Protocol and Consent Form Requirements for Placebo Washout Periods

Studies that involve washout periods (with or without the use of a placebo) present similar concerns about risk to subjects as studies using placebos because both involve withholding available therapy from subjects. Therefore, similar attention should be paid to justification of the use of a washout period including methods to minimize risks to subjects. In Appendix L of the electronic IRB Application researchers must provide:

the reason why active therapy is being withheld, the duration of the washout period, the risks specific to this phase of the study, increased subject monitoring during the washout period, and instructions to the subjects about what to do if they experience problems while off active treatment.

Use of a washout period, possible risks to the subject, and methodology to address problems that may occur during the washout period must be included in the consent form.