This HTML version of the application is read only. This version should only be used if Microsoft Word is unavailable. To prepare an application for submission, you must copy and paste the content into a word processing program.
The preferred format for submission is the Microsoft Word application with expanding text fields provided on the National Children’s Study Web site (under Research/Supplemental Methodological Studies).
Applications for Supplemental Methodological Studies should be a maximum of 5 pages in black 12 point Arial or Georgia font, on 8.5” X 11” pages with 1-inch margins. Figures, graphs, charts, etc. must fit within the page and margin requirements. Include a 1-page abstract with your application. The abstract does not count toward the 5-page maximum.
Requests for just data are NOT Supplemental Methodological Studies (SMS) and do not utilize this application. SMS involve interaction with participants or requests for biospecimens or environmental samples.
- Title of the Proposal:
This proposal requires:
____ Interaction with National Children’s Study participants
____ Request for National Children’s Study biospecimens ____ Request for National Children’s Study environmental samples
____ Request for National Children’s Study data (in addition to the above) |
- Key Words (up to 5 key words, identifying the main topic(s) of the proposal):
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- Principal Investigator: Include an NIH biosketch with application.
Name:
Field(s) of expertise:
Position, organization, location, telephone number, e-mail address:
____ I confirm that I have appropriate expertise and sufficient
institutional support to conduct this research. |
- Proposed collaborators (names, organizations, area(s) of expertise): Include NIH biosketches of key collaborators whose expertise is essential to the study.
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Proposed Study Center(s) and Study location(s) at which to implement this study if known at time of application (can be submitted after provisional approval):
Have the National Children’s Study Co-Investigator and Facilitators been selected? (Note: The National Children’s Study Co-Investigator is not simply a co-investigator of the SMS. The National Children’s Study Co-Investigator has a specific role to oversee the implementation of the SMS as a National Children’s Study advocate. National Children’s Study facilitators have the same role but at the additional locations.)
Include names of proposed National Children’s Study Co-Investigator and Facilitator(s) if known at time of application (can be submitted after provisional approval):
A signed National Children’s Study Co-Investigator/Facilitator Agreement Form must be submitted prior to final approval of an SMS.
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- Goals of the proposed study:
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- Explain the rationale for utilizing the National Children’s Study as a platform for this study. Reflect how this study adds value and supports the goals of the Vanguard phase (to study feasibility, acceptability, and cost of methodological aspects of the National Children’s Study; to inform the Main Study). What is the potential benefit to the National Children’s Study?
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- Study Design:
- Detailed description of study design (include the time allotment/burden for the various aspects of the SMS):
- Data collection activities and any need for National Children’s Study data (see SMS Policies and Procedures, “Data Access and Confidentiality” and “Data Sharing”). Note: Request for just data are not SMS
- Participant interface (numbers, ages, types of participants):
- Biospecimens (purpose, types/quantities, . . .)
- Environmental samples (purpose, types/quantities, . . .):
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- Timeline and schedule of deliverables. Include expected duration and approximate start and end dates of the study. Does the projected timeline align with that of the Vanguard phase at the specified locations? Will it be completed in time to inform the Main Study?
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- Note any potential negative impact on National Children’s Study infrastructure and participants. Are there any perceived obstacles to satisfactorily accomplishing the goals of this study?
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- Funding:
Expected funding source:
Projected approximate cost:
Funding status:
Note any required National Children’s Study contracted services:
Note: Formal funding DETAILS will be requested after provisional approval of Application. The funding source must cover any required charges that are not billable to the National Children’s Study contract.
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- Will this study require local IRB approval? ___Yes ___NO
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- Proposed critetra for evaluation of the project upon completion:
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- Do you agree to comply with National Children’s Study policies and procedures regarding the various aspects of performing a Supplemental Methodological Study (data access, data disclosure, material transer, IRB approvals, publications, etc.)?
___ I agree to comply with National Children’s Study policies and
procedures.
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- Submitted by (corresponding applicant name):
E-mail address:
Date of submission:
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Submission of Application and Related Documentation
Submit the Supplemental Methodological Studies application, the 1-page abstract, the PIs (and any key collaborators’ biosketches, and any specific questions about the application to the National Children’s Study Supplemental Methodological Studies submission mailbox: SuppMethApp@mail.nih.gov.
Please send a signed hard copy to the following address:
National Children’s Study
Supplemental Methodological Studies Team
6100 Executive Boulevard, Suite 3A01
Bethesda, MD 20892-7510
Requests for data access and submissions of the National Children’s Study Data Use Agreement should be sent to NCSDataAccess@nih.gov with a copy to SuppMethApp@mail.nih.gov.
All applicable local IRB determinations (approvals, waivers, etc.) should be sent with the IRB-approved protocol and a cover letter describing any changes to the application that was provisionally approved to NCS_IRBs@mail.nih.gov with a copy to the selected National Children’s Study Co-Investigator and a copy to SuppMethApp@mail.nih.gov.
Material Transfer Agreements requesting use of National Children’s Study biospecimens or environmental samples should be sent to NCSRepository@mail.nih.gov with a copy to SuppMethApp@mail.nih.gov.
All publications must include appropriate acknowledgments and disclaimers.
Disclosure Review: All publications including non public use data must be submitted to NCSDataAccess@nih.gov for disclosure review.