Informed Consent Waivers

Waiver of Documentation of Informed Consent

There is a waiver of documentation of informed consent, in which all of the key elements (45 CFR 46.116) of consent information is provided, but there does not need to be a signature. This is often used with surveys that are mailed (the cover letter contains all the element of the consent and if the individual returns the survey, then it is assumed that they agreed) or on web surveys by clicking on an "I agree" button. If a waiver of documentation of informed consent is being sought for studies involving youth, contact the Human Protections Administrator for guidance.

45 CFR 46.117(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB requires the investigator to provide subjects with a written statement regarding the research.

 

Waiver of Informed Consent

45 CFR 46.116(c) 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.

45 CFR 46.116(d) 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 in this section, or waive the requirements to obtain informed consent provided 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.

Passive Consent

Why can't I use a “passive” process for obtaining consent?

Although the phrases "passive consent" and "active consent" have become a part of custom and practice in certain fields of research, neither term appears in the DHHS regulations, Federal policy, or Federal guidance documents, and therefore, they cannot replace Federal requirements. The DHHS regulations (45 CFR 46.116) state the general requirements for informed consent:

• Prospectively obtained, legally effective informed consent of the subject or the subject's legally authorized representative
• Consent shall be sought only under circumstances that:
• provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate; and
• minimize the possibility of coercion or undue influence.
• Information that is given to the subject or the representative during the consent process shall be in language understandable to the subject or the representative.
• Informed consent, whether oral or written, may not include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to the investigator, the sponsor, the institution or its agents from liability for negligence.

From the NIH Human Subjects Web Site: Frequently Asked Questions.