Informed consent is a process by which researchers provide information on a research study to potential participants and then allow for a dialogue exchange. All potential participants should have ample time to read, review and discuss the information provided. Participants should be encouraged to discuss the research with their family or trusted friends in order to make their decision. Whenever possible, the consent process should occur not only at the beginning of the study, but at other points throughout the subjects’ participation.
Depending on the type of study, the IRB will either approve a written informed consent process, approve a waiver of documentation of informed consent (a verbal consent process) or waive the requirement for informed consent altogether. In most instances, federal regulations require documentation of informed consent. Please contact the IRB Office should you have questions regarding waiver of informed consent or waiver of documentation of informed consent.
Written informed consent process requirements:
- Investigators must use an IRB date stamped consent document. Do not use an unapproved (unstamped) consent document.
- Do not use an expired consent document. Confirm the approval and expiration date within the IRB stamp on the consent document.
- Changes may be made to the informed consent document during the course of the study with IRB approval. It is the investigator’s responsibility to ensure that the participant signs the most current version of the consent document.
- The consent document should be read verbally to the potential participant or, in some cases, the participant’s legally authorized representative (Do not verbally interpret the English version of the consent document into other languages. Contact the IRB Office for direction regarding this matter.)
- Time should be allotted for the participant to read the consent document and to ask questions of the investigator
- The consent document must be signed and dated by the participant or the participant’s legally authorized representative
- The person explaining the study and consent document must sign and date the consent document
- The participant must receive a copy of the consent document to use as their ongoing reference