SOURCES SOUGHT
A -- Jackson Heart Study (JHS) - Coordinating Center
- Notice Date
- 1/11/2012
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HV-13-09
- Archive Date
- 2/9/2012
- Point of Contact
- William H. Etti, Phone: 3014438763, Cheryl A Jennings, Phone: (301) 435-0347
- E-Mail Address
-
William.Etti@nih.gov, cj19f@nih.gov
(William.Etti@nih.gov, cj19f@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The Division of Cardiovascular Sciences of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), plans to establish one (1) Coordinating Center as part of the Jackson Heart Study (JHS) renewal. The JHS also involves a Field Center, Training and Education Center and a Community Outreach Center. Awards for the JHS are anticipated to be made in June 1, 2013 through May 31, 2018. The JHS is a multi-center investigation of predictors of cardiovascular disease (CVD) in 5301 African-Americans living in Hinds, Madison, and Rankin Counties surrounding the Jackson, MS metropolitan area. The JHS represents an expansion of the Jackson, Mississippi site of the Atherosclerosis Risk in Communities (ARIC) Study to increase data collection in an African American population, and improve access to and the participation of African American populations and scientists in biomedical research and professions. The JHS was initiated in 1998 as a collaborative effort among three Jackson-area academic institutions. At the close of the current contracts in May 2013, the JHS will have completed three back-to-back cohort examinations that have produced extensive longitudinal data on traditional and putative CVD risk factors, socioeconomic and sociocultural factors and biochemical analytes; measures of subclinical disease from echocardiography, cardiac magnetic resonance imaging (MRI), computed tomography (CT) scans of the heart, aorta and abdomen; and stored biological samples. Eighty-two percent of the surviving JHS participants (N = 4203) completed Exam 2; projected retention for Exam 3 is 80% (N = 4082). In addition, the JHS has conducted annual cohort follow-up contacts for incident clinical events of interest, a variety of community education and outreach activities to promote healthy lifestyles to reduce disease risk burden, and level-appropriate academic training programs to promote and support public health research. The objectives of the renewal of the JHS program are to 1) Support dedicated time for JHS investigators to conduct data analysis and prepare manuscripts using the wealth of data collected 2) Facilitate access to study resources and expertise in order to • Engage researchers beyond the JHS, including early career investigators, in collaborative analysis of existing data to produce high quality publications • Serve as a training ground for undergraduate and graduate students to help ameliorate the shortage of minority biomedical researchers • Serve as a platform for ancillary studies 3) Conduct annual phone interviews with participants to identify interim hospitalizations and outpatient medical visits, convey information about the JHS, and serve as a vehicle to recruit for ancillary studies 4) Continue clinical events identification, investigation, and validation to improve statistical power for risk prediction and hypothesis testing 5) Perform community health education activities to disseminate health promotion and prevention messages in the Jackson community. NHLBI plans to support one (1) Coordinating Center, one (1) Field Center, up to two (2) Training and Education Centers, and one (1) Community Outreach Center. THIS NOTICE ADDRESSES THE COORDINATING CENTER ONLY. The Coordinating Center shall be responsible for overall study coordination, communications, data management, and analytical/statistical support. The Contractor will maintain via subcontracts or other arrangements a Central Laboratory to manage the JHS stored biological samples; an Image Repository to manage JHS cardiac CT and MRI scans and echocardiograms; a formal collaboration with the ARIC study Coordinating Center for clinical events validation; and other subcontracts as required for study operations. The important overall technical requirements associated with this acquisition for the JHS Coordinating Center include the following: 1. Work collaboratively with the other study centers, including the Coordinating Center, Community Outreach Center, and Training & Education Center(s), subcontractors, consultants, and the NHLBI Project Office in all relevant aspects of study development and execution. 2. In cooperation with other Centers, coordinate updates as needed to existing JHS policies, manuals of operation, and data entry/management systems for cohort follow-up and other study activities. 3. Implement and maintain the JHS Data Management System. The system shall be designed to optimize the accuracy and completeness of collected data and maintain its security. Provide written documentation of the system, training in its use for staff at all study centers, and user service when questions or problems arise. Update as needed to efficiently collect new data, as required in the study protocols. 4. Maintain the JHS database; perform data documentation, closure of annual events files, and archiving. Maintain confidentiality and security of electronic study data. 5. Arrange for review and classification of potential clinical study endpoints and receipt of resulting finalized events data to be coordinated by the ARIC Coordinating Center at the University of North Carolina. Incorporate the received data into the JHS database. 6. Maintain a Central Laboratory/Biospecimen Repository to ensure proper storage of previously collected JHS biospecimens (including approximately 95,000 biospecimen vials) to ensure their integrity and availability for assays or transfer to approved investigators. Maintain and provide periodic updates of the repository inventory. 