- Trunk Line: (02) 558-0888 Local 4728
- Email Address: email@example.com
- Address: 2nd floor, Manila Doctors Hospital, 667 United Nations Avenue, 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
The Strategic Initiative for Developing Capacity in Ethical Review – Forum for Ethical Review Committees in the Asian and Western Pacific Region (SIDCER-FERCAP) Recognition: awarded during the 13th FERCAP General Assembly in Bali, Indonesia on November 20, 2013.
MDH IRB is a member of the Philippine National Health Research Ethics Network (PHREN).
Officers and Members of the 2013 MDH IRB
|Angela Abanilla Du, M.D.||Chair||Obstetrics-Gynecology|
|Roberto L. Ruiz, M.D.||Co-Chair||Family Medicine/ Epidemiology|
|Maria Cielo Balita-Malijan, M.D.||Secretary||Developmental Pediatrics|
|Maria Epifania V. Collantes, M.D.||Member||Neurology|
|Rosie S. De Leon, R.N., PhD||Member||Nursing Director|
|Myrna Buenaluz-Sedurante, M.D.||Member||Internal Medicine-Endocrinology|
|Albert B. Albay, Jr., M.D.||Member||Pulmonology|
|Jose Co Jaymalin, II||Member, External/Lay||Entrepreneur|
|Jose Rico S. Domingo||Member, External/Lay||Christian Pastor|
|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 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 IRB has been granted recognition by the Forum for Ethics Review Committee in the Asia and Western Pacific Regions (FERCAP) last November 20, 2013 in Bali, Indonesia. Currently, the MDH-IRB is an active member 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 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 558-0888 local 4728. Attach a cover letter for each package addressed to:
Dr. Angela Abanilla-Du
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 the month of December. Documents are to be submitted with an Institutional/Review fee payable to: Manila Doctors Hospital
Basic Documents (in 6 copies)
Download All forms here: Institutional Review Board
- Review Checklist [Download form: MDH IRB FORM 2(A)2016 Review Checklist
- Printed Registration and Application Form [Download form: MDH IRB FORM 2(B)2016 Registration and Application Form
- Study Protocol Assessment Form [Download form: MDH IRB FORM 2(C)2016 Study Protocol Assessment Form
- Study Protocol
- Data collection forms (including CRFs)
- CV of PI and study team members
- Electronic copy of study protocol [Download form: MDH IRB FORM 2(A)2016, MDH IRB FORM 2(B)2016, MDH IRB FORM 2(C)2016 and MDH IRB FORM 2(D)2016
Additional Documents for Industry-Sponsored Studies
- Receipt of payment of Review Fee
- Site-specific FDA approval for clinical trials
Additional Basic Documents for Hospital and MDH Medical Staff Study
- Certification of MDH Training Department Chairperson and Department Research Coordinator of technical assessment
- Copy of Letter of Registration to MDH Committee on Research (CORES)
- Certification of Technical Approval by MDH Committee on Research (CORES) Chair
- 6 copies of Study protocol, including ICFs and electronic copy of study protocol and documents for review and approval
Study-specific Documents (6 copies, submit as needed)
- 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)2016 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)
- Certificate of Indemnity Insurance coverage for participants
- Recruitment advertisements (as needed by the study protocol)
- Material Transfer Agreement (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)
- MDH IRB FORM 2(H)2016 Review of Resubmitted Protocol Form
- MDH IRB FORM 3(A)2016 Continuing Review Application / Study Protocol Amendment / Other Documents Submission Form
- MDH IRB FORM 3(B)2016 Progress Report / Annual Report Form
- MDH IRB FORM 3(C)2016 Final Report Form
- MDH IRB FORM 3(D)2016 Study Non Compliance (Deviation or Violation) Report From
- MDH IRB FORM 3(E)2016 Early Study Termination Application Form
- MDH IRB FORM 3(G)2016 Serious Adverse Events Report
- MDH IRB FORM 3(I)2016 Queries or Complaints
- MDH IRB Form 3(J)2016 SAE Report Summary
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.