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The continuing evolution of clinical research ethics
Sloss and colleagues1 describe a qualitative investigation in which they sought the views of parents whose babies had been enrolled into a research study using ‘deferred consent’. In deferred consent, and the related process ‘waiver of consent’, the parent or legal guardian is informed about a study after enrolment and their agreement for their infants’ participation is sought retrospectively. As the procedure or treatment has already taken place, in reality this means seeking consent to use data that have already been collected, and for any continued participation. Research ethics review boards in many countries have accepted the need for deferred consent or consent waivers, because without this, studies in situations where immediate or emergency intervention is necessary would largely be precluded.
The team from the Royal Women’s Hospital in Melbourne interviewed 100 parents who had consented to a deferred request; 62 had also experienced a prospective consent process. The overwhelming majority (89) considered deferred consent acceptable. Additionally, 51 did not think prospective consent would have been preferable, 25 were unsure and 24 thought prospective consent would have been preferable. Of note, 77 parents felt they would have given the same answer if they had been approached prospectively, and only seven thought they would have declined. Parents identified their stress and anxiety following the birth of a preterm or sick baby as likely to have hindered their ability to make clear decisions. These practical and emotional perspectives underpinned their views and of importance, overshadowed any ethical considerations or concern over loss of parental rights.
The study by Sloss and colleagues is a useful addition to the growing body of evidence justifying the continued evolution of research ethics. Ethical considerations, …
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Disclaimer The views expressed are the author’s own.
Competing interests NM is immediate past president of the UK Royal College of Paediatrics and Child Health, current president of the UK Medical Women’s Federation and president-elect of the British Medical Association; she is a member of the National Research Ethics Advisory Service of the UK Health Research Authority.
Provenance and peer review Commissioned; externally peer reviewed.