Documentation of Informed Consent / Waiver of Documentation of Informed Consent

This Lehigh policy describes the Institutional Review Board (IRB) requirements for documenting informed consent in research.

Consent must be documented using an IRB-approved, signed written form (long or short form). A waiver of documentation may be granted if:

1. The consent form is the only link to the research, and the primary risk is a breach of confidentiality.
2. The research is minimal risk and involves no procedures requiring written consent outside the research context.
3. Signing forms is not customary for a distinct cultural group, the risk is minimal, and an alternative documentation method is used.