Informed consent in the NICU setting: an ethically optimal model for research solicitation.

Recruiting patients for studies in the Neonatal Intensive Care Unit is a complex endeavour. Much discussion has occurred regarding the optimal recruitment "model" for this environment. This paper discusses current and suggested recruitment models for the NICU setting and presents a systematic approach to the consent process that focuses on the protection and promotion of parental autonomy. The proposed model incorporates several key considerations for an ethically optimal approach to the inclusion of neonates in research: informing parents about research and their rights prior to any solicitation, asking parents if they wish to be approached for research, approaching for one study at a time, assuring the study is relevant to the infants' current clinical status, minimising information overload, allowing parents appropriate time (which will vary from study to study) to consider their choice, and providing a waiting period between subsequent approaches. It is argued that parental ability to make a truly informed choice may be improved when following the proposed model.