ArticleJournal of translational medicine2020
The generic Informed Consent Service gICS
Article in Journal of translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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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.
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Who cites it
13 citing papers in PubMed.
- Implementing informed consent in federated medical research: a blueprint designed to safeguard data subject rights in Germany.Journal of translational medicine · 2026Article
- Design, implementation and analysis of a quality assurance process for Informed Consents using the DZHK registry TORCH-DZHK1 as an example.PLOS digital health · 2026Article
- Mainzelliste: Ten years of pseudonymization, record linkage, and informed consent management.Patterns (New York, N.Y.) · 2026Article
- Managing withdrawals and exclusions of study participants in COVID-19-research by NUKLEUS.BMC medical research methodology · 2025Article
- The benefits of fully electronic consent management and consent collection via a tablet PC in supporting time-critical pandemic research-an example from a NAPKON COVID-19 project.Frontiers in digital health · 2025Article
- Information Mode-Dependent Success Rates of Obtaining German Medical Informatics Initiative-Compliant Broad Consent in the Emergency Department: Single-Center Prospective Observational Study.JMIR medical informatics · 2024Observational
- On-site electronic consent in pediatrics using generic Informed Consent Service (gICS): Creating a specialized setup and collecting consent data.PLOS digital health · 2024Article
- [Nationally standardized broad consent in practice: initial experiences, current developments, and critical assessment].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2024Article
- Development of a Trusted Third Party at a Large University Hospital: Design and Implementation Study.JMIR medical informatics · 2024Article
- The DZHK research platform: maximisation of scientific value by enabling access to health data and biological samples collected in cardiovascular clinical studies.Clinical research in cardiology : official journal of the German Cardiac Society · 2023Article
- We Know What You Agreed To, Don't We?-Evaluating the Quality of Paper-Based Consents Forms and Their Digitalized Equivalent Using the Example of the Baltic Fracture Competence Centre Project.Methods of information in medicine · 2023Article
- 3LGM2IHE: Requirements for Data-Protection-Compliant Research Infrastructures-A Systematic Comparison of Theory and Practice-Oriented Implementation.Methods of information in medicine · 2022Article
- [Biobanks, translational research and medical informatics].Urologie (Heidelberg, Germany) · 2022Review
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDefining and protecting participants' rights is the aim of several ethical codices and legal regulations. According to these regulations, the Informed Consent (IC) is an inevitable element of research with human subjects. In the era of "big data medicine", aspects of IC become even more relevant since research becomes more complex rendering compliance with legal and ethical regulations increasingly difficult.
methodsBased on literature research and practical experiences gathered by the Institute for Community Medicine (ICM), University Medicine Greifswald, requirements for digital consent management systems were identified.
resultsTo address the requirements, the free-of-charge, open-source software "generic Informed Consent Service" (gICS DISCUSSION: Since the consent's content is a prerequisite for securing participants' rights, application of gICS is no guarantee for legal compliance. However, gICS supports fine-granular consents and accommodation of differentiated consent states, which can be directly exchanged between systems, allowing automated data processing.
conclusiongICS simplifies and supports sustained IC management as a major key to successfully conduct studies and build trust in research with human subjects. Therefore, interested researchers are invited to use gICS and provide feedback for further improvements.
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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.