Informed Consent Checklist
SECTION I : Elements of Informed Consent
45 CFR 46 (HHS-bolded),
21 CFR 50.25 (FDA non-bolded),
38 CFR (VA non-bolded),
ICH Guideline 4.8.10 (italics)
Met / Not Met / waived / Element / Regulatory reference // / / A statement that the study involves research, / 45 CFR 46.116 (a) (1);
21 CFR 50.25(a)(1);
38 CFR 16.116 (a)(1);
ICH E6 4.8.10(a)
/ / / An explanation of the purposes of the research, / 45 CFR 46.116 (a) (1);
21 CFR 50.25(a)(1);
38 CFR 16.116 (a)(1);
ICH E6 4.8.10 (b)
/ / / An explanation of the expected duration of subject’s participation, / 45 CFR 46.116 (a) (1);21 CFR 50.25(a)(1);
38 CFR 16.116 (a)(1);
ICH E6 4.8.10 (s)
/ / / A description of the procedures to be followed, / 45 CFR 46.116 (a) (1);21 CFR 50.25(a)(1)
38 CFR 16.116 (a)(1)
/ / /
The trial procedures to be followed, including all invasive procedures.
/ICH E6 4.8.10 (d)
/ / / Identification of any procedures which are experimental; / 45 CFR 46.116 (a) (1);21 CFR 50.25(a)(1)
38 CFR 16.116 (a)(1);
ICH E6 4.8.10 (f)
/ / / The trial treatment(s) and /ICH E6 4.8.10 (c)
/ / / the probability for random assignment to each treatment. /ICH E6 4.8.10 (c)
/ / /The subject’s responsibilities
(For clinical studies)
/ICH E6 4.8.10 (e)
/ / / A description of any reasonably foreseeable risks or discomforts to the subject; / 45 CFR 46.116 (a) (2);21 CFR 50.25(a)(2);
38 CFR 16.116 (a)(2);
ICH E6 4.8.10 (g)
/ / / A description of any benefits to the subject or to others which may reasonably be expected from the research; / 45 CFR 46.116 (a) (3);21 CFR 50.25(a)(3);
38 CFR 16.116 (a)(3)
/ / / The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this. /
ICH E6 4.8.10 (h)
/ / / A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; / 45 CFR 46.116 (a) (4);21 CFR 50.25(a)(4);
38 CFR 16.116 (a)(4)
/ / / The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks. /
ICH E6 4.8.10 (i)
/ / / A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; / 45 CFR 46.116 (a) (5);38 CFR 16.116 (a)(5)
/ / / That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential. (For clinical studies) / ICH E6 4.8.10 (n) and (o)
/ / / A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, and that notes the possibility that the FDA may inspect the records; (For clinical studies) / 21 CFR 50.25(a)(5)
/ / / 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 further information may be obtained; / 45 CFR 46.116 (a) (6);
21 CFR 50.25(a)(6);
38 CFR 16.116 (a)(6);
ICH E6 4.8.10 (j)
/ / / An explanation of whom to contact for answers to pertinent questions about the research, including concerns or complaints, and / 45 CFR 46.116 (a) (7);21 CFR 50.25(a)(7);
38 CFR 16.116 (a)(7);
ICH, E6 4.8.10 (q)
/ / / Please include details on how to contact someone independent of the research team for concerns, complaints, or general questions about the research, as well as situations when the research staff cannot be reached or when participants wish to talk to someone other than the research staff. / 45 CFR 46.116 (a) (7);21 CFR 50.25(a)(7);
38 CFR 16.116 (a)(7);
ICH, E6 4.8.10 (q)
/ / / An explanation of whom to contact for answers to pertinent questions about research subjects’ rights and / 45 CFR 46.116 (a) (7);
21 CFR 50.25(a)(7);
38 CFR 16.116 (a)(7);
ICH, E6 4.8.10 (q)
/ / / An explanation of whom to contact in the event of a research-related injury to the subject; / 45 CFR 46.116 (a) (7);
21 CFR 50.25(a)(7);
38 CFR 16.116 (a)(7);
ICH, E6 4.8.10 (q)
/ / / A statement that participation is voluntary, / 45 CFR 46.116 (a) (8);
21 CFR 50.25(a)(8);
38 CFR 16.116 (a)(8);
ICH E6 4.8.10 (m)
/ / / A statement that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. / 45 CFR 46.116 (a) (8);
21 CFR 50.25(a)(8);
38 CFR 16.116 (a)(8);
ICH E6 4.8.10 (m)
SECTION II: ADDITIONAL Elements of INFORMED CONSENT
45 CFR 46 (HHS-bolded),
21 CFR 50.25 (FDA non-bolded),
38 CFR (VA non-bolded),
ICH Guideline 4.8.10 (italics)
Met / Not Met / waived / Additional ElementMust Be Included Unless Not Appropriate / Regulatory reference /
/ / / A statement that the particular treatment or procedure may involve risks to the subject (or embryo, or fetus, or nursing infant if subject is or may become pregnant) which are currently unforeseeable;
[Note: If the research involves any investigational drugs or devices or the risk profile of all research-related interventions is not well known, the consent process must disclose that the particular treatment or procedure may involve risks to the participant which are currently unforeseeable. If the research includes women of child bearing potential or includes pregnant women, AND the risk profile of any research interventions or interactions on embryos and fetuses is not well known, the consent process must disclose that the particular treatment or procedure may involve risks to the embryo or fetus, if the participant is or may become pregnant, which are currently unforeseeable.] / 45 CFR 46.116 (b) (1);
21 CFR 50.25(b)(1);
38 CFR 16.116 (b)(1);
ICH E6 4.8.10 (g)
/ / / Anticipated circumstances under which a subject’s participation may be terminated by the investigator without regard to the subject’s consent;
[Note: If it is anticipated that the investigator may terminate the participant’s participationwithout regard to the participant’s
consent, the consent process must disclose anticipated
circumstances under which this could occur.]
