Sources Sought Notice – A– Integrity & Compliance Institutional Review Board Services

Notice Type: Sources Sought Notice

Posted Date: 14-JAN-17

Office Address: Department of Veterans Affairs;Network Contracting Office 8 (NCO 8);8875 Hidden River Pkwy Suite 525;Tampa FL 33637

Subject: A-- Integrity & Compliance Institutional Review Board Services

Classification Code: A - Research & Development

Solicitation Number: VA24817N0230

Contact: Cyrouse Himid Houshyanicyrouse.houshyani@va.gov 813-631-2816 mailto:cyrouse.houshyani@va.gov [Agency]

Setaside: N/AN/A

Place of Performance (address): Department of Veterans Affairs;Network Contracting Office 8 (NCO 8);8875 Hidden River Pkwy Suite 525;Tampa FL

Place of Performance (zipcode): 33637

Place of Performance Country: US

Description: Department of Veterans Affairs

Tampa VAMC

James A. Haley Department of Veterans Affairs Medical Center

Special Notice Request for Information Only.The Department of Veterans Affairs, VISN 08, James A. Haley Veterans Hospital (JAHVAH) is looking for certified, Service Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) and/or Small business sources for the following:

The Services provided by the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC) and Institutional Animal Care and Use Committee (IACUC) of human, animal and biohazardous material research.

Please see the attached Performance Work Statement (PWS). This is not a request for competitive quotes; however, any firm that believes it can meet these requirements, please provide written notification to the Contracting Officer within five (5) days from the date of the publication of this notice. SDVOSB or VOSB must be certified and verified in the U.S. Department of Veteran Affairs, Office of Small & Disadvantaged Business Utilization, Vendor Information Pages web site located at https://www.vip.vetbiz.gov/. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government.

Only responses from authorized representatives of the firm will be considered. Adequate knowledge, skills, and abilities in processing research protocols such as informed consent process, investigation of non-compliance activities, use of laws including Code of Federal Regulations, Title 38 PART 16 Protection of Human Subjects (--16.101 - 16.124) and PART 17 - MEDICAL (---- 17.30 - 17.1008), compliance with Veterans Health Administration (VHA) handbooks 1058.03 Assurance of Protection for Human Subjects in Research and in Veterans Health Administration (VHA) Handbook 1058.01 in the field of maintaining accreditation will be considered.

Responses are due by 1/19/2017 2:30 PM, Eastern Standard Time (EST). The North America Industry Classification System (NAICS) Code is 611310 & 541720. Business Size Standard is 27.5 5 millions of dollars for 611320 and 20.5 millions of dollars for 541720. Contracting Office Address: Department of Veterans Affairs NCO 08 Acquisitions 8875 Hidden River Parkway, Tampa Florida 33612.

Point of contact(s): Cyrouse Houshyani 813-631-2816. Cyrouse.houshyani@va..gov.

Contract Title: Institutional Review Board (IRB), Institutional Biosafety Committee (IBC) and Institutional Animal Care and Use Committee (IACUC) of human, animal and biohazardous material research

The IRB, IBC and IACUC committee is required by Federal Law and will comply with the Terms of the Federal wide Assurance for Institutions within the United States. The service must be carried out by basic ethical principles guiding research involving human subjects that are provided in the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report.

Anticipate that at a minimum of 48 on-going studies, 28 new IRB studies, 151 final IRB reviews, and 220 IRB amendments. These numbers are approximately and it is highly likely that there will be more in each category. The contract with cost efficient vendor to optimized funding. The quality of the essay must be confirmed with the Veteran Affairs (VA) Rehabilitation, Research and Development Department.

Scope: The effort shall be performed locally with JAHVAH only.

Specific Tasks: The services provided by the IRB, IBC and IACUC of human, animal and biohazardous material research conducted at JAHVAH, include, but are not limited to the following:

The review committees will provide full, expedited and exempt review of initial and continuing applications as well as modifications to human, animal and biohazardous research proposals for research that will be or are conducted at JAHVAH.

