The Memorial Sloan Kettering (MSK) electronic informed consent (eIC) platform for clinical trials: An operational model and suite of tools for obtaining informed consent, and managing consent documents.

Buckley, Megan C.; Lengfellner, Joseph; Koch, Matthew J.; Pacheco, Hector O.; Hoidra, Carol; Damron, Dorothy; Cambria, Roy; Rodavitch, Ann; Sabbatini, Paul

doi:10.1200/jco.2018.36.15_suppl.e18577

Cited by 4 publications

(3 citation statements)

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“…The U.S. Food and Drug Administration (2015) defines this as “the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive, and interactive Web sites …. to convey information related to the study and to obtain and document informed consent.” Electronic consent may enhance knowledge and engagement of study participants in comparison to traditional informed consent, and improve quality and consistency of the consent process ( Rowbotham et al, 2013 ; Rothwell et al, 2014 ; Simon et al, 2016 ; Cadigan et al, 2017 ; Buckley et al, 2018 ; Biesecker et al, 2019 ). Additionally, electronic consent leverages digital tools to improve visual clarity and focus on content most important to decision making and reduces the length, complexity, and literacy demand of consent materials.…”

Section: Introductionmentioning

confidence: 99%

Education and Consent for Population-Based DNA Screening: A Mixed-Methods Evaluation of the Early Check Newborn Screening Pilot Study

et al. 2022

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A challenge in implementing population-based DNA screening is providing sufficient information, that is, understandable and acceptable, and that supports informed decision making. Early Check is an expanded newborn screening study offered to mothers/guardians whose infants have standard newborn screening in North Carolina. We developed electronic education and consent to meet the objectives of feasibility, acceptability, trustworthiness, and supporting informed decisions. We used two methods to evaluate Early Check among mothers of participating infants who received normal results: an online survey and interviews conducted via telephone. Survey and interview domains included motivations for enrollment, acceptability of materials and processes, attitudes toward screening, knowledge recall, and trust. Quantitative analyses included descriptive statistics and assessment of factors associated with knowledge recall and trust. Qualitative data were coded, and an inductive approach was used to identify themes across interviews. Survey respondents (n = 1,823) rated the following as the most important reasons for enrolling their infants: finding out if the baby has the conditions screened (43.0%), and that no additional blood samples were required (20.1%). Interview respondents (n = 24) reported the value of early knowledge, early intervention, and ease of participation as motivators. Survey respondents rated the study information as having high utility for decision making (mean 4.7 to 4.8 out of 5) and 98.2% agreed that they had sufficient information. Knowledge recall was relatively high (71.8–92.5% correct), as was trust in Early Check information (96.2% strongly agree/agree). Attitudes about Early Check screening were positive (mean 0.1 to 0.6 on a scale of 0–4, with lower scores indicating more positive attitudes) and participants did not regret participation (e.g., 98.6% strongly agreed/agreed Early Check was the right decision). Interview respondents further reported positive attitudes about Early Check materials and processes. Early Check provides a model for education and consent in large-scale DNA screening. We found evidence of high acceptability, trustworthiness and knowledge recall, and positive attitudes among respondents. Population-targeted programs need to uphold practices that result in accessible information for those from diverse backgrounds. Additional research on those who do not select screening, although ethically and practically challenging, is important to inform population-based DNA screening practices.

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Section: Introductionmentioning

confidence: 99%

Education and Consent for Population-Based DNA Screening: A Mixed-Methods Evaluation of the Early Check Newborn Screening Pilot Study

et al. 2022

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“…Bergmann et al, 57 Bethune et al, 58 Bialke et al, 59 Boutin et al, 60 Buckley et al, 61 Chen et al, 62 Chhin et al, 63 Doerr et al, 64 Fink et al, 65 Grady et al, 66 Greenhalgh et al, 67 Harle et al, 68,69 Haussen et al, 70 Iafrate et al, 71 Kim et al, 72 Kondylakis et al, 73 Nijhawan et al, 74 Phillippi et al, 75 Ramos, 76 Rothwell et al, 77 Schreiweis et al, 78 Shelton, 79 Simon et al, [80][81][82] Sommer et al, 83 Soni et al, 84 St John et al, 85 Stevens et al, 86 Suarez et al, 87 Vanaken, 88 Vanaken and Masand, 89 Warriner et al, 90 Welch et al, 91 Wilbanks 92 Enrollment Electronic informed consent, digital consent management Aamot et al, 93 Bialke et al, 94 Bruland et al, 95 Chevrier et al, 96 Deserno et al, 97 Ebner et al, 98 Jonas et al, 99 Lablans et al, 100 Lautenschl€ ager et a...…”

Section: Recruitment Support Systemmentioning

confidence: 99%

“…17 In recent years, there has been a greater use of electronic methods to gain informed consent (called eIC or e-consent) in research studies. [57][58][59][60][61][62][63][64][65] The New England Journal of Medicine published in "The Changing Face of Informed Consent" innovative approaches to improve and expand the electronic informed consent process for researchers and participants. 66 e-Consents can include multimedia information (graphics or videos) and interactive components to increase the understanding of the study purpose and is less focused on signing legal documents.…”

Section: Recruitment Support Systemmentioning

confidence: 99%

Ausbau des Probandenmanagementsystems der Universitätsmedizin Göttingen für standortübergreifende Kooperationen in der klinischen Forschung

