IRB Consent Form Checklist
INSTRUCTIONAL MEMO
Dear Investigator:
The informed consent process is one of the most crucial components for human research protections. The process often involves a consent document, a copy of which is given to the patient/subject for their review and reference.
It is hoped that with the use of this IRB Consent Form Checklist, we have provided a tool to assist you in protecting your patient/subject's rights and welfare by providing a fair and comprehensible written representation of the research in which they are being asked to participate.
Regards
IRB Office
NEXT STEP
UPON COMPLETION
▪
Once you have completed this application please review your consent form(s) and related material to ensure that you have ALL required components for your new protocol submission. à Remember to check/obtain the IRB Internal Review Memo for impacted departments.
Begin to assemble each of your 3 packets for submission. The required order is outlined on your IRB New Submission Application.
(253) 403.3877 ▪ P.O. Box 5299 ▪ MS: 315-C3-QM ▪ Tacoma, WA 98415
IRB Consent Form Checklist
MHS IRB Office:MultiCare Health System
IRB Office
MS: 315-C3-QM
P.O. Box 5299
Tacoma, WA 98415
Electronically: / The MultiCare Health System (MHS) Institutional Review Board (IRB) convenes the first Monday of every month.
For submission deadlines and questions please contact the
IRB Coordinator at 253-403-3877 / Submission Date:
REQUIREMENTS – CHECK EACH BOX in this Requirements section demonstrating your understanding and acknowledging the proper way to complete this form
Check appropriate box and do not leave any section blankRegulatory Reference - 45 CFR 46: United States Department of Health and Human Services
21 CFR 50.25: Food and Drug Administration
Elements marked as “No or Not Applicable (N/A)”- must be accompanied by an explanation as to why in Comments
section. If a particular element is “waived” please note this in your explanation
Elements marked as “Yes” – Indicate the page and paragraph of your consent form where this element may be found in the z
Comments section
A. IRB STUDY INFORMATION
Protocol Title:Primary Investigator:
B. Consent Form Checklist
Element and Regulatory Reference / Yes / No / N/A / Comments / Page / Paragraph1. A statement that the study involves research
45 CFR 46.116 (a)(1); 21 CFR 50.25(a)(1)
2. Explanation of the purposes of the research
45 CFR 46.116 (a)(1); 21 CFR 50.25(a)(1)
3. Explanation of the expected duration of subject’s participation
45 CFR 46.116 (a)(1); 21 CFR 50.25(a)(1)
4. Description of the procedures to be followed
45 CFR 46.116 (a)(1) 21 CFR 50.25(a)(1)
5. Identification of any procedures which are experimental
45 CFR 46.116 (a)(1); 21 CFR 50.25(a)(1)
6. Description of any reasonably foreseeable risks or
discomforts to the subject
45 CFR 46.116 (a)(2); 21 CFR 50.25(a)(2)
7. 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)
Element and Regulatory Reference / Yes / No / N/A / Comments / Page / Paragraph
8. A disclosure of appropriate alternative procedures or
courses of treatments, if any, that may be advantageous to
the subject
45 CFR 46.116 (a)(4); 21 CFR 50.25(a)(4)
9. A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be
maintained
45 CFR 46.116 (a)(5); 21 CFR 50.25(a)(5)
10. 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
45 CFR 46.116 (a)(6); 21 CFR 50.25(a)(6)
11. An explanation of whom to contact for answers to pertinent
questions about the research
45 CFR 46.116 (a)(7); 21 CFR 50.25(a)(7)
12. An explanation of whom to contact for answers to pertinent
questions about research subjects’ rights (must include
MHS IRB contact information)
45 CFR 46.116 (a)(7); 21 CFR 50.25(a)(7)
13. 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)
14. A statement that participation is voluntary
45 CFR 46.116 (a)(8); 21 CFR 50.25(a)(8)
15. 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
45 CFR 46.116 (a)(8); 21 CFR 50.25(a)(8)
16. 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
45 CFR 46.116 (b)(1); 21 CFR 50.25(b)(1)
17. Any additional costs to the subject that may result from
participation in the research
45 CFR 46.116 (b)(3); 21 CFR 50.25(b)(3)
18. The consequences of a subject’s decisions to withdraw
from the research
45 CFR 46.116 (b)(4); 21 CFR 50.25(b)(4)
19. A description of the procedures for orderly termination of
participation by the subject
45 CFR 46.116 (b)(4); 21 CFR 50.25(b)(4)
Element and Regulatory Reference / Yes / No / N/A / Comments / Page / Paragraph
20. 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
45 CFR 46.116 (b)(5); 21 CFR 50.25(b)(5)
21. Approximate number of subjects involved in the study
45 CFR 46.116; 21 CFR 50.25(b
B. Consent Form Checklist – Form Construction
Element / Yes / No1. Words are familiar to the reader. Any scientific, medical, or legal words are defined clearly
2. Words and terminology are consistent throughout the document (must be at an 8th grade reading
level).
3. Sentences are short, simple, and direct
4. Each idea is clear and logically sequenced (according to audience logic)
5. Paragraphs are short. Convey one idea per paragraph.
ASSURANCE ▪ AUTHENTICATION
I assure that the information provided in this “IRB Consent Form Checklist” form is complete and accurate, and that it is consistent with that of MultiCare Health System Institutional Review Board policies and the Office for Human Research Protections (OHRP).
Signature of Primary Investigator (PI) / DateJ. DESIGNEE
The Primary Investigator has designated the following individual to complete this form and has read and understood the abovestatement as outlined in part VI. Assurance ▪ Authentication of this form.
Designee’s Printed Name / Occupational Title
Designee’s Signature / Date
MultiCare Health System Institutional Review Board
IRB Consent Form Checklist
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