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
PrequisitesNone
Course languageTurkish
Course typeMust 
Mode of DeliveryFace-to-Face 
Learning and teaching strategiesLecture
Discussion
Question and Answer
Problem Solving
 
Instructor (s) PHDPROF. NUKET ORNEK BUKEN, MD, PHDPROF. ERDEM KARABULUT, PHD PROF. PINAR ÖZDEMÄ°R, PHDASSISTANT. PROF. MUGE DEMIR, PHD 
Course objectiveTo 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
  1. Students; 1. Know the concept and stages of a research, 2. Determine the type of a research regarding purpose of it,
  2. 3. Know how to determine the sampling methods and appropriate sample size, 4. Know error sources and prevention methods in a research
  3. 5. Plan and report a scientific research. 6. Describe concepts related to research and publication ethics and responsibilities of researcher for ethically appropriate researches and publications
  4. 7. Describe ethics requirements for research subject (human and animal) in clinical researches, non-interventional clinical researches, and animal researches 8. Know ethical requirements in researches according to the kind of research ethics committees and apply them in reviewing projects for ethics committee approval (the topic of informed consent, in particular)
  5. 9. Know ethical and legal national and international regulations about ethics in research and publication 10. Fulfil ethics requirements in publication process
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. 
References1. 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

WeeksTopics
Week 1Introduction to health research and basic concepts, Population, sample, dependent and independent variables, etc. Variable types, Data collection methods
Week 2Research 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 3Research 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 4Determination of sampling methods and appropriate sample size
Week 5Sources 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 6Scientific research plan/proposal preparation Reporting of scientific studies and commonly used control lists (CONSORT, PRISMA, etc.)
Week 7Points to be considered in writing and examining a scientific article and 1st Midterm Examination
Week 8Research 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 9Ethical issues in research; Laboratory research, animal research, surveys, epidemiological studies, clinical research, non-interventional clinical researches
Week 10Informed consent in researches, research subjects, researcher-subject relationship, selection of research subjects, rights of research subjects, incompetent research subjects
Week 11The use of human biological materials for research purposes, research Biobanking and ethics Protection of personal data, confidentiality and privacy
Week 12Rights 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 13Scientific misconduct, violation of publishing ethics, authorship issues Publication bias, conflict of interest, ethics and editorship
Week 14Assessment and discussion of legal regulation on research and publication ethics in Turkey
Week 15exam preparation
Week 16Final exam

Assesment methods

Course activitiesNumberPercentage
Attendance00
Laboratory00
Application00
Field activities00
Specific practical training00
Assignments00
Presentation00
Project00
Seminar00
Midterms240
Final exam160
Total100
Percentage of semester activities contributing grade succes040
Percentage of final exam contributing grade succes060
Total100

WORKLOAD AND ECTS CALCULATION

Activities Number Duration (hour) Total Work Load
Course Duration (x14) 14 3 42
Laboratory 0 0 0
Application000
Specific practical training000
Field activities000
Study Hours Out of Class (Preliminary work, reinforcement, ect)14798
Presentation / Seminar Preparation000
Project000
Homework assignment000
Midterms (Study duration)13030
Final Exam (Study duration) 14040
Total Workload3080210

Matrix Of The Course Learning Outcomes Versus Program Outcomes

D.9. Key Learning OutcomesContrubition level*
12345
1. Has knowledge of research methods and statistical methods used in the vaccinology and has knowledge about comparing existing studies and evaluating their limitations, accuracy, validity and reliability  X  
2. Has knowledge on ethical principles with respect to all kinds of scientific and professional work in the area of vaccinology, and acts accordingly.   X 
3. Using the knowledge and the skills he/she gained, detects existing vaccination problems in communities, produces recommendations by developing policies and strategies, and shares the information, takes part in a team work   X  
4. Can gather information about the safety of vaccine, X   
5. Comprehends, assesses, and interprets interdisciplinary interaction in vaccinology. X   
6. Can design and apply an experimental setup in a laboratory environment and can analyze the obtained data.    X
7. Know the principles of good laboratory practice and good clinical practice.    X
8. Knows which type of study to conduct in acute conditions, providing required evidence for appropriate interventions and takes part in the process for effective and quick solutions X   
9. Evaluates the international developments in the vaccinology independently regarding conditions, X   
10. Contributes to health policy studiesX    
11. Conducts scientific research, writes and presents scientific papers on vaccinology.    X
12. Evaluate quantitative and qualitative techniques in health economics and pharmacoeconomicsX    

*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest