Checklist for the Enrollment of Minors in Research
Principal Investigator:
IRB #:
Primary Reviewer:
Date of IRB meeting:
Reminders:
“Minimal risk means that the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological
examinations or tests.” (45 CFR 46.102(i), 21 CFR 50.3(k))
If neonates (< 28 days of age) will be enrolled in the study, the research must satisfy the
Massachusetts Fetal Research Statute. Please refer to the specific language of the statute,
available at: http://www.mass.gov/legis/laws/mgl/112-12j.htm. Also, please refer to the separate
IRB decision tree.
I.
CATEGORIES of RESEARCH:
In order to approve the enrollment of children, the IRB must discuss, find, and document in the minutes
that the research falls into one of the following 4 categories of research:
1. 45 CFR 46.404,/21 CFR 50.51


The research is not greater than minimal risk.
There are adequate provisions stated in the protocol for soliciting the assent of the children
and the permission of their parent(s) or guardian(s), as set forth in 45 CFR 46.408/21 CFR
50.55.
YES – Go to Section V.
NO - CONTINUE TO NEXT SECTION
2. 45 FCR 46.405/21 CFR 50.52


The research involves greater than minimal risk but presents the prospect of direct benefit to
the individual subjects.
There are adequate provisions stated in the protocol for soliciting the assent of the children
and the permission of their parent(s) or guardian(s), as set forth in 45 CFR 46.408/21 CFR
50.55.
YES – Go to Section II.
NO - CONTINUE TO NEXT SECTION
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3.
45 CFR 46.406/21 CFR 50.53


The research involves greater than minimal risk and no prospect of direct benefit to
individual subjects, but is likely to yield generalizable knowledge about the subject’s
disorder or condition
There are adequate provisions stated in the protocol for soliciting the assent of the children
and the permission of their parent(s) or guardian(s), as set forth in 45 CFR 46.408/21 CFR
50.55.
YES – Go to Section III.
NO - CONTINUE TO NEXT SECTION
4. 45 CFR 46.407/21 CFR 50.54

