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a. Federal Wide Assurances issued from Health and Human Services
b. Human research Conflicts of Interest
c. Individual Investigator Agreements
d. Institutional Review Board (IRB) Review Agreements
Tasks:
BASE SUPPORT:
DESC: (HP 640/650 G3 Probook Nomen: HP 640/650 G3 Probook Model #: ProBook G3 Qty:
1 Unit Acq cost: $901.00 each)
GENERAL INFORMATION:
Work will be accomplished as telework beginning 30 May 2025.
4=Work schedule is normally 7:30 a.m. to 4:30 p.m., Monday through Friday, however, there may be times when it is necessary for the contractor to work after duty hours or weekends in support of specific taskings. There may be times where the hours may be flexible depending on fluctuating workload volume. Although schedule may be flexible, it will not exceed 40 hours per week.
U.S. Citizenship:
Employee must be a U.S. citizen. For the purpose of base and network access, possession of a permanent resident card (“Green Card”) does not equate to U.S. citizenship.
TRAVEL:
No travel is anticipated for this effort.
SECURITY:
Position of Trust. All contractor personnel require a minimum of a Tier 1 background check (T1)/SF85 for any position that requires access to the internet, use of automated information systems to cover standalone computers or unescorted entry into restricted or controlled areas prior to reporting for duty in support of any requirement. The investigation is not for a security clearance; it is for a position of trust. This is a mandatory requirement set forth in DoDM 5200.02_AFMAN 16-1405, Air Force Personnel Security Program.
The contractor shall provide OPSEC protection for all sensitive/critical information and indicators involved in execution of this contract/Task Order, as defined by AFI 10-701 (Operations Security). 711 HPW Critical Information and Indicators are protected under the 711 HPW Operations Security Program and the 711 HPW Critical Information and Indicators List (CIIL). Contractor employees granted access to critical information and indicators shall be provided initial OPSEC training by the 711 HPW OPSEC Coordinator upon in-processing and prior to being granted access to CIIL items related to the contract/Task Order. The contractor shall also participate in 711 HPW’s annual OPSEC training and education programs, which includes periodic updates and refresher training on CIIL items applicable to the contract/Task Order. The 711 HPW OPSEC coordinator shall evaluate the OPSEC posture of AF contract activities and operations.
DELIVERABLE:
Contractor Progress, Status and Management Report (PSMR).
On a monthly basis, the contractor shall provide a status report. The information will be on project status and describe the work accomplished. The contractor shall also identify any issues/problems anticipated in schedule or cost ceiling during the next reporting period.
The report shall have five sections:
Technical Report – Study/Services:
Point of Contact for Immediate Consideration:
Art Mata
amata@reef-sys.com
Remote Institutional Review Board (IRB) Analyst (25-19 HPW IR Board Analyst)
Anywhere, U.S.A. · Government/MilitaryRemote Institutional Review Board (IRB) Analyst (25-19 HPW IR Board Analyst)
Introduction:
The United States Air Force Small Business Innovation Research (SBIR) program is headquartered in Dayton, Ohio, and is part of the Air Force Research Laboratory (AFRL) RG Technical Directorate. The SBIR program solicits domestic small businesses to engage in Federal research and development with the possibility of commercialization. The 711 HPW/IR ensures implementation of the AFRL Human Research Protection Program (HRPP) across the AFRL enterprise, to include for the AFRL RG SBIR program. The AFRL SBIR program has recently established a significantly new HRPP business model, wherein 711 HPW/IR also implements the Institutional Review Board (IRB) for the AFRL SBIR enterprise and its collaborators. The unique AFRL SBIR HRPP IRB model is aimed at accelerating advancements specific to emerging and novel biotechnologies.
Description of Services:
The contractor shall meet all requirements per the basic contract and provide professionally and technically qualified individual to perform all tasks in the following paragraphs to fulfill the requirements of this task order.
Mandatory Qualifications:
Introduction:
The United States Air Force Small Business Innovation Research (SBIR) program is headquartered in Dayton, Ohio, and is part of the Air Force Research Laboratory (AFRL) RG Technical Directorate. The SBIR program solicits domestic small businesses to engage in Federal research and development with the possibility of commercialization. The 711 HPW/IR ensures implementation of the AFRL Human Research Protection Program (HRPP) across the AFRL enterprise, to include for the AFRL RG SBIR program. The AFRL SBIR program has recently established a significantly new HRPP business model, wherein 711 HPW/IR also implements the Institutional Review Board (IRB) for the AFRL SBIR enterprise and its collaborators. The unique AFRL SBIR HRPP IRB model is aimed at accelerating advancements specific to emerging and novel biotechnologies.
Description of Services:
The contractor shall meet all requirements per the basic contract and provide professionally and technically qualified individual to perform all tasks in the following paragraphs to fulfill the requirements of this task order.
Mandatory Qualifications:
- Contractor shall have experience working directly, within a Human Research Protections Program (HRPP) office, ideally within the Department of Defense (DoD), as an IRB analyst. Such experience must have included not only the technical review and human research protections compliance administrative processing of research proposals, but also the technical administration of an IRB.
- Contractor shall have at least two current years (within the past 5 years) of direct experience as an Institutional Review Board (IRB) analyst, to include pre-review and preparation of research for IRB approval as well as experience in the administration of an IRB. Specialized administration experience shall include independent technical drafting and processing of agendas, committee minutes, and determination letters of the IRB all within the federal regulatory requirements of IRB administration. IRB specialized administration experience will also include knowledge and application of federally mandated IRB procedures, regulatory review pathways, handling of reported adverse events and non-compliance.
- Contractor shall have knowledge of and experience in drafting and ensuring regulatory procedures for:
a. Federal Wide Assurances issued from Health and Human Services
b. Human research Conflicts of Interest
c. Individual Investigator Agreements
d. Institutional Review Board (IRB) Review Agreements
- Contractor shall have 1 year current (with the past 3 years) knowledge and experience in IRB-specific compliance requirements of bio-technology devices, to include the general requirements of Software as a Medical Device and of Abbreviated Experimental Device Exemptions for bio-technology devices.
- Contractor shall have specialized training in, working knowledge of, and experience in creating or assessing scientific practices, research methodology, and statistical research designs.
- Contractor shall be familiar with HRPP and IRB administration including industry-recognized research protocol tracking systems and procedures for technical protocol reviews for administrative compliance, as well as electronic processes for IRBs and multi-site IRB practices.
- Contractor shall have a bachelor’s degree (preferably in a STEM related field) or equivalent and preferably, but not required, meets technical and experience prerequisites to be qualified to test for HRPP professional certification.
- Contractor shall have at least 1 year of current (within the past 3 years) or prior experience in reviewing research proposals for determinations of involvement of human subjects’ research, or technical qualifications (through training, experience, or certification) to conduct such reviews, or specialized research program or administrative experience that would enable contractor to become capable of conducting such reviews.
- Contractor shall have prior experience in independently coordinating and drafting correspondence related to human research protection official (HRPO) review and approval notices and other such technical correspondence for research protections officials, or other such specialized research or program management administrative experience that would enable contractor to learn and apply research protections specific requirements within one month.
- Contractor shall have prior experience in the development, planning, hosting and delivering HRPP and IRB specific training and education materials, including but not limited to web-site materials, workshops, training presentations, and quality assurance visits and discussions related to HRPP general requirements, and specifically IRB administration, IRB requirements, multi-site research compliance designs, Conflicts of Interest, FWAs, and IRB review agreements.
- Contractor shall have knowledge, skill, training, experience and ability to be highly proficient in the use of desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based/web-based research protocol management systems.
Tasks:
- Contractor shall provide human subjects use research protections scientific, technical review and administrative processing of research proposals, contracts and other agreements with sufficient expertise that would enable the contractor to independently provide critical guidance to program managers, contracting officers, researchers, and human research protections officials regarding human subjects research administration, processing, standards and regulations in general, as well as specific to the bio-technology domain. IR supports the AFRL SBIR/STTR program (AFWERX) and routinely reviews SBIR/STTR proprietary material.
- Contractor shall conduct independently all aspects of IRB process and regulatory requirements, including technical and scientific IRB analytical requirements, IRB processing requirements, and IRB technical regulatory administration requirements. Shall create and manage IRB planning, agenda, committee minutes, records management, adverse event reporting, and compliance reporting in accordance with a myriad of regulations pertaining to IRB.
