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In line with the implementation of new regulations for the Philippine Health Research Ethics Board (PHREB), a Regulatory Update Training was conducted for lecturers, accreditors, and other members of the PHREB last 29 to 30 April 2019 at the Consunji Room, Bahay ng Alumni, University of the Philippines (UP) Diliman, Quezon City. The training aims to provide information on data privacy, guidance documents of the US Food and Drug Administration (FDA) in comparison with that of the Philippine FDA, safe data management and reporting for conflicts of interest, serious adverse events, deviations and amendments for a more effective clinical research.

The two-day training was facilitated by Balik Scientist Dr. Fidela Ll. Moreno who is also a Strategic Operations Consultant at the Intermountain Heart Institute, Salt Lake City, Utah, USA. Aside from this, Dr. Moreno is also a Visiting Professor at the University of Santo Tomas (UST), Faculty of Medicine and Surgery; Professional Chair of Medicine and Allied Health Sciences at the University of Perpetual Help; Consultant at Research Institute for Tropical Medicine and Consultant of the FDA Philippines.

Focusing on the regulations for Data Protection, the discussions centered on the compliance of the country with international standards, specifically with the Data Privacy Act of 2012 (Republic Act 10173) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The US FDA Guidance documents were also presented to share the best practices which protect the patient’s rights, safety, and welfare in producing clinical research. An example of this is the Institutional Review Board (IRB) Responsibilities for the review of the qualification of investigators, the adequacy of research sites for the protection of human subjects, and the reduction of regulatory burden.

Regulations governing the informed consent was also discussed, along with its benefits and risks. Dr. Moreno further elucidated this with the privacy laws and its application to digital communication by elaborating the guidelines for the use of electronic informed consent.

Safety management and reporting was also presented as a review for the importance of monitoring and the identification and handling adverse events. This covers the role of the IRB or the Research Ethics Committee (REC) in the management of data safety, in order to safeguard the dignity, rights, and well-being of all actual or potential research participants. The lecture also covered other ethical practices for protocol violations and research practices in line with the guidelines provided by the IRB, REC, FDA and the CFR.  

To conclude the event, participants were given sample cases on breach of data privacy as examples for discussion in line with the Data Privacy Act of the Philippines.

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The Chairs of the Philippine Health Research Ethics Board (PHREB), Dr. Leonardo D. De Castro and the National Ethics Committee (NEC), Dr. Marita V.T. Reyes met with representatives of the National Museum (NM), Ms. Marites Paz Tauro and the National Commission for Culture and the Arts (NCCA), Ms. Renee Talavera on February 17, 2017 to take up steps that can be taken to harmonize efforts to ensure the protection of indigenous populations in research.

The meeting was called in the wake of attempts by a foreign researcher to continue population genetics research without approval by an ethics review committee accredited by the PHREB-CSA. PHREB and NEC learned that subsequently the researcher wrote the NM several times and called the NCCA requesting for a meeting to collaborate on a project. This incident opened the door to have a better coordination among concerned agencies interested in the protection of the rights, dignity and welfare of the Indigenous Peoples (IPs).

This initial meeting was followed by a dialogue among the NCCA, NM and the National Commission on Indigenous Peoples (NCIP) last 30 March 2017 that clarified the mandates and roles of different agencies regarding research involving humans and human materials and identified and developed coordinating mechanisms regarding research involving humans and human materials.

 It was consequently decided that a seminar-workshop be organized to address these issues and ensure better coordination among these agencies. A Research Coordination Seminar was conducted last July 25, 2017 to; a. Clarify the respective mandates of the concerned agencies relating to research activities involving ICCs/IPs; b. Enhance awareness of the staff and officials of the participating agencies on the  national research ethics governance structure and policies and; c. Develop coordinating mechanisms among the different agencies to strengthen implementation of research policies and guidelines for the protection of rights, dignity, and welfare of Indigenous Cultural Communities (ICCs)/Indigenous Peoples (IPs). Each agency elucidated their guidelines, regulations and mandates in the conduct of research.

