SBE601 - RESEARCH METHODS, RESEARCH and PUBLICATION ETHICS
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| RESEARCH METHODS, RESEARCH and PUBLICATION ETHICS | SBE601 | 1st Semester | 3 | 0 | 3 | 7 |
| Prequisites | None | |||||
| Course language | Turkish | |||||
| Course type | Must | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion Question and Answer Problem Solving | |||||
| Instructor (s) | PHDPROF. NUKET ORNEK BUKEN, MD, PHDPROF. ERDEM KARABULUT, PHD PROF. PINAR ÖZDEMİR, PHDASSISTANT. PROF. MUGE DEMIR, PHD | |||||
| Course objective | To provide general information about research stages and research ethics to graduate students and to prepare them to do research. To ensure that students gain knowledge, awareness and sensitivity for ethics in research and publication and accordingly conduct researches and publish them | |||||
| Learning outcomes |
| |||||
| Course Content | - Research planning, - Sources of error in a research, - Sampling methods, determination of the appropriate sample size - Research types - Report writing. - Concept of research ethics, related concepts, - Controversial research ethics topics, - Clinical researches, non-interventional clinical researches, - Animal researches, - Frequently encountered research ethics problems and prevention methods, - Recognition of violation of ethics, what should be done. | |||||
| References | 1. Health Research Methodology, A Guide for Training in Research Methods, World Health Organization, 2001 2. Altman Douglas, Practical Statistics for Medical Research, 1992. 3. Sümbüloğlu Vildan, Sümbüloğlu Kadir. Sağlık Bilimlerinde Araştırma Yöntemleri Ankara 2013 4. Sümbüloğlu Vildan, Sümbüloğlu Kadir. Klinik ve Saha Araştırmalarında Örnekleme Yöntemleri ve Örneklem Büyüklüğü, Ankara 2005 5. Özdamar Kazım. Modern Bilimsel Araştırma Yöntemleri, Ankara 2013 6. The Ethics of Research Involving Human Subjects, Editor: Vanderpool HY, 1996, University publishing Group, Inc. USA. 7. Büken NÖ, Yegenoglu S., ?Physician-Industry Relationships and Promotion Ethics in Turkey.? Clinical Research and Regulatory Affairs, Volume 20, Issue 4, pages: 379-389 (2003). 8. Büken NÖ. ?Klinik Araştırma Etik Kurulları?(Clinical Research Ethics Committees), Sendrom, 20 (3?4): 61?70, Mart-Nisan 2008. 9. Büken NÖ. Büken E. ?Plasebo ve Plasebo Etkisi?, Sendrom, 16(3): 98-103 (2004). | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Introduction to health research and basic concepts, Population, sample, dependent and independent variables, etc. Variable types, Data collection methods |
| Week 2 | Research types in the field of health - Observational and experimental studies (clinical trials) - Experimental design (parallel, cross-over, factorial designs) - Systematic reviews and meta-analysis |
| Week 3 | Research planning and stages Determination of a research topic, determination of the hypothesis, literature review Determining the appropriate statistical methods, interpretation of results and reporting |
| Week 4 | Determination of sampling methods and appropriate sample size |
| Week 5 | Sources of error in research and prevention methods - Bias and sources of bias, prevention of bias (randomization, blinding, use of the control group, etc.) - Measurement errors (random, systematic and proportional error) |
| Week 6 | Scientific research plan/proposal preparation Reporting of scientific studies and commonly used control lists (CONSORT, PRISMA, etc.) |
| Week 7 | Points to be considered in writing and examining a scientific article and 1st Midterm Examination |
| Week 8 | Research and biomedical research , Research according to objectives and methods Historical and ethical milestones of research ethics Concept of research ethics, scientific and ethical methods in research, fundamental principles of research ethics |
| Week 9 | Ethical issues in research; Laboratory research, animal research, surveys, epidemiological studies, clinical research, non-interventional clinical researches |
| Week 10 | Informed consent in researches, research subjects, researcher-subject relationship, selection of research subjects, rights of research subjects, incompetent research subjects |
| Week 11 | The use of human biological materials for research purposes, research Biobanking and ethics Protection of personal data, confidentiality and privacy |
| Week 12 | Rights and responsibilities of concerning parties (researcher, research subject, sponsor, contract research organizations?) Ethical problems arising from research(er)/ industry relations Responsibilities and duties of research ethics committees |
| Week 13 | Scientific misconduct, violation of publishing ethics, authorship issues Publication bias, conflict of interest, ethics and editorship |
| Week 14 | Assessment and discussion of legal regulation on research and publication ethics in Turkey |
| Week 15 | exam preparation |
| Week 16 | Final exam |
Assesment methods
| Course activities | Number | Percentage |
|---|---|---|
| Attendance | 0 | 0 |
| Laboratory | 0 | 0 |
| Application | 0 | 0 |
| Field activities | 0 | 0 |
| Specific practical training | 0 | 0 |
| Assignments | 0 | 0 |
| Presentation | 0 | 0 |
| Project | 0 | 0 |
| Seminar | 0 | 0 |
| Midterms | 2 | 40 |
| Final exam | 1 | 60 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 0 | 40 |
| Percentage of final exam contributing grade succes | 0 | 60 |
| Total | 100 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 14 | 3 | 42 |
| Laboratory | 0 | 0 | 0 |
| Application | 0 | 0 | 0 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 14 | 7 | 98 |
