1. Audit on herbal study protocols reviewed by an Ethics Review Committee of a Western Medical Institution Wanigatunge CA, Warnacula G, Prathapan S Ethics Review Committee, Faculty of Medical Sciences University of Sri Jayewardenepura, Sri Lanka

2. Introduction Sri Lanka’s health system consists of Western and complementary and alternative medical (CAM) care systems 24/11/201515th FERCAP Annual Conference2

3. 24/11/201515th FERCAP Annual Conference3 Veda Sala – Ancient Hospital Complex, Mihintale 9 th century AD

4. 24/11/201515th FERCAP Annual Conference4 Medicinal trough Mortars and pestles

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6. Introduction Exist side-by-side Good acceptance of both by the people CAM system is not evidence based in most instances 24/11/201515th FERCAP Annual Conference6

7. Introduction Increase in research based on CAM products in recent past Most of these protocols submitted to ERCs of medical schools of the Western medical system 24/11/201515th FERCAP Annual Conference7

8. Introduction Reviewing such protocols which are planned based on a different health care system is challenging Two systems have different philosophies and practices CAM therapies are often not about single drugs, herbs or limited combinations alone are based on a package of treatment - massage, diet, plus some herbs 24/11/201515th FERCAP Annual Conference8

9. Introduction Western system is not well designed to handle a multiplicity of interventions Members of ERCs are mostly with a western medical training This leads to the problems when evaluating protocols involving CAM procedures 24/11/201515th FERCAP Annual Conference9

10. Introduction ERC FMS USJ is 1/4 ERCs in Sri Lanka that has SIDECR recognition 1/8 ERCs that can approve phase 2/3 clinical trials in Sri Lanka One of the very few ERCs that review protocols pertaining to CAM and herbal studies 24/11/201515th FERCAP Annual Conference10

11. Objectives Audit the CAM protocols reviewed by ERC, Faculty of Medical Sciences, University of Sri Jayewardenepura (FMS, USJ) To determine the time taken from time of submission to final decision To determine the causes for delays in approval 24/11/201515th FERCAP Annual Conference11

12. Method CAM protocols were identified from the data base for the period of 3 years - 2012 - 2014 Data extraction form used to extract data Data analysed to find reasons for delays in ERC approval 24/11/201515th FERCAP Annual Conference12

13. Results Total of 11 protocols from 2012 - 2014 24/11/201515th FERCAP Annual Conference13

14. Results PI profile 7 – non medical basic degree 4 – medical degree – traditional system Types of studies 5 human – clinical trials 6 animal Average time for approval from the time of submission – 93.8 days (77.5 – 117.3 days) Stop clock delay – 42.1 days (22.5 – 73 days) 24/11/201515th FERCAP Annual Conference14

15. Results Reasons for returning protocol to PI Issues in methodology - 9 (81.8%) Inadequate literature review -7 (63.6%) Inadequate information sheets and consent forms -6 (54.5%) Issues pertaining to fair subject selection – 4 (36.4%) 24/11/201515th FERCAP Annual Conference15

16. Results Reasons for returning protocol to PI Issues with study title - 2/11 (18.1%) Specific/General objectives not clearly stated -3/11 (27.3%) Issues with inclusion/ exclusion criteria - 2/11 (18.1%) Administrative issues - 6 (54.5%) 24/11/201515th FERCAP Annual Conference16

17. Analysis of protocols by the year 24/11/201515th FERCAP Annual Conference17

18. Conclusions There are deficiencies in the knowledge of PIs on How to write a proper protocol – literature review, methodology Ethical aspects of research and how to address these How to write an informed consent form properly Most problems are in methodology and risk benefit assessment ICFs and fair subject selection had improved over time 24/11/201515th FERCAP Annual Conference18

19. Recommendations Education of investigators on how protocols should be written properly how to identify ethical issues and what should be done to address them how to do a proper risk benefit assessment 24/11/201515th FERCAP Annual Conference19

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