SPECIAL NOTICE
R -- Institutional Review Board Review and Medical Support
- Notice Date
- 3/12/2012
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Agriculture, Agricultural Research Service, Acquisition and Property Division, Acqusition Branch (DC), 1280 Maryland Avenue, SW, Suite 580C, Washington, District of Columbia, 20024-2142
- ZIP Code
- 20024-2142
- Solicitation Number
- 572549SJ
- Archive Date
- 4/5/2012
- Point of Contact
- Sheronda Jones, Phone: 301-504-1089, Brandon Levin, Phone: 301-504-1732
- E-Mail Address
-
sheronda.jones@ars.usda.gov, brandon.levin@ars.usda.gov
(sheronda.jones@ars.usda.gov, brandon.levin@ars.usda.gov)
- Small Business Set-Aside
- N/A
- Description
- The USDA Agricultural Research Service intends to make an award, on a sole-source basis, to MedStar Health Research Institute for review of human research through an Institutional Review Board (IRB) and medical services to support human nutrition research, during a six and a half month period of performance. MedStar Health Research Institute is the only vendor that can provide continued protocol review and provide the necessary on-site medical staff with appropriate training who is also permitted to review confidential health records. THIS NOTICE OF INTENT IS NOT A REQUEST FOR PROPOSALS. This notice is for informational purposes only and is not to be construed as a commitment by the Government. Potential sources who believe they can provide the services listed above are invited to submit substantiating documentation in writing to the identified point of contact. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Oral communications are not acceptable in response to this notice. A determination by the Government to compete this proposed contract based on responses to this notice is solely at the discretion of the Government. REQUIREMENTS The Contractor shall provide the following: - IRB review of research protocols to include initial reviews of protocols, amendments, continuing reviews, closure of protocols. - Review through a regular schedule and provide access to out-of-cycle emergency review. - The IRB must be registered with the appropriate federal agency, comply with 21 CFR part 56, have a Federalwide Assurance (FWA) in order to demonstrate that it commits to comply with the requirements in the US Department of Health and Human Services Protection of Human Subjects regulations at 45 CFR part 46. - staff with appropriate certification or licensure as required in the State of Maryland, to support the conduct of studies with human subjects included but not limited to screening and monitoring the health status of study volunteers, and assume liability for work performed during evaluation and screening of potential subjects, and during sample collection processes when conducted by the Contractor's personnel. - Medical support necessary for performing procedures outlined in research protocols approved by the IRB including for example but not limited to measures of glucose metabolism, collection of biopsy material, and other medical procedures. The estimated award date is March 21, 2012. Point of Contact: Sheronda.Jones@ars.usda.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USDA/ARS/PPBDC/572549SJ/listing.html)
- Record
- SN02694207-W 20120314/120312234507-80f02ce3c67f141934789c4997417956 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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