Revisiting “Freely Given Informed Consent” in Relation to the Developing World: Role of an Ombudsman.

Background: Establishment of Sri Lankan Twin Registry demanded development of ethical guidelines, as an effective ethical framework was not available in Sri Lanka.

Design: Objectives were to find out whether the ombudsman concept exists in current informed consent practices and to investigate opinion about ombudsmen. We searched Pub Med, conducted a postal survey, and monitored Internet discussion.

Results: The responses were categorized into current practices and existing models in informed consent process, reservations expressed about current practices, arguments supporting the concept, concerns and issues, alternatives, and how to implement the proposal. The concept of a third person is not entirely novel. How to find a truly independent person, the financial implication, confidentiality, obligations, and liabilities of ombudsmen, also emerged.

Conclusions: The concept of an ombudsman is conceptually and ethically sound and acceptable but the challenges posed by this very same solution to creating a better process of informed consent will have to be faced.