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(p. 172) Recruitment and Parental Permission for Neonatal Clinical Trials 

(p. 172) Recruitment and Parental Permission for Neonatal Clinical Trials
Chapter:
(p. 172) Recruitment and Parental Permission for Neonatal Clinical Trials
Author(s):

Benjamin S. Wilfond

and Anita R. Shah

DOI:
10.1093/med-psych/9780190647254.003.0010
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date: 20 January 2019

This chapter uses the example of a randomized clinical trial of erythropoietin in extremely premature infants to improve neurocognitive outcomes in order to highlight ethical questions related to this clinical context. One question regards whether the recruitment and permission process is more ideally conducted in the prenatal or postnatal setting. A second set of questions regards the role of the person who obtains permission and whether this should be the clinical attending or the researcher, and if it is acceptable for a clinician to hold both roles simultaneously. The normative concerns are that understanding and voluntariness can be affected by specific recruitment approaches. However, excluding some approaches has the potential to limit eligibility, which has implications for generalizability, fairness, and resource utilization. This chapter considers the normative concerns related to these recruitment approaches as well as empirical research about parental permission and parental attitudes.

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