Project Number___________

 

 

THE FRAMINGHAM HEART STUDY

 

Biological Materials and Genetic Analysis Data Application and Proposal Form

 

NOTE:   All proposals must be submitted by email to DNACoord@bu.edu

   All sections of this application must be completed prior to review of the proposal. 

   An application that is not complete may be returned.

   Sections I-V should be no more than 7 pages in length.

 

                                                                              Date of Submission:

 

 

I.                   SUMMARY OF PROJECT:

 

 

 
 
Title of Proposed Project:

 

Name of Project Director:         Tel:

 

Telephone Number:

 

Email:

 

Mailing Address:

 

Institution/Company of Project Director:

 

Name(s) of other Professional Participants:

 

Institution / Company of each other participant:

 

Name of Framingham Investigators (if any):


 

II.         SCIENTIFIC RATIONALE

 

What are the objectives of this research and the background rationale which would justify these objectives?  What are the estimates of heritability related to these objectives? Are there preliminary data that would support this investigation?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

III.              STUDY DESIGN, STATISTICAL METHODS AND POWER CALCULATIONS

 

A.     What will the study design be?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B.     What specific statistical methods will be used?

 

 

 

C.     What is the sample size and what study subjects will be used for this project?

 

 

 

 

 

 

 

 

 

 

D.     Provide power calculations which would show there is adequate statistical power for the hypotheses. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

IV.             PHENOTYPE DEFINITION AND AVAILABILITY

Name the specific phenotypes requested for this study using the variable names listed on http://www.nhlbi.nih.gov/resources/deca/elements.htm- The web site contains descriptions of the Framingham phenotypic data available for use in these research projects. Make sure you specify cohort (Original or Offspring) and exam number(s) for each variable requested. Framingham data not on this website should be described as thoroughly as possible.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

V.                GENETIC DATA

List the genetic data currently available from the Framingham Study that is requested for this research. Please refer to the following web site for descriptions of the genome scan and candidate genes available from the Framingham Study.
http://www.nhlbi.nih.gov/about/framingham/policies/fram.genetic.markers.pdf

http://www.nhlbi.nih.gov/about/framingham/policies/fram.candidate.genes.pdf

 

 

 

 

 

 

 

 

 

 

 

 

VI.            REQUEST FOR BIOLOGICAL MATERIAL

A. What DNA is requested?

Please fill out following table according to the DNA plate set you are requesting:

1) the Standard Plate Sets (Unrelated or Family), or
2) The Custom Plate Set (will require justification below)

 

 

 

Amount of
DNA/
genotype

# of
Genotypes

Total DNA Requested

Type of
DNA
Plate Set

Description of Plate Set

DNA Preparation
Description

__ng/genotype

___

___ng

Custom

You will be required to provide this
information

You will be required to
provide this information
(usually cell-line derived).

 

 

 

 

 

 

__ng/genotype

___

___ng

Unrelated

Approximately 1800 specimens from
biologically unrelated subjects (generally)
one representative from each family)
comprise this cell-line based plate set.
Some subjects can also be on the
Family Plate Set.

The DNA is aliquoted into
96-well plates at a
concentration of 10 ng/ul in
TE Buffer. Generally, 10 ng/μl DNA per genotype
requested is recommended.

__ng/genotype

___

___ng

Family

The current set is cell-lined based and
contains more than 1400 members from
the 330 largest pedigress used in the
Marshfield Genome Scan. Some
subjects can also be on the Unrelated
Plate Set.

The DNA is aliquoted into
96-well plates at a
concentration of 10 ng/μl in
TE Buffer. Generally, 10 ng
DNA per genotype
requested is recommended.

 

 

If requesting customized plates, provide a justification for the need for these plates that cannot be addressed with the standard plate sets.

If 10 ng DNA per genotype is not sufficient for your research provide a description and justification for a request for an increased quantify of DNA for specimen requsted to perform these studies:

 

 

 

 

 

 

B. Describe the laboratory which will conduct the genotyping, the laboratory methods, and quality control.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

C. What genotyping will be performed? Provide a list of the planned typings in the following table. Include as much information as possible so that a person skilled in the art can identify the locus of interest to you.  For example give candidate gene by NCBI Locus Link ID, and/or HUGO name.  GiveSTR's by HUGO name.  Give  SNPs by dbSNP name, and SNP maps by NCBI base positions (e.g. Chromosome 11, 69 Mb - 79 Mb) chromosomal location

 

When the research results are returned to Framingham the genes interrogated will be separately posted on the Framingham website in alphabetical order without identification of the researchers involved. Specific variants within genes will be posted when the typing is completed and returned to the Framingham Heart Study. According to the Distribution Agreement, all investigators approved for DNA distribution will be required to begin returning genotyping information in an annual report.

 

All genes proposed for genotyping must be specifically listed.  In order to fulfill our fiduciary responsibility to the participants of the Framingham Heart Study, requests to genotype linked or haplotype tagged SNPs without actually naming specific rs numbers will not be accepted. The Framingham Genetics Steering Committee will generally not approve applications to genotype “clinically actionable” genes because the resources to follow up at these loci are not available at this time.

 

Please provide a list of the planned genotypings in a table with a format similar to that noted below.  When possible include the candidate gene name by NCBI Locus Link ID, HUGO name, STR=s by HUGO name, SNP by dbSNP name.  

 

 

 

 

Marker/Variant

[GIVE NAME TYPE HERE]  {rs number}

Chromosome

Physical Location

Closest known Gene (within 60 kb)*

 

 

 

 

*if gene is not near a known gene, please specify “none”

 

 

 

 

 

 

 

 

 

 

 

 

VII.              ABSTRACT

 

Provide and abstract of no more than 200 words describing the proposed research. The abstract must include major hypotheses, and outline of laboratory methods
and analytical approached, and phenotypes to be studied. The abstract will be posted on the Framingham website when the projects are approved. Abstracts will posted with the name of the Project Director

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

VIII.             RECIPIENT ENTITY(IES):

 

Name and address of each Institution/Company whose investigators will receive access
to requested:

 

a.       Biological Materials:

 

b.      Genetic Analysis Data:

 

and/or

 

c.       Clinical Data:

 

 

 

IX.                ADDITIONAL DOCUMENTS:

Return by email to the DNA Coordinator: DNAcoord@bu.edu

Please include:

1.                  (1)               This Completed Form

2.                  (2)               Biographical Sketch (NIH format)

3.                  (3)               any other supporting documentation

4.                  (4)               Full or Expedited IRB Approval (can be faxed)***

5.                  (5)               Distribution Agreement

Note: #4 and #5 can be obtained after DNA Committee Approval

 

***A Statement from an IRB that this project is exempt is not acceptable.
This project requires an explicit review by the IRB at each institution involved.

 

 

Submission deadline are January 15, April 15, and October 15. Applicants will be notified of the decision made by the DNA Committee and Research Committee Within ten weeks of the submission deadline.

 

Upon approval, the Project Director will be required to submit a Distribution Agreement to Boston University for the project.  The Distribution Agreement Form can be obtained from the Framingham Heart Study website.  The Project Director will be responsible for obtaining signatures on behalf of the Recipient Entities and returning the signed Distribution Agreement to The FHS DNA Coordinator before the requested materials can be released.