Get UNT Health Science Center Waiver Of Informed Consent (Form B) 2018-2024

A waiver of documentation removes the requirement of collecting signatures from the research participant. All of the required informed consent information is still provided to the participant but the documentation of the process (the actual signature) has been waived by the IRB.

Waiver of Informed Consent (45 CFR 46.116) For research that is no more than minimal risk the IRB may approve a request to waive of some or all of the required elements of informed consent under specific circumstances.

The student must also provide informed consent, unless the consent requirement is waived by an IRB once he or she is being considered for a specific study (45 CFR 46.116).

What is a waiver of consent? A waiver of consent requires a researcher to seek approval from an ethical review body in order to use a person's personal information or personal health information without actually obtaining consent directly from the individual in order to use that information in a research project.

Waiver of Documentation of Informed Consent (45 CFR 46.117) This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document.

Essentially, a waiver removes a real or potential liability for the other party in the agreement. For example, in a settlement between two parties, one party might, by means of a waiver, relinquish its right to pursue any further legal action once the settlement is finalized.

A waiver is legal document releasing or relinquishing a known right, claim, or privilege. In this context, it is the relinquishment to pursue a claim in a certain set of defined circumstances. Informed consent is a written acknowledgement that a participant understands the risks inherent in a particular activity.

An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations (45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.