Under both the pre-2018 Requirements and the 2018 Requirements, unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes or research activities otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Human Research Protections, Department of Health and Human Services (HHS), or any successor office (or to the equivalent office within the appropriate Federal department or agency) and shall also publish them in the Federal Register or in such other manner as provided in department or agency procedures.
Under the 2018 Requirements, the alternative procedures to be followed must be consistent with the principles of the Belmont Report. Additionally, the waiver notice published in the Federal Register must include a statement that identifies the conditions under which the waiver will be applied and a justification as to why the waiver is appropriate for the research, including how the decision is consistent with the principles of the Belmont Report.
Federal Register Notices for Secretarial Waiver
June 20, 2003 -- Notice, HHS, Final Action on Epidemiological Waiver (PDF-166.48KB)
October 7, 2002 -- Notice, HHS, Proposed Waiver for Epidemiological Studies in Prisoners (PDF-161.18KB)
October 2, 1996 -- Notice, HHS, Informed Consent Exemption for Emergency Research (PDF-18.27KB)
July 26, 1995 -- Notice, HHS, Action Regarding Emergency Research (PDF-147.37KB)
March 4, 1982 -- Notice, HHS,Waiver of Requirements as Applied to Medicaid Demonstration Projects Involving Cost-Sharing (PDF-14.32KB)
