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.
