Informed consent for a neonatal clinical trial: parental experiences and perspectives

Shah, Anita; Wilfond, Benjamin S.; Silvia, Amy; Hancuch, Kerry; Woodrum, D. E.; Heagerty, Patrick J.; Ohls, Robin K.; Courtney, Sherry E.; Frantz, Ivan D.; Gogcu, Semsa; Bishop, Christine E.; Ahmad, Kaashif A.; Kathen, Charmaine; Juul, Sandra E.

doi:10.1038/s41372-018-0119-6

Cited by 9 publications

(7 citation statements)

References 21 publications

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“…We administered a survey to parents of infants approached for enrollment in the HEAL trial. The survey instrument was developed using: (1) validated question scales where available, (2) questions from previous surveys on parental participation in pediatric research, and (3) questions created after input from experts in survey design, medical decision-making, clinical trials, neonatology, and research ethics. We received feedback from the neonatal intensive care unit (NICU) parent advisory council at the University of Washington.…”

Section: Methodsmentioning

confidence: 99%

“…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 with only a few exceptions . Low enrollment rates within neonatal clinical trials diminish the quality of data collected and limit the generalizability of results .…”

Section: Introductionmentioning

confidence: 99%

“…Racial and ethnic disparities exist in neonatal research enrollment, but we do not fully understand which groups are overrepresented or underrepresented . Other parental factors that are potentially important in enrollment decisions include study comprehension and medical trust . 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: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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“…For youth, this could mean investing time in making multiple contact attempts [48,52] and using multi-tiered tracking/search protocols [52,57]. For pregnant women, individuals should be approached at a time that is preferable to them (e.g., prenatally versus postnatally) [58], and staff may need to be available during nights and weekends for women who go into labor during this time [44]. Researchers should also provide solutions to logistical barriers (e.g., childcare, transportation) and concerns around privacy.…”

Section: Pregnant Women Children and Adolescentsmentioning

confidence: 99%

“…A common theme in successful recruitment and retention of pregnant women and children was that personalized interaction with study personnel helped build relationship and engender trust [44,45,52,55,57,60]. Support of pregnant women's providers may also increase enrollment rates in this population [55,58].…”

Section: Pregnant Women Children and Adolescentsmentioning

confidence: 99%

Barriers to and solutions for representative inclusion across the lifespan and in life course research: The need for structural competency highlighted by the COVID-19 pandemic

LeCroy

Potter

Bandeen‐Roche

et al. 2022

J. Clin. Trans. Sci.

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Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology

Morain,

Barlevy,

Joffe

et al. 2023

JAMA Netw Open

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ImportanceClassic statements of research ethics generally advise against dual-role consent in which physician-investigators seek consent for research participation from patients with whom they have preexisting treatment relationships. Yet dual-role consent is common in clinical oncology research, as studies are often conducted in close relationship with clinical care.ObjectiveTo explore key stakeholders’ perspectives on dual-role consent in clinical oncology trials.Design, Setting, and ParticipantsThis qualitative study with 43 participants was conducted at a National Cancer Institute–designated comprehensive cancer center from 2018 to 2022. Semistructured qualitative interviews of physician-investigators, research coordinators, and patients were performed. Respondents were recruited from 3 populations: (1) physician-investigators engaged in clinical oncology research; (2) research coordinators engaged in clinical oncology research; and (3) patients, with and without prior clinical trial experience, who had received a new cancer diagnosis at least 2 months prior to enrollment in this study.Main Outcomes and MeasuresInterviews were audio recorded and professionally transcribed. A thematic analysis approach was used to develop a codebook that included both theory-driven, a priori codes and emergent, inductive codes. Two authors double-coded all transcripts and met regularly to compare coding, discuss discrepancies, refine the codebook, and draft memos describing relevant themes and their frequency.ResultsAmong the 43 respondents, 28 (65.1%) were female; 9 (20.9%) were African American, 8 (18.6%) were Asian, 6 (14.0%) were Hispanic, and 21 (48.8%) were White; 15 were physician-investigators (6 [40.0%] with 6-10 years of experience, 4 [26.7%] with at least 20 years of experience), 13 were research coordinators (5 [38.5%] with 0-5 years of experience, 5 [38.5%] with 6-10 years of experience), and 15 were patients (9 [60.0%] aged 46-64 years). Four main themes were found: interviewees (1) perceived greater potential for role synergy than for role conflict; (2) reported dual-role consent as having mixed effects on the consent process, increasing prospective participants’ understanding and likelihood of agreement while also challenging voluntariness; (3) preferred a team-based approach to the consent process in which physician-investigators and research coordinators share responsibility for communicating with prospective participants and safeguarding voluntariness; and (4) offered strategies for managing tensions in dual-role consent.Conclusions and RelevanceThis qualitative study found that concerns about dual-role consent in clinical oncology, while valid, may be outweighed by corresponding advantages, particularly if appropriate mitigation strategies are in place. These findings support a team-based approach to informed consent, in which physician-investigators and research coordinators promote both the understanding and voluntariness of prospective participants.

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Informed consent for a neonatal clinical trial: parental experiences and perspectives

Abstract: Study designers and IRBs may allow flexibility in personnel and timing of consent as it is respectful of parents and may enhance trial enrollment.

Cited by 9 publications

References 21 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

Barriers to and solutions for representative inclusion across the lifespan and in life course research: The need for structural competency highlighted by the COVID-19 pandemic

Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology

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