The waiver of informed consent by the IRB also includes instances where research involving no more than minimal risk could not practicably be carried out without this waiver. The waiver of informed consent must not adversely affect the rights and welfare of subjects.
Deception of subjects is sometimes a part of the study design of social and behavioral research involving no more than minimal risk. Incomplete disclosure during the consent process and deception of research participants about a study's purpose or procedures must be essential and integral for carrying out the research (45 CFR 46.116(d)). Deception techniques should be used with discretion and may only be employed with the prior approval of the IRB.
Where a waiver of informed consent has been approved by the IRB to allow researchers to proceed with incomplete disclosure and deception, researchers, when appropriate, are required to provide subjects with full disclosure and additional pertinent information after participation (45 CFR 46.116(d)). In some instances, full disclosure is done immediately after the subject has completed the research task(s). In other instances, full disclosure to subjects is held off until the completion of the study's data collection.
The debriefing process usually consists of a written statement given to subjects and discussion with the research team providing a thorough explanation of the incomplete disclosure and deception and the true goals of the research.