Inactive
Notice ID:W81XWH21Q0014
Title: Magnetic Resonance Spectroscopy Research for Electrical Transcutaneous Stimulation for Health and Operational Stress (ETHOS) Solicitation: W81XWH21Q0014 Notice Type: Request for Information (RF...
Title: Magnetic Resonance Spectroscopy Research for Electrical Transcutaneous Stimulation for Health and Operational Stress (ETHOS) Solicitation: W81XWH21Q0014 Notice Type: Request for Information (RFI) Response Date: 14 December 2020 NAICS: 541714 Scope: The Contractor shall assist with research evaluating the effects of TENS by providing all staff, equipment, and supplies to complete the MRS protocol design, data collection and data analysis. Specifically, conducting scans on an FDA-approved 7 Tesla (7T) magnetic resonance scanner equipped with MRS technology. Contractor staff shall provide research design and written materials in support of obtaining an IRB-approved protocol. Contractor staff shall also analyze the data and provide reports that include magnetic resonance images, MRS metabolite spectra, and statistical analyses of metabolite changes between experimental groups over time. Objectives: The objectives are as follows: The contractor shall provide the necessary personnel, equipment, supplies and support, to complete the performance of the work outlined below to perform the MRS imaging and analysis. The following section specifies the Performance Objectives and Performance Elements for the contract. Perform MRS Services. The following tasks shall be performed by the contractor independent of Government supervision, direction, or control: Study Design and Protocol Support. The contractor shall provide support for design of the study and protocol to include regular communications (face-to-face, telephonic, and email), intellectual contributions, and written documentation. Perform study. The contractor shall perform all activities related to the MRS procedures, including: Provide qualified and experienced site staff at adequate levels to MRS studies. Prepare and assist in the preparation of procedures (e.g.: Standard Operating Procedures (SOPs) or Site Specific Procedures (SSPs)) necessary for the conduct of the study. Provide Associate Investigator (AI) support to collaborate with USARIEM on human project study designs during protocol development and project progress once initiated via conference calls, emails, written documentation, and face-to-face meetings, and with analysis of the data collected as part of the study. Obtain approval for conducting human research from the local Institutional Review Board (IRB) and the appropriate Human Research Protection Office (HRPO) of the US Army Medical Research and Development Command. Conduct comprehensive statistically-appropriate analyses of collected data. Complete screening procedures on all (up to 70) volunteers, consisting of a medical history questionnaire, medication use/adverse event assessment, physical exam (including blood pressure, pulse, and electrocardiograph measures), Barriers interview, physical activity assessment questionnaire, cardiovascular disease risk stratification, resting metabolic rate assessment, and venipuncture for a chemistry profile. Provide access to an FDA-approved 7 Tesla (7-T) scanner For up to 70 participants, perform three sets of MRS 7-T scans on two separate sessions for a total of six scans per participant. During each scan, image/analyze brain areas of interest specified by the USARIEM research team. Perform data entry services and data collection, oversight, and software management, and transfer services. Provide Study Coordinator Provide Clinic Supplies for MRS scanning Provide Medical Oversight during MRS scanning. Data Analysis. The Contractor shall analyze all MRS data to include: Provide software required to generate MRS spectra and metabolite ratio maps from select brain regions of interest. Perform statistical analysis of analyzed data in a software package that is compatible with IT systems at USARIEM. This shall be SPSS, SAS, MatLab, Statistica, Microsoft Excel, or other software USARIEM currently possesses a license for. Provide data summaries with publication quality summaries, tables, and figures. Protocol Review Support. The Contractor shall support coordination of scientific and human use review of all study protocols by the Institutional Review Board (IRB) of record and by the Office of Research Protections (ORP) of the USAMRDC, Fort Detrick, MD. Data Management. The Contractor shall provide data management services using secure electronic systems to store participant data. Use of paper systems will be limited and only accepted on a case by case basis, such as a site location with limited access to electricity. Final Study Report. The Contractor shall provide scientific/expert and administrative support for development of the final study report. Research Involving Human Subjects: The Contractor shall oversee the execution of the research to ensure compliance with this section. The Contractor shall comply fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD component policies, 10 USC 980 and, when applicable, FDA policies and regulations. The Contractor shall not commence performance of research involving human subjects that is covered under 32 CFR Part 219 or that meets exemption criteria under 32 CFR 219.101(b), or expend funding on such effort, until and unless the conditions of either the following paragraph (c)(1) or (c)(2) have been met: The Contractor furnishes to the ORP, with a copy to the KO and COR, an assurance of compliance and IRB approval and receives notification from the KO that the ORP has approved the assurance as appropriate for the research under the Statement of Work and also that the ORP has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor may furnish evidence of an existing assurance of compliance for acceptance by the ORP, if an appropriate assurance has been approved in connection with previous research. The Contractor shall notify the KO immediately of any suspensions or terminations of the assurance. The Contractor furnishes to the ORP, with a copy to the KO and COR, a determination that the human research proposed meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the KO that the exemption is determined acceptable. The determination shall include citation of the exemption category under 32 CFR 219.101(b) and a rationale statement. In the event of a disagreement regarding the Contractor’s furnished exemption determination, the ORP retains final judgment on what research activities or classes of research are covered or are exempt under the contract. RFI INSTRUCTIONS: Interested parties are asked to respond to this RFI and submit a capabilities statement that supports the focus of this RFI. Please review the place of performance requirements. Please submit written responses via email in Microsoft Office 2000 or 2007 format. All responses should be complete: in 12-point font; and not to exceed 3 pages total, including graphics, tables, and appendices. No hardcopies shall be accepted. No written solicitation document is available at this time. Telephone requests will not be honored, and no bidders list shall be maintained. No inquiries regarding any potential future acquisition activities shall be entertained. Potential offerors are requested to direct all questions via email to the Point of Contact listed below. Responses are due to the Point of Contact, Ms. Flodean Billings at email: flodean.p.billings.civ@mail.mil no later than 10:00AM ET, Monday, December 14, 2020. CAUTION: This is an active requirement. Contractors are strictly prohibited from discussing this requirement with any member of the program office. All discussion shall be with the point of contact listed above. DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any kinds of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned.
