Attachment 1 - SOW.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Collaborative Neuropsychiatric Disorders Research and Research Support for Clinical and Translational Neuroscience Branch

Statement of Need and Purpose:

The Clinical and Translational Neuroscience Branch (CTNB) conducts clinical research on severe neuropsychiatric disorders. The Branch carries out genetic, cognitive, and multimodal brain imaging studies in adults with schizophrenia, children with Williams’ Syndrome, children transition through puberty, and healthy volunteers. This difficult clinical research requires diverse expertise in clinical care and understanding of neuropsychiatric conditions, as well as familiarity with various modalities used in our studies, including functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG) and Positive Emission Tomography with both inpatients and outpatients at NIMH. The CTNB requires collaborative and psychiatric clinical expertise and consultation to enhance the impact of research and ensure data are efficiently and accurately collected with minimal impact on subjects.

Background Information and Objective:

The overall goal of the collaboration with the Branch Chief and contractor is to ensure coordination of all aspects of the Branch’s clinical neuroscience research. Cognitive, genetic, and multimodal imaging are highly technical and specialized areas of which the contractor must have knowledge in order to provide clinical research expertise to study staff and subjects who participate in protocols. CTNB seeks a contractor who is qualified to deliver experienced psychiatric nursing skill as the research involves participation by the seriously mentally ill. The contractor participates in advanced clinical assessments to ensure appropriate subject selection and participation. The contractor is needed to communicate with recruitment, branch, nursing, and medical staff to effect protocols. Finally, the contractor, in coordination with the Branch Chief, interacts with regulatory entities specifically the Institutional Review Board (IRB). The purpose of this acquisition is to acquire a neuroscience research nurse to monitor and implement studies and to provide coordination and management of Intramural Research Program (IRP) and IRB regulatory requirements.

Period of Performance:

The period of performance is one year from the date of the award with two 12-month option periods.

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:

The contractor shall:

-Participate in the recruitment of patients and family members by establishing relationships with referral sources in the D.C. metropolitan area as well as set-up systematic procedures for referrals when possible.

-Complete medical and psychiatric assessments of potential participants in multiple research protocols by collecting and reviewing past and present medical records; conduct interviews with research applicants and their families.

-Evaluate potential participant appropriateness for inclusion according to study criteria, particularly from a medical standpoint.

-Summarize all clinical and medical data into concise psychiatric narrative for presentation to psychiatrists and principal investigators, complete with recommendations for inclusion or exclusion from the protocol.

-Obtain informed consent from research participants.

-Conduct semi-structured psychiatric diagnostic interviews (SCID).

-Use additional clinical protocol preparation, regulatory work for the Branch, and IRB document preparations and processes.

-Provide clinical coverage to MRI scans as necessary.

The contractor also will provide services and materials to the collaborators so that they might complete studies of schizophrenia spectrum illnesses and Williams’ Syndrome. The contractor will perform these duties in collaboration with members of the IRP and CTNB. The contractor will participate in communicating with Branch staff on newly implemented clinical and regulatory procedures.

LEVEL OF EFFORT:

During the period of performance of the first one year from the date of award, the contractor shall provide approximately 15 hours per week. Thereafter, during the option years, the contractor shall provide approximately 15 hours per week.

GOVERNMENT RESPONSIBILITIES

These duties will be performed in collaboration with the personnel of the CTNB. Contractor meets regularly with Branch Chief to review routine Branch and regulatory needs. The CTNB will provide a government-furnished laptop, phone, and office space for the contractor in the Clinical Center.

DELIVERY OR DELIVERABLES

1. Description of Tasks and Associated Deliverables:

A progress report will be submitted six months into the contract in electronic format and every six months thereafter.

REPORTING REQUIREMENTS

A progress report will be submitted six months into the contract in electronic format and every six months thereafter.

OTHER CONSIDERATIONS

Travel:

The Contractor may attend one or two recruitment opportunities (local or nationwide) per year.

Key Personnel:

N/A

Information System Security Plan:

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).

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.

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.

The Contractors 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 NIMH shall have unlimited rights to, and ownership of all deliverables provided under this contract, including reports, recommendations, briefings, work plans and all other deliverables.

This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” is hereby incorporated by reference and made a part of this contract/order.

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:

The contractor will not write scientific publications based on this 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.

Contracting Officer’s Representative (COR)

1. The Contracting Officer's Representative (COR) contact information:

Cheryl Leone National Institute of Mental Health, NIH Direct Line: 301-443-4633 E-mail: cleone@mail.nih.gov

2. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

3. The Contracting Officer is the only person with authority to act as agent of the

Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or

(6) sign written licensing agreements.

4. The Government may unilaterally change the COR designation for this contract.