Glossary of Terms

The Common Rule (45CFR46) allows the IRB to approve a waiver, or an alteration, of the requirement for informed consent to the research if the proposed protocol meets the following specific criteria found at 45 CFR § 46.116(d): 1.) The research involves no more than minimal risk to the privacy of the subjects. 2.) The research could not practicably be carried out without the waiver or alteration. 3.) The research could not practicably be conducted without access to and use of this identifiable protected health information. 4.) Whenever appropriate (generally, when there is a health justification), the subjects will be provided with additional pertinent information after participation. Additional information: http://answers.hhs.gov/ohrp/questions/7268

Per 45 CFR 46.117, 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 may require the investigator to provide subjects with a written statement regarding the research. Additional information: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117