NCS Formative Studies - Supporting Statement - Part A - 2008-Feb

Formative Research and Pilot Methodology Studies for the National
Children’s Study (NICHD)
Supporting Statement and Attachment
OMB Submission – 30 January, 2008

Contact information
Ruth Brenner, MD, MPH
NCS Program Office, NICHD/NIH
6100 Executive Blvd, 5C01
Bethesda, MD 20892
301-594-8668
brennerr@mail.nih.gov

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Contents
Formative Research and Pilot Methodology Studies for the National Children’s Study (NICHD)
Supporting Statement
Part A
Part B
Attachment 1
Examples of cognitive testing probes and process for revisions

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REQUEST FOR OMB CLEARANCE
Formative Research and Pilot Methodology Studies for the National Children’s Study

A.

Justification

A.1

Need for the data collections

Patterns of children’s health and illness have changed dramatically over the past 100 years (Arias 2004).
While infectious diseases were the principal threat during the first half of the last century, today the major
conditions that affect children stem from a complex array of environmental and genetic determinants. Some
have termed this the “new pediatric morbidity”. These conditions include premature births (Ananth et al.,
2005), asthma (CDC Surveillance of Asthma, 1998), injuries (Centers for Disease Control and Prevention,
Injury Center), neurodevelopmental disorders such as learning disabilities, dyslexia, mental retardation
(Centers for Disease Control and Prevention, 2005a), attention deficit/hyperactivity disorder (Centers for
Disease Control and Prevention, 2005), autism (Centers for Disease Control and Prevention, 2007), obesity
(National Center for Health Statistics, 2006), type 2 diabetes (Centers for Disease Control and Prevention,
2005b), birth defects (Centers for Disease Control and Prevention, 2007), and cardiac defects (Centers for
Disease Control and Prevention, 1998). Addressing the causes and contributors to these and other chronic
conditions is now the major task of public health practitioners and pediatric researchers and constitutes the
frontier that must be crossed in order to protect and improve the health of children in developed countries. If
the causes of any of these diseases were to be discovered, billions of dollars could potentially be saved if
viable intervention approaches were made available.
Examining the role of the environment on the health of children is critical to understanding the causes of
these health conditions. A study that investigates the effects of both the natural and the built environment;
components of the environment, such as biological, chemical, physical, and social factors; and aspects of the
child’s immediate environment, including family and cultural influences, behaviors, and geographic aspects
is necessary to preventing and/or curing chronic health conditions. Finally, the genetic makeup of the child
and family would allow for analysis of the gene-environment interactions.
In 2000, the President’s Task Force on Health Risks and Safety Risks to Children concluded that a study to
define the actual risks associated with broad environmental exposures is an essential first step in addressing
these questions. Following this recommendation, the U.S. Congress passed the Children’s Health Act of
2000 (PL 106-310), which directs the National Institute of Child Health and Human Development (NICHD)
to conduct a national longitudinal study of environmental influences (including physical, chemical,
biological and psychosocial influences) on children’s health and development. The scientific rationale for
this program of research has evolved as the National Children’s Study (NCS).
The National Children’s Study is designed as a multi-center longitudinal study that will enroll and follow a
nationally representative sample of approximately 100,000 children born in the U.S. In the first stage of
sampling, 105 locations were randomly selected from all U.S. counties. Of these, 7 locations have been
selected as the Vanguard locations which are currently working with the NICHD Program Office and the
Coordinating Center on Study protocols and procedures. Contracts for 15-20 additional Study Centers will
be awarded in September 2007.
We are requesting approval for programmatic clearance of pilot and formative research to be used in the
development of instruments, materials, and procedures for the NCS. This will include community outreach
materials, medical provider and participant materials, questionnaires and measures, use of technology such
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as Interactive Voice Recognition (IVR), and other aspects related to data collection. Activities will include
small focused surveys to test data collection items and methods on a specific or targeted population,
validation of questionnaires for targeted populations, focus groups within NCS communities to test forms
and procedures, cognitive interviews to test data items, and the use of materials on targeted populations such
as medical providers and hospitals, and materials translated into other languages. These activities will be
conducted over the life of the Study to develop procedures and materials for each stage of data collection.
A.2

Purpose and use of this formative research and pilot testing

The results of these pilot tests will be used to maximize the efficiency of survey procedures, materials, and
methods for community outreach, engagement of the medical community, for recruiting and retaining study
subjects prospectively across study visits and to ensure that data collection methodologies are efficient and
valid for all potential participants. Without this information, NCS will be hampered in its efforts to
effectively publicize the NCS, gain public and professional support, and effectively recruit and retain
respondents and collect data over the life of the Study.

