1. CLINICAL STUDIES AND ETHICS OF SCIENCE Assist.Prof.Dr. Mehmet KARATAS Dept. of History of Medicine & Ethics

2. Clinical Studies Research is valuable for physicians but should be aware of issues that should be avoided

3. Physician/Patient and Researcher/Participant Relationship The primary responsibility of the physician is to seek the patient’s health, whereas the researcher’s primary responsibility is to gain knowledge to help the patient. The role of medical doctor should be superior to the role of researcher

4. Legal Basis International Documents Turkish Penal Code Medical Ethics Charter Good Clinical Practice Guidelines Patients’ Rights Directive Regulation of Clinical Trials

5. International Documents In 1947, Nuremberg Rules In 1964 Helsinki Declaration International Ethical Guidelines for Biomedical Research Involving Human Subjects, which was published in 1993 by the Council for International Organizations of Medical Sciences

6. Nuremberg Rules Informing the research participant about the research and making sure that s/he understood that. Voluntery consent should be taken from the participant of the research.

7. Helsinki Declaration Before applying any kind of medical research on humans, proposal should be evaluated and approved by an independent ethics committee

8. Ethics Committee Approval Requirements The aim and method of the project Identifying the participants in the study Having participants’ consents Preserving patients’ privacy Having sponsors to carry out the research

9. Phase 1 Research Few healthy volunteered people participate in research. Participants often get paid. They determine; -in what dosages should the patient take in order to have a response from the body, -how the body processes the drug -and whether the drug has negative effects

10. Phase 2 Research It is carried out on a group of patients. They examine whether the drug has a negative or positive effect on the patient.

11. Phase 3 Research Large number of participants use the drug. They compare the drug with another drug and examine the placebo effect.

12. Phase 4 Research It is carried out after receiving the drug approval and launched Drug is monitored for side effects that haven’t seen in early phases. Drug companies are usually interested in how satisfied the physicians and patients are.

13. Ethics of Science Scientific data should be obtained from experiments and observations Datas should be evaluated scientifically Conclusions should not be distorted Non-achieved results should not be placed on research results Resources should be clearly stated Datas not belonging to the research should not be shown as research’ data.

14. Ethics of Science It is required to inform the participants about possible risks and have their consent It is important that the research doesn’t harm the environment, human health, participants and experimenters Giving unnecessary harm and suffering to animal participants should be avoided Researchers should not participate in researches that have applications they don’t approve

15. Ethics of Science Scientist should inform the community about results of the research and warn them about the possible threats Not crediting anyone who hadn’t contributed on preparing, planning and designing of the research In jury awards and academic progress, behaving within the requirements of scientific merit

16. Turkish Penal Code It is necessary to have taken the necessary authorization from competent authorities about research It is important to having done the experiment first in non-human experiment environments or testing on sufficient numbers of animals Scientific data, or the results of the experiment on non-human beings or on animals should require this experiment, in terms of achieving the desired goal, to be done on humans

17. Turkish Penal Code The experiment should not leave a lasting harmful impact on human beings. During the experiment, painful methods that are incompatible with human dignity can not be used. The consent that explains in detail about the aim and possible results of the experiment, should be in written form and has no provision of benefits.

18. Turkish Penal Code Failure to follow the rules of consensual scientific experiment on human beings end up in a penalty of imprisonment up to three years.

19. References F. Başak ÇAKMAK/Bilal GÜNENÇ, İnönü Üniversitesi Tıp Fakültesi, translation Tolga GÜVEN, Marmara Üniversitesi Tıp Tarihi ve Etik AD ders notları Gürkan SERT, Hasta Hakları Robert M VEATCH, Medical Ethics Emine ATABEK, Mebrure DEĞER, Tıbbi Deontoloji Konuları Hasta Hakları Yönetmeliği, 1998 Klinik Araştırmalar Hakkında Yönetmelik, 2011 Çağlar Boyu Tıp, Roche Yayınları http://en.wikipedia.org/wiki/Main_Page