Ethical Framework
The CEBU INSTITUTE OF MEDICINE CEBU VELEZ GENERAL HOSPITAL INSTITUTIONAL REVIEW BOARD (CIM-CVGH IRB) is guided in its reflection, advice, and decision by the ethical principles as follows:
• Respect for Persons – principle that states that individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.
• Beneficence – principle that requires investigators to protect participants from harm and secure their well-being.
• Justice – principle that refers to the sense of “fairness in distribution” and “what is deserved.”
Source: Belmont Report, 1979
a. It is guided by the ethical principles and procedures as expressed in the following international guidelines:
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Declaration of Helsinki (2013 and subsequent revisions)
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International Conference on the Harmonization of Good Clinical Practice (ICH-GCP)
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CIOMS 2016
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Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011) by the World Health Organization (WHO)
b. The REC will function in accordance with national laws, regulations, and guidelines.
• National Ethical Guidelines for Health Research by the Philippine Health Research Ethics Board (PHREB)
• Administrative Orders from DOH, Philippine FDA and other relevant agencies
c. The REC adopts its own standard operating procedures based on:
• Operational Guidelines for Ethics Committees That Review Biomedical Research (2000) by the World Health Organization (WHO)
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DOH-REC SOP Template
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FERCAP SOP Templates
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PHREB SOP Workbook
d. The REC adheres to national and international ethical standards and recognizes that the protocols it approves may have undergone review and approved by other ethics committees including the Multi-Site Research Ethics Board (MREB) prior to their implementation in specific sites. e. In evaluating protocols and ethical issues, the REC is cognizant of the diversity of laws, cultures and practices governing health research in various local sites/countries around the world.
f. It attempts to inform itself, whenever possible, of the regulations and requirements of sponsor countries conducting global protocols in the Philippines; and of the requirements and conditions of various localities where a proposed (Name of Hospital) research is being considered. g. The REC will take the initiative to be informed, as appropriate, by current state-of-the-art researches and publications of the impact of the research that it has approved.
ACCESS SOP AND FORMS THROUGH : https://drive.google.com/drive/u/0/folders/1qdVFusasxZA64zLevpiWWoS_hysoi1Yn