7. Maintain an Image Repository to ensure proper storage of JHS cardiac CT (approximately 3,100 scans), MRI (approximately 16,000 scans), and echocardiogram studies and distribute to approved investigators as directed by the Coordinating Center. 8. Arrange for annual Medicare claims data updates linked to JHS cohort data; maintain familiarity with the layout and structure of the Medicare data; utilize the Medicare-linked data to identify additional potential JHS clinical endpoints to be investigated and to conduct analyses for scientific manuscripts. 9. Maintain quality control and monitoring of the performance status of the field centers, lab centers, and other relevant centers. 10. Coordinate receipt of data obtained from ancillary studies through new participant contacts and/or analyses of previously collected images, recordings, and biospecimens including blood, urine, and DNA; incorporate ancillary study data into the main data set for use by other investigators according to JHS and NHLBI policies. 11. Provide original data to the NHLBI as requested, including de-identified data sets according to the NHLBI policy for distribution of data from NHLBI studies. 12. Distribute analytic data sets to qualified researchers with approved JHS paper proposals as described in the JHS Publications and Presentation Guidelines and data sharing policies. 13. Facilitate access to study resources and expertise in order to engage researchers beyond the JHS in collaborative analysis of existing data and provide training opportunities for early career investigators, as appropriate. Provide scientific guidance to researchers on use of JHS data, including information about the design, collected and derived variables, appropriate analytic approaches, and research gaps. 14. Participate actively in data analysis, presentation, and publication of important findings related to JHS study objectives; and prepare at least five paper proposals and five manuscripts each year for submission for publication to peer-reviewed scientific journals. 15. Support the OMB (Office of Management and Budget) Forms Clearance Process for the modified study protocol and to extend the OMB approval period beyond the scheduled expiration date. 16. Coordinate, arrange, participate in, and provide any information necessary for regular study meetings and conference calls for the Steering Committee, subcommittees, and the JHS Observational Study Monitoring Board, as well as other necessary study meetings and calls. This can include scheduling, preparing agendas, handling physical arrangements, distributing handouts and reports for meetings, and preparing and distributing minutes within ten days of the conclusion of the meeting. 17. Maintain and update as needed a public website and an internal website with downloadable files including study manuals, protocols, publications lists, manuscript proposals, and JHS personnel directory, to permit JHS investigators and investigators outside the JHS, following appropriate procedures, to participate in data analysis and publication and to propose ancillary studies. 18. Participate in and provide leadership for the Quality Assurance and Statistics Subcommittee. Participate in the JHS Steering Committee and other subcommittees as deemed appropriate by the Steering Committee and the NHLBI, including but not necessarily limited to the Ancillary Studies Subcommittee, Publications and Presentations Subcommittee, and Events Monitoring Subcommittee. 19. Work cooperatively with staff at the JHS Training and Education Center(s) as well as the other JHS Centers to provide hands-on field training, observation of, or practicum experiences for undergraduate and/or graduate students and to support cohort retention and outreach activities in the Jackson-area community. Small business firms having demonstrated experience in performing tasks as articulated above are invited to submit capability statements. Capability statements must provide evidence of ability to perform and experience in performing the tasks described above and will be reviewed based on the following: 1. professional qualifications of scientific and technical personnel in accordance with the above requirements; 2. demonstrated capacity of individuals and the institutional support to perform the functions of a Coordinating Center for a multi-center collaborative epidemiology study, including operational and scientific coordination, and information processing; 3. evidence of leadership in first-authoring and publishing scientific papers in a collaborative epidemiology study; and 4. the small business status of the firm under NAICS Code 541712. Capability statements submitted in response to this notice that do not provide sufficient information for review will not be considered. This is NOT a Request for Proposals (RFP), and responses should NOT include budgetary information. The Government intends to negotiate one contract for the period of five years with an approximate award date of June 01, 2013. Firms responding to this notice shall provide capability statements (original and three copies) no later than 04:00 pm EST on the fifteenth (15th) calendar day from the date of this announcement to the address shown above. Your submission shall include the name and telephone number of a point of contact. Please reference this notice number. Electronic copies of capability statements will be accepted and shall be sent to William Etti, Contract Specialist (email address: ettiw2@mail.nih.gov and Cheryl Jennings, Contracting Officer (email address: cj19f@nih.gov ).
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