assurance of compliance

A formal declaration of an institution's commitment to the protection of human subjects. Pursuant to Section 491 of the Public Health Service Act, 42 U.S.C. 289, and to human subjects protection regulations at 45 CFR 46.103, institutions engaged in human subjects research covered by U.S. Department of Health and Human Services (DHHS) regulations and conducted or supported by DHHS must submit a written assurance of compliance satisfactory to the secretary.