Research & Biotechnology

We are St. Luke’s.  We are R&B.

Sitting quietly inside the sprawling complex of St. Luke’s Medical Center in Quezon City is a three-storey facility where doctors, scientists and researchers consistently search for answers to the vast questions of the medical universe in their effort to lay the groundwork for Medicine of the Future.

The Research and Biotechnology (R&B) Group was established in 1995 as a partnership between scientists and physicians, all dedicated in their pursuit of quality research and the utilization of its yield in the promotion of health and treatment of disease.

SLMC, through R&B, is the highest ranking medical center in the Philippines in terms of research productivity.

R&B, as a flagship of St. Luke’s Medical Center, currently holds the record as having the highest number of global clinical trials in the Philippines with 246 clinical trials tucked under its belt.   It has 29 international and 15 local research linkages, partnerships and collaborations.   It is the sole institution in the country that offers a Master of Science Program in Molecular Medicine.   It is a trailblazer in translational research, having established the Health Services Outcomes Research (HSOR) Unit that aims to render research output into actual clinical utility.

In the past two years alone, St. Luke’s researches achieved outstanding and widespread recognition, with 40 publications in international scientific journals, 46 presentations in international scientific meetings, 41 publications in national scientific journals, and 73 presentations in national scientific meetings. Presently, there are 151 research projects implemented or under implementation, 12 Databank Research Projects, and eight (8) Research Study Groups running.

Through R&B, research at St. Luke’s is conducted under the strictest standards. All researches must pass the scrutiny of the Institutional Scientific Review Committee (ISRC) and the Institutional Ethics Review Committee (IERC).   The IERC is accredited nationally by the Philippine Health Research Ethics Board (PHREB) with the highest level of accreditation (Level 3), and recognized internationally by the Forum for Ethics Review Committees in Asia and Western Pacific (FERCAP).   The R&B founded a Center for Human Research Protection, the only one of its kind in the country today, to assure the public that the rights, safety and well-being of human research participants are protected.   It also instituted an Office of Research Integrity (ORI) to uphold stringent standards in medical and scientific research.

R&B conducts regular seminars and workshops for International Conference on Harmonisation – Good Clinical Practice (ICH-GCP), protocol reviews, research protocol preparation, scientific paper writing and evidence-based medicine.

We are Pioneers in Our Field

We developed the Philippines’ first serologic detection test for dengue in 1998.

Molecular tests for more diseases followed, available only in St. Luke’s Medical Center, in our now-established tradition of pioneering these developments:

  • Dengue serological detections assay
  • Chikungunya virus detection
  • BRAFv600e molecular test for determining aggressiveness of thyroid cancer
  • Test for Leukemias:  cytogenetics and fluorescence hybridization (FISH)
  • Test for Alzheimer’s dementia:  APO E Genotyping text
  • Identification of unknown microbial infections by DNA sequencing

Other pioneering tests are undergoing further testing and optimization:

  • Molecular biomarker for colon cancer, through Microsatellite Instability (MSI) testing
  • Genetic testing for Chronic Myelogenous Leukemia (CML)
  • Analytic chemistry technique for gene expression imaging in PET scan
  • Rapid point-of-care strip test for detection of dengue infections
  • Detection test for Zika and other mosquito-borne viruses

We also initiated the development of disease databanks in the country, starting with the Stroke and Colon Cancer Databanks.

R&B received the “Outstanding Health Research Award” from the Philippine Council for Health Research Development (PCHRD) and the Department of Science and Technology (DOST) in 2002 for its Dengue Project.

Our Main Areas of Current Research

  • Cancer:  Colon, Stomach, Liver, Nasopharyngeal carcinoma, Non-Hodgkin’s Lymphoma
  • Digestive Diseases:  Liver diseases, H. pylori infection
  • Infectious Diseases:  Dengue, Hepatitis, Japanese encephalitis, Chikungunya, Rotavirus, and Influenza viruses
  • Antimicrobial Resistance
  • Hematologic (Blood) Disorders:  Leukemias and Thalassemia
  • Neurologic Disorders:  Stroke, Dementia
  • Stem Cell Research:  Ocular Surface Diseases
  • Metabolic Disorders:  Diabetes mellitus
  • Cardiovascular Diseases:  Ischemic Heart Disease
  • Pulmonary Disorders
  • Drug discovery from natural products

Present Capabilities of Our Research Facilities

  • Center for Clinical Trials (CCT)
  • Contract Research Services
  • Biobanking
  • Biomedical Engineering Research Center (BiMER)
  • Electron Microscopy
  • Microbiology and Virology Sequencing Techniques
  • Molecular Cytogenetics and Genomics
  • Tissue and Cell Biology
  • Drug Discovery
  • Molecular Assay Development

 

ST. LUKE’S INSTITUTIONAL ETHICS REVIEW COMMITTEE (IERC)

 

The St. Luke’s Institutional Ethics Review Committee (IERC) is responsible for the review and approval of all research involving human subjects. Its primary responsibility is to protect the rights, dignity and welfare of human participants. It operates under the guidance of the Philippine Health Research Ethics Board (PHREB).

History of the IERC

1995 Creation of the Institutional Bioethics Committee (IBC)
2001 IBC renamed as Institutional Ethics Review Board (IERB)
2011 IERB renamed Institutional Ethics Review Committee (IERC) Internationally accredited by Federal Wide Assurance (FWA) as St. Luke’s Medical Center-Institutional Ethics Review Committee with registered Number 00015950
2012 Recognized as Registered Ethics Review Committee with Registration Number 07-033 by Philippine Health Ethics Review Board (PHREB)
2012 Accredited by PHREB as Level 3 Ethics Review Committee Recognized by the Strategic Initiative for Developing Capacity in Ethical Review-Forum for Ethical Review Committees in the Asian and Western Pacific Region (SIDCER-FERCAP) for its quality of review
2015 Obtained renewal of Recognition from SIDCER-FERCAP
2016 Re-accredited as level 3 IERC by PHREB
2019 Re-accredited as level 3 by PHREB and obtained renewal of Recognition from SIDCER-FERCAP

 

St. Luke’s Institutional Ethics Review Committee (IERC) Composition 2023 – 2025

 

Name Profession & Credentials
Chair: Gelza Mae A. Zabat, MD, FPCP, FPSMID Adult Infectious Diseases, Internal Medicine
Vice-Chair: Anthony T. Uygongco, MD General Surgery
Member-Secretary: Mylene U. Cornel, MD, FPCP, FPSE Cardiology, Internal Medicine
Members:  
Melissa Aquino-Villamin, MD, FPCP, FPRA Rheumatology, Internal Medicine
Imelda B. Asetre-Luna, MD, FPPS Pediatrics, Infectious Diseases
Mel Valerie C. Ordinario, MD, FPCP, FPSMO Medical Oncology, Internal Medicine
Joan H. Tan, MD, FPCP, FPCCP Pulmonology, Internal Medicine
Ma. Lucila Martinez-Perez, MD, MSc, FPPS Pediatrics, Community Medicine,Epidemiology
Pacifico Eric E. Calderon, MD, MBEth Bioethics
Jessa Gilda Pandy, MD, FPCP, DPSMO Medical Oncology, Internal Medicine
Lee-Boyd D. Valencia, MD, FPCP Nephrology, Internal Medicine
Ms. Solita B. Lopez Business and finance (non-affiliated)
Josefina Andrea R. Cantiller, RPsy, MA Psychology (non-affiliated)
Alternate Members: Ophthalmology (non-affiliated)
Prospero Ma. C. Tuaño, MD Ophthalmology (non-affiliated)
Marcelo Severino B. Imasa, RPh, MD, FPCP, FPSMO Medical Oncology, Internal Medicine, Pharmacology
Edreck D. Estioko, MAN, MSN, DNM, DFRIN Nursing (non-affiliated)
Perla Pagaduan Housewife/Lay (non-affiliated)

 

Requirements for Initial Submission

 
  1. For investigator-initiated research studies:

      TYPES OF RESEARCH PROPOSAL
    LIST OF REQUIREMENTS Clinical Research Proposal
    (Research with human participants)    		 Databank Research Proposal Non-human Basic Research Projects
    (e.g. Laboratory, Animal, or Plant studies)    		 Case Report and Interesting Cases Systematic review and Meta-analysis Thesis and Dissertations
    1. Endorsement letters from the Institute/Department Research Committee Head noted by the Institute/Department Head addressed to:
    1. ISRC Chair-Dr. Noel D. Atienza for SLMC- QC or ISRC Chair-Dr. Maria Teresa S. Tolosa for SLMC- GC and
    2. IERC Chair-Dr. Gelza Mae Zabat for SLMC- QC and GC
      • and IBRCR Chair-Dr. Ann Florence V. Belvis (If involving handling of hazardous materials in laboratory)
      • IACUC Chair-Dr. Blanquita B. de Guzman (If animal study)
    		 ✅ ✅ ✅
    For ISRC, IBRCR and AICUC only    		 ✅ ✅ ✅
    2. Institute/Department Research Committee approved research proposal in R&B Forms:
    • Form 1A Clinical Research Proposal Template for research with human participants
    • Form 1B Clinical Databank Proposal Template for databank/registry proposal
    • Form 1C Basic Science Research Template
    • Form 1D Case Report Proposal Template
    • Form 1E Systematic review and Meta-analysis Proposal Template
    • Form 1F Proposal template for Scientific Procedures Using Animals in letter size with PROTOCOL VERSION AND DATE in the lower left footnote as seen on the template
    		 ✅
    Form 1A     		✅
    Form 1B    		 ✅
    Form 1C or Form 1F    		 ✅
    Form 1D    		 ✅
    Form 1E    		 ✅
    3. Data collection forms in leter size with PROTOCOL VERSION AND DATE in the lower left footnote as seen on the template ✅ ✅ ✅ ✅    
    4. Informed Consent Form (ICF) if applicable (English and Filipino) in letter size with PROTOCOL VERSION AND DATE in the lower left footnote (Filipino version is notneeded if the participants are professionals.) ✅ ✅   ✅   ✅
    5. Budget Proposal Form (please be advised that the budget being cited in the budget proposal form, is the budget that will be requested from the Research and Biotechnology Group. If no budget will be requested, you are still required to submit the budget proposal form and indicate "no funds will be requested") ✅ ✅ ✅     ✅
    6. Curriculum Vitae (CV) of all Study Team members (with date and signature) ✅ ✅ ✅ ✅ ✅ ✅
    7. Valid Good Clinical Practice (GCP) certificate of all Study Team members (GCP certificate is valid for 3 years only) ✅ ✅   ✅   ✅
    8. Disclosure of Conflict of Interest (COI) Form of all Study team members ✅ ✅ ✅ ✅   ✅
    9. IERC Initial Submission Checklist ✅ ✅ ✅ ✅ ✅ ✅
    10. Technical Review Form/s signed and dated by Research Committee Revie wer/s who are not part of the study team/proponents ✅ ✅ ✅      
    11. Thesis/Dissertation Approval from the school Thesis/Dissertation Committee           ✅
    12. School’s IRB Approval, if applicable           ✅
    13. Complete approved research protocol           ✅
    14. Certification from the school that SLMC will be acknowledged in the manuscript, future publications and oral or poster presentations upon approval of the head for R&B           ✅
    15. Biosafety Clearance Application Form     ✅     ✅
    16. Biosafety Risk Assessment Form     ✅     ✅
    For submission:
    Please send all soft copies of the required documents listed above based on your research proposal (in a .pdf file) to [email protected] or you may call 8723-0101 local 4734 for more questions or clarifications. Thank you.

