Waiver of Consent

Guidelines for Waiver or Alteration of Consent Requirements

According to 45 CFR § 46.116(c), the CHS may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waives the requirement to obtain consent, provided the CHS 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 practically be carried out without the waiver or alteration; and
3. The research is not FDA-regulated.

Additionally, under § 46.116(d) the CHS "may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent” or waive the requirement to obtain consent all together, provided the CHS finds and documents that:

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

According to § 46.117(c) the CHS may waive the requirement for the Investigator to obtain a signed consent form for some or all participants if it finds either:

1. That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; and the research is not FDA-regulated. In each circumstance, the participant should be asked whether they want documentation linking them with the research, and their wishes will govern; or
2. That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

Please note that consent requirements are different in research involving children.

Waiver Requests to the CHS

Investigators must complete a Request for Waiver of Consent to outline/specify waiver requests. The requests must contain the criteria above (as noted in CHS Policies, section 10.3.2), as appropriate, in order to approve the waiver of a specific element(s), to waive consent in general, or to waive documentation of informed consent.

Waivers requested for written documentation of the consent process must be accompanied by a written description of the information that will be provided to participants. The CHS must determine for each waiver of written consent whether the Investigator must provide participants with a written statement regarding the research.

In cases in which the documentation requirement is waived, the CHS may require that the Investigator provide participants with a written statement or short form explaining the research. The CHS will validate such documents with the CHS stamp and this validated document (or version of the document, if translated into another language) must be used with study participants.

Waivers that have been granted by the CHS are noted on the study approval notice.

 

Updated: 10-Dec-2009