What is a criterion for waiving informed consent?

When research is governed by the requirements of the Common Rule, some or all of the elements of informed consent may be either waived or altered by the IRB if specific criteria apply. The Common Rule regulations describe the criteria for applying these waivers and alterations of the informed-consent process. A brief description of these criteria follows.

The Common Rule allows an IRB to approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent (or to waive the requirement altogether) if it finds that the research falls into either of the following two categories: The first category involves research that must be approved by a state or local government, that evaluates a government service program, and that would not be feasible without the waiver or alteration. The second category involves research that meets all of the following conditions: (1) subjects are exposed to no more than minimal risk; (2) the waiver or alteration does not adversely affect subject rights and welfare; (3) the research would not be feasible without the waiver or alteration; and (4) subjects will be provided with additional pertinent information after participation, when appropriate.

When assessing whether a protocol meets each of the criteria for the second category of research, investigators should consider the following: (1) Minimal risk means that the probability and magnitude of harm or discomfort anticipated during the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. A determination of the level of risk posed by a protocol is made during the risk assessment process. More information on the concept of minimal risk and risk assessment can be found in Module 3. (2) The waiver or alteration of informed consent would not be considered to have an adverse effect on the welfare of subjects if not informing potential subjects about the research could not possibly harm or expose them to harm. For example, a study involving the review of medical records, where the subject treatment has already occurred, would not harm the subjects if the data were collected from records without identifiers. (3) The feasibility or practicability standard is generally case-specific. IRBs consider a number of factors, from the amount of time that has passed since subjects contact information was updated (and therefore the difficulty in reaching potential subjects), to the number of potential subjects to be contacted (i.e., it would be impossible to conduct a study of medical records if thousands of potential subjects needed to be contacted and their consent obtained). Furthermore, if the first three criteria are met, the researcher must also consider whether (4) the nature of the research is such that it may be appropriate to provide further information about the research to the subjects at a later date, usually after the study is completed. The provision of this further information as well as the method of contact would need to be reviewed and approved by the IRB.

An example of a research project for which a waiver of informed consent is likely to be granted is available at this link.