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. To gain knowledge about general features, development and pathogenesis of allergic diseases.      
2. To conceive the interaction between innate and adaptive immunities in allergic inflammation and to evaluate their contribution to disease pathogenesis.     
3. To learn cell types and their characteristics and roles in allergic diseases.      
4. To have information concerning genetic basis of allergic diseases and gen-enviroment interactions.      
5. To obtain knowledge on the legal regulations and ethical approaches directed towards clinical studies, and to comply with these ethical principles, being aware of their importance at an individual level and for society    X
6. To follow new developments and Technologies in the field of allergic inflammation, to know the equipment and material used in this field and to be able to use basic molecular and cell biology techniques.      
7. To be able to use information technology effectively in life for professional use.   X 
8. To discuss at a national and international level, topics related to allergic diseases, to possess the knowledge and the capability to solve problems and to master a foreign language, in such a way that this knowledge will serve as principles of life long learning.      
9. To present individually or as a team opinions in a scientific environment on theoretical and practical topics, to discuss systematically with specialists, to defend and question norms, to assess the results in the framework of quality processing.  X  
10. To analyse research data obtained in allergic diseases using statistic methods, to report according to evidence or present in a national/international scientific field.   X 
11. To know the working standards of an allergic research laboratory, to implement the rules of data acquisition and scientific reporting, ethics and biosafety.   X 

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