Pung¹

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Klinische Forschung ist die Grundlage für den Fortschritt in der Medizin. Ihr wichtigstes Instrument sind klinische Studien, in denen an und mit Teilnehmenden geprüft wird, wie wirksam, verträglich und sicher neue Medikamente und Behandlungsmöglichkeiten sind. Bei vielen wissenschaftlichen Fragestellungen ist es sinnvoll, in standortübergreifenden Kooperationen gemeinsam zu forschen. Dies stellt hohe Anforderungen an die Organisation, die Kommunikation und die Arbeitsprozesse, aber auch an die eingesetzten IT-Systeme. So ist die standortübergreifende Verwaltung von Studienteilnehmenden mit einem Probandenmanagementsystem eine große Herausforderung. Besonders die zentrale Verarbeitung der sensiblen Daten der Studienteilnehmenden von unterschiedlichen Studienstandorten beeinflusst die Datenschutz-und IT-Sicherheitsanforderungen. Dabei ist auch das Zusammenspiel mit weiteren IT-Systemen relevant, weshalb die Aufgaben und Funktionen des Probandenmanagementsystems klar benannt und dessen Rolle in einer Forschungs-IT-Infrastruktur geklärt sein muss. In dieser Dissertation wurde der Ausbau des 2015 am Institut für Medizinische Informatik der Universitätsmedizin Göttingen entwickelten Probandenmanagementsystems für die Nutzung in standortübergreifenden Kooperationen in der klinischen Forschung untersucht. In zwei systematischen Literaturrecherchen wurden Literaturquellen mit dem Ziel der Begriffs-und Funktionsbestimmung des Probandenmanagementsystems und der Einordnung des Systems in einer Forschungs-IT-Infrastruktur untersucht. Vier Hauptprozesse der Probandenverwaltung wurden identifiziert: Rekrutierung (1), Erfassung und Verwaltung der Einwilligungen (2), Pseudonymisierung (3) und Verwaltung administrativer Daten (4) der Studienteilnehmenden. Die Prozesse können durch IT-Systeme unterstützt werden, die untereinander über Schnittstellen interagieren und so in einer Forschungs-IT-Infrastruktur zusammenarbeiten. Dabei ist die Zusammensetzung der IT-Systeme abhängig von den Anforderungen des Forschungsprojektes. Das bestehende Göttinger Probandenmanagementsystem vereint die IT-Unterstützung der genannten Hauptprozesse ausgenommen der Rekrutierung und übernimmt damit zentrale Aufgaben und Funktionen in einer Forschungs-IT-Infrastruktur. Zur Erarbeitung eines Konzeptes zum Ausbau des Probandenmanagementsystems wurden die Anforderung an ein in standortübergreifenden Kooperationen nutzbaren Systems identifiziert. Das I Konzept gliedert sich angelehnt an die identifizierten Anforderungen in die Teile: Datentrennung bei der Probandenverwaltung (1), vernetze Probandenverwaltung (2), Zugangs-und Zugriffskontrolle (3) und Datenschutzkonzept (4). Das Konzept sieht die Anwendung von Grundprinzipien datenschutzgerechter Lösungen wie Datensparsamkeit und informationelle Gewaltenteilung vor. Um eine strikte Datentrennung bei der Probandenverwaltung zu gewährleisten, dürfen nur ausgewählte Pseudonyme in der Datenbank des Probandenmanagementsystems gespeichert werden. Das Anlegen neuer Pseudonyme sowie die Abfrage bestehender Pseudonyme ...

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Key components and IT assistance of participant management in clinical research: a scoping review

Pung

Rienhoff

2020

JAMIA Open

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Objectives Managing participants and their data are fundamental for the success of a clinical trial. Our review identifies and describes processes that deal with management of trial participants and highlights information technology (IT) assistance for clinical research in the context of participant management. Methods A scoping literature review design, based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement, was used to identify literature on trial participant-related proceedings, work procedures, or workflows, and assisting electronic systems. Results The literature search identified 1329 articles of which 111 were included for analysis. Participant-related procedures were categorized into 4 major trial processes: recruitment, obtaining informed consent, managing identities, and managing administrative data. Our results demonstrated that management of trial participants is considered in nearly every step of clinical trials, and that IT was successfully introduced to all participant-related areas of a clinical trial to facilitate processes. Discussion There is no precise definition of participant management, so a broad search strategy was necessary, resulting in a high number of articles that had to be excluded. Nevertheless, this review provides a comprehensive overview of participant management-related components, which was lacking so far. The review contributes to a better understanding of how computer-assisted management of participants in clinical trials is possible.

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The Memorial Sloan Kettering (MSK) electronic informed consent (eIC) platform for clinical trials: An operational model and suite of tools for obtaining informed consent, and managing consent documents.

Cited by 4 publications

References 0 publications

Education and Consent for Population-Based DNA Screening: A Mixed-Methods Evaluation of the Early Check Newborn Screening Pilot Study

Education and Consent for Population-Based DNA Screening: A Mixed-Methods Evaluation of the Early Check Newborn Screening Pilot Study

Ausbau des Probandenmanagementsystems der Universitätsmedizin Göttingen für standortübergreifende Kooperationen in der klinischen Forschung

Key components and IT assistance of participant management in clinical research: a scoping review

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