Informed consent for neonatal trials: practical points to consider and a check list

Abstract

Obtaining informed consent from parents of critically ill neonates can be challenging. The parental decision-making process is influenced by the severity of the child’s condition, the benefit–risk balance, their emotional state and the quality of the relationship with the clinical team. Independent of local legislation, parents may prefer that consent is sought from both. Misconceptions about the absence of risks or unrealistic expectations about benefits should be openly addressed to avoid misunderstandings which may harm the relationship with the clinical team. Continuous consent can be sought where it is unclear whether the free choice of parental consent has been compromised. Obtaining informed consent is a dynamic process building on trusting relationships. It should include open and honest discussions about benefits and risks. Investigators may benefit from training in effective communication. Finally, involving parents in neonatal research including the development of the informed consent form and the process of obtaining consent should be considered standard practice.

Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh

“…In western countries and many of the hospitals are doing it already. If you go to corporate hospitals, they will do it"-Clinician 1 (1) Time pressure due to the narrow window period of recruitment Within the limited therapeutic window of cooling therapy, clinicians often had less than an hour to counsel…”

“…Informed parental consent for time-critical trials in neonatal intensive care units (NICUs) is challenging, as parents are likely to be under extreme emotional distress due to the critical clinical condition of their newborn infant. 1 In such situations, the clinical or research staff who approach parents for trial participation require specific training, skills and empathy to assist parents in making an informed and voluntary decision about their baby’s participation in a trial. The depth and level of information provided in the consenting process is expected to be proportionate to the potential for harm and the vulnerability of the trial population; for example, interventional trials may require more discussion than observational studies.…”

“…Informed parental consent for time-critical trials in neonatal intensive care units (NICUs) is challenging, as parents are likely to be under extreme emotional distress due to the critical clinical condition of their newborn infant. 1 In such situations, the clinical or research staff who approach parents for trial participation require specific training, skills and empathy to assist parents in making an informed and…”

Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era

“…However, obtaining IC from parents whose neonate is critically ill may be challenging ( 3 , 17 , 18 ). For example, parents can feel emotionally distressed or the mother can experience interfering medical conditions such as preeclampsia or post-anesthesia ( 3 , 17 , 19 ).…”

“…For example, parents can feel emotionally distressed or the mother can experience interfering medical conditions such as preeclampsia or post-anesthesia ( 3 , 17 , 19 ). Parents are often overwhelmed and may have a poor understanding of the study-related information when being under time pressure ( 18 , 20 ). As a result, they may feel incapable to decide about their neonate's participation in a research study ( 20 ).…”