Having informed consent is an important aspect of any clinical investigation, especially when it involves human subjects. However, in some cases, having a waiver or alteration of informed consent may be necessary. According to the US Food and Drug Administration (FDA), the criteria for waiving informed consent is that the research involves no more than minimal risk to the subjects, the waiver does not adversely affect the rights and welfare of the subjects, and where appropriate, the subjects or legally authorized representative are provided with information regarding the research. In addition, the FDA also states that the research should not involve prisoners, those of legal incompetence, or those with impaired consent capacity.

The Northwestern IRB also explains that informed consent may be waived if the research involves no more than minimal risk to the subjects. In such cases, all or some elements of informed consent may be waived. The protocol must include a justification for how the study meets the criteria for waiving informed consent.

The University of Virginia’s IRB also explains that informed consent can be waived when the research involves no more than minimal risk to the subjects. In addition, they also explain that the IRB can approve a waiver of consent when the risks of the research are so low that requiring consent would be burdensome. Furthermore, the IRB can also approve a waiver of consent when the research involves the use of existing data sets or records.

In conclusion, a criterion for waiving informed consent is that the research involves no more than minimal risk to the subjects. In some cases, the IRB may also approve a waiver of informed consent when the risks of the research are so low that requiring consent would be burdensome, or when the research involves the use of existing data sets or records. It is important that researchers understand these criteria to ensure that the research is conducted in an ethical manner.