Under certain conditions the IRB can waive the requirement that the subject sign an informed consent document. These conditions include the following :
- Where the informed consent document is the only record linking the subject and the research, and the principal risk would be potential harm resulting from breach of confidentiality, subjects may be asked whether or not they want documentation linking them to the research and their wishes should be respected.
- Where the research presents no more than minimal risk to the subjects and involves no procedures for which written consent is normally required outside the research context.
- For projects of minimal risk involving the use of questionnaires, the elements of informed consent may be included in an introductory letter attached to the instrument which should also include a statement to the effect that return of the questionnaire will constitute consent to participate.