ArticleAMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science2019
Evaluation of a REDCap-based Workflow for Supporting Federal Guidance for Electronic Informed Consent.
Article in AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review.Journal of medical Internet research · 2020Pooled it
- Tailoring an auricular point acupressure self-management program for chronic pain: lessons learned from rural partners.Frontiers in pain research (Lausanne, Switzerland) · 2026Article
- On-site electronic consent in pediatrics using generic Informed Consent Service (gICS): Creating a specialized setup and collecting consent data.PLOS digital health · 2024Article
- A randomized clinical trial testing digital mindset intervention for knee osteoarthritis pain and activity improvement.NPJ digital medicine · 2024Article
- User Preferences and Needs for Health Data Collection Using Research Electronic Data Capture: Survey Study.JMIR medical informatics · 2024Article
- Shifting Mindsets: The Impact of a Patient Portal on Functioning and Recovery in a Mental Health Setting.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2024Article
- Global, regional, and national time trends in the burden of epilepsy, 1990-2019: an age-period-cohort analysis for the global burden of disease 2019 study.Frontiers in neurology · 2024Article
- Rationale, design, and protocol for a hybrid type 1 effectiveness-implementation trial of a proactive smoking cessation electronic visit for scalable delivery via primary care: the E-STOP trial.BMC primary care · 2023Article
- Embedding research study recruitment within the patient portal preCheck-in.Journal of the American Medical Informatics Association : JAMIA · 2023Article
- Integrating REDCap patient-reported outcomes with the HealtheIntent population health platform: proof of concept.JAMIA open · 2023Article
- Predicting labor onset relative to the estimated date of delivery using smart ring physiological data.NPJ digital medicine · 2023Article
- An e-consent framework for tiered informed consent for human genomic research in the global south, implemented as a REDCap template.BMC medical ethics · 2022Article
- Electronic informed consent criteria for research ethics review: a scoping review.BMC medical ethics · 2022Article
- Burden of epilepsy in Latin America and The Caribbean: a trend analysis of the Global Burden of Disease Study 1990 - 2019.Lancet regional health. Americas · 2022Article
- An architecture for research computing in health to support clinical and translational investigators with electronic patient data.Journal of the American Medical Informatics Association : JAMIA · 2022Article
- Burnout and Cardiovascular Risk in Healthcare Professionals During the COVID-19 Pandemic.Frontiers in psychiatry · 2022Article
- Toward e-Scales: Digital Administration of the International Parkinson and Movement Disorder Society Rating Scales.Movement disorders clinical practice · 2021Article
- Remote Methods for Conducting Tobacco-Focused Clinical Trials.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2020Review
- Key components and IT assistance of participant management in clinical research: a scoping review.JAMIA open · 2020Article
- The need to balance basic and clinical research with the safety of the research environment and personnel in the time of COVID-19 in the United States.Current medical research and opinion · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
Adoption of electronic informed consent (eConsent) for research remains low despite evidence of improved patient comprehension, usability, and workflow processes compared to paper. At our institution, we implemented an eConsent workflow using REDCap, a widely used electronic data capture system. The goal of this study was to evaluate the extent to which the REDCap eConsent solution adhered to federal guidance for eConsent. Of 29 requirements derived from sixteen recommendations from the United States Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA), the REDCap eConsent solution supported 24 (86%). To the best of our knowledge, this is among the first studies to evaluate an eConsent approach's support for federal guidance. Findings suggest use of REDCap may help other institutions overcome barriers to eConsent adoption, and that OHRP and FDA expand guidance to recommend eConsent solutions integrate with enterprise clinical and research information systems.
Identifiers
31258968PMC6568140What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.