This waiver applies in the special circumstances when the IRB determines that it is not necessary to obtain the participant's 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:
The IRB determines that a research protocol is designed to study conditions, in children or a participant population, for which parental or guardian permission is not a reasonable requirement to protect the participants, for example, neglected or abused children, and the following two additional criteria are also met:
1. An appropriate mechanism is in place to protect the children, and
2. The waiver is not inconsistent with federal, state or local law (45 CFR 46.408(c)). The choice of an appropriate substitute mechanism, for example, appointing a child advocate or an assent monitor, for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition (45 CFR 46.408(c)). Note that an IRB may waive the requirement for obtaining parental or guardian permission under 45 CFR 46.408(c) even if the research involves more than minimal risk to the child subjects.
NKU also allows investigators to request to waive parental or guardian permission under the following provision:
Request to waive parental permission-Pursuant to 45 CFR 46.408 (a) and (b), request that guardian permission be waived as the participants are non-high school students enrolled in a university where they are expected to be treated and conduct themselves as adults and where their guardians have endorsed them to be enrolled and to conduct themselves as adults.
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:
1. Research in general: an IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(d), provided that the IRB finds and documents that all of the following four conditions are met:
2. Public benefit or service programs: an IRB may approve a consent procedure that alters some or all of the elements of informed consent, or waive the requirement to obtain informed consent under HHS regulations at 45 CFR 46.116(c), provided that the IRB finds and documents that both of the following conditions are met:
3. Research in emergency settings: An IRB may also waive the requirement for obtaining informed consent if it finds, and documents, that the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings.
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: