Informed Consent

Informed consent is the knowing consent of an individual or her/his legally authorized representative which is obtained without undue inducement or element of force, fraud, deceit, duress, or other forms of constraint or coercion. A consent form documents informed consent and is designed to protect the investigator and the institution against legal liability. In some instances, including when the research is taking place in an elementary or secondary school, documentation of informed consent may be waived. Some or all of the elements of informed consent may also be altered or waived depending on the research.

Investigators are responsible for obtaining and documenting informed consent from all subjects and for insuring that no human subjects will be involved in the research prior to obtaining their consent. In obtaining informed consent, investigators must avoid the possibility of coercion or undue influence. Unless otherwise authorized by the CPHS/IRB, investigators are responsible for insuring that legally effective informed consent shall:

• be obtained from the subject or the subject's legally authorized representative.
• be in language understandable to the subject or the representative.
• be obtained under circumstances that offer the subject or the representative sufficient opportunity to consider whether the subject should or should not participate.
• not include exculpatory language through which the subject or representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the research investigator, the sponsor, the institution or its agents from liability for negligence.

One of the most common reasons for delay of approval of a protocol is an inadequate consent form. The consent form should be a statement addressed to the subject and should read as such. Ordinarily, it is best worded in the second person. It must be in language the subject can understand (avoid or define technical terminology, adjust for educational background and ages, provide translations in other languages when subjects do not understand English). Separate forms may be required for different subject groups (parents, children, UO students, etc.), as well as for release of particular kinds of information (photographs, video recordings). should consult the guidelines for passive parental consent.

Investigators are responsible for placing the consent documents signed by research subjects in a repository approved by the Office for Protection of Human Subjects and for retaining signed consent forms for a minimum of three years after termination of the project. If the research is grant-funded, the consent forms must be retained for a minimum of five years.

OPHS has developed several consent templates covering common research situations. Researchers should refer to these templates if they are unsure of how to write consent forms; however, the language in the templates need not be copied as long as all required elements are included in the informed consent form.