Aims Decisions made in the ‘best interests’ of the infant as vulnerable members of our society deserve the highest levels of protection. How decisions are made where medical research in infants is conducted has become an area of concern and there are evident gaps in the current research framework, ethical guidance and legal framework pertaining to the approach and conduct of research in infants. The general statements of research principles that currently exist are generic to research in children but are not readily applicable to research in infants. Infants are unique as a research group.

Methods A review was undertaken as part of an LLM thesis to explore the current legal and ethical regualatory framework pertaining to research in infants

Results Current research legal and ethical regulations governing therapeutic and non therapeutic research in infants remains vague, particularly with regard to protection of infants in clinical trials and within the area of non therapeutic research, which is an area of greatest contention concerning the infant who lack mental capacity to make decisions. The law apparently does not appear to actually allow non therapeutic research in infants as the term non therapeutic research confers no personal benefit to the infants and the over-reaching principle is that the interests of the infant must prevail over the interests of science and society. Account must be taken that non therapeutic research is necessary and needed in infants because they do not respond to drugs the way adults or older children do. In the absence of any clear legal guidance in this area, any authorisation of non therapeutic research in infants who are incompetent would not be deemed to be in the infant’s best interest when he/she does not stand to gain from the research participation.

Conclusions Current regulatory framework underpinning medical research are not specific enough to guide how research should be conducted in infants. Where any decisions are made concerning children, the ‘best interests’ principle is familiar and largely uncontested. The current framework is not sufficiently adapted to infants and research, and broad principles such as best interests are themselves subject to a high degree of interpretation.