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1,2MCA De Ungria and 3EB Jimenez

1 DNA Analysis Laboratory, Natural Sciences Research Institute, University of the Philippines Diliman 2 Program on Biodiversity, Ethnicity and Forensics, Philippine Genome Center 3 Ethics Review Board, University of the Philippines Manila

For many years, scientists have been interested in studying the genetics of indigenous cultural communities/ indigenous peoples (ICCs/IPs) in the Philippines because this field can answer questions posited by linguists, anthropologists, and archaeologists on human migration from Africa to Asia and Oceania. Researchers are interested in learning about adaptations to environmental conditions due to the relative isolation of ICCs/IPs. Their culture is less affected by intercultural contact, and their genetics less admixed with other populations.  Areas of inquiry that have also generated interest are health and forensic applications of population genetic variation studies. This paper aims to describe essential processes in the conduct of genetic research on ICCs/IPs in the Philippines. Requirements for conducting studies were surveyed in order to capture the current ethical challenges in conducting genetic research with Philippine ICCs/IPs[1].

Human genetics research in the Philippines must follow policies/guidelines prescribed by the Philippine Health Research Ethics Board (PHREB) following Republic Act No. 10532 or the Philippine National Health Research System (PNHRS) Act of 2013. Rule 23(b) of the PNHRS Implementing Rules states: “All research involving human subjects must undergo ethical review and clearance before implementation to ensure the safety, dignity, and well-being of research participants. The research ethics review shall be facilitated by a Research Ethics Committee duly registered with and accredited by PHREB …”  

Many will argue that ethics review of research involving humans (including biological specimens and data) represent a mere bureaucratic requirement; that a better path is indicated if we just trust researchers, as their work is driven by an objective scientific agenda. But a researcher is only one stakeholder in research, representing his own interests and working in a context that is understandably influenced by institutional thrusts, or even funder agency agenda, and even aspirations of the scientific community.

The research activity does not exist in a vacuum, as different stakeholders promote their own (sometimes competing or conflicted) interests towards scientific objectives. But what about research participants? Research participants are the most unconflicted stakeholders because they have no control in how research is conducted compared to researchers, institutions, and funding agencies. Who will equitably represent their voice as a stakeholder in this system? Ethics review may not be a perfect system. Still, it ideally represents a common standard and understanding of how people should be protected when they are engaged to participate in research by resolving conflicting interests against the scientific objectives of the study. Hence, ethics review should be done correctly, based on consensus guidelines, policies, and even regulations.

PHREB released the 2017 National Guidelines for Health and Health-Related Research (NGHHR 2017), which contains a specific section on indigenous peoples[2]. The guidelines require that investigators must:

  • define the social value of the proposed research;
  • obtain free and prior informed consent from participants while exerting demonstrable efforts of educating volunteers;
  • recognize the vulnerability of participants and provide safeguards to reduce risks and maximize benefits;
  • protect the privacy and confidentiality of participants;
  • disclose any information that could affect the participation of persons; and
  • promote justice where burdens and benefits are equally distributed across all participants, without favoring some groups over others.

The inclusion of ICCs/IPs in research, including human genetics research, adds another layer of review and monitoring to be conducted by any one of the following institutes:

  • The National Commission on Indigenous Peoples (NCIP) that was established by Republic Act 8371 or the Indigenous Peoples Rights Act of 1997; and
  • The Ministry of Indigenous Peoples Affairs (MIPA) for non-Muslim IPs who reside within the Bangsamoro Autonomous Region of Muslim Mindanao (BARMM) includes Basilan, Lanao del Sur, Maguindanao, Sulu, and Tawi-Tawi. In November 2019, MIPA absorbed the functions of the Office of Southern Cultural Communities (OSCC).

In 2012, the NCIP issued two administrative orders, namely A.O. No. 1 known as “The Indigenous Knowledge Systems and Practices (IKSPs) and Customary Laws (CLs) Research and Documentation Guidelines of 2012”[3] and A.O. No. 3 entitled “The Revised Guidelines on Free and Prior Informed Consent (FPIC) and related processes”[4].  A.O. No. 1 provides guidelines for academic research and community-initiated studies that could be used for policy formulations and/or implementation of NCIP mandates and social research. A.O. No. 3 focuses on extensive community-wide consultations through field-based investigations needed to ensure the protection of the rights “to ancestral domains, social justice, and human rights, self-governance and empowerment, and cultural integrity” in projects that aim to commercialize certain products and knowledge as well as affect the ancestral domain of ICCs/IPs. In human genetics, there is the need to clarify the extent and nature of fundamental academic researches vs. commercial initiatives because of the confusion in the understanding of bioprospecting, data and sample ownership, and general fear of the “unknown” story that is contained in an individual or community’s DNA. Both A.O.s have defined procedures that include:

  • Submission of an application (research or project) to the NCIP regional director;
  • Approval of the application and issuance of work order for the NCIP IKSP team;
  • Formulation and approval of the work and financial plan;
  • Consultations and formulation of an agreement with the community;
  • Issuance of the Certificate Precondition by the NCIP regional office;
  • Conduct of research/project within the community with the NCIP IKSP team;
  • Reporting back to the community after the research/project;
  • Issuance of Certificate of Validation to define the level of community consent for the publication of data, use of resources, and other work products; and
  • Publication and sharing of work product to the community, NCIP, and the public.

