The following applies for studies reviewed under an expedited review process and a full review process. See the consent form template on the CUHSR website.
(From 45 CFR 46.116) (a) No investigator may involve a human being as a subject in research covered by these regulations 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 given to the subject or the representative shall be in language understandable to the subject or the representative. The subject or representative must be provided with 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. Informed consent must begin with a concise and focused presentation of key information to assist in understanding the reasons why one may or may not participate. As a whole, the informed consent must present information in sufficient detail and must be organized to facilitate the subject’s or representative’s understanding or the reasons to one might or might not want to participate. 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.
(b) Basic elements of informed consent shall include the following:
Where appropriate, the following elements of informed consent must also be included:
(d) Elements of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the informed consent requirements in paragraphs (b) and (c) of this section. If the subject or the legally authorized representative is asked to provide broad consent, the following shall be provided to each subject or the subject's legally authorized representative:
(e) CUHSR has the authority to approve a consent procedure which does not include or which alters some or all of the previously mentioned elements of informed consent or waive the requirements for informed consent if, either:
The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine
If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.