A Research Ethics Committee (REC) is a body that makes independent decisions regarding the review, approval, and implementation of research protocols/proposals, in order to ensure the protection of the rights, safety, and well-being of human participants and promotes integrity of research data. It shall be constituted by a duly recognized authority and shall adhere to national and international research ethics guidelines.

The Cardinal Santos Medical Center Research Ethics Review Committee (CSMC RERC) was established in May 2003 as then Institutional Review Board (IRB). It is an independent body created by the Cardinal Santos Medical Center (CSMC) under the Vice President & Chief Medical Officer (VP & CMO). Its responsibility is to ensure the protection of the rights, safety, and well-being of human participants involved in health-related research and to provide public assurance of that protection. In accordance with the applicable national/international regulations, the CSMC RERC has the authority to approve, require modifications to, or disapprove research protocols and related documents, as well as, ensure compliance with its procedures after approval. The CSMC RERC reviews and monitors health researches that involve:

• Cardinal Santos Medical Center patients done within the hospital premises by its staff and affiliated organizations.

• Protocols done by Cardinal Santos Medical Center medical, house staff members, Fellows and Residents and Interns, allied medical professionals, within and outside the hospital premises.

• Protocols submitted by outside investigators and study to be performed outside of CSMC. Site visit may be required.

• Industry-sponsored clinical trials CSMC RERC is guided in its reflection, advice, and decision by the ethical principles and procedures expressed in the following international guidelines and documents:

• Declaration of Helsinki (Published on-line 2013)

• Council for International Organizations of Medical Sciences (CIOMS) 2002 and 2009

  CSMC RERC adheres to the national and international ethical standards and functions in accordance with the national laws, regulations, and guidelines. CSMC RERC provides its own standard operating procedures based on:

• Operational Guidelines for Ethics Committees that Review Biomedical Research (2000) by the World Health Organization (WHO)

• Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011) by the World Health Organization (WHO)

• International Conference on the Harmonization of Good Clinical Practice (ICH-GCP)

• National Ethical Guidelines for Health Research (2017) by the Philippine Health Research Ethics Board (PHREB)

• Philippine Food and Drug Authority regulations and other relevant laws and regulations
  
  In evaluating protocols and ethical issues, CSMC RERC is cognizant of the diversity of laws, cultures and practices governing health research in various countries around the world. It attempts to inform itself, whenever possible, of the regulations and requirements of the sponsor countries conducting global protocols in the Philippines; and of the requirements and conditions of the various localities where a proposed Cardinal Santos Medical Center research is being considered. CSMC RERC takes the initiative to be informed, as appropriate, by the national/local ethics committees and researchers of the impact of the research that it has approved.