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Deferred consent for delivery room studies: the providers' perspective.

Abstract

OBJECTIVE

To gain insight into neonatal care providers' perceptions of deferred consent for delivery room (DR) studies in actual scenarios.

METHODS

We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0.

RESULTS

Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent.

CONCLUSION

Insight into providers' perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on.

Authors+Show Affiliations

Division of Neonatology, Leiden University Medical Center, Leiden, Netherlands m.c.den_boer@lumc.nl. Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, Netherlands.Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, Netherlands.Division of Neonatology, Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.Division of Neonatology, Leiden University Medical Center, Leiden, Netherlands.Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, Netherlands. Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, Netherlands.Division of Neonatology, Leiden University Medical Center, Leiden, Netherlands.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31427459

Citation

den Boer, Maria C., et al. "Deferred Consent for Delivery Room Studies: the Providers' Perspective." Archives of Disease in Childhood. Fetal and Neonatal Edition, 2019.
den Boer MC, Houtlosser M, Foglia EE, et al. Deferred consent for delivery room studies: the providers' perspective. Arch Dis Child Fetal Neonatal Ed. 2019.
den Boer, M. C., Houtlosser, M., Foglia, E. E., Lopriore, E., de Vries, M. C., Engberts, D. P., & Te Pas, A. B. (2019). Deferred consent for delivery room studies: the providers' perspective. Archives of Disease in Childhood. Fetal and Neonatal Edition, doi:10.1136/archdischild-2019-317280.
den Boer MC, et al. Deferred Consent for Delivery Room Studies: the Providers' Perspective. Arch Dis Child Fetal Neonatal Ed. 2019 Aug 19; PubMed PMID: 31427459.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Deferred consent for delivery room studies: the providers' perspective. AU - den Boer,Maria C, AU - Houtlosser,Mirjam, AU - Foglia,Elizabeth E, AU - Lopriore,Enrico, AU - de Vries,Martine Charlotte, AU - Engberts,Dirk P, AU - Te Pas,Arjan B, Y1 - 2019/08/19/ PY - 2019/03/22/received PY - 2019/07/22/revised PY - 2019/08/03/accepted PY - 2019/8/21/entrez KW - data collection KW - ethics KW - neonatology KW - qualitative research KW - resuscitation JF - Archives of disease in childhood. Fetal and neonatal edition JO - Arch. Dis. Child. Fetal Neonatal Ed. N2 - OBJECTIVE: To gain insight into neonatal care providers' perceptions of deferred consent for delivery room (DR) studies in actual scenarios. METHODS: We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0. RESULTS: Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent. CONCLUSION: Insight into providers' perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on. SN - 1468-2052 UR - https://www.unboundmedicine.com/medline/citation/31427459/Deferred_consent_for_delivery_room_studies:_the_providers'_perspective L2 - http://fn.bmj.com/cgi/pmidlookup?view=long&pmid=31427459 DB - PRIME DP - Unbound Medicine ER -