The FDA allows verbal consent prior to participation in a research study primarily under circumstances where obtaining a written consent is not feasible or appropriate. This includes situations when the subject is illiterate or has a legally authorized representative (LAR) who can consent on their behalf. Verbal consent is also permitted when the research presents no more than minimal risk of harm to subjects and written consent is normally not required outside the research context. Additionally, verbal consent can be used if the study population belongs to a cultural group in which signing forms is not customary, provided an alternative mechanism for documenting that informed consent was obtained is in place. In such cases, a waiver of signed informed consent must be granted by the Institutional Review Board (IRB), and the verbal consent process must include all elements of informed consent communicated verbally, often with a witness present and proper documentation of the consent discussion.
Key Points About FDA Verbal Consent Allowance
- Verbal consent may be granted when the subject is illiterate or has a legally authorized representative.
- A waiver of signed consent must be approved by the IRB when using verbal consent.
- The research should involve no more than minimal risk or signing forms is culturally inappropriate.
- The consent process includes explaining all elements of informed consent verbally to the participant or LAR.
- A witness fluent in the language of the participant may be required to attest to the verbal consent process.
This ensures the ethical and legal standards of informed consent are maintained even without a signed document.