NCS may submit
formative research directly related to the approved protocol as a
nonsubstantive change. Each formative research proposal requires a
mini supporting statement that clearly identifies the aspect of
the approved protocol that is being tested, the need for such
testing, the study design, the protocol, and the IRB approval.
Inventory as of this Action
Requested
Previously Approved
07/31/2013
36 Months From Approved
07/31/2013
440,665
0
390,068
159,966
0
128,042
0
0
0
The Initial Vanguard Study protocol
was designed to enroll approximately 1,750 pregnant women through
seven study locations after 12 months of data collection. Two of
the locations began recruitment in January 2009 and the remaining 5
in April 2009. As of May 2010, however, approximately 900 pregnant
women have been enrolled, leading to questions about the
assumptions underlying the Initial Vanguard Study recruitment
model. The seven Initial Vanguard sites use a household enumeration
and screening strategy to identify eligible women for recruitment
into the study. Although household enumeration is often considered
a gold standard for maximizing coverage, in that all dwelling units
are identified and enumerated, for the NCS Initial Vanguard Study
this method has not yielded the target number of births in the time
frame projected from initial models. Consequently, additional
methodological research is needed to evaluate the feasibility,
acceptability, and cost of alternate recruitment strategies for
enrollment of pregnant women into the NCS. This research will be
conducted through the NCS Recruitment Substudy. The Recruitment
Substudy will assess three alternate recruitment strategies - (1) a
provider-based recruitment strategy; (2) an enhanced version of a
household enumeration strategy; and (3) a two-tier recruitment
strategy involving high-intensity and low-intensity data collection
efforts.
A second, fundamental research
goal of the Recruitment Substudy is characterization of recruitment
strategies associated with participant retention over time. Toward
this objective, we propose to continue data collection among the 37
Vanguard Study locations up to and including the visit planned to
take place when the sample children have reached 24 months of age.
This would align the study visits approved for the initial 7
Vanguard Study locations (which extend past the birth visit to
include a 3-, 6-, 9-, 18-, and 24-month visit) with the study
visits approved for the 30 additional Vanguard Study locations
(which were initially approved up to and including the birth
visit). A third, central research goal of the Recruitment Substudy
is to systematically identify study visit measures whose
feasibility (scientific robustness), acceptability (burden to
participants and study infrastructure), and cost are ideally suited
for use in the NCS Main Study. We propose reintroduction of a
limited set of study visit assessment measures to all 37 of the
Vanguard Study locations engaged in data collection. Extensive
measures, including biospecimens, were previously approved for use
in the initial 7 Vanguard Study locations. The Phase 2 protocol
would re-incorporate a father interview; maternal blood and urine
collection; cord blood collection; home tap water and dust
collection; a pregnancy health care log; and an infant and child
health care log. In addition to supporting further testing of
refined items, including these measures in the Recruitment Substudy
would result in a data collection scope more closely mirroring the
anticipated scope of the Main Study, thereby allowing better gauge
of data collection scope and resources and the relationship with
retention and study logistics over time. Another research goal of
the Recruitment Substudy is to examine the feasibility,
acceptability and cost of a series of formative research protocols
within a subset of Vanguard Study participants and their peers with
the aim of informing the NCS Main Study.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form 29.1 24-Month Maternal Phone Call (PB, EH, TT-HI)
Supporting Statement Part B 20110211.docx
Vacuum Bag Participant Instructions 20110211.doc
Formative - Developmental