Waiver of Consent

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National Jewish Health will comply with federal regulations requiring the waiver or alteration of informed consent.

PROCEDURES*:

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:

1. The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
2. The research could not practicably be carried out without the waiver or alteration.

OR

If the IRB finds and documents that:

1. The research involves no more than minimal risk to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

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If an investigator wishes to apply for a waiver or alteration of the informed consent document or process, s(he) must submit a request in writing on the Request for Waiver of Informed Consent Form. All elements must be addressed and explained. A statement such as "the rights and welfare of the subjects will not be affected by the waiver or alteration" is not sufficient. The investigator must explain why the rights and welfare will not be affected. Likewise, the investigator must provide justification why the research cannot "practicably" carried out without the waiver or alteration.

The definition of "practicably" will be decided on a case-by-case basis, and will involve considerations such as the number of subjects involved, the difficulty (explained in detail) involved in locating potential subjects, the nature of the research.

The request for waiver or alteration must be submitted and approved before the research can begin. In some instances, the Chair (only) may expedite a waiver or alteration of informed consent request. However, in most cases, a request for a waiver or alteration of informed consent will be decided by the IRB committee at a regularly convened meeting.

The investigator will be notified in writing of the IRB's decision.

*These criteria are not included in the FDA regulations. Both HHS and FDA have additional requirements for waiving informed consent in research involving emergency or acute care.