Waiver of Documentation of Consent [45 CFR 46.117(c)]
Potential participants are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.
(1) The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
(2)The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.
Generally, an electronic consent process is granted a waiver of documentation of consent by the IRB. However, it is possible for an electronic consent process to include a valid electronic signature. Contact the RSPO for more information about this option.
Waiver or Alteration of Consent [45 CFR 46.116(d)]
For some minimal risk research, the IRB can waive the requirement for obtaining informed consent or to approve a consent procedure that leaves out or alters some or all of the elements of informed consent otherwise required under the regulations.
(1) The research involves no more than minimal risk to the participants;
(2) The waiver or alteration will not adversely affect the rights and welfare of the participants;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the participants will be provided with additional pertinent information after participation.
Assent of Children [45 CFR 46.401 (subpart D)]
Although children do not have the legal capacity to “consent” to participate in research, they should be involved in the process to the extent they are able and should usually be asked to agree to participate. This is called “assent.” The process for obtaining assent from children is similar to consent of adults in that the basic elements of consent are required to be presented to the child in language that is applicable to their age. Parental permission is usually required for the child’s participation. If parents will be subjects in the research, separate consent for their own participation must also be obtained. Please consult the RSPO team if you have questions about assent and parental permission processes.
There are times when parental permission is not required for children to participate in a research project. Please refer to the KPNW Guidance on Children and Consent for more information.
Waiver of Assent [45 CFR 46.408 and 46.116(d) and 21 CFR 50.55(d)]
In certain cases where assent of children and/or parental permission is not feasible or appropriate, the IRB can consider waiving the requirement. See the review checklists in the eIRB Library for specific criteria.
Other Types of Waivers
The IRB can also waive consent requirements for certain types of research on emergency medicine practices or public benefit programs. Contact the RSPO about these options.