Application for Supplemental Methodological Studies (SMS) for the National Children’s Study

1. Title of the Proposal: 
   
    

   PI Name:
      
   

   Affiliation:
   
   Email:
   
   Area(s) of Expertise:
   
   
   
   Phone:                Fax:
   
   
   You will be instructed to submit a biosketch or CV with this application

Key Personnel and Collaborators:
You will be instructed to submit biosketches for all key personnel and collaborators

Name _________________ Email ______________

Name _________________ Email ______________

Name _________________ Email ______________

Name _________________ Email ______________

2.  *Keywords: List five keywords that describe your project: 
   

3. *Abstract (one page limit): 

4.  *Leveraging the NCS:
   
   This proposal requires (check all that apply and fill out the corresponding sections  below):
   
   (Note: access to just NCS data is not considered a Supplemental Methodological Study)
   
   
1. ____Interaction with NCS participants
   
2. ____NCS biospecimens
   
3. ____NCS environmental samples
   
4. ____NCS data, in addition to one or more of the above
   
   

A. Participants: If the study requires participant interface, describe the number and demographic characteristics of participants needed. (Leave blank if the study does not require participant interface)

B. Biospecimens: If the study requires biospecimens, detail the types and quantities needed. For what purpose will the biospecimens be used? (Leave blank if study does not require biospecimens) 

C. Environmental Samples: If the study requires environmental samples, detail the types and quantities needed. (Leave blank if the study does not require environmental samples)

D. Data: Specify the data required:

5. *Scientific value and goals of the proposed study: 

    

6. *Explain the rationale for utilizing the NCS as a platform for this study. What is the potential benefit to the NCS? 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 NCS). 

7. *Study Design. Provide a description of the study design including but not limited to: mode of data collection; number of contacts with participants, time required for each contact, ect.    

8. *Human Subjects Considerations: Describe any direct and indirect benefits to participants, risks, incentives, and plans regarding return of results.  
   
   

 

9. *Timeline 
   
   What is the duration of your proposed study from start to completion:
   
   If possible, estimate the start and end dates of your proposed study: 
   
   Start Date ________   End Date _________
   
   Comments (optional):  

10. Answering the following questions when initially submitting the application is optional. Provisional approval can be provided without this information. However, final approval will be granted only after these issues are addressed.
    
    
    
    1. Has a study location (or locations) been identified?
       
       ___ Yes--if yes, indicate study locations (s):
       
       ___ No
       
       ___ N/A
       
       
    2. Has an NCS Co-Investigator (and Facilitator(s), if indicated) been selected?
       
       ___ Yes--if yes, complete the NCS Co-Investigator/Facilitator Form
       
       ___ No  
       
       
    3. Funding documentation is required for final, but not provisional, approval.
       
       
    1. Has funding been secured?
       
       ___ Yes--if yes, indicate source & grant number (if applicable):
       
       ___ No
       
       
    2. What is the expected approximate cost of the study?
         
       
    4. Will this study require local IRB approval?
       
       ____ Yes-- if yes, documentation will be required before final approval.
       
       ____ No
       
       ____ Uncertain

    
    
    Comments (Optional):    
     

11. Agreement
    
    Do you agree to comply with National Children's Study policies and procedures as described in the Supplemental Methodological Studies Overview?
    
    ___ Yes
    
    ___ No 

12.  Submission
    
    Application Submitted by:
    
    Date of Submission:
    
    ___ PI Biosketch or CV attached
    
    ___ Key personnel biosketches are attached