/ 45 CFR 46.116 (b) (2);21 CFR 50.25(b)(2);
38 CFR 16.116 (b)(2);ICH E6 4.8.10 (r)
/ / / Any additional costs to the subject that may result from participation in the research;[Note: If there are any costs to the participant that may result from participation in the research, the consent process must disclose those additional costs to the participant.] / 45 CFR 46.116 (b) (3);
21 CFR 50.25(b)(3);
38 CFR 16.116 (b)(3);
ICH E6 4.8.10 (l)
/ / /
The anticipated prorated payment, if any, to the subject for participating in the trial.
/ICH E6 4.8.10 (k)
/ / / The consequences of a subject’s decision to withdraw from the research and / 45 CFR 46.116 (b) (4);21 CFR 50.25(b)(4);
38 CFR 16.116 (b)(4)
/ / / the procedures for orderly termination of participation by the subject;[Note: If there are any adverse consequences (physical, social, economic, legal, or psychological) of a participant’s decision to withdraw from the research, the consent process must disclose
the consequences of a participant’s decision to withdraw from
the research. If there are procedures that the participant
desiring to withdraw from the research should follow to prevent
harm, the consent process must discloses procedure for orderly termination of participation by the participant.]
/ 45 CFR 46.116 (b) (4);21 CFR 50.25(b)(4);
38 CFR 16.116 (b)(4)
/ / / 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 or the subject's legally acceptable representative in a timely manner;[Note: If the research is taking place over a span of time in which it is possible that significant new findings may occur during the course of the research which may relate to the participant’s willingness to continue participation, the consent process must disclose that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant.] / 45 CFR 46.116 (b) (5);
21 CFR 50.25(b)(5);
38 CFR 16.116 (b)(5);ICH E6 4.8.10 (p)
/ / /The approximate number of subjects involved in the study.
[Note: If the approximate number of participants involved in the study (locally and in total) might be important to a decision to take part in the research, the consent process must discloses the approximate number of participants (locally or in total) involved in the study. For example, the number of anticipated participants might be relevant to an individual enrolling in a clinical trial for an investigational drug or devices, particularly if the numbers are very small or very large.] / 45 CFR 46.116 (b) (6);21 CFR 50.25(b)(6);
38 CFR 16.116 (b)(6);
ICH E6 4.8.10 (t)
For applicable clinical trials, the following statement shall be provided in informed consent documents and processes: ‘A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
/ 21 CFR 50.25(c)SECTION III: ADDITIONAL ELEMENTS
INCLUDING DOCUMENTATION OF INFORMED CONSENT
45 CFR 46 (HHS-bolded),
21 CFR 50.25 (FDA non-bolded),
38 CFR (VA non-bolded),
ICH Guideline 4.8.10 (italics)
Met / Not Met / waived / Additional Element / Regulatory reference // / / Documentation of Informed Consent
Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by subject, or subject’s legally authorized representative. A copy shall be given to the person signing the form. /
45 CFR 46.117(a);
21 CFR 50.27 (a);38 CFR 16.117(a)
/ / / The information that is given to a subject or the representative shall be in language understandable to the subject or representative (i.e., lay terms). / 45 CFR 46.116
21 CFR 50.20
38 CFR 16.116;
ICH 4.8.6
/ / / 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 subjects legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. / 45 CFR 46.116;
21 CFR 50.20;
38 CFR 16.116;
ICH 4.8.4
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