Table 1.

Responsibilities of stakeholders for vulnerable participants

Sponsor	Justification for inclusion of vulnerable participants
	Provisions for protecting safety of participants
	Enable monitoring and quality assurance
Investigator	Recognition of vulnerability
	Ensure additional safeguards for protection of participants
	Justification for inclusion of vulnerable participants
	Address conflict of interest
	Empower the participant to make decisions
	Respect dissent from the participant
	Avoid exploitation/retaliation/reward/credits
	Well-documented informed consent process
	Additional safeguards for protection
Ethics committee	Review of justification for inclusion of vulnerable participants
	Careful examination of risk-benefit, and risk minimization
	More frequent review and monitoring