Chapter 13. Health, Science and Environmental Research

Health research ethics. Clinical trials and health research with human participants are usually subject to formal ethics review by committees and sometimes by national regulators. Many countries require registration of health research in national registers or approval from health ministries (for example, Malaysia’s national medical research register and the Philippines’ PHREB system) [16]. Many committees follow international standards and may be recognized through the FERCAP network [15]. Follow the Declaration of Helsinki and CIOMS guidelines, including standards for research in low-resource settings, community engagement and post-trial access [1][2].

Biological samples. Collecting, storing, exporting and using human biological samples require consent for specific uses, protection of identity, and often specific laws and agreements. Singapore’s Human Biomedical Research Act regulates research involving human tissue [23]. Material Transfer Agreements and export permits are usually required for specimens leaving the country.

Biodiversity and genetic resources. Many Southeast Asian countries have laws on access to biological resources and benefit sharing under the Convention on Biological Diversity and the Nagoya Protocol [26]. Malaysia, for example, has a national access and benefit-sharing law, with additional state-level regulation in Sabah and Sarawak [24]. In the Philippines, wildlife and bioprospecting rules require permits from environmental agencies. Research on plants, animals, microbes and genetic data in the region typically requires permits in advance. Check whether digital sequence information is covered.

Protected species and areas. Research on protected species may need permits under national laws and the CITES convention, which also governs export of specimens [27]. Fieldwork in national parks, forest reserves and marine parks usually requires separate permission from park authorities.

Environmental and field science. Plan for safety, access, seasonal conditions and community relations. Involve local scientists and communities, and share data and specimens in line with agreements. Consider the effect of your presence on fragile ecosystems.

Agricultural and development research. Many projects involve farmers and rural communities. Respect local knowledge and land rights, and design projects with participants to ensure benefits.

Animal research. Use institutional animal care and use committees, apply the “3Rs” (replace, reduce, refine), and follow national and international standards.

Research on health systems and policy. Even non-clinical health systems research may require ethics approval and permission from health authorities.

Data and specimen sharing. Follow FAIR principles while respecting privacy, community rights and legal limits [13].

Reflection: List every permit and agreement needed for the samples, species or locations in your study.