Functions of the IRB

1. Legal and Regulatory Framework

• Regulatory Authorities: obtained from the National Health Research Ethics Review Committee (NHRERC), the IRB plays a supervisory role to all the human subject studies conducted at SPHMMC.
• National Guidelines: SPHMMC has adopted the National Health Research Ethics Guidelines, which align with international standards such as the Declaration of Helsinki and the Belmont Report.
• Institutional Mandate: SPHMMC established an IRB, which operates under the oversight of the institution but in compliance with national guidelines that is independent in its aspect.

2. Structure of IRBs in Medical Institutions

• Composition: As per the national guideline which typically consist of a multidisciplinary panel of experts, SPHMMC IRB has 15 members that includes:
  • Medical and healthcare professionals
  • Legal experts-lawyer
  • Social scientists
  • Community representatives
  • Ethicists
  • Laypersons

With considerations of gender mix in the team

There are more than seventy potential reviewers from different departments.

• Appointment and Training: Members were appointed by the Academic and Vice provost and undergone regular ethics and scientific integrity  training to stay updated on global and national research ethics standards and certified by the national Research Ethics committee under the MOE.