SOURCES SOUGHT
A -- Request for Information; Establishment of Clinical Research Units
- Notice Date
- 4/14/2004
- Notice Type
- Sources Sought
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- Reference-Number-RFI-CRU-04-01
- Response Due
- 6/14/2004
- Archive Date
- 6/29/2004
- Point of Contact
- Robert Best, Chief, Contracts Operations Branch, Phone (301) 435-0330, Fax (301) 480-3338,
- E-Mail Address
-
rb45o@nih.gov
- Description
- This synopsis requests information from the public, and in particular from local hospitals, on the information provided below. Responses should be sent to the Contact Point and Contracting Office Address above. The Clinical Research Program (CRP), Division of Intramural Research (DIR), National Heart, Lung, and Blood Institute (NHLBI) intends to establish one or more clinical research units at local hospitals for purposes of recruitment and enrollment of patients into its clinical protocols. The mission of the CRP, DIR is to engage in innovative clinical research in heart, lung, and blood diseases. To this end, principal investigators in the CRP have written and successfully completed many protocols that explore the natural history and pathophysiology and develop novel therapies for the diseases studied. However, the CRP lacks a sufficient patient base to carry out all its protocols. Therefore, the CRP seeks to develop working relationships with local hospitals for the purpose of recruitment and enrollment of patients into protocols. A Clinical Research Unit (CRU) is the means by which NHLBI plans to work with local hospitals. A CRU will have the capability to address protocols encompassing specific heart, lung, and blood diseases that are of interest to the CRP. It is envisioned that multiple CRU?s would be selected to receive basic indefinite delivery/indefinite quantity (IDIQ) contracts. Then, each protocol would be issued to all IDIQ contractors. Contractors would be given the opportunity to propose specifically on that protocol, or task, and typically only one would be selected to carry out the task represented by that protocol. The selection of a contractor to perform a task would be based primarily on a contractor?s technical approach in terms of understanding of the research needs, expertise and experience of proposed staff, availability of a suitable patient population, and facilities available to carry out the protocol. The CRU will initially study the diseases and procedures below, with the understanding that the list may be expanded over time. a. Chronic coronary artery disease b. Cardiac imaging (CT, MRI, Echo, Nuclear cardiology) c. Congestive Heart Failure d. Asthma e. Chronic obstructive pulmonary diseases (COPD) f. Hemochromatosis g. Chronic heart disease as found in cardiac rehabilitation programs. The CRU approach is intended to bring together the scientific and clinical expertise of physician/scientists at NHLBI with practicing cardiologists and their patients at local hospitals. The need is for a patient population that is willing to participate in research protocols that address the above list. CRP?s experience with previously successful protocols is that interaction on protocols between clinicians and patients at local hospitals, and basic scientists working in the laboratory, has greatly improved the applicability and usefulness of the research being done. NHLBI is interested in learning the extent to which local hospitals would be willing to participate in this effort. Is there sufficient interest in competing for the various protocols that will be issued to warrant an open competition? Are the capabilities and commitments in place in local hospitals to make competition on a protocol-by-protocol basis a meaningful way to approach the integration of this research with the clinicians and their patients? Are there modifications to this approach, or other approaches, that the local hospitals would like NHLBI to consider? This approach represents a potentially significant commitment on the part of local hospitals in terms of senior clinicians, nurses, office space and exam rooms, minor alterations and renovations needed to accommodate research protocols, operating expenses, and training of staff in carrying out research protocols. Thus, we want to know whether local hospitals would be able to propose reasonable, competitive costs on a protocol-by-protocol basis? Research protocols will need to be approved by Institutional Review Boards at both the NIH and the local hospital site. Can this be accommodated by local hospitals and are there any other issues of accessibility and patient safety, confidentiality and privacy that need to be considered in any solicitation that does result? Also, since the collection of research data is likely to include potentially sensitive information on patients, and the Privacy Act is likely to apply to the systems of records used for collection of the research data, there probably will be a need for a hospital to address its automated system security approach. Therefore, it is likely that staff who input and access the data collected will need security clearances. Comments on this aspect of performing research on patients, and the impact it might have on the willingness of hospitals to participate, would be useful to NHLBI. This notice is provided as a Request for Information to help NHLBI further refine its plans and to obtain information as indicated above. Any additional comments will be considered as well in developing the solicitation. Interested parties should direct all comments to the Contracting Officer identified above by June 14, 2004.
- Place of Performance
- Address: Washington, D.C. Metropolitan Area
- Country: USA
- Country: USA
- Record
- SN00565547-W 20040416/040414211743 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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