The discussions surfaced several insights/realizations as follows:

  • The different agencies were stakeholders  in research, albeit  playing   different  roles, ii.e.,  PHREB is the national policy-making body in ethics in research  while   NCIP cultural communities  were  identified as the frequent  site  of  research and the IPs  as participants  in research.  On the other hand, the National Museum is the researcher and the NCCA is a research funding agency.
  • The NCIP FPIC process is many-layered and has made it very difficult for researchers to do research with IPs /ICCs. The FPIC is generally perceived   as not promotive of research.
  • It was explained that the FPIC process was established to protect the rights of the IPs /ICCs rather than to promote and support research.
  • The NCCA requires ethics review of research proposals either by the NCCA ethics committee or the ethics committee of the institutions where proponents come from. The NCCA ethics committee, however, needs to enhance its capacity for review. It will also need to be accredited by PHREB to make it part of the national research ethics system.  
  • Sanctions for ethics violations are not explicit and maybe the reason why researchers are not so keen in minding ethical behavior in research.

The following recommendations were made:

  • For NCIP  to share its research agenda  with the NCCA who, in turn,  can help  with specific projects  as technical  consultants  and  in funding support.  This will contribute to capacity-building in research.
  • For NCIP, NM, and NCCA to consider research collaborations.
  • For PHREB to assist NCIP establishing and capacitating research ethics committees in the different regions to shorten the process on obtaining the FPIC.
  • For PHREB to help enhance the capacity of the NCCA ethics committee.
  • For NCIP to continue its efforts in simplifying the FPIC process. One possible mechanism is to categorize researches match each category with the corresponding complexity and extent of the FPIC process.                                                                                                                                                                                                            
  • For the four (4) agencies (viz, PHREB, NCIP, NM and NCCA) to continue coordination/conversation through an annual meeting similar to the present seminar.
  • The four agencies formed a small group (Task Force) to clarify issues and identify necessary documents establish the nature of ethical violations committed by an identified researcher. The following were suggested as members of the group: Marita Reyes (PHREB), Atty. Gillian S. Dulnuan (NCIP), Ms. Renee Talavera (NCCA) and Maria Paz Tauro (NM).

The first Inter-agency task force meeting was held last 16 November 2017. It was suggested that the “task force” be regularized into a coordinating committee so that its activities and recommendations become official.  The suggested name of the committee is “Interagency Committee on Ethics in Research on Culture and Research Involving IPs”.  This can be affected through a Memorandum from the PHREB. The committee shall essentially function as a steering committee in the joint activities of the four agencies. 

The members of the above committee shall have the following responsibilities:

  • Represent his/her agency and act as point person in its ethics review activities
  • Attend meetings called by any of the four (4) agencies.
  • Share information/ resources relevant to the agenda
  • Regularly update their agencies regarding specific programs and projects
  • Provide possible assistance to the member agencies to enhance coordination/collaboration

Inter-Agency Committee on Ethics in Research on Culture and Research Involving Indigenous Peoples (IPs) will be represented by the following:

  • NCIP – Dr. Carlos P. Buasen, Jr. and Atty. Michael M. Mamukid and Dr. Angelica M. Caliba-Cachola as alternate member
  • NCCA – Ms. Renee C. Talavera
  • NM – Ms. Mary Jane Louise Bolunia
  • PHREB – Dr. Leonardo D. De Castro and Dr. Marita V.T. Reyes

March 18, 2019 when the Memorandum of Understanding (MOU) of the Inter-agency was signed and notarized which formalized the establishment of an Interagency Committee on Ethics in Research on Culture and Research Involving IPs to function as a steering group in joint activities of the parties on research ethics.

The Inter-Agency Committee is organized to build capacities of member-agencies on the establishment of research ethics committees and conduct ethics review; develop appropriate strategies and measures to ensure that research studies conducted on Indigenous Cultural Communities (ICCs)/IPs comply with R.A. 8371, or the Indigenous Peoples Rights Act (IPRA) of 1997 and other related laws; and coordinate and cooperate with the appropriate government agencies, non-governmental organizations, and Higher Education Institutions (HEIs) on the information dissemination campaign on ethics in research on Philippine culture and art, specifically those concerning ICCs/IPs.

This MOU shall remain in full force and effect unless otherwise terminated by operation of law or by a written mutual agreement of teh parties fro termination/cancellation of this Understanding.

Click Here to Download MOU Inter-Agency File

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