SOURCES SOUGHT
R--R -- Overseas Research
- Notice Date
- 4/13/2006
- Notice Type
- Sources Sought
- Contracting Office
- Attn: Department of Veterans Affairs, Acquisition Operations Service, (049A3), 810 Vermont Avenue, N.W., Washington, District Of Columbia 20420
- ZIP Code
- 20420
- Solicitation Number
- 101-14-06
- Response Due
- 5/15/2006
- Archive Date
- 6/14/2006
- Small Business Set-Aside
- N/A
- Description
- The Department of Veterans Affairs Central Office (VACO), Office of Research Oversight (ORO), Washington DC is issuing a sources sought notice regarding a requirement for an indefinite delivery indefinite quantity (IDIQ) service contract to investigate for cause regulatory compliance oversight activities of research programs being conducted outside of the United States. ORO serves as the primary VHA office in advising the Principal Under Secretary for Health (10A) on all matters of compliance and quality assurance regarding human subject protections, animal welfare, research safety, and research misconduct. ORO is seeking the assistance of one or more well qualified commercial enterprises that can be called on to collect information related to research compliance in non-U.S. settings. Assistance may be needed in all of ORO?s mission areas, but it is anticipated that compliance related to human research protections will be the primary area of concern. The Contractor(s) must have expertise in application of pertinent U.S. laws, regulations and standards relating to the protection of human subjects in research, e.g., Common Rule for the Protection of Human Subjects and Food and Drug Administration Regulations, as well as ICH-GCP standards. The Contractor must also be familiar with VA policy regarding protection of human research subjects. The Contractor(s) must also be knowledgeable of the laws and regulations of the country(ies) in which research activities and data collection are carried out. Task orders issued on the IDIQ contract will vary from case to case depending on the nature of alleged or identified noncompliance, and the types of data needed by ORO to understand and address any noncompliance in the VA research. Typically, the contractor might be expected to perform activities, such as the review of: medical files; case history files of individuals participating in research; records of institutional review boards (or similar ethical review bodies) in country; informed consent documents; adverse event reporting documents; recruitment lists; correspondence of principal investigators and U.S. and in-country facilities relating to the research; correspondence relating to in-country and U.S. clearances; correspondence among co-investigators; investigator or laboratory notes; specimen shipping information; logs relating to operation of equipment used in research; documents related to storage, handling or analysis of data, tissues and specimens. Depending on the nature of the compliance case, the contractor may be requested to copy and ship documents directly to ORO, generate summary documents or complete checklists; or ship specimens and samples to locale(s) designated by ORO in accordance with U.S. and local laws and regulations. Interested firms should provide company profile including qualifications statement (e.g., Small Business, Small Disadvantaged Business, Veterans-Owned or Women-Owned Business, or if firms have a GSA Federal Supply Schedule Contract), professional staff both clinical and behavioral sciences, past experience of regulatory research monitoring, for cause investigations, and data collection at overseas locations, references including names and phone numbers of past contract work. The detailed qualification statements from interested sources are to be submitted via email to Mr. Thomas Wagner, Project Manager at Thomas.Wagner@mail.va.gov and Priscilla.lee@mail.va.gov within 30 calendar days (May 15, 2006) from publication of this notice. Please reference RFI number 101-14-06.
- Place of Performance
- Address: Washington, DC
- Zip Code: 20420
- Country: United States
- Zip Code: 20420
- Record
- SN01027410-W 20060415/060413220503 (fbodaily.com)
- Source
-
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