Chapter 4. International and Regional Ethical Frameworks
Foundations in research ethics. Modern research ethics grew from responses to abuses of research participants. Key documents include the Nuremberg Code (1947), the Declaration of Helsinki, first adopted by the World Medical Association in 1964 and revised several times, most recently in 2024 [1]; the Belmont Report (1979), which set out respect for persons, beneficence and justice [3]; and the CIOMS International Ethical Guidelines for Health-related Research Involving Humans (2016), which address research in low- and middle-income settings [2].
Core ethical requirements [1][2][3][62][63]:
Social and scientific value: research should answer a question worth asking, with sound methods.
Fair participant selection: do not target vulnerable groups merely for convenience.
Favourable risk–benefit balance: minimize risks and maximize benefits.
Independent review: by a competent research ethics committee.
Informed consent: voluntary, based on understandable information, with the right to withdraw.
Respect for participants: privacy, confidentiality, welfare and, where relevant, post-trial access and benefit.
Research integrity. The Singapore Statement on Research Integrity (2010) sets four principles (honesty, accountability, professional courtesy and fairness, and good stewardship) and fourteen responsibilities for researchers [4]. The Montreal Statement (2013) deals with integrity in cross-border collaborations, which is highly relevant for projects between regional and non-regional partners [5]. The Hong Kong Principles (2020) encourage institutions to assess researchers on responsible practices and open science [14].
Fair research partnerships. The Global Code of Conduct for Research in Resource-Poor Settings (2018) sets out principles of fairness, respect, care and honesty for collaborations between better- and less-resourced partners, including involvement of local communities and researchers, fair benefit sharing and avoidance of “ethics dumping” (exporting ethically problematic research to places with weaker oversight) [6]. If your project is led from outside the region, this code is essential reading.
Indigenous peoples and data. The UN Declaration on the Rights of Indigenous Peoples (2007) recognizes rights to self-determination, culture and free, prior and informed consent (FPIC) [8]. The CARE Principles for Indigenous Data Governance (Collective benefit, Authority to control, Responsibility, Ethics) complement the FAIR data principles and are increasingly expected by funders and communities [7][13]. Decolonizing methodologies challenge researchers to examine whose interests research serves [9].
Digital research ethics. The Menlo Report (2012) adapts ethical principles for information and communication technology research, and the Association of Internet Researchers provides guidelines on internet research ethics [10][70].
Regional frameworks. ASEAN is a political and economic organization and does not have a single binding regional research ethics regime. However, it supports cooperation through bodies such as the ASEAN Committee on Science, Technology and Innovation, the ASEAN University Network and the Southeast Asian Ministers of Education Organization (SEAMEO) and its specialized centres [28][31][32]. ASEAN-wide statistical and citation resources, such as the ASEAN Statistical Yearbook and the ASEAN Citation Index, support regional research [29][30]. Ethical review in practice is national and institutional, with FERCAP and national networks promoting good practice [15].
What to do
Identify which international guidelines your funder, sponsor and journal expect.
Follow the stricter of international guidance and local rules.
Do not use lower standards because local oversight seems weaker.
Document how your project addresses fairness, benefit sharing and community engagement.
Reflection: Which of the frameworks in this chapter apply to your project, and where might they conflict with local expectations?