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 should always be remembered that informed consent is an ongoing process. It is not a single event or just a form to be signed—rather it is an educational process that takes place between the investigator and the prospective subject. It is the responsibility of the researcher to ensure that the full informed consent educational process is fulfilled prior to engaging in research with the subject.
All consent and assent documents must bear an OSU IRB approval stamp. An officially approved and stamped copy of these documents will be returned to the PI(s) with the approval letter. These are the only versions of these documents that should be distributed or otherwise used to gain consent from potential subjects. Any copies distributed to the subjects should bear the IRB approval stamp. Any change to the consent document(s) must be submitted as a modification to the IRB. Upon approval of the consent modification, a new approved and stamped form will be returned to the PI. It is the responsibility of the PI to insure that the most recently approved versions of the consent documents are being used.
