ABSTRACT

For research involving competent adults, obtaining informed consent is a process that recognises and respects the autonomy of the individual. Its purpose is to enable adults to make informed choices about themselves and to safeguard their own best interests, in the full knowledge of risks versus potential benefits. In general, parents are charged with responsibility for protecting their infant from harm. In order for research ethics committees to take prime responsibility for protecting the infant from harm, they must be properly constituted to include the expertise necessary to make these and other evaluations, their function must be regulated and they must be consistent and not idiosyncratic in their approach. The Euricon study found that many parents stated that one of the reasons that they agreed to participation was because they trusted the doctor to act in the best interest of their baby. However, nearly all said that they did not wish doctors to make decisions without involving parents.