This waiver applies in the special circumstances when the IRB determines that it is not necessary to obtain the participants’ consent to conduct the research.
The IRB may approve research where investigators leave out or alter elements of informed consent, provided the research meets all applicable regulations.
HHS regulations allow the IRB to waive the requirement for obtaining informed consent or parental permission 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.
The IRB may waive the requirements for obtaining parental or guardian permission under the following provision:
NKU also allows investigators to request to waive parental or guardian permission under the following provision:
For adults and children, a waiver or alteration of the requirements for obtaining consent can occur under any of the following three provisions set forth by HHS:
If you plan to use or share protected health information (PHI) when conducting your research, you must conduct your study in accordance with the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA).
This means that when applying for a waiver of documentation of consent, you will also have to request a waiver or alteration of HIPAA Authorization. The IRB can grant the waiver of alteration if it deems the following criteria are met: