Statement_of_Work.pdf

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Autism Neurocognitive Data Support Services

Statement of Need and Purpose:

The Developmental Neurogenomics Unit (DNU), Human Genetics Branch has a requirement for consulting services in autism spectrum disorders with the level of expertise necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). These services are needed to help further certain aspects of our existing research. The DNU has reached a crucial point in its research on Autism Spectrum Disorders where the consultation service is critical in support of our research on youth with autism.

Background Information and Objective:

The DNU, HGB, Division of Intramural Research Program (DIRP), National Institute of Mental Health (NIMH) has a research program that operates multi-faceted investigations of the brain through genomic, functional and structural imaging, neurocognitive and diagnostic characterizations of youth with neurogenetic disorders. The contract requests consultation services on the validation of specimen data collected by DNU staff and obtained based on our clinical and research diagnostic characterization of the participants in these studies who have an autism spectrum disorder. The contract also requires that the consultation services be provided to DNU staff members regarding autism specific features as well as to address staff inquiries which arise from their investigation in the development of neurocognitive paradigms to measure clinically relevant features in autism, along with how to appropriately collect and score cognitive data for phenotyping and hypothesis generation and the dissemination of our scientific findings. This is a modification to contract number HHSN271201800706P with Children’s National Medical Center. The modification will allow additional work to be performed in order to support the increase in the caseload of patients being evaluated by Children’s medical staff.

Period of Performance:

Base Period: 09/30/2018 - 09/29/2019 Option Period One: 09/30/2019 - 09/29/2020 Option Period Two: 09/30/2020 - 09/29/2021

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish consultation services; qualified personnel and materials, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

The Contractor shall:

1. Assist DNU staff with preparing written reports describing diagnostic and neurocognitive findings;

2. Provide consultation services on neurocognitive data collection, data analysis, and dissemination of scientific findings both through publications and conference presentations;

3. Utilize expertise in the gold standard autism diagnostic characterizations during their consultations with DNU staff members; and

4. Attend weekly meetings and advise DNU Post-baccalaureate IRTAs, Postdoctoral fellows and other DNU staff on clinical considerations for data collection and hypothesis generation when evaluating patients.

LEVEL OF EFFORT:

During the period of performance of one year from date of award, the contractor shall provide a minimum of twenty (28) hours per week, not to exceed 1456 labor hours. This increase relative to SOW for the previous statement of work is required to support an increase in patient flow through our protocol.

GOVERNMENT RESPONSIBILITIES

The government will provide workspace, desktop computers and telephones for the contractor’s personnel. The government will also provide diagnostic materials and kits for defining the presence of an autism diagnosis and other psychiatric disorders, as well as cognitive assessment materials. The government will allow the three (3) designated contractors to access NIH Building 10 laboratory and clinic facilities for them to consult with DNU staff.

DELIVERY OR DELIVERABLES

Description of Tasks and Associated Deliverables:

1. The contractor is expected to provide a minimum of twenty (28) hours each week of consultation services. This increase relative to SOW for the previous statement of work is required to support an increase in patient flow through our protocol.

2. The contractor shall provide written reports of assessment results throughout the term of the contract on a weekly basis. The consultant services of the Contractor(s) shall be directly with the DNU in support of our current research study on child and adolescent neurodevelopmental disorders.

3. All deliverables shall be prepared and submitted in a Microsoft Word format with a minimum font size of 10 points. All “hard copy” deliverables will be submitted on recycled-content paper and printed double-sided.

REPORTING REQUIREMENTS

Throughout the period of performance of this contract, the Contractors are required to provide weekly progress and/or updates to the government point of contact (Dr. Armin Raznahan). The Contractor(s) verbal and/or written reports on laboratory staff assessment results are also provided on a weekly basis to Dr. Armin Raznahan and upon request by lab staff involved with this project.

OTHER CONSIDERATIONS

Travel:

The principal location of the work being performed under this contract is the National Institutes of Health, Building 10, Bethesda Main Campus. Accordingly, reimbursable travel and per diem for the contractor’s employees performing work on a regular basis at this place of performance is not authorized. However, travel is authorized for diagnostic training courses.

Key Personnel:

The key personnel required in the performance of this requirement must:

1. Possess expertise in the field of clinical psychology and pediatric neuropsychology;

2. Have demonstrated research and interests in the treatment of the neuropsychological phenotype of autism along with diagnosing and conducting assessments of pediatric patients with autism spectrum disorders;

3. Possess a Psychology graduate degree (Masters or PhD);

4. Be clinically certified in research reliability on 2 gold-standard autism diagnostic tools, the Autism Diagnostic Observation Schedule-2 and the Autism Diagnostic Interview;

5. Have at least five years in clinical psychology and pediatric neuropsychology; and

6. Have expertise in the treatment of pediatric neuropsychological phenotype of autism.

Information System Security Plan:

1. An Information system security plan is applicable to this requirement because contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility;

(2) physical access to an HHS-controlled information system; (3) access to sensitive

HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

2. The information system security plan pre-solicitation has been completed by the cognizant program official and signed by the NIMH Information Systems Security Officer and attached to the statement.

3. The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information – Contractor—Employee Non-Disclosure Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract.

4. The Contractor(s) will maintain compliance with NIH requirements for training and certification in the ethical conduct of research and the protection of participant information, as well the security of NIH computers and communications.

Data Rights:

The Government shall retain all rights to the data collected under this requirement.

Section 508—Electronic and Information Technology Standards:

Section 508 is not applicable under this requirement.

Publications and Publicity:

The Contractor(s) shall assist the DNU staff in writing and preparing for publication the data produced in the performance of the statement of work.

Confidentiality of Information:

The Contractor(s) will not disclose, publish, divulge, release, or make known, in any manner or to any extent, to any individual other than the authorized government employee, the content of any sensitive information provided under this contract. For this requirement, the government may provide to the contractor(s) information or data of a personal nature about individual(s) or proprietary information or data pertaining to this project, which is confidential. This requirement is expected to generate information or data which is confidential. The Contractor(s) shall handle all sensitive information or data in a secure manner and consult with the authorized government employee prior to any release, disclosure, dissemination, or publication.