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e-CFR data is current as of September 22, 2020

Title 45Subtitle ASubchapter APart 46Subpart C → §46.303


Title 45: Public Welfare
PART 46—PROTECTION OF HUMAN SUBJECTS
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects


§46.303   Definitions.

As used in this subpart:

(a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.

(b) DHHS means the Department of Health and Human Services.

(c) Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

(d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

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