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The Institutional Review Board was first established at RITM in 1981. At the outset, it consists of the Internal Technical Review Board, which initially evaluates all research protocols submitted by the staff and the Ethical Review Board, which is responsible for the evaluation of the ethical aspect of human experimentation. The ethics board consisted of members from various disciplines including community leaders, housewives, lawyers and theologians.

Today, the composition of the boards is the same but collectively known as the Institutional Review Board (IRB). Review of protocols has been more comprehensive because the adoption of the ICH guidelines. All research proposals involving humans are done as full review with the Technical and Ethical Review Boards meeting en banc. Expedited reviews, however, are done only for proposals using secondary data. Although the evolution of the review process is very much influenced and mostly patterned after guidelines used in United States, the ethical review of research as regards human experimentation is done according to the Helsinki Declaration (2000) along with other guidelines, namely: 1) Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Biomedical Research Involving Human Subjects; 2) WHO Good Clinical Practice; and 3) International Conference on Harmonization.

The present management has now formulated institutional policies of research and intellectual property and members are given continuing education in ethics as a result of long history of experience in international research collaboration. Institutional investigators are given lectures on ethics at least once a year, during research seminars.

Currently, the RITM IRB is registered at the Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services (Registration Number IRB00000919). RITM IRB also has an approved assurance for the protection of human research subjects filed at OHRP (Assurance No. FWA00000195). It has recently adopted the WHO Operational Guidelines for Ethics Committees that Review Biomedical Research, along with the guidelines recommended by the Department of Science and Technology, Philippine Council for Health Research and Development, National Ethics Committee.

Another institutional committee of RITM is the Animal Use and Protections Committee that review protocols or proposals involving animal experimentation. Aside from the internal policies, the committee adheres to the International Guiding Principles for Animal Research and the Republic Act 8485 – an act to promote animal welfare in the Philippines, otherwise known as "The Animal Welfare Act of 1998".



Marilla G. Lucero, MD, PhD (Chair of IRB and Technical Review Board) E-mail: mlucero@ritm.gov.ph

Gemiliano DL. Aligui, MD, MPH, PhD (Co-Chair of IRB and Chair of Ethics Review Board)
E-mail: galigui@ritm.gov.ph or gdla@laguna.net (preferred)

Veronica L. Tallo, MSc H Ed, PhD (Co-Chair of Ethics Review Board)
E-mail: vtallo@ritm.gov.ph

Mary Elizabeth G. Miranda, DVM, DVPH (Chair of Animal Care and Use Committee)
E-mail: mmiranda@ritm.gov.ph

2001 Research Institute for Tropical Medicine