scholarly journals PARENTAL OPINION FOLLOWING DEFERRED CONSENT FOR NEONATAL RESEARCH

2019 ◽  
Vol 55 (S1) ◽  
pp. 49-49
Keyword(s):  
Deferred Consent ◽  
Parental Opinion

Observational study of parental opinion of deferred consent for neonatal research

2020 ◽  
pp. fetalneonatal-2020-319974
Author(s):  
Samantha Sloss ◽  
Jennifer Anne Dawson ◽  
Lorraine McGrory ◽  
Anthony Richard Rafferty ◽  
Peter G Davis ◽  
...  
Keyword(s):  
Decision Making ◽  
Observational Study ◽  
Neonatal Intensive Care ◽  
Research Study ◽  
Consent Process ◽  
Tertiary Level ◽  
Parental Rights ◽  
Deferred Consent ◽  
Negative Comments ◽  
Parental Opinion

ObjectiveTo evaluate the opinions of parents of newborns following their infant’s enrolment into a neonatal research study through the process of deferred consent.DesignMixed-methods, observational study, interviewing 100 parents recently approached for deferred consent.SettingTertiary-level neonatal intensive care unit, Melbourne, Australia.ResultsAll 100 parents interviewed had consented to the study/studies using deferred consent; 62% had also experienced a prospective neonatal consent process. Eighty-nine per cent were ‘satisfied’ with the deferred consent process. The most common reason given for consenting was ‘to help future babies’. Negative comments regarding deferred consent mostly related to the timing of the consent approach, and some related to a perceived loss of parental rights. A deferred approach was preferred by 51%, 24% preferred a prospective approach and 25% were unsure. Those who thought prospective consent would not have been preferable cited impaired decision-making, inappropriate timing of an approach before birth and their preference for removal of the decision-making burden via deferred consent. Seventy-seven per cent thought they would have given the same response if approached prospectively; those who would have declined reported that a prospective approach under stressful conditions was unwelcome and too overwhelming.ConclusionIn our sample, 89% of parents of infants enrolled in neonatal research using deferred consent considered it acceptable and half would not have preferred prospective consent. The ability to make a more considered decision under less stressful circumstances was key to the acceptability of deferred consent.

Deferred consent for the enrolment of neonates in delivery room studies: strengthening the approach

2019 ◽  
pp. fetalneonatal-2018-316461 ◽  
Author(s):  
Maria C den Boer ◽  
Mirjam Houtlosser ◽  
Elizabeth E Foglia ◽  
Peter G Davis ◽  
Anton H van Kaam ◽  
...  
Keyword(s):  
Delivery Room ◽  
Deferred Consent

scholarly journals Co-enrolment to UK Critical Care Studies – A 2019 update

2020 ◽  
pp. 175114372097154
Author(s):  
Timothy Felton ◽  
Natalie Pattison ◽  
Simon Fletcher ◽  
Simon Finney ◽  
Tim Walsh ◽  
...  
Keyword(s):  
Critical Care ◽  
Health Research ◽  
Time Frame ◽  
High Quality Research ◽  
Deferred Consent ◽  
Ventilation Weaning ◽  
Trial Outcomes ◽  
Mechanical Ventilation Weaning ◽  
Short Time ◽  
Critical Care Trial

In 2013, a group of clinicians on behalf of the National Institute for Health Research, collaborated with ICU Steps to produce guidance about people being enrolled in more than one critical care trial. This is referred to as “co-enrolment” and can be where a person takes part in one study at the same time as another study (or one after the other in a short time-frame). For instance, being part of a study looking at sepsis drugs and a mechanical ventilation weaning study. The drivers for developing this guidance were a lack of any existing guidance, nationally and internationally, at that time, and a desire to ensure high quality research is conducted. The emphasis was on making trials as safe as possible for patients and ensuring robust trial outcomes. Critical care was seen to lead in this, with our exemplar guidance used across all health research. We wish to revisit this guidance now that there is more experience of coenrolment in critical care trials. There is also more awareness of different consent models, such as deferred consent (taking consent when a person is awake and able to give consent) and consultee consent (asking families or independent professionals to consent). Consenting to coenrolment is an important ethical consideration for the revision of this guidance.

UTILIZATION OF THE DEFERRED CONSENT MECHANISM IN CLINICAL TRAUMA RESUSCITATION RESEARCH

1993 ◽  
Vol 35 (1) ◽  
pp. 159
Author(s):  
Collin E.M. Brathwaite ◽  
Christina G. Rehm ◽  
Steven E. Ross
Keyword(s):  
Trauma Resuscitation ◽  
Deferred Consent

Deferred consent in a multicenter prehospital clinical trial

1994 ◽  
Vol 23 (3) ◽  
pp. 619-620
Author(s):  
M.T. Craig ◽  
N.S. Abramson ◽  
P. Safar ◽  
H. Herzog
Keyword(s):  
Clinical Trial ◽  
Deferred Consent

scholarly journals Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e018562 ◽  
Author(s):  
Jeremy Furyk ◽  
Kristin McBain-Rigg ◽  
Kerrianne Watt ◽  
Theophilus I Emeto ◽  
Richard C Franklin ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Care ◽  
Qualitative Evaluation ◽  
Febrile Seizures ◽  
Therapeutic Window ◽  
Critically Ill Children ◽  
Emergency Research ◽  
Ethical Guidelines ◽  
Deferred Consent ◽  
Paediatric Emergency

BackgroundA challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency research.ObjectivesTo explore the attitudes of parents to the concept of DC and to expand the knowledge of the limitations to informed consent and DC in these situations.MethodChildren presenting with uncomplicated febrile seizures or bronchiolitis were identified from three separate hospital emergency department databases. Parents were invited to participate in a semistructured telephone interview exploring themes of limitations of prospective informed consent, acceptability of the DC process and the most appropriate time to seek DC. Transcripts underwent inductive thematic analysis with intercoder agreement, using Nvivo 11 software.ResultsA total of 39 interviews were conducted. Participants comprehended the limitations of informed consent under emergency circumstances and were generally supportive of DC. However, they frequently confused concepts of clinical care and research, and support for participation was commonly linked to their belief of personal benefit.ConclusionParticipants acknowledged the requirement for alternatives to prospective informed consent in emergency research, and were supportive of the concept of DC. Our results suggest that current research practice seems to align with community expectations.

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