Institutional Review Board
(734) 712-5470
Waiver of Documentation of Consent
"Waiver of documentation of consent" means that consent is obtained from the participants, but is done via verbal consent orby a consent document without the signature lines (commonly referred to as an 'informational sheet'). This option is useful if you are conducting an Internet survey or telephone research or other types of minimal risk research.
You will need to document in the research record or other location that a consent process took place.
The consent process should include the required elements of consent. If you would like to exclude or alter the elements, please also complete the Alteration of Consent form.
In order to qualify for waiver of documentation of consent for some or all of the participants, the research study must:
- OHRP-regulated research- meet EITHERthe 1stor 2ndrequirementbelow[see 45 CFR 46.117(c)]
- FDA-regulatedresearch-meet the 2nd requirementbelow [see 21 CFR 56.109(c)(1)]
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Waiver of Documentation of Consent Consent will be obtained, either
verbally or with an Info Sheet
Title of Research Project:
Which method will you use?
Verbal consent*-- Please submit a verbal script
Consent document without signatures obtained/ informational sheet
*Note that the IRB may still require that written information is given to some or all of the participants (info sheet).
Indicate thedocumentation that will be used to note thatconsent took place: The protocol or departmental procedures shouldindicate how and where to document the consent discussion (such as in a progress note, study file or research record).
Progress note
Study file
Other
Please indicate the status of the research study:
New Project Application is being submitted –please complete the informed consent section of the application, describing the consent process that will be used.
Study has been approved – please attach or describe below the consent process that will be used:
Choose either the 1st or the 2ndoption, below, for OHRP-regulated research;
Choose the 2nd option only for FDA-regulated research;
Complete both a) and b) for the chosen requirement:
1st Requirement (OHRP only)
a) The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality and privacy. Explain how your study meets this criterion.Please note: the IRB may decide to require that the researcher provide the participants with a written statement about the research (information sheet/consent form without signature lines).
AND
b) Each participant will be asked whether the participant wants documentation linking them with the research(i.e. sign a consent document or provide evidence that they gave consent for the study), and the participant's wishes regarding documentation of consent will govern.
I will comply with this requirement
OR
2nd Requirement (OHRP &/or FDA)
a) The research presents no more than minimal risk of harm to participants. Explain how your study meets this criterion. Minimal risk means that "the probability and magnitude of harm or discomfort anticipated in 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".
AND
b) The research involves no procedures for which written consent is normally required outside of the research context. Explain how your study meets this criterion.
Checklist before you submit to the IRB:You must submit either a consent script or information sheet/letter to the IRB for approval:
Script or Information Sheet is attached
The informed consent process and where it will be documented:
is described above, attached or included in the New Project Application.
Please return this completed form via e-mail to:
Waiver of Documentation of Consent 12-2015 1