Institutional Review Board

Contact Information:

  • Trunk Line: (02) 524-3011 Local 4728
  • Email Address: irbmdh@yahoo.com
  • Address: 2nd floor, Manila Doctors Hospital, 667 United Nations Avenue, Ermita, Manila 1000

Year IRB was Established: 2000

PHREB Registration No.: 07-024

 

Officers and Members of the 2013 MDH IRB

Name

Designation

Expertise

Angela Abanilla Du, M.D. Chair Obstetrics-Gynecology
Roberto L. Ruiz, M.D. Co-Chair Family Medicine/ Epidemiology
Maria Luz Joanna B. Soria, M.D. Secretary Cardiology
Ma. Epifania V. Collantes, M.D. Member Neurology
Rosie S. De Leon, R.N., PhD Member Nursing Director
Cielo Balita-Malijan, M.D. Member Developmental Pediatrics
Myrna Buenaluz-Sedurante, M.D. Member Internal Medicine-Endocrinology
Jeanette Nora I. Silao, M.D. Member Surgery
Jose Co Jaymalin II Member, External/Lay Mortuary Business
Catherine C. Lagayan Secretariat

 

What is an Institutional Review Board?

The International Council on Harmonization (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well- being of human beings involved in a clinical trial by reviewing all aspects of the trial and approving its startup.  IRBs can also be called independent ethics committees (IECs).  The Manila Doctors Hospital uses the term IRB to represent its institutional review board.

The  Manila Doctors Hospital institutional review board (MDH-IRB)  does not only review the ethical aspects of a research protocol but also the informed consent process, participant recruitment, advertisement, research staff suitability and risk-benefit balance. It operates in accordance with national and/or local regulations as well as with ICH good clinical practices (GCPs) guidelines.

Brief History of the MDH IRB

The Manila Doctors Hospital Ethics Review Board (MDH-ERB) was officially created in 2000 as an arm of the Committee on Research (CORES) and functioned to review and document approvals of all clinical researches conducted at the Manila Doctors Hospital.  Before that time, there were no records of the activities of the MDH-ERB or any functioning body in the hospital.  ERB functions were simply an additional responsibility of the Committee on Research and/or the Hospital Ethics Committee. The Philippines General Hospital ERB guidelines served as the basis for the review process.

In 2007, the MDH-IRB was registered as an established review body by the Philippine Council for Health Research Development Board (PCHRD). Two years later, the ERB was renamed the Manila Doctors Hospital Institutional Review Board (MDH-IRB).

The MDH-IRB reviews researches conducted by medical consultants and medical staff-in-training: fellows, residents and interns of the Manila Doctors Hospital.  Majority of its workload comes from review of industry-sponsored clinical trials by principal investigators who are consultants of the Manila Doctors Hospital.

What are clinical trials?

A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.

How do we submit clinical trials for review?

Accomplish the checklist of basic and study-specific documents and submit in six (6) copies of each forms to MDH IRB Secretariat at 2nd floor Manila Doctors Hospital, 667 United Nations Avenue, Manila 1009, telephone number 5243011 local 4728.   Attach a cover letter for each package addressed to:

Dr. Angela Abanilla-Du
Chair
Institutional Review Board
Manila Doctors Hospital

 Cut-off of submission is every 15th of the month and IRB review is every last Tuesday of the month except for holidays.  Documents are to be submitted with an Institutional/Review fee payable to:  Manila Doctors Hospital

Basic Documents (in 6 copies)

Study-specific Documents (6 copies)

  • Investigator’s Brochure (for clinical trials phase I, II, III) or Basic Product Information Document (for clinical trials phase IV)
  • Informed Consent Assessment Form (for studies with human participants) [Download form: MDH IRB FORM 2(D)2012 Informed Consent Assessment Form]
  • Informed consent form in English (for studies with human participants)
  • Informed consent form in local language (for studies with human participants)
  • Assent form in English (for studies involving minors and relevant populations deemed incompetent to sign an informed consent form )
  • Assent form in local language (for studies involving minors and relevant populations deemed incompetent to sign an informed consent form)
  • Good Clinical Practice (GCP)  Training Certificate of PI, Co-I and the rest of the study team (for clinical trials)
  • Recruitment advertisements (as needed by the study protocol)
  • Other information or documents for participants (such as diaries, etc.)
  • Material Transfer Agreement (for any research involving transfer of biological specimens)
  • Memorandum of Agreement (for collaborative studies)
  • Previous ethical review approvals/clearances (for  students/personnel of foreign universities researching in the Philippines or those with prior ethical review)
  • Food and Drugs Administration Approval
  • Certificate of Product Registration in the Philippines for PMS
  • Curriculum Vitae of Investigators
Other forms:

Frequently Asked Questions (FAQs)

1.    How long does it take for MDH IRB to approve a protocol?
The MDH IRB approves a reviewed and deliberated protocol after the IRB meeting date set every last Tuesday of the month, or otherwise declared, and releases its approval letter 1 to 5 days after the said IRB meeting.

2.    How many copies of the protocol should I submit?
Six copies of the protocol package for review and approval should be submitted on or before the cutoff date which is every 15th of the month.

3.    How long is the validity of the ethical clearance?
The validity of the ethical approval is for one year only, hence, the Principal Investigator should apply for a continuing review.

4.    Do we pay for storage of clinical trial drugs? 
Storage of clinical trial drug and other expenses are not included in the institutional /review fee.  There should be a separate agreement with the MDH Pharmacy or the concerned department.

5.    When do we pay ethics review fee?
Upon submission of the protocol otherwise it will not be reviewed.

6.    Who prepares the CTA?
The Sponsor prepares the tri-partite clinical trial agreement to be signed by the Sponsor, PI and MDH (Medical Director).  CTA undergoes IRB review prior to submission to the Medical Director.