Waiver of Documentation
With some research designs it may not be appropriate to gather signed Informed Consent forms from participants. In these instances, Investigators may request a Waiver of Documentation of Informed Consent. A few examples of research where a Waiver of Documentation of Informed Consent may be appropriate are below:
- Participants will be recruited by email and the research only involves the completion of an on-line survey
- Participants will be asked to complete an anonymous paper survey
- The inclusion criteria for partcipation includes that a participant has taken an illegal substance in the last three months
The IRB will grant Waivers of Documentation of Informed Consent if the research meets one of the following two criteria:
- 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. Each subject will be asked whether the subject wants documentation linking the subject with the researcher, and the subject’s wishes will govern;
- 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.
Waiving Documentation of Informed Consent does not mean that participants do not need to be presented with a consent form containing all of the required elements of informed consent, it only means that participants do not need to sign a consent form. If an Investigator wishes to Waive Documentation of Informed Consent a Consent Statement needs to be submitted to the IRB for review.
To request a Waiver of Documentation of Informed Consent, investigators must submit a "Request for Waiver of Documenation of Informed Consent" form and attach it to the "Application for IRB Review."
Even when a waiver of documentation is granted, this does not mean that the consent process has been waived. The IRB still requires that investigators have procedures in place for making contact with participants, presenting information about the study, and obtaining agreement from prospective participants to participate in the research. When the Documentation of Informed Consent is waived participants still need to be presented with a Consent Statement, which contains all of the required elements of informed consent.
Request for Consent Waiver