Notice Number: NOT-NS-08-002
Release Date: October 16, 2007
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
The National Institute of Neurological Disorders and Stroke (NINDS) is considering issuing a contract to develop and implement a training program in Spinal Cord Injury (SCI) research methodologies that will emphasize hands-on experience, at a site to be designated as a NINDS “Facility of Research Excellence in Spinal Cord Injury.”
The National Institute of Neurological Disorders and Stroke (NINDS) is the lead NIH Institute for funding of SCI research, and the major supporter of basic science to develop novel therapeutic strategies for this disorder. In the United States, the incidence of SCI is approximately 11,000 per year. Over the past three decades, academic researchers have developed and increasingly utilized standardized techniques designed to model human SCI in the rodent. These include contusion, compression and partial or complete transection, and most have targeted thoracic spinal segments. Several new models have been developed in recent years including mouse SCI and cervical injuries in both rat and mouse. It is a great challenge for researchers new to the field to learn these procedures based solely on the literature. It is difficult to learn to use these standard animal models of SCI with precision and to develop the expertise and facilities to adequately maintain and assess the animals after surgery.
SCI at different levels of the spinal cord result in a range of functional deficits in motor, sensory and autonomic functions. A crucial element in conducting SCI research is to have the ability to evaluate the return of behavior and function in a careful and meaningful manner. Behavioral measures of motor and sensory function have been developed, including the Basso-Beattie-Bresnahan (BBB) open-field locomotor score, and more recently, the Basso Mouse Scale (BMS). These metrics were developed to be sensitive to a range of injury severities, and are now used widely to assess novel therapeutic strategies, in conjunction with anatomical and physiological assessments. New investigators require instruction and practice in the performance and use of these procedures in order to interpret their results accurately and reproducibly. In addition, a number of other functional measures of forelimb and autonomic and sexual functions have been introduced recently, as well as training modalities and robotic devices designed to model rehabilitative therapies and monitor recovery. Several of these measures were developed in previously awarded Facilities of Research Excellence in Spinal Cord Injury (FORE-SCI) facilities and, as yet, have not been used extensively by other laboratories.
A significant number of potential therapeutic approaches to protect and repair the injured spinal cord have been identified, but few of these have reached the stage of clinical trials and none have been successfully translated into clinical practice. Among several key factors limiting successful translation, the quality and reproducibility of the reported results is one that can be directly addressed by training opportunities for investigators and trainees in laboratories undertaking SCI research. Based on a series of workshops, NINDS identified several unmet needs in the field of SCI and issued a Broad Agency Announcement in 2002 to develop contracts for FORE-SCI for training in SCI research methods, replication studies, and development of improved outcome assessments. To date, the FORE-SCI hands-on course has been run at a single site, for three continuous weeks annually, accommodating 16 students per year. A report published in 2005 by the Institute of Medicine emphasized the need for continuing instructional and collaborative opportunities in SCI research, specifically citing the training supported by the NINDS contract. The NINDS now seeks to re-compete this effort by soliciting proposals for a program to teach standard SCI research techniques and to provide opportunities for hands-on experience with these techniques.
GOALS AND OBJECTIVES OF THE CONTRACT:
This solicitation is for development and implementation of a training program in SCI research methodologies that will emphasize hands-on experience, at a site to be designated as a NINDS “Facility of Research Excellence in Spinal Cord Injury.” Its purpose is to provide short-term intensive training for researchers new to SCI research on the best practices in the field, including the standards of current research methodology, analytical procedures and functional outcome evaluations. The FORE-SCI Contractor shall provide resources, capabilities and expertise in SCI research and the ability to work with multiple standard rodent models of injury. The Contractor shall provide facilities and personnel for expert handling, care and medical management of animals with SCI, and FORE-SCI participants will become expert the ethical conduct of experiments in SCI and associated animal care. The site will provide dedicated facilities and expertise for conducting surgery, including microsurgery such as transplants and grafts, and for cellular analyses ranging from neuroanatomy and histology to electrophysiology and other cutting-edge technologies. This FORE-SCI program will provide training for participants, from graduate student to faculty level, to promote consistency of procedures and practices across laboratories.
It is anticipated that this annual training program will yield a well-trained cadre of researchers dedicated to advancing research to relieve the burden of SCI. A successful program will prepare FORE-SCI participants to return to their organizations/institutions with the ability to perform rigorous experimental programs of the highest quality, and to disseminate the techniques they have learned to others in their laboratories.
SPECIFIC PERFORMANCE GOALS OF THIS CONTRACT ARE:
1. To develop the scientific content, curriculum and format of a comprehensive, hands-on training program in SCI research to investigators interested in SCI research, utilizing standard models of SCI in rodents. The training program must:
o Cover topics including, but not limited to, surgical techniques, functional/behavioral outcomes, preparation of samples and analysis of histological endpoints, and physiological measures;
o Afford students sufficient hands-on experience to become proficient in these techniques and expert in methods for proper daily handling and medical maintenance of animals incapacitated by SCI; and
o Provide students with a basic understanding of the nature of human spinal cord injury, and the perspective and needs of individuals that have sustained such injuries.
2. To organize and conduct the training program, including provision of facilities, recruitment and selection of faculty and participants.
3. To conduct formal evaluation of the course on a yearly basis and, where relevant, incorporate results into subsequent course offerings.
This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government’s use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government’s evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked.
All interested organizations are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Veteran-owned Small Business, Service-disabled Veteran-Owned Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization.
Responses should be identified with NINDS RFI NS-08-002 and are due by October 26, 2007. Please submit two copies of your response to:
Laurie A. Leonard
NINDS R&D Contracts Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3287, MSC 9531
Bethesda, Maryland 20892-9531
(for FedEx or courier, use: Rockville, MD 20852)
Phone Number: 301-496-1813
Fax Number: 301-402-4225
E-mail responses, sent to LL44S@nih.gov will also be accepted.
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Office of Extramural
National Institutes of Health (NIH)
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Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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