Trust and consent: a prospective study on parents’ perspective during a neonatal trial

Dahan, Sonia; Jung, Camille; Dassieu, Gilles; Durrmeyer, Xavier; Caeymaex, Laurence

doi:10.1136/medethics-2019-105597

Cited by 13 publications

(9 citation statements)

References 32 publications

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“…We found higher levels of trust in medical researchers among enrolled parents compared with parents who declined, but no difference in trust in clinicians on 2 trust scales. The higher trust in medical researchers among enrolled parents is consistent with reflections of experienced NICU clinical researchers 15 as well as interview 7 and survey 16 studies of parents considering research participation.…”

Section: Trustmentioning

confidence: 83%

“…[3][4][5][6] There are limited data to explain how parents decide whether to participate in neonatal clinical trials. Previous research has struggled to include the views of those who decline neonatal research 7,8 with only a few exceptions. 9,10 Low enrollment rates within neonatal clinical trials diminish the quality of data collected and limit the generalizability of results.…”

Section: Introductionmentioning

confidence: 99%

“…12,13 Other parental factors that are potentially important in enrollment decisions include study comprehension 9,14 and medical trust. 7,15,16 Understanding these factors may enable researchers to improve recruitment processes, optimize enrollment rates, and decrease disparities in research participation.…”

Section: Introductionmentioning

confidence: 99%

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Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

et al. 2021

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IMPORTANCE It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations.Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation. OBJECTIVE To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial. DESIGN, SETTING, AND PARTICIPANTSThis survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020. EXPOSURE Parental choice of enrollment in neonatal clinical trial. MAIN OUTCOMES AND MEASURES Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers. RESULTSOf a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment. CONCLUSIONS AND RELEVANCEIn this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and (continued) Key Points Question How do parents with infants enrolled in a neonatal clinical trial differ from those who decline participation? Findings In this survey study including 269 parent responses, participants who enrolled their infant had different demographic characteristics (lower rate of Medicaid participation, higher income, less likely to identify as Black), reported their infant's medical condition as more serious, and reported ...

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Section: Trustmentioning

confidence: 83%

Section: Introductionmentioning

confidence: 99%

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Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

et al. 2021

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“…HCPs indicated that the trusting relationship with parents is one of the main reasons to consent, which is in line with the available literature. For example, it was reported that information written in the IC form did not always support parents' understanding ( 47 ). Similarly, HCPs raised that IC documents are often difficult to understand, due to scientific and legal information.…”

Section: Discussionmentioning

confidence: 99%

Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era

et al. 2021

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Background: Currently, many initiatives are devoted to optimizing informed consent for participation in clinical research. Due to the digital transformation in health care, a shift toward electronic informed consent (eIC) has been fostered. However, empirical evidence on how to implement eIC in clinical research involving neonates is lacking.Methods: Semi-structured interviews were conducted with 31 health care professionals active in Belgium or the Netherlands. All health care professionals had experience in conducting clinical research involving neonates. Interviews were audio-recorded, transcribed and analyzed using the framework method.Results: Interviewees generally supported the use of eIC in clinical research involving neonates. For example, eIC could enable parents to receive study feedback via the eIC system. Requirements were expressed for parental involvement to decide on which feedback would be appropriate to return. Moreover, experts specialized in presenting information and designing electronic systems should be involved. Broad consensus among health care professionals indicates that the face-to-face-interaction between parents and the research team is vital to establish a relationship of trust. Therefore, it is necessary that the use of eIC runs alongside personal interactions with the parents. Concerns were raised about the accessibility of eIC to parents. For this reason, it was suggested that parents should always be given the possibility to read and sign a paper-based informed consent form or to use eIC.Conclusions: Health care professionals' views indicate that the use of eIC in clinical research with neonates may offer various opportunities. Further development and implementation will require a multi-stakeholder approach.

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“…3 An important determining factor to the success of the informed consent process requires diligent communication and the establishment of trust between the medical team and parents, wherein ''effective interactions,'' if possible, become essential. 4 This concept establishes the focus of the research team to engage in a long-term relationship with parents beyond the initial consent approach that provides a long consideration phase and the opportunity to ask questions or otherwise interact with embedded clinical research nurses (CRNs) in the NICU.…”

Section: Introductionmentioning

confidence: 99%

Tiny Bodies, Big Needs: Prospective Biobanking of Neonatal Clinical Remnant Samples

Schleif

Hamblin

Graham

et al. 2021

Biopreservation and Biobanking

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Repurposing biological samples collected for required diagnostic purposes into suitable biobanking projects is a particularly useful method for enabling research in vulnerable populations. This approach is especially appropriate for the neonate in the neonatal intensive care unit (NICU), where blood volume reductions can quickly increase beyond minimal risk for adverse events, such as iatrogenic anemia, and proxy consent provided by parents or guardians is required. The method described in this study provides a framework to prospectively collect and store blood-derived clinical samples after all clinical and regulatory requirements are fulfilled. The consent approach incorporated a 30-day window to allow parents and guardians ample consideration time with follow-up involvement with NICU embedded study team members. The study enrolled 875 participants over a 3-year period. This established a critically needed biobank to support investigator-initiated research with explicit study aims requiring samples at defined day of life frequencies within the NICU and created a normative control reference bank for case comparisons for premature and full-term neonates with brain injury.

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Trust and consent: a prospective study on parents’ perspective during a neonatal trial

Cited by 13 publications

References 32 publications

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era

Tiny Bodies, Big Needs: Prospective Biobanking of Neonatal Clinical Remnant Samples

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