The RITM—IRB was created under Office Order no. 6, s. 1983 dated February 7, 1983 of Executive Director Dr. Alberto G. Romualdez Jr., to evaluate the ethical aspect of human experimentation in accordance with local and international guidelines in the conduct of research. It was given the authority to approve, require modifications or revisions or disapprove research protocols that falls within its jurisdiction.
It is a multi-disciplinary and multisector board composed of eleven (11) members with gender distribution of 8 females: 3 males. Of these number four (4) have medical background, three (3) are scientist members and four (4) are non-medical/non-scientists members. Three (3) out eleven (11) are non-affiliated with the institute.
The medical and scientist IRB members are responsible for the review of the technical and science component of research protocols i.e. appropriateness of the research design and methods, sample size calculation, soundness of the inclusion and exclusion criteria, internal and external validity of study tools and procedures. The lay members of the IRB are primarily entrusted with the task of reviewing the information sheets used in obtaining consent, parental consent and assent.
Current Standing of the IRB :
- Level III Accredited by PHREB from May 20, 2018 to May 19, 2022
- Registered with the Office of the Human Research Protection (OHRP) of the US Department of Health and Human Services (DHHS) (IRB Registration Number 00000919) since March 2001.
- Has been given Federal Wide Assurance (FWA Assurance No. 00000195) by OHRP until June 8, 2021
- Has been recognized by WHO Strategic Initiative for the Development of Capacity for Ethical Review (SIDCER) through the Forum for Ethics Review Committees for Asia and the Pacific (FERCAP) since 2007.
Downloadable IRB Forms:
- Form 2.1: Request for Initial Review of New Research Protocol
- Form 2.8: Form and Worksheet for Resubmissions
- Form 3.1: Application for Review of Proposed Amendment
- Form 3.3: Application for Continuing Review
- Form 3.5: Report and Assessment of Research Completion
- Form 3.6: Request for Protocol Withdrawal or Early Termination
- Form 3.7: Assessment of SAE Report
- Form 3.8: Report and Assessment of Protocol Deviation
- RITM-RIO-FM-004: Conflict of Interest Declaration Form