What is a waiver or alteration of informed consent requirements? It is a consent procedure in which informed consent is not obtained from subjects; or that eliminates or alters some (or all) of the elements of informed consent as set forth in Federal regulations (45 CFR 46.116d):
Examples of Waivers of Documentation of Informed Consent: Survey and Telephone Screening. A Waiver of Documentation of Informed Consent is customarily requested for research where subjects will provide consent but not written consent for some or all of the research.
For example, clients that are asked to waive or consent to conflicts typically should consider whether there is any material risk that “their” attorney will be less zealous or eager on their behalf due to the conflict.
Consent & Waiver of Consent - Northwestern University
The IRB often grants a waiver of consent for retrospective chart review studies. On rare occasions, prospective collection of data through intervention or interaction with participants may be granted a waiver of consent.
This document is intended to provide guidance to investigators regarding the information needed for the IRB to grant a full waiver of informed consent under 45cfr46.116(d) when a study involves the use of secondary data and/or specimens. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Sample Consent Forms - UNC Research
Jan 17, 2020 · Consent Form Templates. These consent form templates have been posted for your reference. When completing and IRB submission in IRBIS, please fill in the application and use the consent form builder specific to your project. For …
A Waiver of Informed Consent is customarily requested for research where: There will be no contact with human subjects, and It would be impracticable to obtain legally- effective informed consent