Implementing two-stage consent pathway in neonatal trials

Area of Science:

• Neonatal research
• Clinical trial methodology
• Informed consent procedures

Background:

• Perinatal clinical trials often necessitate rapid participant recruitment for time-critical interventions.
• A two-stage consent pathway, involving initial oral assent and subsequent written informed consent, is supported by national guidance for such trials.
• Apprehension exists regarding the oral assent component due to concerns about record-keeping, information standardization, and process familiarity.

Purpose of the Study:

• To describe the implementation of a two-stage consent pathway in the fluids exclusively enteral from day one (FEED1) trial.
• To outline the support provided to trial sites by the FEED1 trial team.
• To offer recommendations for future trials considering a similar consent pathway.

Main Methods:

• The FEED1 trial utilizes a two-stage consent process, requiring randomization within 3 hours of birth.
• Trial sites were provided with specific support measures to facilitate the implementation of the oral assent pathway.
• The study describes the practical application and challenges encountered during the oral assent phase.

Main Results:

• The FEED1 trial has implemented a two-stage consent pathway to enable rapid recruitment for time-critical interventions.
• Specific strategies were employed to support clinical sites in managing the oral assent process.
• Apprehensions regarding the oral assent pathway were identified, mirroring previous research findings.

Conclusions:

• The two-stage consent pathway, including oral assent, is a viable method for rapid recruitment in time-critical perinatal trials like FEED1.
• Proactive support and clear guidelines are essential for successful implementation of oral assent procedures.
• Recommendations are provided to assist future research endeavors in adopting similar consent strategies.