Checklist for Investigator Review of Consent/Assent Forms for Non-Therapeutic Research
a) Required Consent/Assent Forms
_____ 1. Is there an Adult Consent Form (studies involving adults age 19 and
above)?
_____ 2. Is there a Parental Consent Form (studies involving minors)?
_____ 3. Is there a Guardian Consent Form (studies involving incompetent
subjects)?
_____ 4. Is there a Child Assent Form (studies involving minors ages 6-12)?
_____ 5. Is there a Youth Assent Form (studies involving minors ages 13-18)?
b) Review of Consent form Format and Style
_____ 1. Is the consent form printed on appropriate University of Nebraska at
Kearney
stationery?
_____ 2. Is each element of informed consent identified by the required subheading
in bold type (research that is minimal risk or greater)?
_____ 3. Are the elements of informed consent arranged in the correct sequence?
_____ 4. Does each element contain only content relevant information without
unnecessary repetition.
_____ 5. Is the consent form written in the second person?
_____ 6. Is the language written at the appropriate educational level?
_____ 7. Are all complex terms appropriately defined/simplified?
c) Review of the Elements of Informed Consent
_____ 1. Is the scientific title of the study the same as the title listed on the IRB
application form?
_____ 2. Does the consent form have the IRB standard Invitation to Participate?
_____ 3. Is the Basis for Subject Selection clearly stated with only major
inclusion/exclusion criteria listed?
_____ 4. Is there a clear statement of the scientific purpose of the research which is
not directed toward the subject?
_____ 5. Are all procedures applied to subjects, including method of subject
assignment, explained clearly and sequentially?
_____ 6. Is the description of Potential Risks and Discomforts complete, adequately
explained and presented using the required format?
_____ 7. Is the Protection against Risks adequately explained?
_____ 8. Is the statement of Potential Benefits to the Subject realistic/supportable?
_____ 9. Is the statement of Potential Benefits to Society realistic/supportable?
_____ 10. Is there a statement concerning Alternatives to Participation? (required for
studies involving compensation in the form of academic credit)
_____ 11. Are any economic incentives/rewards for participation clearly stated in the
Financial Compensation section?
_____ 12. Is the standard In Case of Emergency Contact Procedure statement
present?
(required for more than minimal risk studies)
_____ 13. Is the standard Emergency Care and Compensation in Case of Injury
statement present? (required for more than minimal risk studies)
_____ 14. Is the Assurance of Confidentiality clear and complete?
_____ 15. Is the standard IRB statement concerning the Rights of Research Subject
present?
_____ 16. Is the standard IRB Voluntary Participation and Withdrawal statement
present?
_____ 17. Are the correct standard IRB concluding consent statement present for the
subject, investigator and the witness (if required)?
_____ 18. Are there dated subject, investigator, and witness signature blanks?
_____ 19. Is the name and office phone number of the investigator(s) placed at the
end of the form?
_____ 20. Is the day/night phone numbers of the investigator(s) present (required
for more than minimal risk studies)?
d) Review of Parental/Guardian Consent Form
_____ 1. Is the Parental/Guardian Consent Form written in a proxy consent style?
e) Review of Youth Assent Forms
_____ 1. Is the language written at the level of the youngest prospective subject
in the youth age range (13-18)?
_____ 2. Is each element of youth assent identified by the correct subheading?
(research that is minimal risk or greater)
_____ 3. Are the elements of youth assent arranged in the correct sequence?
_____ 4. Is the required consultation with parents statement included as the second
part of the Invitation to Participate?
f) Review of Child Assent Form
_____ 1. Is the language written at the level of the youngest prospective subject
in the child age range (6-12)?
_____ 2. Are the elements of child assent arranged in the correct sequence and
identified by a number?
_____ 3. Is the required consultation with parents statement included as part of the
Invitation to Participate?