| Presentation / Seminar Preparation | 0 | 0 | 0 |
| Project | 0 | 0 | 0 |
| Homework assignment | 0 | 0 | 0 |
| Midterms (Study duration) | 1 | 30 | 30 |
| Final Exam (Study duration) | 1 | 40 | 40 |
| Total Workload | 30 | 80 | 210 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| 1. Gaining up-to-date knowledge and experience regarding fetal and neonatal effects of high-risk pregnancies (maternal auto-immune, iso-immune and hypertensive diseases; teratogenic substance-drug or substance-alcohol use, non-immune hydrops fetalis, intrauterine-perinatal infections); problems about traumatic delivery and also diagnosis, treatment and management of these babies before, during and after delivery. | X | ||||
| 2. Gaining up-to-date knowledge and experience regarding development, maturation, surfactant metabolism of lungs, respiratory physiology in newborns, respiratory evaluation - follow-up, diagnostic approach to respiratory distress, ethiopathogenesis and advanced treatments of severe respiratory diseases of the newborn (respiratory distress syndrome, bronchopulmonary dysplasia, important congenital anomalies of the respiratory system), mechanical ventilation support in newborns | X | ||||
| 3. Gaining up-to-date knowledge and experience regarding hemodynamic evaluation and follow-up of newborns, cardiotonic drugs, diagnosis, ethiopathogenesis, management and advanced treatments of severe circulatory system diseases (congenital heart diseases, patent ductus arteriosus, arrhythmias, pulmonary hypertension), preoperative and postoperative care in congenital cardiac disaeses, ECMO treatment. | X | ||||
| 4. Gaining up-to-date knowledge and experience regarding prevention of central nervous system damage in newborns, central nervous system monitoring, ethiopathogenesis and advanced treatments of severe diseases of the central nervous system (perinatal hypoxic ischemic injury, hypoxic ischemic encephalopathy, bilirubin encephalopathy, kern icterus, intraventricular-intracranial hemorrhage, white matter injury, periventricular leukomalacia, congenital malformations of the central nervous system, neonatal convulsions, apnea), hypotonia, neuromuscular diseases, retinopathy of prematurity, diagnosis, treatment and management of pain in newborns, identification of newborns with neurological-developmental high-risk and their follow-up. | X | ||||
| 5. Gaining up-to-date knowledge and experience regarding development of immune system in newborns, immunization of premature newborns, neonatal infections, sepsis, necrotizing enterocolitis, probiotic use in newborns. | X | ||||
| 6. Gaining up-to-date knowledge and experience regarding fluid, electrolyte, acid-base balance disorders in newborns, acute kidney injury, disorders of coagulation system (bleeding and thrombosis), hypoglycemia, hereditary metabolic diseases, disorders of calcium-phosphorus metabolism, diagnosis, treatment and management of osteopenia of prematurity | X | ||||
| 7. Gaining up-to-date knowledge and experience regarding current, new and candidate treatment methods in neonatal diseases (mesenchymal stem cell, cellular-regenerative treatment methods), acute and enzyme / new drug treatments given to rare hereditary diseases (genetic, neurologic, metabolic etc) in neonatal period, renal replacement therapies, ECMO therapy, preoperative end postoperative care in newborn?s surgical diseases. Gains up-to-date knowledge and experience regarding medical and technical equipment used in the field of neonatology and uses computer and information technologies effectively. | X | ||||
| 8. Learning ethical principles and problems related to perinatal-neonatal period and clinical research, ethics of scientific publications, legislation and legal regulations related to clinical research, their importance for the individual and society and to give genetic advice, obeys ethical principles. As an individual, behaves appropriately to laws, regulations and legislation regarding duty rights and responsibilities and also to professional code of ethics. | X | ||||
| 9. Acquires theoretical and practical knowledge required by the field of neonatology, offers short- and long-term solutions to problems, obtains up-to-date and evidence-based scientific knowledge, follows current international literature, produces research hypothesis by combining it with scientific curiosity. Learns clinical and experimental scientific research planning; project writing, execution, finalization; scientific presentation methods; article writing methods; scientific article evaluation and basic concepts and skills related to research and publication statistics. Analyzes the results of the research with statistical methods, documents the evidence-based reports and presents them in national / international scientific fields. | X | ||||
| 10. Presentations, discussions and questions the themes related to neonatal diseases, and also his / her theoretical knowledge and opinions about applications independently or as a team manner in national and international scientific environments, defends the results within the framework of scientific evidence and ethical principles. Is sensitive and responsible for the problems related to health care and health policies concerning baby-child-mother-family and community health within the scope of Neonatology. Produces short- and long-term solutions to problems in individual and social context. Knows the importance of team work in the field of neonatology, works as a leader and / or team member, conducts research. | X | ||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest