Institutional Review Board

Contact Information:

• Trunk Line: (+632) 8558-0888 local 4728
• Fax: (+632) 8558-0888 local 0579
• Email Address: irb@maniladoctors.com.ph.
• Address: 8^th floor, Norberto Ty Medical Tower 2, Manila Doctors Hospital, 664 T.M. Kalaw St., Ermita, Manila 1000

Year IRB was Established: 2000

PHREB Registration No.: 07-024

• PHREB Level 3 Ethics Review Committee Accreditation No. L3-2014-002-01
  • Effectivity Date: March 14, 2014
  • Expiry Date: March 14, 2017
•  PHREB Level 3 Ethics Review Committee accreditation No. L3-2017-002-02
  • Effectivity Date: March 14, 2017
  • Expiry Date: March 13, 2021
• ​PHREB Level 3 Ethics Review Committee Accreditation No. L3-2021-002-03
  • Effectivity Date: December 8, 2021
  • Expiry Date: December 7, 2025

The Strategic Initiative for Developing Capacity in Ethical Review – Forum for Ethical Review Committees in the Asian and Western Pacific Region  (SIDCER-FERCAP) awarded its recognition to  MDH-IRB during the 13th FERCAP General Assembly in Bali, Indonesia on November 20, 2013 for compliance to ICH Guidelines, GCP standards, CIOMS Guidelines, WHO Standards for Operational Guidance for Ethics Review and Health-related Research and Surveying and Evaluating Ethical Review Practices, EC/IRB Standard Operating Procedures, and Local Regulations and Standards in Ethical Review.  The SIDCER-FERCAP renewed its recognition to MDH IRB on November 23, 2016 at the BhumiSiriManglanusorn Building, King Chulalongkorn Memorial Hospital and on December 11, 2021 during the 21st FERCAP Online International Annual Conference conducted at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.

MDH IRB is one of the founding members of the Philippine National Health Research Ethics Network (PHREN) established in 2013.

Officers and Members of the 2022 MDH IRB

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 Philippine 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 hospital and medical staff, residents, fellows and other trainees of the Manila Doctors Hospital (MDH).  Majority of its workload comes from review of industry-sponsored clinical trials by principal investigators who are consultants of the Manila Doctors Hospital.  The MDH IRB was granted Level III Ethics Review Committee Accreditation by the Philippine Health Research Ethics Board (PHREB) of the Department of Science and Technology on March 14, 2014 until March 14, 2017, and has undergone its second re-accreditation and granted Level III Ethics Review Committee last March 14, 2017 until March 13, 2021. The MDH IRB had its third re-accreditation and was granted Level III Ethics Review Committee effective December 8, 2021 until December 7, 2025.

The MDH –IRB has been granted international recognition by the Strategic Initiative for Developing Capacity in Ethical Review – Forum for Ethical Review Committees in the Asian and Western Pacific Region  (SIDCER-FERCAP)  last November 20, 2013 in Bali, Indonesia.  SIDCER-FERCAP renewed its recognition to MDH IRB on November 23, 2016 at the BhumiSiriManglanusorn Building, King Chulalongkorn Memorial Hospital in Bangkok, Thailand. The MDH IRB received its third recognition from SIDCER-FERCAP on December 11, 2021 during the 21st FERCAP Online International Annual Conference conducted at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.

Currently, the MDH IRB is one of the founding members of the Philippine Health Research Ethics Network (PHREN).

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, email protocol package submission in PDF format and all IRB Forms in MS Word format to irb@maniladoctors.com.ph. Submit in one (1) hard copy to MDH IRB Secretariat at 8th floor, Norberto Ty Medical Tower 2, Manila Doctors Hospital, 664 T.M. Kalaw St., Ermita, Manila 1000, telephone number 558-0888 local 4728.   Attach a cover letter for each package submission addressed to:

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

Cut-off of submission is every 15th of the month except for the month of December which will be on the 5th. IRB Review is scheduled every last Tuesday of the month except for holidays, unforeseen events and eventualities, as well as for the month of December. Documents are to be submitted with a Review fee payable to:  Manila Doctors Hospital

Basic Documents for All Studies

• Review Checklist [MDH IRB FORM 2(A)2021 ]
  
• Printed Registration and Application Form [MDH IRB FORM 2(B)2021]
• Study Protocol Assessment Form [MDH IRB FORM 2(C)2021]
• Study Protocol
• Data collection forms (including CRFs)
• CV of PI and study team members
• Good Clinical Practice (GCP) Training Certificate of Principal Investigator (PI), Co-Investigator (Co-I) and the research coordinators of the study team (for clinical trials); On-line GCP is accepted if submission is for renewal.
• Electronic  copy of study protocol [MDH IRB FORM 2(A)2021, MDH IRB FORM 2(B)2021, MDH IRB FORM 2(C)2021]

Additional Documents for Clinical Trials and other Industry-Sponsored Studies

• Receipt of payment of Review Fee
• Site-specific FDA approval for clinical trials
• 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) [MDH IRB FORM 2(D) 2021]
• 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)
• Certificate of Indemnity Insurance coverage for participants
• Recruitment advertisements (as needed by the study protocol)
• Materials Transfer Agreement (MAT) (for any research involving transfer of biological specimens)
• Significant Risk (SR) or Non-Significant Risk (NSR) classification for investigational device
• Memorandum of Agreement (for collaborative studies)
• Other information or documents for participants as needed.

Additional Basic Documents for Studies initiated by Hospital and MDH Medical Staff, Fellows, Residents, and Interns  

• Certification of MDH Training Department Chairperson and Department Research Coordinator of technical assessment
• Copy of Letter of MDH Committee on Research (CORES) Endorsement to MDH IRB
• Certification of Technical Approval by MDH Committee on Research (CORES) Chair
• Informed Consent Assessment Form (for studies with human participants) [MDH IRB FORM 2(D) 2021]
• 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)
• Recruitment advertisements (as needed by the study protocol)
• Materials Transfer Agreement (MTA) (for any research involving transfer of biological specimens)
• Significant Risk (SR) or Non Significant Risk (NSR) classification for investigational device
• Memorandum of Agreement (for collaborative studies)
• Other information or documents for participants as needed.

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/query letter 1 to 5 days after the said IRB meeting.  Turnaround time from submission to approval is usually around 2 to 3 months.

2.    How many copies of the protocol should I submit?
The electronic copy of the protocol package for review and approval should be submitted on or before the submission cut-off date which is every 15th of the month. One (1) hard copy should be submitted within the week after the electronic submission.

3.    How long is the validity of the ethical clearance?
The validity of the ethical approval is for one (1) 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 review fee.  There should be a separate agreement with the MDH Pharmacy or the Committee on Research (CORES) for storage.

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, Principal Investigator and Manila Doctors Hospital.  MDH signatories are:

HIAN HO N. KUA, MD
First Vice President
and Hospital Director

and

ARLENE P. LEDESMA
President

The IRB is NOT a signatory of the CTA.  The CTA undergoes IRB endorsement prior to approval of the Hospital Director and President.