3. INTERNATIONAL PATIENTS RIGHTS CONGRESS Antalya, 7-10.12.2011.

1. 3. INTERNATIONAL PATIENT'S RIGHTS CONGRESSAntalya, 7-10.12.2011. Patient's right in medical researches� in� Federation of� Bosnia� and� Herzegovina Zarema Obradovic1, Amina Obradovic2 1 Public Health Institute of Canton Sarajevo, Faculty� for� Health Studies, University� of� Sarajevo Bosnia� and� Herzegovina 2 Association of Citizens of Mostar 1

2. More and more drugs are used More medical procedures More devices in health institutions 2

3. All have to be tested / more and more demands for different kind of medical researches 3

4. Medical researches are the basis for improvement of health sector (for improvemnet of health ) 4

5. We, in Bosnia and Herzegovina, are a part of the World, and we are included in many different medical researches Some researches are a part of the some international researches, and some are local based 5

6. We have own Factory of drugs, we need researches for the new drugs before it will be introduce in practice ( before it will be at the market) 6

7. IT MEANS: WE HAVE TO DO MEDICAL RESEARCHES but at the same time to respect human rights 7

8. The Law of Patient�s Rights� in Federation of� Bosnia� and� Herzegovina came� into� force ����July 8, 2010 Some articles are about medical and� scientific researches on patients� and their rights 8

9.  Informed consent It could be given by patients 18 and older Explicit informed consent of the patient is needed for: 1. medical and scientific research on patients 2. clinical trials of drugs and medical devices on patients 3. involment in medical education 9

10. Consent shall be: given in written form (problem with illeterete people) the script understandable for patient 10

11. It will be written after the patient agrees to be sufficiently, comprehensive, accurate and timely informed about: purpose objective procedures expected outcomes potential risks unexpected consequences 11

12. Giving of informations - this is sometimes very difficult process Some people are not able to understand medical professionals Some people think -they know enough, they don�t need any other informations For each person we need personal assessment, ther is not any universal model for sharing informations 12

13. For young patients, or patients with disability, the consent will be given by parents, tutor or legal representative The names of legal representative and tutor have to be in writen form 13

14. The opinion of this patient must be considered ! 14

15. Other rights Patient, or legal representative have to be warned that they are free to refuse or to revoke at any time ( not good for the research, but have to be accepted) 15

16. For the patients with mental disorder which are included in some researches, the existing regulation on protection of this persons has to be applied 16

17. For the patients which are participating in clinical trials, regulation on drugs and medical devices has to be applied 17

18. For the participation in surveys on behavioral risks (followed by small medical interventions, such as taking of a small quantity of blood for sampling) persons that are 15 and older can give consent by themselves 18

19. Compensation A patient who suffered damage to his body or health because of: medical and scientific research clinical trials of drugs and medical devices or participating in medical education has the right on compensation from the health institution or purchaser of this research, if the damages are a result of research and testing, as well as participation in education. 19

20. In case of death of a patient patient's family members or relatives have a right on compensation of damage 20

21. The patient has the right on compensation as a voluntary participant in research and teaching ( something new) 21

22. In the previous period � Ethics Committees were established Committees checked all demands for medical researches before they starting realisation 22

23. Each Medical Faculty, Dentist Faculty, Faculty for Pharmacy and Faculty for Health Studies, as well as each Clinical Center has one Ethics Committee Members are professors and specialist from different area Ethics proffessionals 23

24. All candidates for master or PHD thesis connected with human health have an obligation to ask Ethics Committee for permission for the work 24

25. All students connected with human health (doctors, dentist, pharmacyst, nurses, sanitary engineurs, engineurs of radiology, of laboratory) have a subject: Medical ethics Everyone pass this exam and lern about ethics in health and health institutions 25

26. Many NGOs are wery well involved in this topic They want to protect people Sometimes they don�t have enough informations about researche and they do wrong things 26

27. This Law cover all aspect of patients right in medical research, we hope it will be fully implemented in Federation of Bosnia and Herzegovina very soon 27

28. We expect better treatment of our patients, according to ethics regulations and principles. 28

29. THANK YOU ! 29