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Modifying the Consent Process

Since written informed consent is a basic principle in the protection of human subjects, the federal regulations allow the HSPC to waive or alter the requirements only under special conditions. As a result, the waiver of informed consent is one of the most misunderstood provisions of the federal regulations. There is oftentimes confusion as to whether an investigator is requesting a waiver of documentation of informed consent or a waiver to all or part of the consent process.

The HSPC may only grant a waiver of or modification to the informed consent process by a vote of the full Committee. Therefore, the HSPC may not approve a request for waiver or modification of the informed consent process through the process of expedited review. (Please see Section 3, The HSPC Review Process: Expedited Review, for details regarding expedited review.) [Corrected August 2004]

Research that qualifies for a claim of exemption from HSPC review is not necessarily exempt from the informed consent process. Provisions for informed consent are evaluated with any request for exemption. (Please see, "The HSPC Process: Exempt from HSPC Review", earlier in this chapter, for more details regarding the Claim of Exemption from HSPC review.)

For studies under the jurisdiction of the FDA, the HSPC may not approve a short form or waive the requirements for written informed consent except under specific conditions. (Please see Chapter 9, "FDA Requirements: Informed Consent Requirements", for more information) [Corrected August 2004]

Waiver of Documentation of Informed Consent

Under certain conditions, the HSPC may waive the requirement that subjects sign the consent form. A waiver of documentation of informed consent, however, does not constitute a waiver of informed consent. In cases where documentation is waived, the HSPC may require the investigator to provide subjects with a written statement regarding the research. The HSPC is required to review and approve the written statement prior to its distribution to subjects.

The HSPC may waive the requirement to obtain a signed consent form for some or all of the subjects enrolled in the study if one of the following conditions exist:

1. The consent document is the only record linking the subject and the research, where the principle risk would be potential harm resulting from a breach of confidentiality. The HSPC will request that the investigator ask subjects whether or not they want documentation linking them to the research and subject’s wishes will prevail.
2. 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. 
3. For projects of minimal risk involving the use of questionnaires, the required elements of informed consent may be included in an introductory letter attached to the instrument, which includes a statement that completion and return of the questionnaire will constitute consent to participate in the project.

Waiver or Alteration of Informed Consent

The HSPC 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 document informed consent, provided one of the following sets of conditions exists and is documented:

1. The research or demonstration project is conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
   1. programs under the Social Security Act, or other public benefit or service programs;
   2. procedures for obtaining benefits or services under those programs;
   3. possible changes in or alternative to those programs or procedures; or
   4. possible changes in methods or levels of payment for benefits or services under those programs; and
   5. the research could not practicably be carried out without the waiver or alteration.
2. The HSPC may also grant a waiver if the research meets all of the following conditions:
   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 whenever appropriate, the subjects will be provided with additional pertinent information after participation.

NOTE: The federal regulations do not allow a waiver of the conditions of informed consent because the conditions are difficult or because the conditions make it difficult to enroll subjects into the research.