Research

RESEARCH

ManilaMed, one of the premier tertiary hospitals based in the heart of Manila, is duly committed to continously uphold its mission of “being responsive to the needs of the community in the preservation of health through education, training, and research,” by conducting research with proper regulation of an independent and functional governing body. Through the MMERC (ManilaMed Ethics Review Committee), which serve as a steadfast group of individuals appointed by the Medical Director from the healthcare
industry that regulate research while answering the complexities and questions to help improve the health of
individuals, organizations and communities.

Established in November 2013, the MMERC (ManilaMed Ethics Review Committee) is composed of
doctors, healthcare workers and lay who aim to establish the protection and promotion of the well-being,
safety, and dignity of all research participants.

Following the Joint Memorandum Order 2012-001 in the Philippines, the MMERC ensures all healthcare
research involving human subjects undergo ethical review and clearance before implementation. In addition,
researches which are in compliance with the international and national guidelines and health-related laws
such as the ICH-GCP, CIOMS, Declaration of Helsinki, National Ethical Guidelines for Health and Health-
Related Research 2017, DOST AO’s related to research and Data Privacy Act of 2012 are supported by the
MMERC.

Any type of research involving human subjects or has procedures and results that impact the health of
individuals, or the community must be evaluated by the MMERC. Applicable when research conducted is
within the hospital setting or community. The research proposals could be institution-based or multi-center
studies, and may include a joint review with the Single Joint Review Ethics Board (SJREB of DOH). The
scope of these studies includes research on vulnerable groups, medical devices, clinical trials, research
involving indigenous populations, animal studies, studies that could pose biosafety risks to the environment,
research conducted by students and trainees, and advancements in technology that impact humans, such
as Artificial Intelligence (AI).

With the purpose to maintain the standards of ethical research, MMERC shall established a Research
Integrity Office; this office will serve as a definitive mechanism to scrutinize claims of unethical behavior by
its researchers. The RIO (Research Integrity Office) will conduct investigations about any allegations of
ethical conduct and enforce appropriate consequences necessary. It is also a requirement that all
researchers affiliated with the RIO should be trained on their relevant duties and responsibilities for ethical
conduct of research.

ManilaMed’s responsibility as a research institution governs its internal and external stakeholders
conducting any type of research through the provision of such mechanisms of care for research related
injuries. These are as follows:

The MMERC is responsible for reviewing and approving initial submissions, resubmissions, post-approval
notifications, inquiries, and complaints, as well as conducting site visits. The review process will cover the
completeness of the documentation, the scientific validity of the research, ethical considerations, potential
conflicts of interest, informed consent, and the capability of the research sites. There are specific
assessment forms available for each of these activities.

There are established guidelines that govern these activities, including the Standard Operating Procedures
for research, the Hospital Data Protection Policy, and other procedures related to health research activities
such as data archiving and retrieval. These guidelines are followed in the execution of these activities.

MMERC MEMBERS

DOWNLOADBLE SOP

MMERC-MANUAL

1 file(s) 5.69 MB  

Download

Note: Cut-off of protocol submission is every 30th of the month or 2 weeks before the MMERC scheduled meeting. MMERC Review is scheduled every second Wednesday 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: Medical Center Manila Inc.

PROTOCOL APPLICATION REQUIREMENTS AND INITIAL REVIEW PROCEDURE

DOWNLOADBLE MMERC

• Table of Content and Introduction

• MMERC Glossary

• Appendix

SOP 1 – ERC Structure and Composition

• MMERC Form 2.0_ Protocol Application Checklist

• MMERC Form 2.0A_Checklist for Exemption from Ethical Review

• MMERC Form 2.1 Application Form for Initial Protocol Review

• MMERC Form 2.3_Protocol Evaluation Form

• MMERC Form 2.3A_Resubmission Form

• MMERC Form 2.4_Informed Consent Evaluation Form

SOP 3 FORMS

• Post Approval Procedures

• MMERC Form 3.0 _Notification Form

• MMERC Form 3.1_Amendment Form

• MMERC Form 3.2_Deviation Form

• MMERC Form 3.3_Early Protocol Termination Form

• MMERC Form 3.4_Progress Report Form

• MMERC Form 3.4A_Continuing Review Form

• MMERC Form 3.5_ Final Report Form

• MMERC Form 3.6_SAE Form

• MMERC Form 3.7_Reportable Negative Event Form

• MMERC Form 3.8_Site Visit Report Form

• MMERC Form 3.9_Site Visit Checklist

SOP 4 – Conduct of Meeting

SOP 5 – Documentation and Archiving

SOP 6 – Writing and Revising SOPs

Frequently Asked Questions (FAQs)

1. How long does it take for MMERC to approve a protocol?
   • The MMERC approves a reviewed and deliberated protocol after the ERC meeting date set every second Wednesday of the month, or otherwise declared, and releases its approval/query letter 1 to 5 days after the said ERC meeting. Turnaround time from submission to approval is usually around 1 to 2 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 30th of the month. One (1) soft copy should be submitted and (4) hard copies 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. When do we pay ethics review fee?

   • Upon submission of the protocol, otherwise, it will not be reviewed.

5. Who prepares the CTA?

   • The Sponsor prepares the tri-partite clinical trial agreement to be signed by the Sponsor, Principal Investigator and Medical Center Manila Inc. MCM signatories are: VICENTE D.R BERNARDO III, M.D. (Medical Director) and EDUARDO S. ESEQUE, M.D. (President).

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

Contact Information

• • Trunk Line: 8523-8131 local 2553

• • Email Address: ethicsreviewcommittee@manilamed.com.ph

• • Address: Penthouse Floor Medical Center Manila Bldg. 850 United Nations Avenue, Paco, Manila