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6. ETHICS AND REGULATORY CONSIDERATIONS

6.1 Independent Ethics Committee This was an observational research and its conduct was unlikely to impact on the safety and well being of human subjects involved. However the protocol was still subjected to review and approval by the Medical Research Ethics Committee MREC of the Ministry of Health MOH. 6.2 Patient Information and Consent We did not request a written informed consent from the study subjects because it was not possible to do so even from the next of kin due to logistic difficulties. Our justifications were as follows: 1. This was an observational research and involved no risk to the late subjects. 2. This did not adversely affect the rights and welfare of the late subjects or the subjects’ next of kin. No identifiable personal information on individuals would be captured and for publication purposes only aggregate results would be reported. 6.3 Patient Data Protection Deceased’s anonymity was maintained at all times as no identifiable personal information on individuals was captured. This was to respect the privacy and confidentiality rules in accordance with applicable regulatory requirements. All electronic data processed at the Clinical Research Centre of Hospital Kuala Lumpur CRC HKL were identified by patient number only, thereby ensuring that patient’s identity remained unknown to the CRC staff. 20

7. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE

Principal Investigators Dr Hussain Imam Muhammad Ismail Dr Wong Swee Lan Head, Department of Paediatrics Paediatric Institute, Hospital Kuala Lumpur. Senior Consultant Paediatrician Hospital Tuanku Jaafar, Seremban. Co- investigators Dr Hung Liang Choo Senior Consultant Paediatrician Paediatric Institute, Hospital Kuala Lumpur. Dr Nur Rashidah Mohd Zaini Paediatrician Hospital Ampang, Selangor. Dr Noor Khatijah Nurani Head, Department of Paediatrics Hospital Sultanah Aminah, Johor Bahru. Dr Norsiah Ali Family Medicine Consultant Tampin Health District, Negeri Sembilan. Dr Hasri Hafidz Head, Department of Paediatrics Hospital Tuanku Ampuan Najihah Negeri Sembilan. Dato Dr Jimmy Lee Kok Foo Head, Department of Paediatrics Hospital Sultanah Nur Zahirah Kuala Terengganu. Dr Kuan Geok Lan Head, Department of Paediatrics Hospital Melaka. Dr HSS Amar Singh Head, Department of Paediatrics Hospital Ipoh, Perak. Dr Rohana Ismail Senior Principal Assistant Director Family Health Development Division Ministry of Health. Dr Jafanita Jamaludin Assistant Director Medical Development Division Ministry of Health. Project Manager Dr Jamaiyah Haniff Head, Clinical Epidemiology Unit Clinical Research Centre Hospital Kuala Lumpur. Statistician Lena Yeap Lay Ling Clinical Research Centre Hospital Pulau Pinang. Data Manager Ms Lim Jie Ying Clinical Research Centre Hospital Kuala Lumpur.