**REVIEW AND AWARD CODES FOR THE NIH INCLUSION OF CHILDREN POLICY**

#### March 1999

**I. Introduction to Children Codes 2**

**II. Children Representation Codes 4**

**III. Instructions for Use of New Codes for Children 5**

**IV. Codes on Summary Statement Headers 7**

**V. Summary Card of Inclusion Codes for**

**Scientific Review Group Reviewers 8**

**NOTE:**

**These codes and procedures are applicable to all initial (type 1)
applications received after October 1, 1998.**

**Division of Research Programs, Training and Review Policy**

**Office of Extramural Programs**

**Office of Extramural Research**

**Office of the Director, NIH**

**March 26, 1999**

**I. INTRODUCTION TO CHILDREN CODES**

In the March 6, 1998, issue of the NIH Guide for Grants and Contracts,
guidelines were published on the NIH policy on inclusion of children in
research involving human subjects.
(<http://www.nih.gov/grants/guide/notice-files/not98-024.html>)

The guidelines and policy provide that applicants:

-   Include children in research unless there are scientific and ethical
    reasons not to include them.

-   Address the age-appropriate inclusion or exclusion of children in
    their applications under a special heading "Participation of
    Children"

-   Justify not including children; 7 possible exemptions are allowed
    with justification(see below).

**Codes for Children Representation**: A three-character coding scheme
has been developed to enable the NIH to track applications and proposals
in relation to the new policy. Codes pertaining to Children will start
with "**C**". A detailed description of these codes and guidelines for
their use follows.

**Applicability:** The codes are intended to apply to applications for
research grants, individual fellowships and individual career awards,
cooperative agreement awards, and for contract proposals and awards, as
well as intramurally supported research. They are in addition to the
codes used for inclusion of women and minorities.

-   Codes need not be applied to applications for Institutional research
    training grants or Institutional career awards, since most
    appointees will be involved in research projects that have already
    been approved.

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-   When the research under review is essentially a service (e.g.,
    statistical center or analysis laboratory) in support of
    [another]{.underline} activity already found to be in compliance
    with this policy, a second review is not necessary.

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-   Training grants (T32, T34, T35) are exempt from coding requirements
    but a term or condition of award will specify that all projects to
    which trainees are assigned must already be in compliance with the
    NIH policy on inclusion of children in research involving human
    subjects.

**Human Subjects Research to be Coded**: The policy extends to
[all]{.underline} research involving the use of human organs, tissues,
and body fluids from living individuals as well as to graphic, written,
or recorded information derived from living individuals. The policy uses
the definition in Federal regulations for human subjects: "\...living
individual(s) about whom an investigator conducting research obtains:
(1) data through intervention or interaction with the individual; or (2)
identifiable private information." \[45 CFR 46.102(f)\] However,
research exempted from human subjects protection regulations as defined
by 45 CFR 46.101(b) is [not]{.underline} exempted from the NIH policy on
inclusion of children and must be evaluated and coded. Autopsy material
is not covered by the policy.

**Justifications Allowed for Exclusions of Children in Research (from
the NIH GUIDE)**

It is expected that children will be included in all research involving
human subjects unless one or more of the following exclusionary
circumstances can be fully justified:

**1.** The research topic to be studied is **irrelevant** to children.

**2.** There are **laws or regulations** barring the inclusion of
children in the research. For example, the regulations for protection of
human subjects allow consenting adults to accept a higher level of risk
than are permitted for children.

**3.** The **knowledge** being sought in the research is **already
available** for children or will be obtained from another ongoing study,
and an additional **study will be** **redundant.** Documentation of
other studies justifying the exclusions should be provided. NIH program
staff can be contacted for guidance on this issue if the information is
not readily available.

**4.** A **separate, age-specific study in children is** **warranted**
and preferable.

Examples include:

**a.** The relative **rarity of the condition in children**, as compared
to adults(in that extraordinary effort would be needed to include
children, although in rare diseases or disorders where the applicant has
made a particular effort to assemble an adult population, the same
effort would be expected to assemble a similar child population with the
rare condition);

**b.** The **number of children is limited** **because** the majority
are already accessed by a **nationwide pediatric disease research
network**, so that requiring inclusion of children in the proposed adult
study would be both difficult and unnecessary(in that the topic was
already being addressed in children by the network) as well as
potentially counterproductive (in that fewer children could be available
for the network study if other studies were required to recruit and
include them);

**c.** **Issues of** **study design** preclude direct applicability of
hypotheses and/or interventions to both adults and children (including
different cognitive, developmental, or disease stages or different
age-related metabolic processes). While this situation may represent a
justification for excluding children in some instances, consideration
should be given to taking these differences into account in the study
design and expanding the hypotheses tested or the interventions to allow
children to be included rather than excluding them.

