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IRB-HSR > Managing Protocol After Initial Approval > Informed Consent > Waiver of Documentation of Informed Consent

 

 

 

 

 

 

Waiver of Documentation of Informed Consent

The federal regulations allow the IRB to waive the requirement for the Principal Investigator to obtain a signed consent form if it finds either:

  • 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 a breach of confidentiality; or
  • 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. In cases in which the documentation requirement is waived, the IRB may require the Principal Investigator to provide subjects with a written statement regarding the research.

Principal Investigators may request a waiver of a signed consent document by indicating this request in the protocol. Under this type of an approval the researcher would still obtain a verbal approval from a potential subject to participate.

*Taken from UVa IRB-HSR Research Guidance