Project Number___________
THE
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
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
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)
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Amount of |
# of |
Total DNA
Requested |
Type of |
Description of
Plate Set |
DNA Preparation |
__ng/genotype |
___ |
___ng |
Custom |
You will be required to provide this |
You will be required to |
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__ng/genotype |
___ |
___ng |
Unrelated |
Approximately 1800 specimens from |
The DNA is aliquoted into |
__ng/genotype |
___ |
___ng |
Family |
The current set is cell-lined based and |
The DNA is aliquoted into |
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
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)*
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*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
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