MRI INSTITUTIONAL REVIEW BOARD

INFORMED CONSENT DOCUMENT REVIEWER FORM

IRB PROJECT #: / Principal Investigator:
REVIEWER: / Review Date:

Many protocols are returned to investigators due to problems with meeting regulatory concerns in the informed consent forms. Below is a copy of the three-part "Informed Consent Checklist" that an IRB member can use when they review consent forms for content.

A similar resource is available from the OHRP Guidance Document Consent Checklists at:

SECTION I – Basic Elements of Informed Consent
45 CFR 46 (HHS), 21 CFR 50.25 (FDA),38 CFR 16 (VA), and ICH Guideline 4.8.10 (in italics)
Regulatory/ MRI IC Template Reference /

Element

/ Assessment
Introduction [CL1] / A statement that the study involves research, / (Choose One:)MetNot MetN/A
Comments:
What is the purpose? [CL2] / An explanation of the purposes of the research, / (Choose One:)MetNot MetN/A
Comments:
What else should I know [CL3] / A statement that participation is voluntary, / (Choose One:)MetNot MetN/A
Comments:
What else should I know . . .?[CL4] / A statement that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled; a statement that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. / (Choose One:)MetNot MetN/A
Comments:
What Happens if I Agree[CL5] / The probability for random assignment to each treatment. / (Choose One:)MetNot MetN/A
Comments:
What Happens if I Agree [CL6] / A description of the procedures to be followed, / (Choose One:)MetNot MetN/A
Comments:
What Happens if I Agree [CL7] / The trial procedures to be followed, including all invasive procedures. / (Choose One:)MetNot MetN/A
Comments:
What Happens if I Agree [CL8] / Identification of any procedures which are experimental; / (Choose One:)MetNot MetN/A
Comments:
What Happens if I Agree [CL9] / The trial treatment(s) and / (Choose One:)MetNot MetN/A
Comments:
What Happens if I Agree [CL10] / The subject's responsibilities (For clinical studies) / (Choose One:)MetNot MetN/A
Comments:
How Long . . .[CL11] / An explanation of the expected duration of subject's participation, / (Choose One:)MetNot MetN/A
Comments:
What are the Risks [CL12] / A description of any reasonably foreseeable risks or discomforts to the subject; / (Choose One:)MetNot MetN/A
Comments:
Are There Any Benefits [CL13] / A description of any benefits to the subject or to others which may reasonably be expected from the research; / (Choose One:)MetNot MetN/A
Comments:
Are There Any Benefits [CL14] / The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this. / (Choose One:)MetNot MetN/A
Comments:
What Other Options [CL15] / A disclosure of appropriate alternative procedures or courses of treatments, if any, that may be advantageous to the subject; / (Choose One:)MetNot MetN/A
Comments:
What Other Options [CL16] / The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks. / (Choose One:)MetNot MetN/A
Comments:
What About Confidentiality[CL17] / A statement 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 result of the trial are published, the subject's identity swill remain confidential; (For clinical studies) / (Choose One:)MetNot MetN/A
Comments:
What About Confidentiality[CL18] / A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, and [where applicable] that notes the possibility that the FDA may inspect the records; (For clinical studies); / (Choose One:)MetNot MetN/A
Comments:
What If I am Injured [CL19] / For research involving more than minimal risk, an explanation as to whether any compensation is available if injury occurs, 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; / (Choose One:)MetNot MetN/A
Comments:
Who Do I Call [CL20] / An explanation of whom to contact for answers to pertinent questions about the research / (Choose One:)MetNot MetN/A
Comments:
Who Do I Call[CL21] / An explanation of whom to contact for answers to pertinent questions about research subjects' rights / (Choose One:)MetNot MetN/A
Comments:
Who Do I Call[CL22] / An explanation of whom to contact in the event of a research-related injury to the subject; / (Choose One:)MetNot MetN/A
Comments:
SECTION II - Additional Elements of Informed Consent
45 CFR 46 and 21 CFR 50.25; ICH Guideline 4.8.10 (in italics)
Reference /

Element

/ Assessment
How Long . . . OR
What Happens if I Agree[CL23] / A description of the procedures for orderly termination of participation by the subject; / (Choose One:)MetNot MetN/A
Comments:
How Long…[CL24] / Anticipated circumstances under which a subject's participation may be terminated by the investigator without regard to the subject's consent; / (Choose One:)MetNot MetN/A
Comments:
How Long . . .[CL25] / The consequences of a subject's decision to withdraw from the research and / (Choose One:)MetNot MetN/A
Comments:
What are the Risks [CL26] / 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; / (Choose One:)MetNot MetN/A
Comments:
Will I Be Paid . . .?[CL27] / The anticipated prorated payment, if any, to the subject for participating in the trial. / (Choose One:)MetNot MetN/A
Comments:
What Are the Costs? [CL28] / Any additional costs to the subject that may result from participation in the research; / (Choose One:)MetNot MetN/A
Comments:
What are My Rights as a Participant[CL29] / 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; / (Choose One:)MetNot MetN/A
Comments:
How Many People[CL30] / Approximate number of subjects involved in the study. / (Choose One:)MetNot MetN/A
Comments:
Signatures[CL31] / If research involves children (minors), neonates, or fetuses, appropriate parental signature(s) are included and assent is included when appropriate. / (Choose One:)MetNot MetN/A
Comments:
SECTION III - Additional Elements, Including Documentation of Informed Consent
45 CFR 46.117 (HHS) AND 21 CFR 50 (FDA)
Reference /

Element

/ Assessment
Regulatory [CL32] / 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. / (Choose One:)MetNot MetN/A
Comments:
Regulatory[CL33] /
Documentation of Informed Consent
Informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by subject, or subject's legally authorized representative. A copy shall be given to the person signing the form. / (Choose One:)MetNot MetN/A
Comments:
Regulatory[CL34] / The information given to a subject or the representative shall be in language understandable to the subject or representative (i.e., lay terms). / (Choose One:)MetNot MetN/A
Comments:

Please email this form to the appropriate IRB Regulatory Associate before the full IRB meeting.

