Human Research Protections
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Waiver of Authorization:

In some situations, the IRB can waive the requirement that research subjects sign an Authorization Form. To qualify for a Waiver of Authorization, the research use of the health information should not represent more than a minimal risk to privacy, and the researcher should indicate that the research could not be done without the requested health information, that it would not be practical to obtain signed authorizations from the research subjects, and that the specific elements of health information that are requested are not more than the minimum necessary to accomplish the goals of the study.

  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.
Waiver of Informed Consent:

Occasionally there are reasons to waive written consent or to alter the requirements of consent. Only the IRB can make the determination to waive some (written) or all (written and verbal) consent requirements. In order to qualify for a Waiver of Consent, the following conditions should be met: 1) that the research pose no more than minimal risk to subjects; 2) no adverse effects as a result of the waiver or alteration; 3) without the waiver or alteration the research in question could not be carried out; and 4) information will be provided after participation is completed, if appropriate.

Weill Cornell Medicine Human Research Protections 575 Lexington Avenue New York, NY 10022 Phone: (646) 962-8200