. | X | |||||
| 8 | PY8) Develop new ideas and methods in the field of health law by using high level mental processes such as creative and critical thinking, problem solving and decision making. | X | |||||
| 9 | PY9) Defend original views when exchanging ideas in the field of health law and itssub-disciplines with professionals and communicate effectively by showing competence in the field. | X | |||||
| 10 | PY10)Ability to communicate and discuss orally, in written and visually with peers by using a foreign language at least at a level of European Language Portfolio C1 General Level. | X | |||||
| 11 | PY11) Demonstrate functional interaction by using strategic decision making processes in solving problems encountered in the field of law. | X | |||||
| 12 | PY12) With developing understanding of honesty, justice and ethics are required to be lawyer, teach around them. | X | |||||
| 13 | PY13)Contribute to the solution finding process regarding social, scientific, cultural and ethical problems in the field of law and support the development of these values. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 50 | |
| Rate of Final Exam to Success | 50 | |
| Total | 100 | |
| ECTS / Workload Table | ||||||
| Activities | Number of | Duration(Hour) | Total Workload(Hour) | |||
| Course Hours | 14 | 3 | 42 | |||
| Guided Problem Solving | 10 | 6 | 60 | |||
| Resolution of Homework Problems and Submission as a Report | 14 | 2 | 28 | |||
| Term Project | 0 | 0 | 0 | |||
| Presentation of Project / Seminar | 0 | 0 | 0 | |||
| Quiz | 0 | 0 | 0 | |||
| Midterm Exam | 10 | 3 | 30 | |||
| General Exam | 12 | 3 | 36 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 196 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(196/30) | 7 | |||||
| ECTS of the course: 30 hours of work is counted as 1 ECTS credit. | ||||||
Detail Informations of the Course
Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| CLINICAL STUDIES and ETHICAL COMMITTEES | - | Spring Semester | 3+0 | 3 | 7 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | Third Cycle (Doctorate Degree) |
| Course Type | Elective |
| Course Coordinator | Prof.Dr. Fulya İlçin GÖNENÇ |
| Name of Lecturer(s) | Prof.Dr. Fulya İlçin GÖNENÇ |
| Assistant(s) | Res. Assist. Sinem Taştekin |
| Aim | The primary function of the course is to discuss the relationship between the law and the practise of modern developments in the latter. During the course, in the context of medical law and ethics with explaining fundamental concepts, basic issues of clinical trials and research ethics committees will be explained in accordance with current international declarations and medical ethic. |
| Course Content | This course contains; A brief history of clinical trials and medical research,Basic concepts and definitions and ethical norms,Context and purpose of clinical researches,Codes, declerations and other ethical guidance of research with humans,Transparency of clinical trials,Phases of drug clinical trials (Phase 1,2,3,4),Protecting Study Subjects, Insurance, Consenting to Research, and Responsibility,Selection of subjects; research with healty volunteers, Research involving women, children, those at risk of impared desion making capacity,Legal and ethical standarts of informed consent in research,Privacy and confidentialy, justice in research,Organization, duties, and operating guidelines and procedures of research ethics committees,Composition, membership, standard operating procedures of Ethics Committees,Case studies.,General assessment.. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| -Analyzes the basic legal and ethical conflicts which arise in the practise of clinical trials. | 10, 14, 16, 9 | A, E |
| -Understand such concepts as personhood, transparency and autonomy will be able to evaluate the importance and limitations of consent to clinical trials. | 13, 14, 9 | A, E |
| -At the end of this course students will also acquire an appreciation of what research is and of how it is regulated. | 10, 9 | A, E |
| -Have knowledge about national and international legal regulations on clinical research. | 10, 9 | A, E |
| -Have knowledge about how clinical research is conducted in an ethical framework. | 10, 9 | A, E |
| Teaching Methods: | 10: Discussion Method, 13: Case Study Method, 14: Self Study Method, 16: Question - Answer Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam, E: Homework |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | A brief history of clinical trials and medical research | lecturer's notes on the course |
| 2 | Basic concepts and definitions and ethical norms | lecturer's notes on the course |
| 3 | Context and purpose of clinical researches | lecturer's notes on the course |
| 4 | Codes, declerations and other ethical guidance of research with humans | lecturer's notes on the course |
| 5 | Transparency of clinical trials | lecturer's notes on the course |
| 6 | Phases of drug clinical trials (Phase 1,2,3,4) | lecturer's notes on the course |
| 7 | Protecting Study Subjects, Insurance, Consenting to Research, and Responsibility | lecturer's notes on the course |
| 8 | Selection of subjects; research with healty volunteers, Research involving women, children, those at risk of impared desion making capacity | lecturer's notes on the course |
| 9 | Legal and ethical standarts of informed consent in research | lecturer's notes on the course |
| 10 | Privacy and confidentialy, justice in research | lecturer's notes on the course |
| 11 | Organization, duties, and operating guidelines and procedures of research ethics committees | lecturer's notes on the course |
| 12 | Composition, membership, standard operating procedures of Ethics Committees | lecturer's notes on the course |
| 13 | Case studies. | lecturer's notes on the course |
| 14 | General assessment. | lecturer's notes on the course |
| Resources |
| Power point presentations, study texts that relevant with subject. |
| Course notes, articles, books or electronic resources. |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PY1) In light of the current developments in the field of health law, develop and deepen the knowledge about the main sources, legislation and jurisprudence which related to the health law. | X | |||||
| 2 | PY2) With understanding relationships among concept, institution and method that related to disciplines of health law, come up with original solutions by using knowledge requiring proficiency on analysis, synthesis and assessment of new and complex ideas | X | |||||
| 3 | PY3) Evaluate and use new information within the health law in a systematic approach | X | |||||
| 4 | PY4) Evaluate innovative aproach an already known knowledge about health law or research and implement an original subject. | X | |||||
| 5 | PY5) Solve the problems encountered in the legal theory and practice by using research methods that specific to field of law. | X | |||||
| 6 | PY6) Evaluate innovative aproach an already known knowledge about public law or carry out an independent study which needs expertise in the field of health law and its sub-disciplines. | X | |||||
| 7 | PY7) Develop different perspectives and take responsibility to solve complex issues which require expertise and encountered in the field of health law and its sub-disciplines. | X | |||||
| 8 | PY8) Develop new ideas and methods in the field of health law by using high level mental processes such as creative and critical thinking, problem solving and decision making. | X | |||||
| 9 | PY9) Defend original views when exchanging ideas in the field of health law and itssub-disciplines with professionals and communicate effectively by showing competence in the field. | X | |||||
| 10 | PY10)Ability to communicate and discuss orally, in written and visually with peers by using a foreign language at least at a level of European Language Portfolio C1 General Level. | X | |||||
| 11 | PY11) Demonstrate functional interaction by using strategic decision making processes in solving problems encountered in the field of law. | X | |||||
| 12 | PY12) With developing understanding of honesty, justice and ethics are required to be lawyer, teach around them. | X | |||||
| 13 | PY13)Contribute to the solution finding process regarding social, scientific, cultural and ethical problems in the field of law and support the development of these values. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 50 | |
| Rate of Final Exam to Success | 50 | |
| Total | 100 | |