Informed Consent Checklist © MedStar Research Institute 2004 – Version: 01/06/05 ORA2005 7.0 Page 1 of 4

[CL1]1

45 CFR 46.116 (a) (1);
21 CFR 50.25(a)(1);
38 CFR 16.116 (a)(1);
ICH E6 4.8.10(a)

[CL2]1

45 CFR 46.116 (a) (1);
21 CFR 50.25(a)(1);
38 CFR 16.116 (a)(1)
ICH E6 4.8.10 (b)

[CL3]1

45 CFR 46.116 (a) (8);
21 CFR 50.25(a)(8);
38 CFR 16.116 (a)(8);
ICH E6 4.8.10 (m)

[CL4]1

45 CFR 46.116 (a) (8);
21 CFR 50.25(a)(8);
38 CFR 16.116 (a)(8);
ICH E6 4.8.10 (m)

[CL5]1

ICH E6 4.8.10 (c)

[CL6]1

45 CFR 46.116 (a) (1)
21 CFR 50.25(a)(1)
38 CFR 16.116 (a)(1)

[CL7]1

ICH E6 4.8.10 (d)

[CL8]1

45 CFR 46.116 (a) (1);
21 CFR 50.25(a)(1)
38 CFR 16.116 (a)(1);
ICH E6 4.8.10 (f)

[CL9]1

ICH E6 4.8.10 (c)

[CL10]1

ICH E6 4.8.10 (e)

[CL11]1

45 CFR 46.116 (a) (1);
21 CFR 50.25(a)(1);
38 CFR 16.116 (a)(1);
ICH E6 4.8.10 (s)

[CL12]1

45 CFR 46.116 (a) (2);
21 CFR 50.25(a)(2);
38 CFR 16.116 (a)(2);
ICH E6 4.8.10 (g)

[CL13]1

45 CFR 46.116 (a) (3);
21 CFR 50.25(a)(3);
38 CFR 16.116 (a)(3)

[CL14]1

ICH E6 4.8.10 (h)

[CL15]1

45 CFR 46.116 (a) (4);
21 CFR 50.25(a)(4);
38 CFR 16.116 (a)(4)

[CL16]1

ICH E6 4.8.10 (i)

[CL17]1

ICH E6 4.8.10 (n) and (o)

[CL18]1

45 CFR 46.116 (a) (5);
38 CFR 16.116 (a)(5)

21 CFR 50.25(a)(5)

[CL19]1

45 CFR 46.116 (a) (6);
21 CFR 50.25(a)(6);
38 CFR 16.116 (a)(6);
ICH E6 4.8.10 (j)

[CL20]1

45 CFR 46.116 (a) (7);
21 CFR 50.25(a)(7);
38 CFR 16.116 (a)(7);
ICH, E6 4.8.10 (q)

[CL21]1

45 CFR 46.116 (a) (7);
21 CFR 50.25(a)(7);
38 CFR 16.116 (a)(7);
ICH, E6 4.8.10 (q)

[CL22]1

45 CFR 46.116 (a) (7);
21 CFR 50.25(a)(7);
38 CFR 16.116 (a)(7);
ICH, E6 4.8.10 (q)

[CL23]1

45 CFR 46.116 (b) (4);
21 CFR 50.25(b)(4);
38 CFR 16.116 (b)(4)

[CL24]1

45 CFR 46.116 (b) (2);
21 CFR 50.25(b)(2);
38 CFR 16.116 (b)(2);
ICH E6 4.8.10 (r)

[CL25]1

45 CFR 46.116 (b) (4);
21 CFR 50.25(b)(4);
38 CFR 16.116 (b)(4)

[CL26]1

45 CFR 46.116 (b) (1);
21 CFR 50.25(b)(1);
38 CFR 16.116 (b)(1);
ICH E6 4.8.10 (g)

[CL27]1

ICH E6 4.8.10 (k)

[CL28]1

45 CFR 46.116 (b) (3);
21 CFR 50.25(b)(3);
38 CFR 16.116 (b)(3);
ICH E6 4.8.10 (l)

[CL29]1

45 CFR 46.116 (b) (5);
21 CFR 50.25(b)(5);
38 CFR 16.116 (b)(5);
ICH E6 4.8.10 (p)

[CL30]1

45 CFR 46.116 (b) (6);
21 CFR 50.25(b)(6);
38 CFR 16.116 (b)(6);
ICH E6 4.8.10 (t)

[CL31]1

45 CFR 46.408

45 CFR 46.204(d) and (e)

45 CFR 46.205(b)(2) and 46.205(c)(5)

[CL32]1

45 CFR 46.116;
21 CFR 50.20;
38 CFR 16.116;
ICH 4.8.4

[CL33]1

45 CFR 46.117(a);
21 CFR 50.27 (a);
38 CFR 16.117(a)

[CL34]1

45 CFR 46.116
21 CFR 50.20
38 CFR 16.116;
ICH 4.8.6