The Philippine Health Research Ethics Board (PHREB) launched the 2020 Standard Operating Procedures (SOPs) Workbook online last June 23, 2020, updating the first edition released in 2015. The document serves as a guide for institutions in establishing research ethics committees (RECs), applying for PHREB accreditation, and revising their current SOPs.
 
Emphasizing the importance of ensuring the rights, safety, and welfare of human participants in conducting health research, the Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD) Executive Director Jaime Montoya referred to the workbook as a “testament to PHREB’s commitment to the universal principles for the protection of human participants in research.”
 
Authored by  former PHREB chair, Dr. Marita V.T. Reyes, the second edition of the workbook is a product of the critique and inputs of various institutions using the 2015 PHREB SOP Workbook. Dr. Reyes presented the amendments applied to the document which provides guidelines on streamlining ethical review processes and how they can be applied from the perspective of RECs. In this edition, the guidelines are reorganized and simplified to facilitate convenient referencing for its users.
 
With the updated SOPs, the current workbook addresses concerns the previous edition did not tackle. These include the policies on management of resubmissions, review of reportable negative events, management of applications for continuing review, management of appeals, and policies on exemption from review. New sections such as the glossary of terms and sample forms were also added which can be used as bases for the creation of SOPs specific to a certain REC.
 
“Ang workbook ay isang napakahalagang hakbang para sa professionalization ng ating ethics review (The workbook is a crucial contribution for the professionalization of ethics review),” said current PHREB Chair Dr. Leonardo de Castro. 
 
As of June 2020, there are currently 104 PHREB accredited RECs throughout the country.
 
The 2020 PHREB Standard Operating Procedures (SOPs) Workbook can now be downloaded through http://www.ethics.healthresearch.ph/.

Developed with funding from the Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD), the Axis Knee System was shown to attain correct mechanical axis on patients while costing 50%-100% less than its competitors in the research article entitled, “Clinical Evaluation of the Mechanical Axis Finder (MAF) by Radiologic Scanogram of 100 Consecutive Axis Total Knee Replacements.”

Mechanical axis refers to the proper alignment of the knee to the femural head (highest part of the thigh bone) when moved into different positions. 

Published in the Orthopedic Research Online Journal, the article written by Axis Knee lead developer Dr. Ramon Gustilo, Dr. Rupesh Man Sherchan, and Dr. Arlan Troncillo recorded a 93.3% correct mechanical axis rate among 100 procedures that used the mechanical axis finder or MAF, an instrument specific to the Axis Knee System. The MAF is used to locate the proper mechanical axis of the knee which improves functionality and durability of the implant for optimal use of the patient. 

The paper also highlights the Axis Knee System as a cost-effective option for total knee replacements in the country. Offering quality performance, it comes at a 50-100% lower cost than existing knee replacements in the country and 200-300% compared to its western counterparts.

The Axis Knee System was developed to address the high cost of knee implants in the country which poses a huge burden to patients in getting treatment. According to Dr. Ilustre Guloy, orthopedic surgeon at the Asian Hospital and Medical Center and one of the developers of Axis Knee System, the cost is a common reason why patients postpone or decline their surgery.

Priced at ₱60,000-₱70,000, the Axis Knee System makes world-class knee implants accessible to more Filipinos. “The Axis Knee System shows the DOST-PCHRD’s commitment to making lives better by providing high quality and affordable health solutions through research and development,” said DOST-PCHRD Executive Director Jaime Montoya.

The device has been in the market since 2015 through Orthopaedic International Inc. For more information about the Axis Knee System, you may visit this link: http://pchrd.dost.gov.ph/index.php/programs-and-services/create-article/6349-axis-knee-system-confidence-in-every-step



References

 

Citing examples of health research frameworks from countries including the Philippines, the World Health Organization (WHO) highlights the role of establishing regional and international partnerships for stronger national health research systems in the report: “What is the evidence on policies, interventions and tools for establishing and/or strengthening national health research systems and their effectiveness?” by the Health Evidence Network (HEN).

 

Emphasizing the importance of continued commitment and adequate funding for health research, the report elaborated on how regional and international partnerships can help “generate benefits from combined resources and diverse perspectives.” 

 

“Building partnerships or regional initiatives or interventions through which countries analyse their situation and might collaborate with peers (will help) identify ways to strengthen the health research system of each country,” the report states.

 

Accordingly, the Philippine National Health Research System (PNHRS) is built through cross-cutting partnerships among international, national and regional agencies. Institutionalized in 2013, the PNHRS is implemented by four core agencies --- the Department of Science and Technology (DOST), Department of Health (DOH), Commission on Higher Education (CHED), and the University of the Philippines Manila.

 

Aiming to harness the potential of each region, the PNHRS framework is mirrored in all regions of the country through the Regional Health Research and Development Consortia (RHRDC). Each RHRDC addresses concerns relating to its health research agenda, development of human resource, conduct of researches, dissemination of research results, research utilization, resource mobilization, leadership and management addresses concerns related to health research, and mobilizes resources specific and abundant to each region.

 

The RHRDCs are the bridge of PNHRS to reach the communities. PNHRS connects with the communities through the RHRDCs to learn from them, understand their needs, and develop responsive health research initiatives," DOST-Philippine Council for Health Research and Development (PCHRD) Executive Director Jaime C. Montoya explains.

 

As one of the implementing agencies of the PNHRS, WHO also cites the partnership of DOST-PCHRD with the United States National Institutes of Health (US-NIH) and the United Kingdom Medical Research Council (UK-MRC) as an approach in line with the objective of “launching a proactive policy (which) will encourage and accompany consistent international collaborations,”   by Inserm--the National Institute of Health and Medical Research of France.

