An alteration of consent is when the [IRB [. . . approves] a consent procedure that omits some or alters some or all of the elements of informed consent]. The IRB may grant alterations to your informed consent form if specific criteria are met. In this article we will discuss these specific criteria, along with examples of when an alteration of consent may be granted.
For a waiver of informed consent to be granted the following criteria must be met;
- The research involves no more than minimal risk.
- The research could not be carried out practicably without the waiver. (*Please note this cannot simply be because it is more convenient for the researcher to not obtain consent.)
- The waiver will not adversely affect the rights and welfare of the subjects.
- When appropriate, the subjects will be provided with additional information about their participation.
Below are examples of when an alteration of consent may be granted, pending the above is met;
- In research that involves deception or in cases where subject knowledge of the purpose of research may alter their responses. You may need to omit some information from participants in order to answer your research question. E.g. they are told they are completing a survey on overall happiness but in reality you are looking to see if the room temperature has an effect on a person’s mood
- Where medical records or biospecimens are being reviewed and identifiers will not be kept with the data.
- When obtaining consent from a large number of individuals in a retrospective chart review is not practical
- In research examining public benefit or service programs not regulated by the FDA that looks at or evaluates procedures for obtaining benefits or services, changes or alternatives to these programs, or changes in methods or levels of payment for these programs.
To read more about alteration and waiver of consent and when they apply, please refer to CFR at § 46.116.f(2). If you would like to talk through waiver of consent and your study, please feel free to reach out to the Solutions IRB administrative team, at email@example.com or 1-855-226-4472.
Author: Cora Crawford