Informed Consent

Informed Consent

Informed consent of the subject is one of the fundamental principles of ethical research for human subjects.Informed consent is also mandated by Federal regulations (45 CFR 46) and University policy for research with human subjects.

Informed consent is a PROCESS not a form. It is the knowing consent of an individual or his/her legally authorized representative that is obtained without undue inducement or element of force, fraud, deceit, duress, or other forms of constraint or coercion. Informed consent is designed to provide information to the potential subject about the research and the subject's involvement in the research.An informed consent form is able to document voluntary informed consent and should be only one of many means used to obtain informed consent. A clear oral explanation, a demonstration of the procedures, showing an informative video, and eliciting and answering questions are other means to obtain informed consent.The following guidelines explain the steps for obtaining informed consent.

Types of Consent

Written Consent: Written, signed consent should always be sought unless there are compelling reasons to seek a partial or full waiver of consent.

Verbal Consent: Certain populations (including, but not limited to, nonliterate or politically vulnerable populations) may call for special informed consent procedures. Verbal consent means that subjects are read a verbal version of informed consent. In order to use verbal consent, your study must meet ONE of the following criteria:

1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from breach of confidentiality.Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject's wishes will govern.Example: If you are conducting research in a politically repressive region, a subject's name on a consent form might result in the subject being imprisoned or worse.
2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.Example: Asking a person on the street (meaning you don't know their name, job, etc) what they think of some basically innocuous topic (e.g., road repairs, the record of a local sporting team).

Further points to consider:

• Whether you should use a signed witness to confirm verbal consent.
• How to proceed with illiterate subjects.
• The importance of user-friendly language in either written/verbal consent.

Waived Consent: An IRB, in rare cases, may waive the requirements to obtain informed consent. All of the following criteria must be met for this to occur:

• The research presents no more than minimal risk of harm to subjects
• The waiver or alteration will not adversely affect the rights and welfare of the subjects
• The research could not practicably be carried out without the waiver or alteration
• Whenever appropriate, the subjects will be provided with additional pertinent information after participation