ArticleJournal of translational medicine2018
MAGIC: once upon a time in consent management-a FHIR
Article in Journal of translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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
12 citing papers in PubMed.
- Secondary use of health care data and left-over biosamples within the 'Medical Informatics Initiative' (MII): a quasi-randomized controlled evaluation of patient perceptions and preferences regarding the consent process.BMC medical informatics and decision making · 2022Trial
- Implementing informed consent in federated medical research: a blueprint designed to safeguard data subject rights in Germany.Journal of translational medicine · 2026Article
- Pediatric Consent on FHIR.Applied clinical 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
- A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine.BMC medical informatics and decision making · 2022Article
- HL7 FHIR-based tools and initiatives to support clinical research: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2022Article
- Fast Healthcare Interoperability Resources (FHIR) for Interoperability in Health Research: Systematic Review.JMIR medical informatics · 2022Review
- Key components and IT assistance of participant management in clinical research: a scoping review.JAMIA open · 2020Article
- The generic Informed Consent Service gICSJournal of translational medicine · 2020Article
- Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative.BMC medical informatics and decision making · 2020Article
- Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020Article
- A Parser to Support the Definition of Access Control Policies and Rules Using Natural Languages.Journal of medical systems · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
backgroundThe use of medical data for research purposes requires an informed consent of the patient that is compliant with the EU General Data Protection Regulation. In the context of multi-centre research initiatives and a multitude of clinical and epidemiological studies scalable and automatable measures for digital consent management are required. Modular form, structure, and contents render a patient's consent reusable for varying project settings in order to effectively manage and minimise organisational and technical efforts.
resultsWithin the DFG-funded project "MAGIC" (Grant Number HO 1937/5-1) the digital consent management service tool gICS was enhanced to comply with the recommendations published in the TMF data protection guideline for medical research. In addition, a structured exchange format for modular consent templates considering established standards and formats in the area of digital informed consent management was designed. Using the new FHIR standard and the HAPI FHIR library, the first version for an exchange format and necessary import-/export-functionalities were successfully implemented.
conclusionsThe proposed exchange format is a "work in progress". It represents a starting point for current discussions concerning digital consent management. It also attempts to improve interoperability between different approaches within the wider IHE-/HL7-/FHIR community. Independent of the exchange format, providing the possibility to export, modify and import templates for consents and withdrawals to be reused in similar clinical and epidemiological studies is an essential precondition for the sustainable operation of digital consent management.
Indexed as
Identifiers
What 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.