45 CFR 46 (Common Rule)

DATED 2009-01-15 · VERSION 20160502_rev01 · COMPARED WITH 20160425_rev01 · ARCHIVE SNAPSHOT

Full text changes — 20160425_rev01 to 20160502_rev01

COLOUR MARKS THE SEVERITY OF A FLAGGED CLAUSE · + AND − MARK ADDED AND REMOVED

149149[§46.505]() When must IRB registration information be renewed or updated?
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151151- * *
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153153Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).
154154
155Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the Social Security Act, which test the use of cost--sharing, such as deductibles, copayment and coinsurance, in the Medicaid program. For further information see [47 FR 9208, Mar. 4, 1982](https://hhs.gov/ohrp/archive/documents/19820304-notice-text.pdf).
155Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the Social Security Act, which test the use of cost--sharing, such as deductibles, copayment and coinsurance, in the Medicaid program. For further information see [47 FR 9208, Mar. 4, 1982](http://www.hhs.gov/ohrp/archive/documents/19820304-notice-text.pdf).
156156
157157**\* \* \***
158158
159159## Subpart A - Basic HHS Policy for Protection of Human Research Subjects
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161161**Authority:** 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
162**Source:** [56 FR 28012, 28022](https://hhs.gov/ohrp/sites/default/files/frcomrul.pdf), June 18, 1991, unless otherwise noted.
162**Source:** [56 FR 28012, 28022](https://hhs.gov/ohrp/sites/default/files/ohrp/policy/frcomrul.pdf), June 18, 1991, unless otherwise noted.
163163
164164 **§46.101 To what does this policy apply?**
165165
166166 (a) Except as provided in paragraph [(b)]()) of this section, this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the federal government outside the United States.
167167
168168> (1) Research that is conducted or supported by a federal department or agency, whether or not it is regulated as defined in [§46.102]()), must comply with all sections of this policy.