(i) 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 (DHHS), or any successor office, and shall also publish them in the Federal Register or in such other manner as provided in department or agency procedures.1


(a) Department or agency head means the head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated.

(b) Institution means any public or private entity or agency (including federal, state, and other agencies).

(c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

(d) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.


Institutions with DHHS-approved assurances on file will abide by provisions of Title 45 C.F.R. Part 46 Subparts A-D. Some of the other departments and agencies have incorporated all provisions of Title 45 C.F.R. Part 46 into their policies and procedures as well. However, the exemptions at 45 C.F.R. § 46.101(b) do not apply to research involving prisoners, Subpart C. The exemption at 45 C.F.R. § 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, Subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

[56 FR 38012, 28022, June 18, 1991; 56 FR 29756, June 28, 1991; 70 FR 36325, June 23, 2005]

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