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Human Subjects Research (IRB) - Consent Process
Do you need help determining the process you will need to use to obtain consent?
These sample documents contain helpful information on the required content of a consent form.
What is informed consent?
Informed consent is the voluntary choice of an individual to participate in research based on an accurate understanding of its purposes; the procedures (or methodology); any risks or benefits; and any other factors specific to the research that may affect a person's decisions to participate. It is the responsibility of the researcher to ensure that the subject is fully informed prior to engaging in research with the subject.
What should be included in a consent document?
The links below are provided to help you understand what information is required to be included in a consent document and to address unique situations that may be faced by the researcher:
- Required Content - Explains the required elements of consent
- Consent/Assent Process for Minors (under 18 years of age) - Required elements for consent/assent of minors
- Language Barriers - How to ensure that non English speaking participants understand what is being asked of them in the study
- Foreign Countries - Research conducted outside the U.S.
- Internet Research - Things to consider when conducting research via the internet
- Waiver of Written Documentation of Informed Consent - One of these two criteria must be met to waive documentation of consent
- Waiver of Informed Consent - All of these criteria must be met to waive the entire consent process
All consent and assent documents must bear an OSU IRB approval stamp. An officially approved and stamped copy of these documents will be available to the PI(s) with the approval letter in the attachments related to the approved application in the IRBManager system. These are the only versions of these documents that should be distributed or otherwise used to gain consent from potential subjects.