 

In 2017, DOST-PCHRD signed a partnership with the US-NIH for the establishment of the Regional Prospective Observational Research in Tuberculosis (RePORT) Consortium in the Philippines to create a platform for collaborative research on tuberculosis (TB) in the country. Meanwhile, DOST-PCHRD’s partnership with the UK-MRC through the Newton Agham Program in 2016, supports research projects which address diseases that impact the most vulnerable in the society such as malaria, HIV, schistosomiasis, dengue, antimicrobial resistance, tuberculosis, rabies, and diabetes.

 

DOST-PCHRD also pursued local and international partnerships to capacitate the country’s pool of experts. Together with the Asia Pacific Association of Medical Journal Editors (APAME) and the  Philippine Association of Medical Journal Editors (PAMJE), DOST-PCHRD organizes a biannual medical research writing program for Filipino researchers. DOST-PCHRD was also able to secure partnerships with the University of Trieste (UNITs) and Fondazione Italiana Fegato (FIF) in 2019, which allows the country to send scholars to UNITs for the PhD Program in Molecular Biomedicine.

 

The PNHRS is an integrated national health research framework which aims to provide an enabling environment for health research for the achievement of the country’s national health goals through partnerships, collaborations and cross-cutting strategies.

 

Through the continuous effort of the System and its implementing agencies, WHO cites the Philippines as among countries with important progress in health research and as an NHRS model for low- to middle-income countries in the same report by HEN.  Previous report can be read here: bit.ly/pnhrswho-report.

As COVID-19 continues to be a public health burden with the lack of existing vaccines, the University of the Philippines - Philippine General Hospital (UP-PGH) with support from the Department of Science and Technology - Philippine Council for Health Research and Development (DOST-PCHRD) will conduct the project: “Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients with COVID-19.”

 

Adjunctive therapy is a treatment used to support the main or primary treatment of diseases. As definite therapy for COVID-19 is still lacking, the project aims to evaluate the efficacy and safety of convalescent plasma transfusion as adjunctive therapy to prevent disease progression among hospitalized COVID-19 patients. Convalescent plasma is taken from the blood of patients who recovered from infection and contains neutralizing antibodies against it.

 

According to Dr. Michael Ryan, Executive Director of the Health Emergencies Program of the World Health Organization (WHO), the use of convalescent plasma transfusion is a valid approach in treating infectious diseases as demonstrated in previous outbreaks such as the H1N1 influenza virus pandemic, 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic. In a press conference in Geneva last February, he explained that through the transfusion, “you're giving (the patients) a boost of antibodies to hopefully get them through the very difficult phase.

 

“For the past months, we have been mobilizing our resources and maximizing our capacities to help combat COVID-19. Through this project, we are hoping to provide supportive treatment to COVID-19 patients to avoid worst-case scenarios,” DOST-PCHRD Executive Director Jaime C. Montoya says. “If the project proves to be successful, we can also contribute to developing a treatment that will help reduce the mortality rate of COVID-19,” he adds.

 

Aside from potentially developing locally-produced convalescent plasma which may be used as part of the COVID-19 treatment regime, the project also aims to strengthen the capacities of healthcare professionals in its clinical use, not only for COVID-19, but also for other emerging infections in the future.

 

The team has started the call for blood donations from COVID-19 survivors last April 2020. The project will run for 12 months.

References:

The Association of Southeast Asian Nations (ASEAN) celebrates the ASEAN Dengue Day every 15th of June since its declaration in 2011. According to the World Health organization (WHO), the celebration aims to raise awareness on dengue, mobilize resources for its prevention and control, and demonstrate the region’s commitment to tackling the disease.

While the Department of Health (DOH) announced last January that there is a steady decline in cases of dengue in the country, DOH Secretary Francisco Duque reminded the public to not be complacent, remain vigilant, and sustain the gains of the enhanced 4S strategy to keep dengue at bay.

To further mitigate the threat of dengue, the Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD) continues to support the DOH by funding relevant studies to improve the dengue situation in the country. Some of these studies are:

The Performance of an Innovative Auto Dissemination of Insecticides (InDAI) for Dengue Mosquito Control in the Philippines Program which aims to evaluate the efficacy of the InDAI trap in the reduction of mosquito densities in selected cities in the National Capital Region.

The Aedes Genomics Adaptation Program that investigates the genomic underpinnings of Aedes species’ adaptation to extreme temperature conditions. To date, the program is the first to publish the full genome of a female Aedes aegypti - a piece of data which will be key to understanding vector biology.

A program on Philippine land use change and arbovirus diversity surveillance and monitoring of viral pathogens in the country which sought to investigate how land use change in Barangays Bagong Silang, Lalakay, and Bayog in Los Baños, Laguna, have affected the transmission of dengue within the communities.

In the spirit of awareness, the Council encourages everyone to follow simple but effective steps like removing or covering all areas with stagnant water, installing screens on windows, using mosquito repellants, and wearing long-sleeved shirts when outdoors.

 

Sources:

https://www.who.int/philippines/news/feature-stories/detail/asean-dengue-day-the-philippines-leads-efforts-in-dengue-control-and-prevention

https://www.doh.gov.ph/doh-press-release/doh-reports-steady-decline-in-dengue-cases

https://www.nea.gov.sg/docs/default-source/resource/first-asean-dengue-day-with-inauguration-of-the-environmental-health-institute-as-a-who-collaborating-centre_1.pdf