Defining Malaysia's health research ethics system through a stakeholder driven approach

Area of Science:

• Health Research Ethics
• Health Systems Research
• Network Analysis

Background:

• Understanding health research ethics (HRE) systems is crucial but empirical descriptions are limited.
• Existing knowledge gaps hinder the effective support and oversight of ethical health research globally.
• Malaysia's HRE system lacked comprehensive mapping, necessitating empirical investigation.

Purpose of the Study:

• To empirically define Malaysia's health research ethics (HRE) system using participatory network mapping.
• To identify key functions and actors within the Malaysian HRE system.
• To pinpoint areas for enhancing HRE system capacity.

Main Methods:

• Participatory network mapping involving 13 Malaysian stakeholders.
• Identification of 4 overarching and 25 specific HRE system functions.
• Mapping of 35 internal and 3 external actors responsible for HRE functions.

Main Results:

• Key functions needing attention include advising on HRE legislation, optimizing research value, and defining oversight standards.
• Internal actors with high potential influence: national and non-institution-based research ethics committees, and research participants.
• The World Health Organization (WHO) emerged as an external actor with significant untapped influence.

Conclusions:

• The stakeholder-driven process successfully identified critical HRE functions and actors in Malaysia.
• Targeting specific functions and actors can effectively increase the capacity of the HRE system.
• This empirical mapping provides a foundation for strengthening ethical health research governance.