Legislative Process Framework : HHS Requirements for Use of Human Subjects in Research
Subpart C of 45CFR46 governs research done with prisoners. Subpart D regulates research conducted with children. These regulations became effective on December 13, 2001.
HHS research regulations are codified in Title 45 of the CFR, Part 46 (45CFR46). The HHS Office for Human Research Protections enforces Title 45CFR46.2
Title 45CFR46 has four subparts: A, B, C, and D. Subpart A, known as the "common rule," is the basic policy that governs human subjects research for virtually all HHS agencies. The principal goal of the common rule is to minimize harm to research participants. The HHS regulations apply to human research of all types (biomedical as well as social and behavioral) conducted or funded, wholly or in part, by HHS or any of its agencies.
The regulations require (with rare exceptions) informed consent of all humans participating as subjects in federally funded research:
46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.3
Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.3
The HHS regulations stipulate that:
