Let’s Get Ethical

| Written by Jo. Florendo B. Lontoc

In a research university, not all vetting requires ethical certifications and clearances, but all work must pass standards of excellence, which cannot exclude research ethics. Incumbent upon the university is the institutionalization of ethical review.

Research ethics has many components. One is data privacy. In all aspects, UP Manila has something to offer the rest of the UP System.

Research proposals in UP Manila by regular faculty members, students, clinical faculty members, residents and fellows of the UP Manila-Philippine General Hospital and other UP Manila researchers are reviewed by a centralized ethics board prior to implementation. “No research project happens without the prior review and approval of the board,” Dr. Cecilia Jimeno of the UP Manila College of Medicine, chair of the UP Manila Ethics Board (UPM-REB) Panel 1, reiterates. This ensures that every research work protocol complies with ethical criteria, which include the data privacy of research participants.

“We preceded the Data Privacy Act,” states Dr. Jacinto Blas Mantaring, overall chairman of the UPM-REB, which currently has six reviewing panels. The Data Privacy Act, or Republic Act No. 10173, was passed in 2012.

Two years prior, UPM-REB was established to integrate ethics committees that had already been operating in UP Manila as far back as 1979. The National Institutes of Health, UP Manila’s resource center for health research, the UP Manila-Philippine General Hospital, which conducts hospital research, and the UP Manila College of Medicine had their own respective ethics review boards. They were three of only four internationally accredited research ethics boards in the Philippines in the 1990s, according to Dr. Mantaring.

 

The UP Manila Research Ethics Board during an anniversary program of the UP Manila-National Institutes of Health. Photo from the UPM-REB.

 

In streamlining the structure of continuing research ethics review, UP Manila harmonized these research protocols, forerunning the UP System directive.

According to the UPM-REB Rationale: “This strategic move will provide a strongly supportive and enabling environment for research. In addition, it will maximize the utilization of its human and institutional resources, and ensure that all types of protocols are reviewed in accordance with international and national requirements.”

According to Dr. Mantaring, UP Manila is a fitting pioneer in promoting research ethics. UP Manila is a campus where international research is conducted. As with journal publications, it requires approval of accredited ethics review committees. But foremost, UP Manila as a health sciences center deals with the health of human beings, whose rights are no less a priority when they become subjects of research. “We have to make sure that our patients and participants of research are protected.”

Consequently, UP Manila has become a go-to campus for the rest of the University for research works that directly involve human subjects and those that would require formal ethical review.

Approval from UPM-REB assumes compliance with international and national guidelines to protect human participants in research and to ensure the integrity of the scientific data. These include those of the World Medical Association Declaration of Helsinki (WMA-DoH); the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonised Tripartite Guidelines for Good Clinical Practice E6(R1); the Council for International Organization of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS-Biomedical); and, the Council for International Organization of Medical Sciences International Ethical Guidelines for Epidemiological Studies (CIOMS-Epidemiology).

Nationally, UPM-REB complies with the following: the National Ethical Guidelines for Health Research, Department of Science and Technology (DOST) Administrative Order 001 Series of 2007, which requires ethics review of all health research involving human participants; the Department of Science and Technology (DOST) Administrative Order 001 Series 2008, which requires all Ethics Review Committees (ERB)/Institutional Review Committees (IRB) to register with the Philippine Health Research Ethics Board (PHREB); and, the Commission on Higher Education (CHEd) Memorandum Order 34 Series 2007 in support of the DOST memorandum, which requires all academic institutions engaged in human research to establish ethics review boards/committees.

These guidelines on data privacy precede the Data Privacy Act of 2012. They are in compliance with the Act that the UP System issued earlier for the establishment of research ethics committees or boards in each CU throughout the UP System and their accreditation with the Philippine Health Research Ethics Board (PHREB).

While other constituent universities may not focus on health research, “the Philippine National Health Research System (PNHRS) Act and the National Ethical Guidelines on Health and Health-Related Research 2017 (NEGHHR) define health broadly, such that social research and other research will fall under the definition of ‘health research’ and ‘health-related research’ under the PNHRS law.” This is according to the memorandum from the Office of the UP President on Organizational and Technological Security Measures for Data Privacy Act Compliance dated February 13, 2019.

“The CUs do a lot of health-related research where they have special expertise,” Dr. Mantaring expounds. “If UP Los Baños researchers submitted to us protocols on food and nutrition, that would not be our expertise. We would need to get a reviewer for that who would most likely come from the CU itself.” It is better a CU forms its own research ethics board.

Dr. Jimeno is glad for the affirmation brought about by the Data Privacy Act and its implementation by the UP System. “It’s easier for us to just tell [researchers] to be compliant in the way the protocols are run, the way they obtain informed consent [in the privacy and confidentiality section], even the process of securing informed consent, down to the site where the consenting will take place.”

The UPM-REB, the pioneer, currently composed of 150 regular members and independent consultants, can be tapped to share these experiences with the other CUs to help the UP System implement its directive institutionalizing data privacy and, by extension, research ethics.

 

A collage of the review panels and the Serious Adverse Events Committee of the UP Manila Research Ethics Board. Photo from the UPM-REB.

 


 

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