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 in the Contributions Readme. If you feel you have made a significant contribution, but do not see your name in the Contributions Readme, please submit an issue using the [GitHub Issue Tracker](LINK NEEDED).
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.
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.
- 2UL1TR000433-06
- U2C-DK114886
- NIH/NHGRI 5U01HG009454-03
- MCubed
- MIDAS
- MiCHAMP
- Robert Wood Johnson Foundation Future of Nursing Scholarship
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.