Research and Ethics Committee
The Research and Ethics Committee is established by the Board of Management (BOM) of Pantai Hospital Kuala Lumpur (PHKL) based on the ethical guidelines stated in the Declaration of Helsinki (2013). The operation of the REC is guided by the ethical principles outlined in World Health Organisation (WHO) Operation Guidelines for Ethics Committee that Review Biomedical Research, International Council for Harmonisation (ICH) and Malaysian Guideline for Good Clinical Practice, National and International Ethics Guidelines for Biomedical Research Involving Human Subjects (CIOMS).
At the PHKL Clinical Research Centre (CRC), patient safety is our top priority. Our Research Ethics Committee is formally recognized and registered under the National Pharmaceutical Regulatory Agency (NPRA), ensuring that every study adheres to stringent ethical standards and regulatory frameworks. This strong commitment empowers us to confidently pursue groundbreaking research while consistently ensuring the highest standard of care for our patients, while maintaining the highest standard of care.
Roles and Responsibilities
The responsibilities of Pantai Hospital Kuala Lumpur Research and Ethics Committee include:
- Safeguard the rights, safety and wellbeing of all research subjects in accordance with the local and international guidelines.
- Review applications for ethics approval for research involving human participants undertaken in the hospital and make decision whether to approve, modify or disapprove the applications based upon consideration of human subject protection.
- Oversee all the research being conducted in the hospital. Request progress reports from the investigator and make decision whether the studies could be continued, suspended or terminated if there is any ethical concern.
- Suspend or revoke ethics approval of the proposed research, if necessary.
- Impose restrictions and conditions on the proposed research, if necessary.
- Participate in continuing education activities in biomedical ethics and biomedical research.
- Develop, implement, monitor and review policies and guidelines related to ethical procedures
Composition of Pantai Hospital Kuala Lumpur Research and Ethics Committee
The Research and Ethics Committee comprises of both genders and a mix of scientific/ medical members, a legal representative and at least one (1) lay member.
To oversee the various specialties of research undertaken at the hospital, the Research and Ethics Committee should consist of a minimum of 7 and maximum of 20 members who collectively have the qualifications and experience to review and evaluate the science, medical and ethical aspects of the proposed research.
The Research and Ethics Committee Chairman, Deputy Chairman and Members will be appointed by hospital Person in Charge (PIC) upon the advice of the Medical and Dental Advisory Committee (MDAC).
The duration of membership will be two (2) years.
Clinical Research Centre Manager
PHKL Research and Ethics Committee
Email: [email protected]
Phone: +603-2280 1320/ 1321
Committee Members
Dato’ Dr Mahendra Raj
Chairman
Consultant Gastroenterologist
Medical Member
MBChB (Glasgow), MD (Glasgow), MRCP (UK), FRCP (Glasgow), FAMM
Dr Sharifah Roohi
Deputy Chairman
Consultant Orthopaedics
Medical Member
FRCS (Edin), MS Orth (UKM), European Diploma in Hand Surgery, Fellowship in Hand & Reconstructive Microsurgery (NUH, S‘pore), Fellowship in Hand & Microsurgery (CMKI, USA)
Dato’ Dr Balwant Singh Gendeh
Member
Consultant ENT Surgeon
Medical Member
MBBS, MS(ORL-HNS) UKM, FAMM (Rhinology-Allergy, Endoscopic Nasal and Sinus Surgery),FMSA,FASC,DPTJ,DSAP
Dr Harwant Singh
Member
Consultant Orthopaedics
Medical Member
MCh Orth (Liverpool), FRCS (Edin)
Dr Josephine Rosalind Subramaniam
Member
Consultant Radiology
Medical Member
MBBS (Ind) , FRCR (UK), Master Neurovascular Diseases (France)
Datuk Dr Lam Kai Seng
Member
Consultant Oncology
Medical Member
MBBS, DMRT (Lon), AM (Mal)
Dr Mastura Md Yusof
Member
Consultant Oncology
Medical Member
MBBS, MCO (UM)
Dr Mohammed Ridzuan Abdul Razak
Member
Emergency Medicine
Medical Member.
Dr. Ridzuan Razak is the Head of Accident and Emergency Department in Pantai Hospital Kuala Lumpur
Dr Patricia Alison Gomez
Member
Consultant Breast Surgery
Medical Member
MBBS (Ind), FAMM, Clin. Fellowship B&E Imperial College (UK), M.Med. General Surgery (Mal)
Dr Sarala Ravindran
Member
Consultant Pathology
Scientific Member
M.B.B.S, Master of Pathology, FRCPath
Dr Vijay Ananda Paramaswaran
Member
Consultant Endocrinology
Medical Member
MB BCh, BAO (QUB), MRCP (UK), MRCPI, FRCP (Edin)
Dr Yong Sin Chuen
Member
Consultant Paediatrics
Medical Member
MRCP(UK), FAMM, CCST(UK), FRCPCH (UK)
Ms Ammira Marlini Abu Samah
Member
Consultant Law and Ethics
Non-Medical Non-Scientific Member
Ms Ammira Marlini is currently a senior executive in Pantai Hospital’s human resource. She is an Advocate and Solicitor of High Court of Malaya (Admitted to the Bar in Oct 2015) and a Registered Trademark Agent (2018 and 2019)
Mr. Yip Cha Ming
Member
Pharmacy
Scientific Member
Bachelor of Pharmacy (HONS)
Datuk Mumtaz Ali
Member
Consultant Layperson
Non-Medical Non-Scientific Member
Dato Mumtaz Ali acts as the public representative in the ethics committee of Pantai Hospital Kuala Lumpur. He has been on the Board of Visitors (BOV) of Pantai Hospital Kuala Lumpur from 2011 to 2014.
Dr Wong Shin Yee
Secretariat
Chief Research Scientist /
Clinical Research Centre Manager
Scientific Member (Non-Voting)
Dr. Wong Shin Yee is the senior research scientist in the clinical research centre of Pantai Hospital Kuala Lumpur.