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.
The ICO development was initiated in 2012 with the support of a MCubed project (awarded to Drs. Marcelline Harris, Yongqun "Oliver" He, and Alla Karnovsky) at the University of Michigan. The University of Michigan teams have been a major force for the continuous ICO development and applications.
In 2018, much of the The Common Rule Ontology, developed by Frank J. Manion in his PhD thesis research (his PhD mentor: Dr. Cui Tao), was merged into ICO. Details on The Common Rule Ontology can be found in the Common Rule Readme.
Dr. Tuan Amith has utilized ICO to experiment with applied usage for software integration using SWRL since 2022.
Ms. Rahma Alifia and her mentor Dr. Adela Grando from the College of Health Solutions in the Arizona State University have joined our ICO development team since 2025. They have helped further develop ICO and applied ICO for different applications.
Since 2012, 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. We also appreciate more collaborations from the community. Thanks!
- Rahma Alifia
- Jonathan Bona
- Mathias Brochhausen
- Christoph Brochhausen
- Melanie Courtot
- William Duncan
- Elizabeth Eisenhauer
- Helena Ellis
- Adela Grando
- 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.
- Amith M “Tuan,” He Y, Smith E, Harris M, Manion F, Tao C. Integrating a conceptual consent permission model from the informed consent ontology for software application execution. AMIA Jt Summits Transl Sci Proc. 2025 Jun 10;2025:46-55. PMID: 40502263. PMCID: PMC12150727.
- Umberfield EE, Stansbury C, Ford K, Jiang Y, Kardia SLR, Thomer AK, et al. Evaluating and extending the Informed Consent Ontology for representing permissions from the clinical domain. Appl Ontol. 2022 May 4;17(2):321–336. doi:10.3233/AO-210260. PMID: 36312514. PMCID: PMC9616177.
- Amith M, Harris MR, Stansbury C, Ford K, Manion FJ, Tao C. Expressing and Executing Informed Consent Permissions Using SWRL: The All of Us Use Case. AMIA Annu Symp Proc AMIA Symp. 2021;2021:197–206. PMID: 35309008; PubMed Central PMCID: PMC8861693.
- 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]