Statement of Work for Dr. Didem Ozdemir\`-Ozenen

> **Justification**
>
> Attached is a request for \$4,500.00 to be provided monthly according
> to the attached payment fee schedule. In addition to the services of
> Dr. Didem Ozdemir\`-Ozenen, these funds will also provide for any
> travel expenses that may be incurred during the contract period. Under
> this contract, Dr. Ozdemir\`-Ozenen will provide clinical research
> services to the Human and Craniofacial Genetics Section, NIDCR. Her
> contract will run from November 15, 2007 to March 31, 2008. The work
> requires specialized clinical skills and basic research skills for
> sample preparation. Dr. Ozdemir\`-Ozenen is a dentist with specialized
> training in the field of Pediatric Dentistry. She also has received
> training in human genetics during a Clinical Research Fellowship
> performed at the NIDCR. Dr. Ozdemir\`-Ozenen is experienced in the
> area of Amelogenesis Imperfecta, and has published scientific
> manuscripts related to this topic. The procedures described need
> technical skill and expertise in the area of normal and abnormal
> enamel development. She is also proficient with the methods related to
> establishing the needed database and recording the appropriate
> information.
>
> Additionally, Dr. Ozdemir\`-Ozenen has the expertise and self
> motivation to successfully perform the project. She is familiar with
> all goals of the proposal, and understands when to support different
> aspects of the project to ensure successful completion. Her specific
> expertise in the area of amelogenesis imperfecta research makes her an
> ideal candidate for this work.
>
> **[Task Description:]{.underline}**
>
> Firm will issue 5 checks on the following payment days for the
> following amounts:
>
> 11/15/2007 -- 12/14/2007 - \$1,000.00
>
> 12/15/2007 -- 1/14/2008 - \$1,000.00
>
> 1/15/2008 -- 2/14/2008 - \$1,000.00
>
> 2/15/2008 -- 3/14/2008 - \$1,000.00
>
> 3/15/2008 -- 3/31/2008 - \$500.00

1.  [Objectives]{.underline}

> The contractor will work with Dr. Thomas Hart and other members of the
> Human and Craniofacial Genetics Section. The contractor will perform
> recruitment and clinical assessment of individuals from families
> segregating Amelogenesis imperfecta (AI). Dr. Ozdemir\`-Ozenen work
> will focus on identification of families segregating amelogenesis
> imperfecta, diagnosing which family members are and which are not
> affected by AI, obtaining informed consent from individuals to
> participate in studies to identify the underlying genetic basis of AI
> in their families and understanding the mechanism of this disease. The
> areas of the investigation include ascertainment of affected AI
> probands and their family members, determination of who does and who
> does not have the disease, obtaining appropriate samples for DNA
> isolation including peripheral blood, buccal swabs or oral rinses.
> Isolated DNA will be used to perform genetic linkage studies and
> perform mutational analysis of candidate genes through DNA sequencing.
> These studies are aimed at identification of the underlying gene
> defect in each family and in determining how the mutations act to
> cause defective enamel development.

2.  [Approach]{.underline}

> The contractor will be involved in implementing clinical ascertainment
> of individuals with Amelogenesis Imperfecta. The contractor will be
> involved in ascertaining family members of individuals with AI, and
> diagnosing affected status. The Contractor will be involved with
> tissue procurement and treatment of affected individuals in her
> clinic. The contractor will be responsible for preparation of samples
> and shipment to the Human and Craniofacial Genetics laboratory for
> analysis. The contractor will work with personnel from the Human and
> Craniofacial Genetics section in preparation of reports including
> scientific manuscript describing findings of molecular genetic
> studies.

3.  [Methods]{.underline}

> The services will be performed as follows:

a)  The contractor will participate in ongoing research related to
    identification of the genetic basis of Gingival Fibromatosis and
    characterization of the functional defect that causes the disease.
    Specifically the contractor will ascertain individuals affected by
    Gingival Fibromatosis, including clinical diagnosis, collection of
    specimens and preparation of specimens for DNA extraction, cell
    culture and immunohistochemistry.

b)  The contractor must have expertise in clinical diagnosis of various
    forms of Gingival Fibromatosis and the ability to distinguish the
    condition from sporadic phenocopies of the condition. The contractor
    must have a background in genetics, and have the ability to record
    accurate pedigrees.

c)  The contractor will have expertise to inform the affected
    individuals of the appropriate treatment of their condition
    (gingival overgrowth) and provide gingivectomy treatment if the
    patient elects.

d)  The contractor will have expertise to perform standard biopsies of
    gingival tissues.

e)  The contractor will maintain clear and accurate records relating to
    clinical information as well as tracking samples.

f)  The contractor should have excellent oral communication skills and
    be able to participate in writing scientific reports as well as
    clinical records.

[Personnel, evaluation and schedule]{.underline}

> [A. Personnel]{.underline}
>
> The contractor must have a working knowledge of general dentistry and
> expertise in Pediatric Dentistry. The contractor must have a working
> knowledge of genetics including modes of transmission of Mendelian
> diseases. The contractor must have expertise in the various forms of
> Amelogenesis Imperfecta. The contractor will be skilled in sample
> preparation for DNA isolation and for transport of tissue samples
> cytogenetics when needed. Personnel provided under the contract will
> comply with the rules and policies of the NIDCR and its staff.
>
> [B. Evaluation]{.underline}
>
> The contractor is expected to work in an independent self-motivated
> fashion. The contractor is expected to work closely with the Section
> Chief and other members of the laboratory and will be evaluated at
> least once a week by discussing a weekly progress report with the
> section chief. If the contractor is considered to be substandard in
> the judgment of the section chief, the contractor will initially
> receive notice of the problem from the section chief and will be
> required to take corrective measures and to demonstrate improved
> performance.
>
> [C. Schedule]{.underline}
>
> The contractor will perform duties related to the study for a minimum
> of 12 hours a week. The contractor will have flexibility to determine
> the days the work is performed, as this will be dictated in large
> measure by subject availability and study subjects availability.
> Failure to schedule and perform the necessary duties shall be
> considered default of the contract.
>
> [D. Reporting Requirements]{.underline}
>
> The contractor shall provide professional services for the Human and
> Craniofacial Genetics Section, NIDCR during the period of November 15,
> 2007 to March 31, 2008. The contractor will be paid a total of
> \$4,500.00 for this 4 1/2 month period.
>
> Mailing Address:
>
> Renata Baginski
>
> Building 10, Room 1N103A

National Institutes of Health

10 Center Drive, MSC 1197

Bethesda, MD 20892-1197