Under certain circumstances, the IRB may approve a consent process that does not include, or that alters, some or all of the elements of informed consent, or may waive the requirement to obtain informed consent, provided the IRB finds and documents that all of the following requirements apply:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Requests for alterations in, or a waiver of, informed consent requirements should be made in the study protocol and justified by addressing each of the points above in sufficient detail to substantiate requirement.