MIPA is pending to issue requirements for research or projects under its jurisdiction. The OSCC, which preceded MIPA, has approved research and projects after proponents consulted their offices.

To ensure that health research that includes ICCs/IPs as participants follow relevant policies in the NGHHR and NCIP A.O., a memorandum of understanding was signed by PHREB and NCIP on 13 May 2016. In this MOU, NCIP agreed to advise persons applying to conduct research with ICCs/IPs to secure an ethical clearance from a PHREB accredited committee. PHREB committed to approving projects only after the proponent has secured the free and prior informed consent from the relevant ICCs/IPs. Also, the cooperation between NCIP and PHREB formalized the two institutions’ commitment to upholding the rights of ICCs/IPs by screening and holding research proponents accountable for their work. The MOU resulted in modifications of the review process of academic research conducted by accredited ethics committees of PHREB to protect IPs.

PHREB adopted the World Health Organization’s definition of health which is ”… a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity[5].  This holistic definition of health has not changed since 1948. Hence all research that includes human persons, and affects human persons, must follow NGHHR of 2017. On 7 June 2017, PHREB issued Memorandum 2017-001, which reminded all ethics review committees, higher education institutions, research institutions, and researchers to follow all existing human health research policies, including those that include ICCs/IPs, and provided the basis for these policies[6].

Following this definition of health and health research, two additional institutions, namely the National Museum (NM) and the National Commission of Culture and the Arts (NCCA) that have mandates “to study and preserve the nation’s artistic, historical and cultural heritage” and “to preserve, develop and promote Philippine arts and culture”, respectively were invited into the conversations about best practices in protecting ICCs/IPs from harm resulting of unethical research practices, as well as in promoting the development of ICCs/IPs by helping them share their own stories to the world. On 18 March 2019, the Inter-Agency Committee on Ethics in Research involving Culture and the Indigenous Cultural Communities/Indigenous Peoples (ICC/IPs) was established under a memorandum of understanding amongst these four agencies.

The Inter-Agency Committee is working towards a greater understanding of the need to protect ICCs/IPs against exploitation from knowledge derived from their DNA, natural resources, and cultural treasures, through training programs and activities with higher education institutions and agencies that are actively working with ICCs/IPs.  In fact, the ethics review committees that handled the applications for population genetics research requires:

  • the proponents to adopt an iterative process of community consultations that are appropriately documented before the issuance of an ethics clearance for the project;
  • submit informed consent forms that are understandable to the ICCs/IPs volunteers;
  • biobanking and data sharing policies that include provisions for removal of samples/data when needed; and
  • defined data privacy requirements following the Data Privacy Act of 2012.

Amidst these developments, the Inter-Agency Committee with PHREB and NCIP at the forefront must address the ethical challenges posed by researchers who have not complied with these requirements and continue to conduct research without ethical clearance and NCIP monitoring. Moreover, there is an urgent need for policies that would cover the use of samples from ICCs/IPs stored in biobanks, locally or internationally, and are being sequenced without any application for a waiver of individual consent, if justified or an appropriate community consent. Because genomic science provides information about an individual and his family, the iterative process adopted for genetic/genomic studies involving ICCs/IPs must include procedures to obtain both individual and community consent.

With the rapid development of genomic science and technologies to sequence entire genomes, including human genomes, vulnerable ICCs/IPs face challenges that they are likely ill-equipped to address. There is urgency for Philippine agencies such as the PHREB, NCIP, NM, and NCCA to formulate appropriate policies to protect IPs from exploitation arising from unethical research. Academic researchers, including those keen on knowledge discovery and publication of scientific papers to fulfill their educational mandate, must reflect on the social impact of the information in human genomic data about the people, their ancestry and origins, and cultural history. We must recognize the rights of indigenous peoples/indigenous cultural communities “…. to maintain, control, protect and develop their cultural heritage, traditional knowledge, and traditional cultural expressions, as well as the manifestations of their sciences, technologies, and cultures, including human and genetic resources, seeds, medicines, knowledge of the properties of flora and fauna, oral traditions, literature, designs, sports, and traditional games, visual and performing arts. They also have the right to maintain, control, protect and develop their intellectual property over such cultural heritage, traditional knowledge, and traditional cultural expressions.” [7]

[1] PHREB. Policies and Regulations regarding Research involving Indigenous Peoples / Indigenous Cultural Communities: Philippine Health Research Ethics Board, Memorandum No. 2017-001, 2017.
[2] PHREB. National Ethical Guidelines for Health and Health-related Research Manila: Philippine Council for Health and Research Development; 2017.
[3] NCIP. The Indigenous Knowledge Systems and Practices (IKSPs) and Customary Laws (CLs) Research and Documentation Guidelines of 2012. 2012. p. 19.
[4] NCIP. The Revised Guidelines on Free and Prior Informed Consent (FPIC) and related processes National Commission on Indigenous Peoples, 2012.
[5] Preamble to the Constitution of WHO as adopted by the International Health Conference, New York, 19 June – 22 July 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of WHO, no. 2, p. 100) and entered into force on 7 April 1948.
[6] PHREB Memorandum No. 2017-001 issued by Dr. Leonardo D. de Castro,
[7]  United Nations Declaration on the Rights of Indigenous Peoples of 2007. Article 31, Section 1.