SOLICITATION NOTICE
R -- NIH Institutional Review Board Minute Taker
- Notice Date
- 3/9/2012
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(HG)-2012-094-DLM
- Archive Date
- 3/29/2012
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute (NHGRI) intends to negotiate and award a renewal purchase order on a noncompetitive sole source basis with Jeffrey Menzer, 120 E Street, SE, Washington, DC 20003-2613 to continue providing the National Human Genome Research Institute, Office of the Clinical Director, Bioethics Core professional services of taking minutes for the Institutional Review Board (IRB) Research Program. The sole source determination is based on the fact that National Institute of Health (NIH) is the nation's largest medical research agency and the primary Federal agency conducting, supporting and making medical discoveries that improve people's health and save lives. The National Human Genome Research Institute (NHGRI), IRB is required by federal regulations to prepare and maintain adequate documentation of activities. The NHGRI Institutional Review Board (IRB) reviews research conducted in the NHGRI Intramural Research Program. The IRB's mission is to protect the rights and welfare of individual subjects and to ensure programmatic compliance with Federal, State and Institutional regulations. The IRB carries out its mission by reviewing, approving and monitoring all human subjects' research within our Institutes' Intramural Research Programs. The NHGRI IRB was established and functions in accord with the NIH Federal-wide Assurance, FWA00005897 [ohsr.od.nih.gov]. It is guided by the NIH OHSR IRB standard operating procedures [ohsr.od.nih.gov]. In addition to extensive protocol-related documentation, this is achieved via "minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution." (45 CFR 46.115(a)(2)) The NIH Office for Human Subjects Research (OHSR) provides additional guidance and specificity regarding the requirements for sufficient IRB minutes. IRB minutes are detailed records of the IRB's deliberations and decisions. NHGRI IRB requires someone with specialized skills and extensive knowledge of the regulatory requirements for protecting human research subjects in writing and documenting the minutes. NHGRI is requesting to continue procuring the expert skills and knowledge of minute taking of the IRB Review meetings with Contractor Jeffrey Menzer for this requirement. The Contractor being procured has served ably in the role of NHGRI IRB meeting minute-taker for several years. Additionally, the Contractor has extensive knowledge of clinical research, the regulations and policies for the protection of human research subjects generally, and of the procedures and operations of the NHGRI IRB in particular and freedom of information act. The Contractor understands how the proceedings of the meetings are to be conducted and how the minutes should be transcribed for the final product. Including inclusion of last names of the members listed in the minutes. SCOPE OF WORK : The Contractor will assist the NHGRI IRB by carrying out the following tasks : • Attend monthly IRB meetings; • Take detailed notes of deliberations at each monthly meeting of the NHGRI IRB; • Create a timely, detailed draft of minutes for each monthly meeting that fulfills requirements per 45 CFR 46, the NIH FWA, and the NIH SOPs; • Review IRB minutes from previous years to ensure continuity in our review of protocols from year to year; and • Stay abreast of regulatory developments and guidance via attendance at annual IRB retreat and other continuing education opportunities. • The Contractor will generate detailed drafts of minutes for every NHGRI IRB meeting. These minutes are then reviewed and edited by the Vice Chair and the Chair, and they are distributed for review and approval by the full IRB at its next convened meeting. The minutes must be written according to 45 CFR 46 and various NIH policies. PROGRAM MANAGEMENT AND CONTROLS : • The Contractor shall work under the supervision of the Government (Director), NHGRI Bioethics Core, who will review, inspect and approve all documentation to guarantee that this work is in line with the type of work needed for the NHGRI IRB, and is in line with the scope of work outlined. The proposed period of performance for this requirement is: 12 Month Base with four (4) Option Year Periods, for 12 Months. Base: August 2012 through August 2013 @103 Hours Option 1: August 2013 through August 2014 @103 Hours Option 2: August 2014 through August 2015 @103 Hours Option 3: August 2015 through August 2016 @103 Hours Option 4: August 2016 through August 2017 @103 Hours The estimated level of effort for this requirement is 515 hours for base and four (4) option year periods. Industry Classification (NAICS) Code is 541990, All Other Professional, Scientific and Technical Services with business size standard $7.0M Per Annum. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001) and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-56 (March 2, 2012). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by March 14, 2012, 7:30 a.m. Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurement. Inquires to this announcement, referencing synopsis number NHLBI-CSB-(HG)-2012-094-DLM, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(HG)-2012-094-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02693137-W 20120311/120309235016-6fa8a80749f4eee9981cdad54427a19e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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