A.3.

Use of automated data collection and burden reduction

The focus of these data collections is the improvement of data collection methodologies for the NCS,
including the use of automated data collection (e.g., IVR) and other procedures designed to decrease
participant burden and improve data accuracy.

A.4

Identification of duplication

Attention has been paid to the extant literature on isolated facets of individual data collection (e.g.,
comparisons of different methods of questionnaire administration), as well as the experience of other large
Federal studies (e.g., National Health and Nutrition Examination Survey, National Health Interview Survey,
Early Childhood Longitudinal Study-Birth Cohort). However, the breadth and depth of data collection
proposed for the NCS combined with the population-based enrollment of women during and before
pregnancy pose circumstances unique to the NCS.
A.5

Impact on small businesses

The potential impact of these data collections on small businesses will be limited to a small number of
medical providers, hospitals, and perhaps community organizations asked to provide structured comment on
potential NCS materials. Where requested, the study will reimburse providers for any expenses incurred as
part of filling requests for information.

A.6

Consequences of not collecting the information

These data collections are designed to decrease participant burden and improve data collection for the NCS,
a crucial requirement given the mandated scope of the Study. Without these small studies, data collection for
the NCS is likely to be less efficient than it could be.

A.7

Special circumstances relating to guidelines of 5 CRF 1320.5
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There are no special circumstances that would cause this information collection to be conducted in a manner
inconsistent with 5 CFR 1320.5.

A.8

Comments in response to the Federal Register Notice and efforts to consult outside agency

The 60-day Federal Register Notice regarding the NCS is published on pages 65047 through 65048 of
Volume 72, Number 222 of the Federal Register on November 19, 2007.
Comment #1 (abridged) – “…THERE IS ENDLESS PAPER COLLECTION BY NIH AND THEY NEVER

SPEND THE TIME IN THE LAB FINDING AN ANSWER TO ANY DISEASE AT ALL.

INSTEAD DEVOTE THIS TIME AND MONEY TO GETTING AT THE ANSWER TO WHY ONE OUT
OF 60 CHILDREN IN NJ IS BEING BORN AUTISTIC AT THE PRESENT TIME.
SOMETHING IS DESPERATELY WRONG. WE HAVE A STUDY GROUP ALL READY FOR
INVESTIGATION. LETS GET TO THE BOTTOM OF SOMETHING RATHER THAN THIS ENDLESS
PAPER COLLECTION BY NIH WITH NO ACTION AND NO ADVANCEMENT FOR HEALTH
ISSUING FROM NIH.”

A.8.1

Efforts to consult outside agency

Several committees and many individuals have been consulted on the NCS methodology, sampling and
hypotheses, as well as specific instruments and samples to be collected, for the National Children’s Study.
The Study committees are described below.
National Children’s Study Federal Advisory Committee—The National Children’s Study Federal Advisory
Committee (NCS-FAC), constituted under the Federal Advisory Committee Act, provides advice and
recommendations to the Director of the National Children’s Study, the Director of the National Institute of
Child Health and Human Development, and the Interagency Coordinating Committee regarding critical
aspects of the Study. Members of the FAC include representatives from academia, industry, health care
practice, and other professions. Early in the planning phase of the NCS, 22 Working Groups were convened
under the auspices of the NCS-FAC, to enable the Study to receive input from literally hundreds of nonFederal scientists and other professionals.
Interagency Coordinating Committee—The Interagency Coordinating Committee (ICC) organizes and
directs operations of the Study. This committee is made up of staff from two federal agencies: the U.S.
Department of Health and Human Services (DHHS) and the U.S. Environmental Protection Agency (EPA).
Within DHHS, staff is contributed from the Centers for Disease Control and Prevention (CDC) and the
National Institutes of Health (NIH). CDC contributes staff from the National Center on Birth Defects and
Developmental Disabilities and the National Center for Health Statistics; NIH contributes staff from the
National Institute of Child Health and Human Development and the National Institute of Environmental
Health Sciences. EPA contributes staff from the National Center for Environmental Research, the National
Health and Environmental Effects Research Laboratory, the Office of Children's Health Protection, and the
National Exposure Research Laboratory.
Steering Committee—The National Children’s Study Steering Committee consists of members from each of
the Vanguard Centers; the NCS Program Office, the Coordinating Center, the ICC, and invited community
representatives. This list will be expanded as additional Study Centers are added to represent additional study
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locations. Various working teams within the Steering Committee have convened and provided input into the
study protocol and procedures (e.g, Sampling Team, Outreach and Engagement Team).