**5.** **Insufficient data are available in adults to judge potential
risk in children** (in which case one of the research objectives could
be to obtain sufficient adult data to make this judgment). While
children usually should not be the initial group to be involved in
research studies, in some instances, the nature and seriousness of the
illness may warrant their participation earlier based on careful risk
and benefit analysis.

**6.** Study designs aimed at collecting additional data on
**pre-enrolled adult study participants** (e.g., longitudinal follow-up
studies that did not include data on children).

**7.** **Other special cases** justified by the investigator and found
acceptable to the review group and the Institute Director.

**II. CHILDREN REPRESENTATION CODES**

**DEFINITION:** Children are defined as individuals under the age of 21.

**CODE FORMAT:** Single alphanumeric field, 3 characters, e.g., C2A

1^st^ character: C (indicates that code is for representation of
children)

2^nd^ character: 1/2/3/4 (representation proposed in project or in
award)

3^rd^ character: A/U (acceptable/unacceptable)

**Representation Proposed in Project**

**1** = Both children and adults

**2** = Only children

**3** = No children included

**4** = Representation of children is unknown

**Acceptability/Unacceptability of Representation of Children**

**A** = Representation of children is scientifically
[acceptable]{.underline} and recruitment/retention has been
realistically addressed, **OR** an acceptable justification for
exclusion has been provided.

**U** = Representation of children is [unacceptable]{.underline}.
Application fails to conform to NIH policy guidelines in relation to the
scientific purpose of the study; **OR** fails to provide sufficient
information; **OR** does not adequately justify that children are not
included; **OR** does not realistically address recruitment/retention.
(This code constitutes a bar to funding unless or until resolved by NIH
staff.)

**Examples:**

C1A - Both children and adults are included; inclusion is scientifically
acceptable.

C1U - Both children and adults are included; no rationale is provided
for selecting

or excluding a specific age range of children. Scientifically
unacceptable.

C2A - Only children are represented in the study; inclusion is
scientifically acceptable.

C2U - Only children are represented in the study, but age range is too
restricted to be

scientifically acceptable, e.g., including only children of ages 18-21.

C3A - No children included. Acceptable justification for exclusion is
provided.

C3U - No children included. Acceptable justification for exclusion is
not provided.

C4A - Representation of children is not known. The information on age of
individuals providing specimens or in existing datasets cannot be
accurately determined (e.g., pooled blood samples, stored specimens),
and this does not compromise the scientific objectives of the research.
Scientifically acceptable.

C4U - Representation of children is not known. The application does not
provide sufficient information about the age distribution of the study
population. The application does not comply with requirements and is
unacceptable.

**III. INSTRUCTIONS FOR USE OF NEW CODES FOR CHILDREN**

**1.** All applications for research grants, individual fellowships,
individual career awards, cooperative agreement awards, and all
proposals for research and development contract awards, that involve
human subjects are covered by this policy. Each project or protocol must
be individually evaluated for compliance with the policy.

**2.** It is only necessary to assign codes to applications that are
scored by the Scientific Review Group (SRG).

**3.** Reviewer's written comments explaining the basis for the codes
assigned should be included in a critique section entitled
"PARTICIPATION OF CHILDREN".

**4.** For foreign applications, proposals and awards, as well as
foreign components of domestic awards, the policy on inclusion of
children is the same as for research conducted in the U.S.

**5.** A code should be assigned to each single project application
(e.g., R01 application) that is under the policy.

**6.** A code should be assigned to each individual project or
subproject in an application or proposal containing multiple projects or
subprojects and involving distinct populations or specimen collections.

**A single overall code ALSO should be assigned to the entire
application as follows:**

-   **Acceptability/Unacceptability -** Each project/subproject must
    satisfy at least one of the acceptability conditions for an
    "Acceptable" (A) code to be assigned to the application as a whole.
    If any project/subproject is found "Unacceptable" (U), the overall
    code should be U.

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-   **Representation Proposed in Project -** Coding should reflect the
    total representation in all projects/subprojects, even if some
    involve no children.

**7.** For any project/subproject receiving a code for representation of
children that is U (unacceptable) and that is being considered for
funding, designated staff in each IC will resolve the issue before
attempting to process the award and have the code revised to reflect
revision in design or circumstances. The code "R" will be replace the
"U" for any case that is satisfactorily resolved by program staff before
award.

