Statement_of_Work__-_MU_PANDAS_Recovery_Project_(amended)_mc.doc

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

PANDAS Data and Samples Statement of Need and Purpose:

The National Institute of Mental Health (NIMH), National Institutes of Health (NIH) is in need of detailed clinical information and crucial biological specimens obtained from children evaluated in Missouri. Samples must be from 50 children meeting with abrupt onset neuropsychiatric symptoms (PANS and PANDAS). The phenotypic profiles and biospecimens of these children will be compared against those obtained from children living in other geographically diverse sites (Massachusetts, Arizona, Florida, Minnesota and California). The Missouri patient profiles also will be compared against data and samples previously obtained at NIMH in order to ascertain temporally-related changes in clinical presentation, microbial virulence and host reactivity. The clinical information and biological specimens will help NIMH investigators to accomplish four specific aims:

The clinical information and biological specimens will help NIMH investigators to accomplish four specific aims:

1. Identify unique and distinctive clinical, paraclinical and laboratory features of acute-onset neuropsychiatric symptoms among children meeting criteria for PANS (Pediatric Acute-onset Neuropsychiatric Syndrome).

2. Determine the role of environmental pathogens, such as Group A streptococci, in disease onset and recurrences.

3. Investigate factors influencing host susceptibility and resistance.

4. Elucidate the role of immune dysfunction in PANS or its subgroups.

The samples and data must be accompanied by consent forms from the 50 patients and will remain on site throughout the contract period (and beyond, per institutional requirements for consent documents.)

Background Information and Objective:

The Section on Behavioral Pediatrics (SBP), Intramural Research Program, National Institute of Mental Health conducts clinical research on a variety of childhood behavioral problems including research to identify both biological and clinical factors which influence the onset and expression of behavioral symptoms and to develop more effective treatment and prevention strategies for childhood disorders. The Section’s research currently is focused on understanding the etiology, pathophysiology and clinical features of obsessive compulsive disorder, including acute-onset subtypes.

Period of Performance:

The period of performance will be one year (12 months) from date of award.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

GOVERNMENT RESPONSIBILITIES

Analysis of medical records data and measurements will be conducted by researchers at NIH and others to whom NIH designates. The provider of the samples will not be involved in the analysis phase of the project.

Publications will be the responsibility of NIH and the individual researchers. Where appropriate, acknowledgement can be given to those who provided the clinical information and samples.

DELIVERY OR DELIVERABLES

De-identified serum samples collected from 50 children with PANDAS at various time points will be allocated as 250mg samples into numbered vials and stored at -80o The de-identified aliquots will be shipped to NIH for inclusion in the Repository Protocol of the Section on Behavioral Pediatrics (09-M-N216).

Sputum samples will be de-identified and sent to NIH for storage in the Repository Protocol.

The samples must be identifiable with an original patient identification code which is securely stored. The medical records from each subject will be reviewed to fill out information relevant to the subject’s medical history, physical examination and health status (acutely ill, convalescent or well). This information is designed to be comparable to data and samples collected from other researchers at other parts of the U.S. Once de-identified the data will be sent electronically to NIH and housed there in the NIH Clinical Trials Database.

REPORTING REQUIREMENTS

Provision of samples and data will suffice for reporting requirements.

OTHER CONSIDERATIONS

Travel:

N/A Key Personnel:

A party designated by the vendor will determine who will retrieve the clinical information from their electronic medical records, de-identify samples and prepare materials for shipping to NIMH.

Information System Security Plan:

Work under this contract is UNCLASSIFIED. The Contractor shall comply with all applicable NIH regulations and procedures during the performance of this contract. The Contractor shall not disclose and must safeguard procurement of sensitive information, computer systems and data, privacy act data, and Government personnel work products that are obtained or generated in the performance of this contract. If necessary, the Contractor will be required to provide clearances for personnel requiring access to Government computers and workstations. Contractor personnel performing work under this contract will receive de-identified data for analysis. They will not have access to sensitive information and information systems belonging to or being used on behalf of the Section of Behavioral Pediatrics Data Rights:

The Section on Behavioral Pediatrics, NIMH shall have unlimited rights to and ownership of all deliverables provided under this contract, including data, samples and other deliverables.

Section 508—Electronic and Information Technology Standards:

The Contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. 794d) as amended by the Workforce Investment Act of 1998 (P.L. § 105-220), August 7, 1998.

Publications and Publicity:

Publications will be the responsibility of NIH and the individual researchers. Where appropriate, acknowledgement can be given to the vendor for providing the samples, and obtaining the clinical information and samples.

Confidentiality of Information:

NIMH is not providing any information or data of a personal nature about individual(s) or proprietary information data. Data sent to NIMH will be stored on a password-protected server (behind the NIH firewall). All data are de-identified and no confidential information is exchanged.

Version 11-30-2016-1

FAR Part 11—Describing Agency Needs