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Title 45—Public Welfare
SUBTITLE A—Department of Health and Human Services
SUBCHAPTER A—GENERAL ADMINISTRATION
PART 46—PROTECTION OF HUMAN SUBJECTS
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
§ 46.116 General requirements for informed consent.
Ҥ 46.116 General requirements for informed consent.
(a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b) through (d) of this section …
(2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence …
(4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
(5) Except for broad consent obtained in accordance with paragraph (d) of this section: ...
(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.
(6) No informed consent may include any exculpatory language through which the subject or the legally authorized 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.
(b) Basic elements of informed consent. … [I]n seeking informed consent the following information shall be provided to each subject or the legally authorized representative: ...
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”
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