Human Subjects Research
IRB Waiver of Written Documentation of Informed Consent
The IRB may waive the requirement for written documentation of consent in cases where:
- The principle risks are those associated with a breach of confidentiality concerning the subject's participation in the research; and the consent document is the only record linking the subject with the research; or
- The research presents no more than minimal risk and involves procedures that do not require written consent when performed outside of a research setting.
In such situations, the researcher must demonstrate how they will go through the consent process with the participants. This can be accomplished by providing the participants with an “Information Sheet” that contains the elements of an informed consent form, but does not require signature. Alternately, a script of proposed oral discussion can be prepared for situations where personal interaction will not occur (i.e., telephone surveys). Both of these items should be submitted for IRB review with the application.
It is advisable to discuss these exceptions with the IRB chair prior to starting the research. These exceptions are evaluated on a case-by-case basis by the IRB.