NCS may submit formative research directly related to the approved protocol as a nonsubstantive change. Each formative research proposal requires a Âmini 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.
Formative - Developmental