  2. For sponsor-initiated clinical trials, human research studies:
    • Letter of intent addressed to SL-IERC Chair
    • Soft copy of the Protocol with the following attachments:
      - Informed Consent Forms (English and Filipino)
      The mobile number of the Principal Investigator should be included in the ICF, Patient card and Patient Diary aside from the clinic’s phone number.
      - Informed Consent Process
      - Subject Recruitment Process
      - Case Report Forms
      - Investigator’s Brochure
      - Disclosure of Conflict of Interest
      - Initial Submission Sheet for Clinical Trial
      - Initial Protocol Review Acknowledgement Form
      - Pharmacokinetics (If applicable)
      - Subject Worksheets/Patient Diary/Alert Cards (English and Tagalog versions
      - Questionnaires (English and Tagalog Versions)
      - Philippine Food and Drug Administration Approval
      - Certificate of Product Registration in the Philippines for Postmarketing Surveillance Studies (PMSS)
      - Curriculum Vitae of Investigators and study team members
      - GCP Certificates of Investigators and study team members
      - PRC License of Investigators and Sub-Investigators
      - Delegation of Authority from the Sponsor
      - Certificate of Insurance and a copy of the policy
      - License to Operate (LTO) to conduct a clinical trial
      - Other related study materials
     

For initial submission of sponsor-initiated clinical trials:

Please send all soft copies of the required documents listed above (in a pdf file) to [email protected] / [email protected] or you may call 8723-0101 local 5562 for more questions or clarifications.

Note:

  • If the dossier is incomplete, the SL-IERC Secretariat will not accept the submission.

For Post-approval SL-IERC Forms and requirements (Protocol Amendments/SAE/PD/PV/Progress Reports etc.)

Please send an email request to [email protected] or you may call 8723-0101 local 7391 for any inquiries. Thank you.

For protocols only awaiting approval from the PFDA, the SL-IERC can conduct a parallel review; however, the issuance of Ethical Clearance shall be withheld until completion of said requirements.

Review fees

Initial review: P60,000.00
Amendments: P10,000.00
Continuing review: P20,000.00

For more queries, please call the Center for Clinical Trials at (632) 87275562.

 

Schedule of IERC Meetings

Every 3rd Wednesday of the month, 8:30AM
January 17, 2024
February 7, 2024
March 20, 2024
April 17, 2024
May 15, 2024
June 19, 2024
July 17, 2024
August 21, 2024
September 18, 2024
October 16, 2024
November 20, 2024
December 18, 2024
 

Note: Cut-off time for submissions of protocols is 2 weeks before the next scheduled IERC Full-board review meeting.

For more queries, please contact the following:
IERC Office Tel. no. - 87230101 local 7391
IERC Email address - [email protected]

Location - 6th floor, East, IERC Office, Research and Biotechnology Group
Address: - 279 E. Rodriguez Sr. Blvd. Quezon City, Philippines

    IERC Budget

    • The budget for operative expenses of SL-IERC comes from the Operating Budget of the St. Luke's Medical Center
    • The training and honorarium of the Reviewers and Staff comes from the Ethics Review Fee
     

    IERC SOP Manual

     

    Guidelines on the conduct of ethical research


     

     

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