1. Informed Consent Issues in Research in Clinical Trial Unit, Universiti Sains Malaysia (USM), Malaysia Shaiful Bahari Ismail, Nik Hazlina Nik Hussain, Wan Mohd Wan Bebakar, Hans Rostenberghe School of Medical Sciences

2. CLINICAL TRIAL UNIT SCHOOL OF MEDICAL SCIENCES UNIVERSITI SAINS MALAYSIA Background 1980’Clinical trial by Medical Lecturers in School of Medical Sciences Personnel approach by pharmaceutical company 1998Clinical research was given priority by Malaysia government Clinical Research Centre established in HKL 1999Malaysian version of GCP Clinical Trial Unit at School of Medical Sciences

3. OBJECTIVES To provide state of the art infrastructure which will allow the conduct of trials according the international Conference on Harmonization Good Clinical Practice (ICH-GCP) guideline To provide training for future clinical investigator on Good Clinical Practice for the conduct of clinical trial To provide consultancy services on the conduct of clinical trials from protocol development, conduct of the trial, statistical analysis and report writing. Each activity is guided by a Standard Operating Procedure (SOP)

5. Number of Clinical Trial Research in CTU (2012-2015) YearsNumber of clinical trial Research 20128 20137 201411 201510

6. ICH Definition of Informed Consent Process by which a subject voluntarily confirms his/her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to a subject’s decision to participate. –Informed Consent is documented by means of a written signed & dated informed consent form (Verbal one is not acceptable)

7. Informed Consent of Trial Subjects Examples of audit finding in IC –inv. & subject’s signature and dates were missing –dated by site personnel on behalf of subject –dates overwritten with no explanation –use of white-outs –use of different pens by one person –Signature using language different from the IC

8. Informed Consent Form (1)

9. Informed Consent Form (2)

10. Informed Consent Form (3)

11. Informed Consent Form (4)

12. Informed Consent Form (5)

13. How do we (USM) strengthen the procedures GCP Training Mandatory 3-days GCP workshop for investigators, coordinators and whoever plan to get involved in clinical trials Must pass assessment (questions from DCA, MOH) with 80% passing marks

15. More stringent monitoring from the Human Research and Ethics Committee, USM The HREC has improved its process of review and follows international standards (FERCAP) and guidelines. Better scrutiny by the reviewers of the the informed consent and patient information forms, the practice of site visits by the HREC How do we (USM) strengthen the procedures (continue)

16. JEPeM members Chairman & Co-chairman - Professors Members – ◦Clinicians ◦bio-statistician, ◦social scientists ◦Director of Hospital USM [HUSM] or representative ◦Director of Hospital Kota Bharu or representative ◦Lay persons [ex public servants, non science based; lawyer, ustaz] ◦Lady members ◦secretary [Research officer]

17. Future Plan Forum for the public to discuss about the clinical trials and the process of IC Further audit to ensure effectiveness of the measures taken so far

18. Take Home Message ICF is the most important document in any clinical trial Early audit findings wrt ICF from patients have noted important ‘errors’ that can lead to detrimental effect to subjects Measures including mandatory GCP certifications and more vigilant assessment/monitoring by HREC have been very successful in producing error-free ICF future forums with the public are expected to further improve the informed consent process in the CTU