Informed Consent Ontology (ICO) represents the domain of informed consent, including: consent forms, policies governing informed consent, agents working with patients and biospecimens accompanied by consent, and the process of informed consent itself. ICO aims to support informed consent data integration and reasoning in the clinical research space.
As part of the consent process in human subjects research, potential participants receive information about the purpose of a study, potential risks and benefits of participation, their rights, and the procedures to be undergone as part of the study. If the individual decides to participate, an informed consent document is signed and preserved as a record of voluntary participation in the research study. Following OBO Foundry principles and extending from the top-level ontology Basic Formal Ontology (BFO), ICO represents universals and relations in the domain of informed consent.
ICO was initiated in 2012 with the support of the MCubed project at the University of Michigan. Since then, many researchers and funding resources have helped to advance the development and application of ICO. Details of contributions to ICO can be found below. If you feel you have made a significant contribution, but do not see your name, please submit an issue using the GitHub Issue Tracker.
In 2018, much of the The Common Rule Ontology, developed by Frank J. Manion was merged into ICO. Details on The Common Rule Ontology can be found in the Common Rule Readme.
- Jonathan Bona
- Mathias Brochhausen
- Christoph Brochhausen
- Melanie Courtot
- William Duncan
- Elizabeth Eisenhauer
- Helena Ellis
- Jian Guan
- Marcelline Harris
- Yongqun "Oliver" He
- Alla Karnovsky
- Asiyah Yu Lin
- Frank J. Manion
- Anna Maria Masci
- Mark Miller
- Jihad Obeid
- J. Neil Otte
- Cooper Stansbury
- Chris Stoeckert
- Cui Tao
- Muhammad "Tuan" Amith
- Elizabeth Umberfield
- Jonathan Vajda
- Jie Zheng
This project was supported by a a number of mechanisms. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding parties.
- U2C-DK114886
- NIH/NHGRI 5U01HG009454-03
- University of Michigan MCubed
- Michigan Institute for Data Science (MIDAS)
- Michigan Integrated Center for Health Analytics & Medical Prediction (MiCHAMP)
- 2UL1TR000433-06
We encourage collaboration. For those looking to make contributions to the ontology content, or to propose aternative defintions or design patterns, please visit the Contributing Guidelines. For developers new to ICO, please see the Developer Readme.
ICO is licensed under the Creative Commons Attribution 4.0 International Public License(CC BY 4.0). Please see the License File for more information.
- Otte JN, Stansbury C, Vajda J, Manion F, Umberfield E, He Y, Harris M, Obeid J, Brochhausen M, Duncan W, Tao C. Coordinated evolution of Ontologies of Informed Consent (http://ceur-ws.org/Vol-2285/ICBO_2018_paper_59.pdf). International Conference on Biomedical Ontology 2018 (ICBO-2018), August 7-10, 2018, Corvallis, Oregon, USA. Pages 1-2.
- Lin Y, Zheng J, He Y. VICO: Ontology-based representation and integrative analysis of vaccination informed consent forms. J Biomed Semantics. 2016 Apr 19;7:20. doi: 10.1186/s13326-016-0062-4. PMID: 27099700. PMCID: PMC4837519.
- Lin Y, Harris MR, Manion FJ, Eisenhauer E, Zhao B, Shi W, Karnovsky, He Y. Development of a BFO-based Informed Consent Ontology (ICO). Proceedings of the 5th International Conference on Biomedical Ontologies (ICBO), Houston, Texas, USA. October 8-9, 2014. Page 84-86. [http://ceur-ws.org/Vol-1327/icbo2014_paper_54.pdf]
- Muhammad Amith, Marcelline R Harris, Cooper Stansbury, Kathleen Ford, Frank J Manion, Cui Tao. Expressing and Executing Informed Consent Permissions Using SWRL: The All of Us Use Case. AMIA Annu Symp Proc. 2021; 2021: 197–206. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8861693/.