23-003981 - Goodwin SOW Brotman 2023.pdf

STATEMENT OF WORK (SERVICES)

(SOW)

Section 1: GENERAL INFORMATION

1.1 Title of Project:

Collaborative Computational Deep Phenotyping of Irritability

1.2 Statement of Need and Purpose:

The goal of the Neuroscience and Novel Therapeutics Unit (NNT) is to address the need to develop new treatments for youth by integrating brain-based studies, scalable mobile technology, and clinical trials of novel interventions for pediatric psychiatric disorders. Given burdens of pharmacology, coupled with the pathophysiological malleability of children through learning and social contexts, NNT focuses on developing psychological interventions for the pediatric phenotype. NNT requires a leading authority in research and clinical experience working on assessing anger and irritability in children on the autism spectrum. NNT requires that the consultant has developed and evaluated innovative technologies for behavioral assessment and intervention, including naturalistic video and audio capture, telemetric physiological monitors, wireless accelerometry sensors, and digital video/facial recognition systems.

1.3 Background Information and Objective:

The overall goal of collaboration with the contractor is to develop psychophysiologically-based protocols for irritable children and implementation of such psychophysiologically-based protocols using a mobile platform. Ultimately, this work would provide the foundation for potential novel closed-loop real time therapeutics. The contractor has a leading role in all these projects including overseeing the technical work of choosing hardware, overseeing the technical work of research fellows, data analysis, and writing of scientific reports. The purpose of this acquisition is to continue this work as a follow-on to a previous professional services contract (75N95020P00590) with Matthew Goodwin in order to further oversee the dissemination of these methods to other collaborating laboratories.

1.4 Period of Performance:

The period of performance is one 12-month base year from the date of award and two 12-month option years.

Section 2: SCOPE OF WORK

2.1 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. Neither the contractor nor NNT have the goal of pursuing the contents of this work for intellectual property.

2.2 Specific Requirements:

The Contractor shall:

a. Provide expertise in ambulatory physiological measurement;

b. Provide expertise in psychological and behavioral experiments in research on predicting anger and emotional outbursts. Specialized expertise in computer paradigms is required;

c. Provide expertise in the use of cognitive training paradigms as potential clinical treatments; and

d. Provide expertise and prior work experience in a biomedical setting, with diverse types of scientists. The Contractor shall be familiar with multiple types of data and procedures for collecting such data.

2.3 LEVEL OF EFFORT:

During the period of performance of twelve months from date of award, the contractor shall provide approximately 1 hour per week, not to exceed 60 labor hours per year. During the two one-year option years, the contractor shall not exceed 60 labor hours per year.

2.4 GOVERNMENT RESPONSIBILITIES

The Government shall provide, if necessary, workspace and access to EDB databases (if subscription-based) during regular operating hours.

The Government shall review activities and provide feedback. Reports generated shall be reviewed and approved within two weeks of submission.

2.5 DELIVERY OR DELIVERABLES

1. Description of Tasks and Associated Deliverables:

A progress report will be submitted six months into the contract to Dr. Brotman.

2. Reporting Requirements:

A progress report will be submitted six months into the contract and a subsequent report every six months throughout the duration of the contract.

3. OTHER CONSIDERATIONS

3.1 Travel:

The Contractor shall visit NNT on the NIH campus between one and two times during each of the contract years.

3.2 Key Personnel:

The following individual is considered to be essential to the work being performed hereunder:

Matthew Goodwin, Ph.D.

Dr. Matthew S. Goodwin is a founding and key faculty member of a new doctoral program in personal health informatics and director of the Computational Behavioral Science Laboratory at Northeastern University and visiting associate professor in the Department of Biomedical Informatics at Harvard Medical School (2018-2020), the former director of Clinical Research at the MIT Media Lab (2008-2011) and adjunct associate research scientist in the Department of Psychiatry & Human Behavior at Brown University. Dr. Goodwin is an international expert who has twenty years of research and clinical experience assessing anger and irritability in children and adults on the autism spectrum and developing and evaluating innovative technologies for behavioral assessment and intervention, including naturalistic video and audio capture, telemetric physiological monitors, wireless accelerometry sensors, and digital video/facial recognition systems. Dr. Goodwin received his B.A. in Psychology from Wheaton College, M.A. in Experimental Psychology from University of Rhode Island, and his Ph.D. in Behavioral Science from the University of Rhode Island. He has over 100 published papers, juried conference papers, and book chapters.

The key personnel specified in this contract are essential to the work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel.

3.3 Information System Security Plan:

1. An Information system security plan is applicable to this requirement because contractor personnel are expected to have routine access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy.

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 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.

3.4 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.

3.5 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.

3.6 Publications and Publicity:

The Contractor shall assist the NNT staff in writing and preparing for publication the data produced in the performance of the statement of work.

3.7 Confidentiality of Information:

The Contractor 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 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 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.

3.8 Contracting Officer’s Representative (COR)

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

Courtney White National Institute of Mental Health Section on Development and Affective Neuroscience 31 Center Drive, Bethesda, MD 20892-2370 Phone: 301-443.8060 E-mail: Courtney.white@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.