Exceptions to Informed Consent Several exceptions to the requirement for informed consent include 1) the patient is incapacitated, 2) life-threatening emergencies with inadequate time to obtain consent, and 3) voluntary waived consent.

However, pragmatic trials have been criticized for having the following problems: i) high rates of loss to follow-up; ii) nonadherence to study intervention; iii) unblinded treatment and patient self-assessment, which can potentially create bias; iv) being less perfect experiments than efficacy trials; v) sacrificing ...

The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject's legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b); (2) the IRB finds and documents ...

Data validity and quality is mentioned as the main argument to waive consent for some types of research, such as research with self-reported outcomes or research in which the intervention consists of giving information in such a way that informing people about the study arms would interfere with the outcome.