IRBNet #: PI: University of Denver Institutional Review Board (IRB) Office of Research Compliance APPENDIX F – RESEARCH INCLUDING CHILDREN
Complete this appendix only if requesting children be included as subjects in the proposed research.
Section 1 – Regulatory Risk/Benefit Determination Applicable to Children Federal regulations (45 CFR 46, subpart D) define risk/benefit categories as they apply to children.
1.1 Select the category that describes the potential risks and benefits to the children participating in this
research.
(404) Minimal Risk (if applying for expedited review may only be included under this category)
(405) Greater than minimal risk, but holds prospect of direct benefit to subjects.
(406) Greater than minimal risk, no prospect of direct benefit
1.2 Explain how the proposed research fits the category selected
Section 2 – Parental Consent Requirements 2.1 Indicate plan for obtaining parental consent
One parent must give permission
Required attachments
Provide a copy of the parental permission form
with the IRB application
Allowable if the research is minimal risk (404) or greater than
minimal risk but holds prospect of direct benefit (4050
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.
Required if the research is greater than minimal risk and holds
no prospect of direct benefit (406)
The researcher requests a waiver of parental
consent. Provide justification below for waiving
parental consent:
DU IRB / Office of Research Compliance Appendix F – Research Including Children, v.1, dated 7/7/15 Provide a copy of the parental permission form
with the IRB application
None
IRBNet #: University of Denver Institutional Review Board (IRB) Office of Research Compliance PI: Section 3 – Assent Requirements – Subjects 8 to 17 Years Old An assent form should be used for subjects who are 8 to 17 years old. In certain circumstances, assent may be
waived and an information sheet used to inform minor participants about the research. Justification for waiver of
assent is required.
3.1 Does the proposed research include children between the ages of 8 and 17 years old?
Yes
Section complete, Go to Section 4 – Consenting
No
Subjects who Reach the Age of Majority
3.2 Are the minor subjects capable of providing assent?
Yes
No
Indicate below when assent will be obtained or if the researcher proposes to waive assent. If requesting to waive
assent, indicate whether an information sheet (an assent form without signature lines) will be provided.
Select the option below that describes whether
Required attachments
assent will be obtained or waived.
Provide a copy of the assent form with your IRB
Assent will be obtained.
By selecting this option the researcher confirms that the application
minor subject may choose not to participate and will
his/her dissent be honored
Provide a copy of the information sheet with your IRB
An information sheet will be provided
application
(assent waived)
Provide justification for waiving assent:
None
The researcher will not obtain assent nor
provide an information sheet (assent
waived)
Provide justification for waiving assent:
Section 4 – Consenting Subjects Who Reach the Age of Majority 4.1 Will any of the subjects continue to actively participate in this study when they reach the age of
majority? (18 years in Colorado)
Appendix complete
No
Describe the plan to re-consent subjects once reaching the age of majority. The plan
Yes
must follow the consent guidelines applicable to adults:
DU IRB / Office of Research Compliance Appendix F – Research Including Children, v.1, dated 7/7/15