In order to approve such a waiver of documentation, the proposed research project must meet one of the following two situations.
1. For non-FDA regulated projects, the IRB must find either:
The research presents no more than minimal risk of harm to subjects and that the research involves no procedures for which written consent is normally required outside of the research context.
OR
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. In this case, each subject must be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes must govern.
2. For FDA regulated projects, the IRB must find:
The research presents no more than minimal risk of harm to subjects and that the research involves no procedures for which written consent is normally required outside of the research context.
When the consent documentation requirement is waived, the IRB may require the investigator to provide the research subject with a written statement concerning the research. When making a request to use telephonic consent, the telephone script (the planned text to be used by the researcher making a call) must be included in the application for IRBMED approval.
In order to obtain valid telephonic consent, an investigator will need to follow these steps:
- Obtain a waiver of documentation of consent.
- Read the informed consent script over the phone.
- Discuss questions with the subject.
- Research may begin only after the subject consents.