A.9

Explanation of payment or gifts to respondents

In order to maximize cooperation, many research studies, particularly those involving medical procedures,
offer compensation for participants. For example, the National Health and Nutrition Examination Survey
(NHANES) has offered their participants compensation since the 1970’s. Participants in NCS pilot studies,
especially focus groups and cognitive interviews, will receive monetary compensation for their time and any
expenses incurred (e.g., transportation costs). The amount of compensation will be determined by the amount
of time required of the participant for the particular test, as well as the type of activities that will be required.
Compensation amounts will be addressed specifically in IRB submissions for each pilot.

A.10

Assurance of confidentiality for respondents

For each pilot test, confidentiality procedures will be developed and submitted to the relevant IRB’s. Since
some tests will be done by the Study Centers, and others will be performed by the Coordinating Center,
different sets of IRB’s will be involved, depending on the specific pilot test. Study participants will be
assured that the data collected will be safeguarded closely and that actions will be taken to protect
confidentiality. Participants in cognitive testing or focused surveys will be provided with the appropriate
informed consent documents to sign (as approved by the relevant IRB’s). Westat, the NCS Coordinating
Center, has clear policies and procedures regarding assurance of confidentiality and a pledge that all
employees must sign. In addition, Westat provides all safeguards mandated by NICHD. IRB approval will
be sought from relevant IRB’s for individual pilot tests.

A.11

Justification for sensitive questions

The NCS will be collecting information on sensitive topics such as pregnancy status, reproductive and
medical histories, and recreational drug use. Some of these items may be included in one or more of the
pilot tests to ensure that they meet the needs of respondents in assuring them that the data collected will be
kept confidential, and that the data items are sensitive to the needs of the participants.

A.12

Estimates of hour burden including annualized hourly costs

The costs to respondents will vary depending on the type of data collection (e.g. focus group vs. cognitive
interview), the length of the data collection and the participant’s role (e.g. healthcare providers, such as
doctors, will be compensated at a higher rate). The 2005 median income in the Vanguard Center states
ranged from $41,000 per year up to $59,000. Compensation for participants is usually based on median
hourly income for their areas of residence. Exhibit 1 presents the estimated hour and annual cost response
burden for respondents.
Exhibit 1. Estimated Hour and Annual Cost Response Burden

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Data collection activity

Small focused surveys
Focus groups with potential
participants
Focus groups with health care
professionals
Focus groups with community
leaders
Medical provider feedback on
materials through informal inperson contacts
Cognitive interviews
Total
A.13

Total
number of
respondents

1.5

Annual
burden
hours
1,875

$10

Annual
burden
cost
$18,750

1

3.0

1,050

$10

$10,500

350

1

3.0

1,050

$50

$52,500

350

1

3.0

1,050

$10

$10,500

700

1

.5

350

$50

$17,500

150
3,150

1

3.0

450
5,825

$10

$4,500
$114,250

1,250

Responses
per
respondent
1

350

Hours per
response

Cost per
hour

Estimate of other total annual cost burden to respondents or record keepers

Participants in these formative or methods development studies will be reimbursed for any expenses
resulting from their participation in such studies. This may include transportation costs to and from focus
groups or cognitive interview sites, and babysitting or elder care expenses. Medical providers, hospitals, and
day care centers participating in such studies will be reimbursed at their usual and customary rates. There are
no other known costs to study participants.

A.14

Estimate of annualized cost to Federal Government

The estimated cost to the Federal Government of these pilot and formative studies is $500,000 per year over
the three year period.
A.15

Explanation of program changes or adjustments

Not applicable, as this is a new data collection request.

A.16

Timeline for publication plans

The proposed data collections are small scale pilot studies and focus groups intended to increase data
collection efficiency for the NCS and do not have a planned publication schedule. The studies will take place
over the three year period specified in this submission.

A.17

Display of expiration date of OMB approval

The NCS is not seeking an exemption from displaying the expiration date of OMB approval.

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A.18 Exception for Item 19, “Certification for Paperwork Reduction Act Submissions.” of OMB
Form 83-I
NCS is not requesting exceptions from OMB Form 83-I.

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