Answer:

The requirement for documentation of informed consent may be waived when the Institutional Review Board (IRB) finds and documents that certain criteria have been met. The criteria includes that the research involves no more than minimal risk to the participants, the research could not practicably be carried out without the waiver or alteration of the requirement, the participants or their legally authorized representatives will be provided with an explanation of the research and their participation and will be given the opportunity to ask questions and to decide whether or not they wish to participate.

In accordance with 45 CFR 46.116(d), the IRB may approve a consent process which does not include, or which alters, some or all of the elements of informed consent set forth in §46.116, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

• the research involves no more than minimal risk to the participants;
• the waiver or alteration of the consent will not adversely affect the rights and welfare of the participants;
• the research could not practicably be carried out without the waiver or alteration;
• whenever appropriate, the participants or their legally authorized representatives will be provided with additional pertinent information after participation;
• the participants or their legally authorized representatives will be provided with an explanation of the research and their participation and will be given the opportunity to ask questions and to decide whether or not they wish to participate.

The IRB can also approve a consent process involving waiver of documentation of consent when it determines that the research involves no more than minimal risk to the participants and their informed consent can be fairly inferred from the participants’ words or actions.

In addition, an IRB may also waive the requirement for written informed consent for research involving benign behavioral interventions in conjunction with the collection of information from subjects which is voluntarily self-reported, such as surveys, interviews or naturalistic observation that would not involve deception, if it finds and documents that adequate provisions are made to protect the privacy of the participants.

In order to protect the rights and welfare of the participants, it is essential that investigators obtain informed consent from the participants. Waiver of the requirement for documentation of informed consent and any alteration or waiver in the elements of informed consent should only be granted if such actions are necessary and appropriate.