Recruitment and Data Collection Services to Study the Heterogeneity in Symptoms of Autism and Co-Morbid Features in a Mid-Atlantic Twin Registry Cohort

DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The Section on Social and Cognitive Developmental Neuroscience (SoCoDeN) conducts population and clinical neuroscience research on neurodevelopmental disorders including autism spectrum disorder (ASD), specifically in twins. The long-term goals of the research are to better understand individual differences in youth with mental health disorders, including the interplay between genes, environment, and stochastic processes. The primary objective of this project is to collect data from a large twin population to measure both autism and comorbid symptom levels along a continuum and to assess their interplay. 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: The contractor will primarily be responsible for contacting and recruiting twin families in the MATR. The contractor will collect data and share in a de-identified format with SoCoDeN from families willing to participate in the survey. Salient characteristics include: The specific requirements can be broken down into the following mandatory 3 categories: study development, recruitment and participation, and data collection and delivery. Study Development The contractor will provide a programmer to convert the questionnaire to an electronic data capture system. A copy of the data dictionary from the electronic data capture system will be provided to SoCoDeN. The contractor will secure any necessary copyright approvals for the use of questionnaires. The contractor will provide storage for the questionnaire data until the data is transferred to SoCoDeN and to the length determined by their IRB. The contractor will submit a protocol and obtain IRB approval for the study from their institution. Recruitment and Participation The contractor will put together a list of all twins from the Mid-Atlantic region and adjacent areas who can be contacted between the ages of 6 and 17. The contractor will consent all participants for the study. The contractor will mail/email letters to all identified eligible participants. Phone calls will be made by the contractor in addition to the mailed/emailed letters to recruit a subset of families whose twin(s) fall on the autism spectrum. Follow-up emails and/or calls will be made to participants who do not respond to the initial inquiry. Data Collection and Delivery The contractor will monitor and maintain data collected via the electronic data capture system. All study participant data will be sent to the government (SoCoDeN) with identifiers removed and replaced by an ID. Each informant will have a unique ID as well as each twin that the informant provides information about. The contractor will also assemble all available non-identifiable birth record and environmental data and deliver this to SoCoDeN using the same twin ID as that established during the questionnaire data collection to allow for linking of data. The contractor will provide data to SoCoDeN on a monthly basis via CSV files Anticipated Period of Performance Start Date: July 06, 2023 - July 05, 2023 DELIVERY OR DELIVERABLES The contractor will provide CSV files of the data collected from study participants and birth record and environmental data, as well as a copy of the data dictionary from the electronic data capture system. The data will be collected in 2 rounds with the first round consisting of 10% of the sample. Any data that has been collected from the first round within the first four weeks will be sent to SoCoDeN at that time. SoCoDeN will review this data and then give the go ahead for the questionnaire to be sent to the remaining 90% of the sample. The data from this second round will be sent to SoCoDeN monthly until study completion. LEVEL OF EFFORT: The contractor will provide the following: Administrator (3% effort) Project Coordinator (8% effort) Programmer (6% effort) Data Entry (2% effort) Interviewer supervisor and trainer (0.5% effort) Twin data management and information lookups (2% effort) Interviewer (100% effort) The project is estimated to take between 500 and 550 hours to complete. GOVERNMENT RESPONSIBILITIES SoCoDeN will provide the background and goals of the study to include in the protocol submitted to the contractor's institution. SoCoDeN will also be responsible for choosing and developing the questionnaires that the contractor will use to create the electronic data capture system. In addition, SoCoDeN will review data upon receipt from the contractor. TRAVEL Not Applicable KEY PERSONNEL The key personnel required for successful performance include: Administrator Project Coordinator Programmer with knowledge of REDCap Data Entry Personnel Interviewer supervisor and trainer Interviewer REPORTING REQUIREMENTS A summary report will be sent to SoCoDeN by the contractor 6 months into the project and final report will be sent one year after the project commenced. The report should contain the following: Number of families contacted Numbers of letters/emails sent Number of families called Number of follow-up calls made Number of questionnaires completed after first contact Number of questionnaires completed after second contact Number completed after 3 or more contact attempts Total number of questionnaires completed When available, the following demographic information about families who did not respond or declined: Age Gender Race Ethnicity Socioeconomic Status Maternal Education DATA RIGHTS The National Institute of Mental Health shall have unlimited rights to and ownership of all de-identified data including reports. 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. 52.227-17 -- Rights in Data -- Special Works is hereby incorporated by reference and made a part of this contract/order. INFORMATION SECURITY PLAN The contractor will not need to develop, access or maintain a federal information system during the course of this project. 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. CONFIDENTIALITY OF INFORMATION The government will not provide the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential. The contractor will generate information which is confidential and will be overseen by the IRB at the contractor's institution. All data received by SoCoDeN will be deidentified by the contractor before it is transferred, and the contractor will be the only one with the key to link the data to any identifying information. PUBLICATIONS AND PUBLICITY The contractor should not publish nor share with others from the data that is collected until SoCoDeN has the opportunity to publish first, or two years have passed since the completion of data collection, whichever comes first. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Virginia Commonwealth University is the only vendor in the marketplace that can provide the services required by the Section on Developmental Neurogenomics. The intended source is: Virginia Commonwealth University 910 West Franklin Street Richmond, VA 23284 CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95023R00056. Responses must be submitted electronically to Diedra S. Prophet, Contract Specialist, at diedra.prophet@nih.gov. U.S. Mail and fax responses will not be accepted.