Informed Consent Checklist
Basic and Additional Elements
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A statement that the study involves research |
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An explanation of the purposes of the research |
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Expected duration of the subject's participation |
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A description of the procedures to be followed |
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Identification of any experimental procedures |
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A description of any reasonably foreseeable risks/discomforts to the subject |
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A description of any benefits to the subject (or to others) that may reasonably be expected from the research |
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A disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject |
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A statement describing the extent, if any, "confidentiality of records identifying the subject" will be maintained |
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For research involving more than minimal risk: An explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs. And if so, what they consist of or where can further information be obtained |
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Research Qs |
Explain who to contact for answers to pertinent questions about the research and research subjects' rights, along with who to contact in the event of a research-related injury to the subject |
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Rights Qs |
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Injury Qs |
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A statement that participation is voluntary, refusal to participate will involve no penalty or loss of entitled benefits, and the subject may discontinue participation at any time without penalty or loss of entitled benefits |
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Additional Elements (as appropriate) |
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A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable |
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Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent |
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A statement that provides notice about possible commercial profit (Refer to 45 CFR 46.116(c)(7), (8) and (9) of the revised Common Rule) |
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A statement that provides notice about whether clinically relevant research results will be returned to the subjects |
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A statement that provides notice about whether research activities will or might include whole genome sequencing |
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Any costs to the subject resulting from participation in the research |
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The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject |
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A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject |
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The approximate number of subjects involved in the study |
Documentation of Informed Consent Checklist
Informed consent must be documented by the use of a written consent form approved by the IRB (except as explain in bullet 3 below). It must be signed by the subject or the subject's legally authorized representative. A copy must be given to the person signing the form.
The consent form may be either of the following:
- A WRITTEN consent document that embodies the elements of informed consent required by 搂46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.
- A short form written consent document, stating that the elements of informed consent required by 搂46.116 have been presented ORALLY to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
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An IRB may WAIVE the requirement for the investigator to obtain a signed consent form for some or all subjects, though the IRB may still require the investigator to provide subjects with a written statement regarding the research, if it finds:
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That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
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That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context.
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That the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research involves no more than minimal risk, and there is an alternative method for documenting that consent was obtained (Refer to 45 CFR 46.117(c)(1)(iii)).
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- Under the revised Common Rule, an IRB may approve a proposal for the investigator to obtain information or biospecimens to screen, recruit, or determine eligibility of prospective subjects for a research study without informed consent. In other words, the revised Common Rule removes the pre-2018 Common Rule requirement for an IRB to approve a waiver of informed consent for these types of activities. This is applicable if (1) the information is obtained through oral or written communication with the subject or the subject鈥檚 legally authorized representative, or (2) identifiable private information or identifiable biospecimens are obtained by accessing records or stored identifiable biospecimens [Refer to 45 CFR 46.116(g) of the revised Common Rule].
- This provision only applies to consent forms from clinical trials conducted or supported by a Common Rule department or agency. Under the revised Common Rule, the term 鈥渃linical trial鈥� refers to research studies in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes. For such studies, one IRB-approved version of a consent form that has been used to enroll participants must be posted on a public federal website designated for posting such consent forms. The form must be posted after recruitment closes, and no later than 60 days after the last study visit. Federal departments or agencies may permit or require redactions as appropriate. The purpose of this requirement is to be more transparent about the consent forms being used and, over time, improve the quality of consent forms.
Special Requirements - 45 CFR 46 Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research
Assent/Waiver
The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances, in which consent may be waived in accord with 搂46.116 of Subpart A..
Parents
The IRB may find that the permission of one parent is sufficient for research to be conducted under 搂46.404 or 搂46.405, i.e. (Research not involving greater than minimal risk or research involving greater than minimal risk but presenting the prospect of direct significant benefit to the individual subjects).
Where research is covered by 搂46.406 and 搂46.407 (Research involving greater than minimal risk and no prospect of direct significant benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition, and research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children), and permission is to be obtained from parents, both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
If the IRB determines that a research protocol is designed for conditions or for a subject population, for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.鈥�
Identifiable Private Information or Identifiable Biospecimens (Refer to 45 CFR 46.116(e) and 45 CFR 46.116(f))
In cases with research involving identifiable private information or identifiable biospecimens: The IRB must determine that the research could not practicably be carried out without using the information or biospecimens in an identifiable form. If the research could be done using non-identifiable information, then that is what should be done.