**Responsibilities:**

**A. Reviewers' Responsibilities:**

Complete the separate evaluation and coding for inclusion of children in
each project in which human subjects are involved, and determine whether
or not the scientific basis for the study population is acceptable.
Evaluate each project separately for inclusion of children.

**ACTION:** Assign codes for children (Cxx) for each individual project
and briefly explain the basis for the acceptable/unacceptable (A/U)
codes assigned.

**ACTION:** Assign an overall code for the application. If there is only
one project, this will be the application code; if there is more than
one project or subproject covered by the policy, assign an overall code
to reflect the total representation in all projects or subprojects, even
if some involve no children.

**B. Review Staff (SRA/GTA) Responsibilities:**

[At meeting:]{.underline}

**ACTION:** Ensure that reviewers address the inclusion of children
policy when relevant for each project or subproject as well as the
application overall, and assign codes for scored applications.

[After meeting]{.underline}:

**ACTION:** Prepare summary statements, reporting codes for each project
or subproject and, as appropriate, the justification for those codes
under a heading following the critique for each project. One section
entitled "Gender/Minority/Children Inclusion" will be prepared that
includes comments on inclusion of gender, minorities and children. An
overall section may also be necessary for applications or proposals
containing multiple projects or subprojects.

**ACTION:** In IRG interface, for each scored application enter
appropriate codes in response to prompts: "Enter Children Code".

**NOTE:** In the future, programming will permit codes for each project
or subproject to be entered into the IMPAC II system. In the interim,
the codes recorded in the text of the summary statements will provide
for tracking of inclusion.

**C. Post-Review Responsibilities of Institute/Center Staff:**

For any project/subproject receiving a code for children that is U
(unacceptable) and that is being considered for funding, designated
staff in each IC will resolve the issue before attempting to process an
award and will have code(s) revised to reflect revisions in design or
circumstances.

**ACTION:** After resolution of "unacceptable" codes, change the codes
using IC or IAS interface to the most appropriate code (in this case the
"U" will be replaced with "R", denoting "resolved").

**ACTION:** Enter subproject information, if applicable, including SRG
codes for subprojects, for those applications that will be funded.

**ACTION:** For training grants (T32, T34, T35) that are exempt from
coding requirements, include a term or condition of award , when
appropriate, specifying that all projects to which trainees are assigned
must already be in compliance with the NIH policy on inclusion of
children in research involving human subjects.

**IV. CODES ON SUMMARY STATEMENT HEADERS**

##### One of the following Code lines will be on the Header of Summary Statements that are scored and include human subjects.

C1A - Both children and adults, scientifically acceptable

C2A - Only children, scientifically acceptable

C3A - No children included, scientifically acceptable

C4A - Children Representation unknown, scientifically acceptable

C1U - Both children and adults, scientifically unacceptable

C2U - Only children, scientifically unacceptable

C3U - No children included, scientifically unacceptable

C4U - Children Representation unknown, scientifically unacceptable

**V. SUMMARY CARD OF INCLUSION CODES FOR SCIENTIFIC REVIEW GROUP
REVIEWERS:**

**Inclusion of Women, Minorities, and Children in Clinical Research**

###### Revised Codes Effective October 1998

All biomedical or behavioral research projects involving human subjects
are considered clinical research. Scored clinical applications are
assigned the codes shown below. For scored applications with
subprojects, such as for program projects, each subproject must receive
its own gender, minority, and children codes, and an overall set of
codes must also be assigned to the application.

####### Is this an NIH-defined clinical trial? Y or N 

(For an application to be coded as a clinical trial, it must fit the NIH
definition of a phase III clinical trial.)

**[GENDER CODE:]{.underline}**

*First character* = G

*Second character*:

1 = Both genders

2 = Only women

3 = Only men

4 = Gender unknown

*Third character*:

A = Scientifically acceptable

U = Scientifically unacceptable

**[MINORITY CODE:]{.underline}**

*First character* = M

*Second character*:

1 = Minority and nonminority

2 = Only minority

3 = Only nonminority

4 = Minority representation unknown

*Third character*:

A = Scientifically acceptable

U = Scientifically unacceptable

**[CHILDREN CODE:]{.underline}**

*First character* = C

*Second character*:

1 = Children and adults

2 = Only children

3 = No children included

4 = Representation of children is unknown

*Third character*:

A = Scientifically acceptable

U = Scientifically unacceptable

**Examples:** G1A = Both genders, scientifically acceptable

M3U = Only nonminorities, scientifically unacceptable

C2A = Only children, scientifically acceptable