- Trunk Line: (02) 524-3011 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
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 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
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)
- Review Checklist [Download form: MDH IRB FORM 2(A)2012 Review Checklist]
- Printed Registration and Application Form [Download form: MDH IRB FORM 2(B)2012Registration and Application Form]
- Study Protocol Assessment Form [Download form: MDH IRB FORM 2(C)2012 Study Protocol Assessment Form]
- Study Protocol
- Data collection forms (including CRFs)
- CV of PI and study team members
- Electronic copy of study protocol, MDH IRB FORM 2(A)2012, MDH IRB FORM 2(B)2012, MDH IRB FORM 2(C)2012, and MDH IRB FORM 2(D)2012
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
- MDH IRB FORM 2(H)2012 Review of Resubmitted Protocol Form
- MDH IRB FORM 3(A)2012 Study Protocol Amendment Submission Form
- MDH IRB FORM 3(B)2012 Continuing Review Application Form
- MDH IRB FORM 3(C)2012 Final Report Form
- MDH IRB FORM 3(D)2012 Study NonCompliance Report
- MDH IRB FORM 3(E)2012 Early Study Termination Application Form
- MDH IRB FORM 3(F)2012 Site Visit Report Form
- MDH IRB FORM 3(G)2012 Serious Adverse Events Report
- MDH IRB FORM 3(I)2012 Queries or Complaints
- MDH IRB Form 3(J)2012 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.