Research IRB

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP
Attachment 2: Request for Sole Source Justification Format >$150K
OFOC SOP Revision 06 Page 4 of 4
Original Date: 03/22/11
Revision 06 Date: 08/30/2017
DEPARTMENT OF VETERANS AFFAIRS
Justification and Approval (J & A)
For
Other Than Full and Open Competition (>$150K)
Acquisition Plan Action ID: 521-18-3-8175-0895
Contracting Activity: Department of Veterans Affairs, VISN 7, Birmingham VA Medical Center
Nature and/or Description of the Action Being Processed: Ethical Oversight of Human Subjects Research. The contractor shall and will provide oversight and review of the BVAMC use of humans and/or data for the VA human Research Protection Program (HRPP).
This will be awarded as a new firm-fixed price contract.
Description of Supplies/Services Required to Meet the Agency s Needs:
This contract will be for a base plus four option years.
To conduct initial reviews of research studies submitted to ensure that all safeguards and requirements for ethical research and protection of vulnerable subjects are met prior to approval.
To conduct continuing reviews of research studies and to determine which projects require continuing review more often than annually
To conduct review of proposed informed consent forms/process involving human subjects and review proposed exemptions to informed consent
To conduct review of modifications and amendments to previously approved research; to ensure that changes in approved research are not initiated without IRB review and approval; and to determine whether projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review
To conduct reviews by the expedited process, when appropriate
To conduct review of study closures
To conduct review of and ensure that unanticipated problems involving risks to subjects, protocol deviations, and adverse effects, whether research related or not, are promptly reported to the IRB
To conduct review of allegations and findings of noncompliance
To conduct review of participant recruitment and outreach materials
To conduct review of safety issues, compliance audits, and quality improvement activities
To determine if an investigational device is of significant risk or can be categorized as a non-significant risk device.
The UAB IRB will review 20-30 documents, at a minimum, monthly by full board review or chair review.
Statutory Authority Permitting Other than Full and Open Competition:
( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy
Agency Requirements per FAR 6.302-1;
( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;
( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability
or Expert Services per FAR 6.302-3;
( ) (4) International Agreement per FAR 6.302-4
(X) (5) Authorized or Required by Statute FAR 6.302-5;
( ) (6) National Security per FAR 6.302-6;
( ) (7) Public Interest per FAR 6.302-7;
FAR13.5 Simplified Procedures for Certain Commercial Items: FAR 13.5
Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):
All VA research that includes human subjects and/or their data must have oversight by an ethical committee called the IRB (Institutional Review Board). This station is currently phasing out our own on site IRB for the oversight and ethical review of human subjects research and must contract this service from another accredited facility in order to support approved and potential research grants.
UAB IRB is the only IRB within a 10 mile radius of our program and the only other facility that reviews research following all of the federal and local regulations regarding human subjects research. An intent to sole source notice (RFI) was posted to FBO (36C24718Q9245) with no response received from vendors that could provide this requirement.
Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:
Market research determines that only one contractor, UAB IRB Program, can provide the necessary and unique experience with the ethical overview and oversight necessary to maintain the ethical approval for human subjects research within the federal and state regulations regarding human subjects research. An intent to sole source notice (RFI) was posted to FBO (36C24718Q9245) with no response received from vendors that could provide this requirement.
Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:
The anticipated cost of $300,000.00 for a base and 4 option years has been determined to be fair and reasonable based on the provided IGCE. The IGCE was provided by the Medical Research department and incorporated the cost of services. After review of the IGCE and the Market Research the prices is determined to be fair and reasonable.
Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:
Market research determines that only one contractor, UAB IRB Program, can provide the necessary and unique experience with the ethical overview and oversight necessary to maintain the ethical approval for human subjects research within the federal and state regulations regarding human subjects research. An intent to sole source notice (RFI) was posted to FBO (36C24718Q9245) with no response received from vendors that could provide this requirement.
Any Other Facts Supporting the Use of Other than Full and Open Competition:
As stated in #5 above, UAB is the only facility within a 10 mile radius that can provide this specific service within the federal and state regulations. Additionally, UAB and the VA have an MOU that spells out the specifics of the human subjects review by the UAB IRB program. Both the VA and UAB have Federal Wide Assurances that include the overview by UAB IRB of human subjects research at the Birmingham VA Medical Center (BVAMC).
This service required approval from Central Office the Office of Research Oversight, and Central Office the office of Research and Development. An intent to sole source notice (RFI) was posted to FBO (36C24718Q9245) with no response received from vendors that could provide this requirement.
Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:
There is no other service or competition that can provide this service to us at this time. An intent to sole source notice (RFI) was posted to FBO (36C24718Q9245) with no response received from vendors that could provide this requirement.
A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:
There is no other service or competition that can provide this service to us at this time. The Birmingham VA will continue to look for additional providers and/or distributors.
Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.
Having a IRB to review and provide oversight for human subjects research is a VA, federal and state requirement.
_____________________________ ________________________
Name Date
Title
Facility
Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:
Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.
_____________________________ ________________________
Date
Contracting Officer
Birmingham AL VA Medical Center
One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.
_____________________________ ________________________
Date
NCO 7 Supervisor
.