TEXAS A&M UNIVERSITY HUMAN SUBJECTS PROTECTION PROGRAM
WAIVER OF PARENTAL PERMISSION AND/OR CHILD’S ASSENT FOR THE USE OF HUMAN SUBJECTS
RESEARCH
The purpose of this worksheet is to provide support for IRB members or the Designated Reviewer when
reviewing research involving children as subjects. This worksheet must be used and submitted by investigators
conducting research with children when requesting a waiver of parental permission and/or child’s assent. The
IRB members or the Designated Reviewer are to review this checklist with the protocol and determine if the
criteria have been met, as documented by the checkboxes in the left column.
Definitions (45 CFR §46.402):
(a) Children are persons who have not attained the legal age for consent to treatments or procedures
involved in the research, under the applicable law of the jurisdiction in which the research will be
conducted.
(b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should
not, absent affirmative agreement, be construed as assent.
(c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in
research.
(d) Parent means a child's biological or adoptive parent.
(e) Guardian means an individual who is authorized under applicable State or local law to consent on
behalf of a child to general medical care.
Waiver of Parental Permission
Waiver of Parental Permission (45 CFR §46.116(c)) (All must be “Yes”)
Yes
No The research is not FDA-regulated.
Yes
No The research does not involve non-viable neonates.
Yes
No The research or demonstration project is to be conducted by or subject to the approval of state or
local government officials.
Yes
No The research or demonstration project is designed to study, evaluate, or otherwise examine one
or more of the following: (Check boxes that are true)
Public benefit or service programs.
Procedures for obtaining benefits or services under those programs.
Possible changes in or alternatives to those programs or procedures.
Possible changes in methods or levels of payment for benefits or services under those
programs.
Yes
No The research could not practicably be carried out without the waiver or alteration.
Protocol Specific Discussion on how these items are true:
1
Waiver of Parental Permission (45 CFR §46.408(c)/45 CFR §46.116(d)) (All must be “Yes”)
Yes
No The research is not FDA-regulated.
Yes
No The research does not involve non-viable neonates.
Yes
No The research involves no more than minimal risk to the subjects.
Yes
No The waiver or alteration will not adversely affect the rights and welfare of the subjects.
Yes
No The research could not practicably be carried out without the waiver or alteration
Yes
No Whenever appropriate, the subjects will be provided with additional pertinent information after
participation.
Protocol Specific Discussion on how these items are true:
2
Waiver of Parental Permission (45 CFR §46.408(c)) (All must be “Yes”)
Yes
No The research is not FDA-regulated.
Yes
No The research does not involve non-viable neonates.
Yes
No The research protocol is designed for conditions or for a subject population for which parental
or guardian permission is not a reasonable requirement to protect the subjects.
Yes
No An appropriate mechanism for protecting the children who will participate as subjects in the
research is substituted.
Yes
No The waiver is not inconsistent with Federal, State, or local law.
Protocol Specific Discussion on how these items are true:
3
Waiver of Assent
Adequate Provisions to Solicit the Assent of Children (Must be “Yes”)
Yes
No Assent will be obtained from:
All children.
None of the children. (Complete Section 5)
Some children. (Complete Section 5 and 6. The application needs to describe which
children will not be asked for assent)
Protocol Specific Discussion on how these items are true:
4
5 Reason Why Assent is Not Necessary
One or more of the following are true. (Check all boxes that are true.)
Based on the ages, maturity, and psychological state of the children involved The capability of these children
is so limited that they cannot reasonably be consulted under 45 CFR §46.408(a)/21 CFR §50.55(c)(1).
The intervention or procedure involved in the research holds out a prospect of direct benefit that is important
to the health or well-being of the children and is available only in the context of the research under 45 CFR
§46.408(a)/21 CFR §50.55(c)(2)
Assent is requested to be waived under 45 CFR §46.116(c)/21 CFR §50.55(c) (Complete Section 7)
Assent is requested to be waived under 45 CFR §46.116(d) (Complete Section 8)
Protocol Specific Discussion on how these items are true:
Documentation of Assent (May be “Yes” or “No.”)
Yes
No If “Yes”, specify the process for documentation:
Investigator will document assent in the consent signature block.
Other (NOTE: The protocol needs to describe the process of assent documentation)
Protocol Specific Discussion on how these items are true:
6
7
Waiver of Child Assent (45 CFR §46.408(a)/45 CFR §46.116(c)/21 CFR §50.55(c)) (All must be “Yes”)
Yes
No The research involves no more than minimal risk to the subjects.
Yes
No The waiver or alteration will not adversely affect the rights and welfare of the subjects.
Yes
No The research could not practicably be carried out without the waiver or alteration
Whenever appropriate, the subjects will be provided with additional pertinent information after
participation.
Protocol Specific Discussion on how these items are true:
Yes
No
Waiver of Child Assent (45 CFR §46.408(a)/45 CFR §46.116(d)) (All must be “Yes”)
Yes
No The research is not FDA-regulated.
Yes
No The research or demonstration project is to be conducted by or subject to the approval of state or
local government officials
Yes
No The research or demonstration project is designed to study, evaluate, or otherwise examine one
or more of the following: (Check all boxes that are true.)
Public benefit or service programs.
Procedures for obtaining benefits or services under those programs.
Possible changes in or alternatives to those programs or procedures.
Possible changes in methods or levels of payment for benefits or services under those
programs.
Yes
No The research could not practicably be carried out without the waiver or alteration.
Protocol Specific Discussion on how these items are true:
8
IRB Use Only
Approved
Denied
Portions of the study
Comments:
All of the study