The services associated with the complete review, processing and monitoring of research protocols, include, but not limited to, continuing review, amendment review, adverse event review, monitoring of the conduct of research including the informed consent process if applicable, and any investigation of non-compliance activities, as required by the law and this PWS.

Data will be provided in a paper form from VA committee member in a committee meeting.

Initial and continuing review (or de novo) of research involving human and animal subjects and biological agents. This includes the review of amendments, procedural changes, unanticipated problems and other adverse events;

Ensure compliance with all relevant VHA handbooks for research including the reporting of unanticipated problems and noncompliance to the facility director per the Handbook;

Three of the four IRBs and each of the IACUC and IBC committees are dedicated to the review and oversight of VA regulated research;

Processing of paper Animal Component of Research Protocol (ACORP) applications for animal research (processing of these applications takes approximately five (5) times the effort of electronic applications or 40 hours per application);

Execution of individual Memorandums of Understanding (MOU) for each compliance program according to VA regulations;

Investigation into issues of noncompliance with the approved protocols;

Attendance at VA Research and Development (R&D) Committee meetings (two Research Integrity and Compliance (RI&C) staff attend monthly meetings to address any concerns and provide updates on programmatic issues);

Coordination of VA mandated training for animal research;

Coordination of certification for IACUC approved research staff including WOC appointments;

Coordination of information regarding financial conflicts of interest in research and associated management plans;

Semi-annual review of IACUC program including meetings with Facility Director by the IACUC Chairperson and VA R&D Committee member;

Maintenance of American Association for the Accreditation of Lab Animal Care (AAALAC) accreditation for the animal research program (reaccreditation occurs every three years);

Maintenance of Association for the Accreditation of Human Research Protection (AAHRPP) accreditation for the human subjects research program (reaccreditation occurs every five years);

Attendance at JAHVAH site visits for interviews with Office of Research Oversight (ORO) personnel; and quarterly meetings with JAHVAH and RI&C staff

Performance Monitoring: The contractor's timely performance of requested sequencing will be monitored by the Chief of Rehabilitation Research and Development and or his or her designees.

Position Sensitivity: The position sensitivity has been designated as (low) risk.

Qualifications: The requirements for each of the above committees are as follows:

1. IRB will maintain accreditation as required by VA regulations.

2. IBC will continue to be constituted in accordance with National Institute of Health (NIH)

requirements.

3. IACUC will continue to be constituted in accordance with federal

regulations.

4. When applicable, each of the above committees will abide by VHA

Handbooks.

Responsibilities of the contractor: It is the contractor s responsibility to provide local space where services will be performed.

Conflicts of Interest: Contractor has reviewed applicable Federal, State or local conflict of interest laws to assure that conflict of interest situations do not inadvertently arise during this contract.

Assignment: Neither this contract nor the rights or obligations hereunder shall be assignable or otherwise transferred or subcontracted by the VA or the Contractor without prior written consent of both parties.

Copyright/Patents/Technical Data: Any information, invention or discovery, innovation, suggestion, idea, communication and report (whether patentable or not) (collectively, Invention ) conceived, reduced to practice, made or developed using resources provided by the Department of Veterans Affairs or by the Principal Investigator as a result of conducting the Study, are controlled by Federal law (35 USC sections 102 & 200-212, 37 CFR Part 501 and 38 CFR sections 1.650-1.663).

Publication: Any publication by the contractor must be submitted to the Principal Investigator at least 60 days before publication and contractor agrees to delete any information identified by Principal Investigator as confidential prior to submitting such manuscript and/or abstract for publication. Contractor agrees to credit the Department of Veterans Affairs in any published work and limit such publications to scientific/engineering and/or other professional journals.

Confidentiality: Contractor agrees to abide by all applicable federal laws and regulations pertaining to the privacy of patients and or VA employees, including all Health Insurance Portability and Accountability Act (HIPAA) of 1996/Information Security regulations as they are implemented within the VA, during the period of this contract. The contractor also agrees to abide by the confidentiality requirements of the protocols.

DISCLAIMER This Request for Information (RFI) is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

Link/URL: https://www.fbo.gov/spg/VA/TaVAMC673/TaVAMC673/VA24817N0230/listing.html