Research not otherwise approvable, which presents an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of children
YES – Go to Section IV.
NO - CONTINUE TO NEXT SECTION
5. II. 45 CFR 46.405/21 CFR 50.52
In order to approve the enrollment of children under 45 CFR 46.405/21 CFR 50.52 (research involving
greater than minimal risk but presenting the prospect of direct benefit to the individual subjects), the IRB
must discuss, find, and document in the minutes that ALL 3 of the following conditions have been met:
1. The risk is justified by the anticipated benefit to subjects
YES
NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children.
COMMENT:
2. The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that
presented by available alternative approaches.
YES
NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children.
COMMENT:
3. Adequate provisions are made for soliciting the assent of the children and permission of their
parents or guardians, as set forth in 45 CFR 46.408/21 CFR 50.55
YES – Go to Section V.
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NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children.
COMMENT:
III.
45 CFR 46.406/21 CFR 50.53
In order to approve the enrollment of children under 45 CFR 46.406/21 CFR 50.53 (research involving
greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subject’s disorder or condition), the IRB must discuss, find, and
document (in the minutes) that ALL 4 of the following conditions have been met:
1. The risk represents a minor increase over minimal risk.
YES
NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children.
COMMENT:
2. The intervention or procedure presents experiences to subjects that are reasonably commensurate
with those inherent in their actual or expected medical, dental, psychological, social, or
educational situations.
YES
NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children.
COMMENT:
3. The intervention or procedure is likely to yield generalizable knowledge about the subjects’
disorder or condition, which is of vital importance for the understanding or amelioration of the
subjects’ disorder, or condition.
YES
NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children.
COMMENT:
4. Adequate provisions are made for soliciting assent of the children and permission of their parents
or guardians, as set forth in 45 CFR 46.408/21 CFR 50.55
YES – Go to Section V.
NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children. Go to Section V.
COMMENT:
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IV.
45 CFR 46.407/21 CFR 50.54
In order to approve the enrollment of children under 45 CFR 46.407/21 CFR 50.54 (research not
otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children.), the IRB must discuss, find, and document (in the minutes)
that both of the following conditions have been met (if not DHHS supported, only the first condition
need be met):
1. The IRB finds that the research presents a reasonable opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting the health or welfare of children.
YES
NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children.
COMMENT:
2. (For HHS Supported Research ONLY) The Secretary, after consultation with a panel of experts
in pertinent disciplines and following opportunity for public review and comment has made its
required determinations under 45 CFR 46.407/21CFR 50.54. NOTE: The IRB cannot approve
the research until the DHHS Secretary has issued its findings.
YES, The DHHS Secretary has issued its finding in favor of approval – Go to Section V.
NO, the DHHS Secretary has not yet issued its findings or does not recommend approval. Go
to Section V, but note that the research is NOT APPROVABLE because of this condition.
COMMENT:
V.
45 CFR 46.408/21 CFR 50.55: REQUIREMENTS FOR PERMISSION BY
PARENTS/GUARDIANS AND FOR ASSENT
In order to approve the enrollment of children under 45 CFR 46 the IRB must discuss, find, and document
ALL 4 of the following conditions in the minutes favorably on each of the following issues, as
applicable:
1. Adequate provisions are made for soliciting the assent of children (when the IRB
determines capability to do so).
YES
NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children.
COMMENT:
1(a) The provisions for assent take into account, ages, maturity, and psychological state for
decisions made on behalf of all children or each child (as the IRB deems appropriate).
YES
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NO – The research cannot be approved for children under this category. Recommend changes
or recommend disapproval of the inclusion of children.
COMMENT:
1(b) For research that holds a prospect for direct benefit (available only through the research),
will assent be required for the research to proceed?
YES
NO – Explain why it should not be required or is not needed.
COMMENT:
2. Is a waiver of consent requested?
YES
NO – Go to question 3 in this section.
COMMENT:
2(a) The IRB must find that the requirement for parental permission is not reasonable in order to
protect the subjects (e.g., abused children).
YES
NO – The research cannot be approved with a waiver of consent. Go to question 3 in this
section.
COMMENT:
2(b) The IRB must ensure that an appropriate mechanism for protection of the children is
substituted.
YES, an appropriate mechanism has been described in the protocol and is adequate.
NO – The research cannot be approved with a waiver of consent. Proceed to question 3 in
this section.
COMMENT:
2(c) Consideration must be given to the nature of the research, risks and benefits, and the
subject’s age, maturity, status, and condition.
YES, consideration has been given to the above and the waiver is recommended. – Go to
Section VI.
NO – The research cannot be approved with a waiver of consent. Proceed to question 3 in
this section.
COMMENT:
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3. Provisions are made for soliciting the permission of each parent or guardian.
For 45 CFR 46.404 and 405/21 CFR 50.51 and 52: If the research involves 45 CFR 46.404 or
405/21 CFR 50.51 or 52 the IRB may find that the permission of one or both parents or guardians
is adequate/necessary.
For 45 CFR 46.406 and 407/21 CFR 50.53 and 54: If the research involves 45 CFR 46.406 or
407/21 CFR 50.53 or 54 the IRB must find that the permission of BOTH parents or guardians is
necessary unless one parent or guardian is deceased, unknown, incompetent, not reasonable
available, or not a custodial parent.
Please indicate your recommendation based upon the research category and the nature of the
research activity:
ONE parent or guardian signature is adequate.
BOTH parents or guardians signatures are necessary (required for research conducted under
45 CFR46.406 and 407/21 CFR 50.53 and 54).
COMMENT:
4. Documentation of Consent and Assent:
4(a) Where not waived, consent must be documented in accordance with 45 CFR 46.117/21 CFR
50.2.
4(b) Where the IRB requires assent, it must determine whether and how it must be documented.
Check all that apply:
Assent signature required for ages 7 and older.
Assent signature required for ages
and older (fill in start to age range).
Assent is presented as a separate form.
Assent is presented as an additional signature block on the consent document that the
parent/guardian sign.
VI.
RECOMMENDATIONS / REQUIRED CHANGES:
Is it reasonable and allowable under regulations to permit the inclusion of this vulnerable population
in this research (with any/all changes that the IRB may require)?
YES
NO
Are there any recommendations, comments, or required changes (including any notations made in
responses above) to be communicated to the principal investigator?
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YES - (Please use complete sentences and clearly note recommendation or change in the exact
language to be used in correspondence to the PI - attach additional page as necessary).
NO - (only those listed above)
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