Online Pediatric Research: Addressing Consent, Assent, and Parental Permission

Brothers, Kyle B.; Clayton, Ellen Wright; Goldenberg, Aaron J.

doi:10.1177/1073110520917038

Cited by 10 publications

(4 citation statements)

References 13 publications

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“…Challenges to online pediatric research include parent consent and pediatric assent [ 23 , 24 ], and in longitudinal studies, reconsenting and following children as they transition to adulthood. For instance, a pediatric biobank experienced challenges recruiting children, including re-consenting pediatric populations after they turned 18 [ 25 ].…”

Section: Recruitment Of Vulnerable Populationsmentioning

confidence: 99%

Effectiveness of multimodal participant recruitment in SPARK, a large, online longitudinal research study of autism

Daniels,

Law,

Green Snyder

et al. 2023

J. Clin. Trans. Sci.

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Background: SPARK launched in 2016 to build a US cohort of autistic individuals and their family members. Enrollment includes online consent to share data and optional consent to provide saliva for genomic analysis. SPARK's recruitment strategies include social media and support of a nation-wide network of clinical sites. This study evaluates SPARK's recruitment strategies to enroll a core study population. Methods: Individuals who joined between January 31, 2018, and May 29, 2019 were included in the analysis. Data include sociodemographic characteristics, clinical site referral, the website URL used to join, how the participant heard about SPARK, enrollment completion (online registration, study consents, and returning saliva sample), and completion of the baseline questionnaire. Logistic regressions were performed to evaluate the odds of core participant status (completing enrollment and baseline questionnaire) by recruitment strategy. Results: In total, 31,715 individuals joined during the study period, including 40% through a clinical site. Overall, 88% completed online registration, 46% returned saliva, and 38% were core participants. Those referred by a clinical site were almost twice as likely to be core participants. Those who directly visited the SPARK website or performed a Google search were more likely to be core participants than those who joined through social media. Discussion: Being a core participant may be associated with the "personal" connection and support provided by a clinical site and/or site staff, as well as greater motivation to seek research opportunities. Findings from this study underscore the value of adopting a multimodal recruitment approach that combines social media and a physical presence.

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Section: Recruitment Of Vulnerable Populationsmentioning

confidence: 99%

Effectiveness of multimodal participant recruitment in SPARK, a large, online longitudinal research study of autism

Daniels,

Law,

Green Snyder

et al. 2023

J. Clin. Trans. Sci.

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“…For example, dynamic consent portals can be used to log participant choices and potentially allow those choices to be modified over time (3,68). Biobanks can use public-facing websites that automatically inform participants whenever their samples are used and allow them to opt out of specific uses (69). For instance, the dynamic consent portal that has been pilot tested with BioTrust, the Michigan blood spot biobank mentioned above, allows ongoing control of children's specimens (70).…”

Section: Technological Toolsmentioning

confidence: 99%

Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues

Kasperbauer

Halverson

2021

Front. Med.

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Research biobanks that enroll minors face important practical, ethical, and regulatory challenges in reconsenting participants when they reach the age of 18. Federal regulations governing research in the United States provide minimal guidance and allow for a range of practices, including waiving the requirement to obtain reconsent. Some commentators have argued that institutional review boards should indeed grant such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18. There is also significant ethical debate about the age at which adolescents can make authentic, autonomous decisions regarding their research participation. This paper reviews these issues in detail, describes the current state of the ethical discussion, and outlines evidence-based policies for enrolling minors into research biobanks.

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“…Researchers establishing this authentication process must be particularly vigilant when it comes to assessing prospective participants' age and capacity to consent to participate in health research. 127 Additionally, unregulated health research may create or exacerbate the potential for other harms to individuals and groups. For example, groups that disproportionately rely upon mobile devices for access to the internet, such as those with a low-income, members of racial minorities, and rural residents, may be more vulnerable in the context of mobile health research.…”

Section: E Heightened Obligationsmentioning

confidence: 99%

Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations

Rothstein¹,

Wilbanks²,

Beskow³

et al. 2020

J. Law. Med. Ethics

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Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.

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Online Pediatric Research: Addressing Consent, Assent, and Parental Permission

Abstract: This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.

Cited by 10 publications

References 13 publications

Effectiveness of multimodal participant recruitment in SPARK, a large, online longitudinal research study of autism

Effectiveness of multimodal participant recruitment in SPARK, a large, online longitudinal research study of autism

Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues

Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations

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