ii. Rationale

Some research projects would not be possible if informed consent from participants were required.  The IRB may consider waiving the requirement for some or all of the elements of informed consent (45 CFR 46.116(d)) only if the study is not under the authority of the FDA.  The regulations state that informed consent may be waived in full or in part if the IRB determines that:

1. the research involves no more than minimal risk to the subjects; AND
2. the waiver or alteration will not adversely affect the rights and welfare of the subjects; AND
3. the research could not practicably be carried out without the waiver or alteration; AND
4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.