Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial

Joseph, Jill G.; Ulysse, Christine A.; Ascenzi, Judith; Curley, Martha A. Q.; Wypij, David; Allen, Geoffrey L.; Angus, Derek C.; Asaro, Lisa A.; Ascenzi, Judy; Bateman, Scot T.; Borasino, Santiago; Bowens, Cindy Darnell; Bysani, G. Kris; Cheifetz, Ira M.; Cowl, Allison S.; Dodson, Brenda; Faustino, E. Vincent S.; Fineman, Lori D.; Flori, Heidi R.; Franck, Linda S.; Gedeit, Rainer; Grant, Monica J.; Harabin, A. L.; Haskins-Kiefer, Catherine; Hertzog, James H.; Hutchins, Larissa; Kirby, Aileen; Lebet, Ruth; Matthay, Michael A.; McLaughlin, Gwenn E.; Natale, JoAnne E.; Oren, Phineas P.; Polavarapu, Nagendra; Schneider, James; Schwarz, Adam; Shanley, Thomas P.; Simone, Shari; Singer, Lewis P.; Sorce, Lauren R.; Truemper, Edward J.; Heyden, Michele A. Vander; Watson, R. Scott; Wells, Claire R.

doi:10.1016/j.jpeds.2017.02.006

Cited by 34 publications

(32 citation statements)

References 15 publications

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“…The broader literature on the association between parents’ willingness to have their children participate in medical research and sociodemographic factors has substantial limitations; secondary analyses of actual recruitment rates often lack important sociodemographic and attitudinal data (Natale et al 2017), and prospective studies are frequently inadequately powered to perform logistic regression analyses (Wendler and Jenkins 2008; Hoberman et al 2013). Adequately designed studies have evaluated different factors and have found varying results.…”

Section: Discussionmentioning

confidence: 99%

Parents’ attitudes toward consent and data sharing in biobanks: A multisite experimental survey

Antommaria

Myers

Feygin

et al. 2018

AJOB Empirical Bioethics

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Background: The factors influencing parents’ willingness to enroll their children in biobanks are poorly understood. This study sought to assess parents’ willingness to enroll their children, and their perceived benefits, concerns, and information needs under different consent and data sharing scenarios; and to identify factors associated with willingness. Methods: This large, experimental survey of patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups. Participants were randomized to receive one of three consent and data sharing scenarios. Results: 90,000 surveys were mailed and 13,000 individuals responded (15.8% response rate). 5,737 respondents were parents of minor children. Overall, 55% (95% CI: 50-59%) of parents were willing to enroll their youngest minor child in a hypothetical biobank; willingness did not differ between consent and data sharing scenarios. Lower educational attainment, higher religiosity, lower trust, worries about privacy, and attitudes about benefits, concerns, and information needs were independently associated with less willingness to allow their child to participate. Of parents who were willing to participate themselves, 25% were not willing to allow their child to participate. Being willing to participate, but not willing to allow one’s child to participate was independently associated with multiple factors, including race, lower educational attainment, lower annual household income, public healthcare insurance, and higher scores on a scale of religiosity. Conclusions: Fifty-five percent of parents were willing to allow their youngest minor child to participate in a hypothetical biobank. Building trust, protecting privacy, and addressing attitudes may increase enrollment and diversity in pediatric biobanks.

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Section: Discussionmentioning

confidence: 99%

Parents’ attitudes toward consent and data sharing in biobanks: A multisite experimental survey

Antommaria

Myers

Feygin

et al. 2018

AJOB Empirical Bioethics

View full text Add to dashboard Cite

show abstract

“…A final option we explored was the use of DocuSign [ 12 ] or similar electronic signature systems to obtain signed consent, either from the patient or from their LAR. Due to regulations and information security controls within the VA while our trial was open and enrolling, we were not able to use this process in our facility; however, its use for both COVID and non-COVID research may be a possibility for other institutions with access to this software or similar software [ 13 ].…”

Section: Resultsmentioning

confidence: 99%

Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial

Woods¹,

Flynn²,

Monach³

et al. 2021

Contemporary Clinical Trials Communications

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Background and objective The communicable nature of many infectious diseases, including SARS-CoV-2 creates challenges for implementing and obtaining regulatory-compliant written informed consent. The goal of this project was to identify and evaluate processes that address these barriers while maintaining clinical and research staff safety. Methods We reviewed Federal Drug Administration (FDA), World Health Organization (WHO), and VA Office of Research and Development (ORD) guidance about informed consent during the COVID-19 pandemic, and identified and pilot-tested several mechanisms for obtaining regulatory-compliant consent during our COVID-19 therapeutics clinical trial. Results Several processes were identified. These included a standard face-to-face consent with a plan for maintaining a paper copy of the signed consent form, a phone or video chat consent process that included taking a picture of the signed consent form or a screen shot of the signed document during a video chat, integration of the consent forms into software embedded within the electronic health record, and secure software programs with electronic signature. These processes are FDA-compliant but time-intensive, often requiring four or more hours of coordination between the clinical team, research staff, patients, and legally authorized representatives. Conclusions Future studies could evaluate how to improve efficiency, and whether some elements of the consenting process, such as the requirement for documented written signed consent, rather than a witnessed oral consent, is an acceptable standard for research participants with communicable diseases.

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“…In multinational trials local beliefs, customs and traditions should be taken into consideration. 55 ☐ ☐ ☐…”

Section: ☐ ☐ ☐mentioning

confidence: 99%

Informed consent for neonatal trials: practical points to consider and a check list

Aurich

Vermeulen²,

Elie

et al. 2020

bmjpo

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Obtaining informed consent from parents of critically ill neonates can be challenging. The parental decision-making process is influenced by the severity of the child’s condition, the benefit–risk balance, their emotional state and the quality of the relationship with the clinical team. Independent of local legislation, parents may prefer that consent is sought from both. Misconceptions about the absence of risks or unrealistic expectations about benefits should be openly addressed to avoid misunderstandings which may harm the relationship with the clinical team. Continuous consent can be sought where it is unclear whether the free choice of parental consent has been compromised. Obtaining informed consent is a dynamic process building on trusting relationships. It should include open and honest discussions about benefits and risks. Investigators may benefit from training in effective communication. Finally, involving parents in neonatal research including the development of the informed consent form and the process of obtaining consent should be considered standard practice.

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Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial

Cited by 34 publications

References 15 publications

Parents’ attitudes toward consent and data sharing in biobanks: A multisite experimental survey

Parents’ attitudes toward consent and data sharing in biobanks: A multisite experimental survey

Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial

Informed consent for neonatal trials: practical points to consider and a check list

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