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Mandates pertaining to the ethical review of researches involving humans, and the establishment and accreditation of research ethics committees

SPMC J Health Care Serv. 2021;7(1):1 ARK: http://n2t.net/ark:/76951/jhcs744ssd


Alvin S Concha,1 Clarence Xlasi D Ladrero1


1Research Utilization and Publication Office, Southern Philippines Medical Center, JP Laurel Ave, Davao City, Philippines


Correspondence Alvin S Concha, alvinconcha@gmail.com

Received 3 March 2021

Accepted 19 March 2021

Cite as Concha AS, Ladrero CXD. Mandates pertaining to the ethical review of researches involving humans, and the establishment and accreditation of research ethics committees. SPMC J Health Care Serv. 2021;7(1):1. http://n2t.net/ark:/76951/jhcs744ssd


In 2003, the secretaries of the Department of Health (DOH) and the Department of Science and Technology (DOST) signed a memorandum of understanding to institutionalize the Philippine National Health Research System (PNHRS) for the management of research in the country.1 One of the groups constituted under the PNHRS was the Technical Working Group (TWG) on Ethics, which created strategies that highlight the role of ethics in a responsible health research system. Among the recommendations of the Ethics TWG was the establishment of the Philippine Health Research Ethics Board (PHREB).2 In 2006, the PHREB was formally created through DOST Special Order 2006-91 “to ensure that all phases of health research shall adhere to universal ethical principles that value the protection and promotion of the dignity of health research participants.” Since then, PHREB has become the country’s policy making body on health research ethics.2 3


In 2013, the Republic Act 10532一or the PNHRS Law一was enacted.4 The Act strengthened the mandate of PHREB to ensure protection of the welfare, rights, and safety of human research participants, and the implementing rules and regulations (IRR) of the Act specified the policies that facilitate the achievement of the PHREB mandate.5 In 2017, through DOST Special Order 2017-248, DOST established research ethics monitoring boards (REMBs) in Region I, Region VI, and Region XI to assist in the comprehensive and consistent implementation of PHREB policies at the regional level.6 The creation of PHREB in 2006 initiated several other mandates from PHREB and other agencies that implement the PNHRS. These mandates一shown in the infographic一support human research participant protection through ethical reviews of research protocols, establishment of research ethics committees, and maintenance of quality standards of these committees through accreditation. Many of these mandates are national in scope, but a few are specific to Davao Region (Region XI).



Infographic

Contributors

ASC wrote the original draft and subsequent revisions of this article. CXDL did the layout for the infographics. All authors gave their approval of the final version to be published. All authors agreed to be accountable for all aspects of the work.


Acknowledgments

We would like to thank Dr Marita VT Reyes of the Philippine Health Research Ethics Board for her inputs on the historical aspects of some mandates mentioned in this article.


Article source

Submitted


Peer review

Internal


Competing interests

None declared


Access and license

This is an Open Access article licensed under the Creative Commons Attribution-NonCommercial 4.0 International License, which allows others to share and adapt the work, provided that derivative works bear appropriate citation to this original work and are not used for commercial purposes. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc/4.0/


References

1. Department of Health. Strengthening partnerships for health, DOH Annual Report 2003 (2004 March).


2. Philippine National Health Research System. National Ethical Guidelines for Health Research. Taguig: Philippine Council for Health Research Development; 2006.


3. Department of Science and Technology. Creation of the Philippine Health Research Ethics Board (PHREB), DOST Special Order No. 091 series 2006 (2006 March 1).


4. Republic of the Philippines. An act institutionalizing the Philippine National Health Research System, Republic Act No. 10532 (2013 May 7).


5. Republic of the Philippines. Philippine National Health Research System Implementing Rules and Regulations (Republic Act No. 10532), (2013 June 1).


6. Department of Health. Establishment of the Regional Ethics Monitoring Board (REMBs) in Region I, Region VI, and Region XI, DOST Special Order No. 248 series 2017 (2017 March 31).


Mandates mentioned in the infographic

2007

Department of Science and Technology. Requirement for Review of all health researches involving human subjects/participants, DOST Administrative Order no. 001 series 2007 (2007 March 2).


Commission on Higher Education. Policy requirement in the conduct of health research involving human subjects/participants, CHED Memorandum Order No. 34 series 2007 ( 2007 June 13).


2012

Department of Health, Department of Science and Technology, Commission on Higher Education, University of the Philippines Manila. Requirement for ethical review of health research involving human participants, Joint Memorandum Order No. 2012-001 (2012 December 28).


2013

Republic of the Philippines. Philippine National Health Research System Implementing Rules and Regulations (Republic Act No. 10532), (2013 June 1).


2014

Philippine Health Research Ethics Board. PHREB requirements for registration and accreditation of research ethics review committees, 2014 February 2.


2015

Philippine Health Research Ethics Board. Registration and accreditation of all ethics review committees in the Philippines, Memorandum (2015 February 27).


Commission on Higher Education. Philippine Health Research Ethics Board - registration and accreditation of all ethics review committees in the Philippines, Memorandum from the Chairperson (2015 March 30).


Department of Health. Research Ethics Review Committees (RERCs) registration and accreditation, Department Circular No. 2015-0059 (2015 February 27).


2017

Department of Health. Guidelines for the streamlined research ethics review process in the Department of Health, Department Order No. 2017-0265 (2017 July 11).


2018

Regional Development Council Davao Region. Enjoining Davao Region’s higher education institutions to establish their respective research ethics committees and apply for accreditation with the Philippine Health Research Ethics Board, RDC XI Resolution No. 65, Series of 2018 (2018 June 22).


Commission on Higher Education Region XI. Re-iteration of Philippine Health Research Ethics Board (PHREB) accreditation of all ethics review committees in the Philippines, Memorandum from the Director No. 052 series 2018 (2018 March 27).


2019

Department of Health. Guidelines on the implementation of clinical research policy in DOH hospitals, Department Order No. 2019-0163 (2019 June 13).


Commission on Higher Education. Policies, standards, and guidelines for graduate programs, CHED Memorandum Order No. 15 series 2019 (2019 December 19).


Commission on Higher Education Region XI. Re-iteration on the accreditation of all ethics review committees in Region XI with Philippine Health Research Ethics Board (PHREB), Memorandum from the Director No. 183 series 2019 (2019 September 26).


Copyright © 2021 AS Concha, et al.


Published
March 19, 2021

Issue
Volume 7 Issue 1 (2020)

Section
Editorial




SPMC Journal of Health Care Services


           

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