Abstract:
Objective: To document and explore the views and experiences of key stakeholders regarding the consent procedures of an
emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for
similar trials in future.
Methods: A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with
trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti,
Uganda, and Kilifi, Kenya.
Findings: Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the
interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the
validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be
balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays.
Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that
clinicians want to absolve themselves of any responsibility for the child’s outcome (some parents’ interpretation of the need
for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such
vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household
decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal.
Conclusion: While the challenges identified are faced in all research in low-income settings, they are magnified for
emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to
particular studies and settings, and might best be informed by consultation with staff members and community
representatives using a deliberative approach.