- Contractor shall work within the 711 HPW/IR office and shall analyze/evaluate contract proposals, statements of work, Conflicts of Interest, FWAs, IRB review agreements, multi-site study plans, and/or research proposals seeking Department of Defense funding/awards and coordinate/assist such efforts with investigators, IRBs, AF Human Research Protection Official (HRPO) in the 711 HPW/IR office and its oversight organization at the Air Force Medical Readiness Agency (AFMRA) SGE-C, program managers, technical points of contact (TPOC), and Contracting Officers (CO) to guarantee efficient and timely human research protections compliance processing.
- Tasks shall align to ensure that prior education, training and/or experience enables the Contractor to be skillfully knowledgeable with federal and commercial IRB administrative, scientific and technical requirements, and unique aspects of biotechnology in human centric research. Tasks shall be of a specialized variety and Contractor shall independently apply knowledge of and discharge timely analysis of human subject research related to a wide range of regulatory requirements including but not limited to: 10 USC 980; HHS 45 CFR 46; DoD 32 CFR 219; DoDI 3216.02_AFI 40-402; DODI 3216.01, AFRLI 40-402, 21 CFR, 15 U.S.C 2051-2089.
- Tasks require high degrees of proficiency in English writing and oral communication. These capabilities, obtained through higher educational academics or experience, shall enable the Contractor to independently draft e-mail and official correspondence as needed to facilitate the administrative and regulatory lifespan of human subject research programs and studies pursuant to HRPP and IRB federal requirements.
- Contractor shall be qualified to develop, plan, host and deliver HRPP and IRB specific training and education materials in various venues: web-site materials, workshops, training presentations, and quality assurance visits and discussions related to IRB processes and requirements, as well as human research protections official administrative processing.
- Contractor shall use prior knowledge, skill, training, experience to independently use a desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based/web-based research protocol management systems. The Contractor shall perform tasks within an electronic web-based system and will train customers on the use of such a system. Contractor shall utilize electronic, and web-bases systems to administer an IRB and IRB actions.
- Contractor shall develop and maintain 711 HPW/IR human research protections compliance data bases and web-based systems, including those pertaining to IRB, for administrative management of tracking and documenting human research protections training, research proposal reviews, and human research HRPO approval coordination and IRB actions.
BASE SUPPORT:
- The contractor shall be provided office/laboratory space, furniture and equipment, routine office/laboratory supplies, computer hardware and software necessary to perform tasks described in this performance work statement. The government will also provide telephone service and access to a fax machine and a copier as required. All software and hardware, passwords/access to military Internet/E-mail and applicable database will be available within the scope of the contract. The contractor shall comply with local, AF and DoD policies.
- Per the approval of the Contracting Officer or COR, government laptops may be provided. The government will provide a government laptop to facilitate needed access to the Virtual Private Network (VPN), .mil access, and shared file access. All software and hardware, passwords/access to military Internet/E-mail and applicable database will be available within the scope of the contract. Data analyses software as necessary to perform tasks described in this performance work statement, for example, accessing and storing data on AF network drives and communication via AF government email. The contractor shall comply with local, and DoD policies concerning information technology applications and connectivity to military systems, when using their government issued computer laptops.
DESC: (HP 640/650 G3 Probook Nomen: HP 640/650 G3 Probook Model #: ProBook G3 Qty:
1 Unit Acq cost: $901.00 each)
- The contractors will need Air Force network accounts to use the computers and will be subject to the requirements for a normal computer account to include IA training that is current within the previous 12 months, a favorable NACI background investigation, and a signed AF 4394 (AF Network User Agreement). Non-compliance with IA policies and principles can result in computer access being suspended or withdrawn.
- Any Controlled Unclassified Information on the computer must be encrypted at all times except during use; Encryption Wizard is provided on every computer. All Classified Uncontrolled Information (CUI), Personally Identifiable Information (PII), and HIPAA data MUST be sent encrypted; Outlook has digital encryption capabilities for this.
- Computers may not connect to the contractor network or other systems, networks, or equipment. Computers may only be used by the personnel that have Air Force accounts on this contract; allowing anyone else to use the systems is considered "inappropriate use" and will result in loss of access.
- Each user is required to connect the laptops to the Air Force network for a minimum of two days per week, for a minimum of 4 hours per day for updates and patches. The screen needs to be locked and device secured to prevent theft or unauthorized access, as applicable.
- All maintenance and adjustments with the computers must be done by AFRL IT departments; no contractor modifications or changes are authorized. NOTE: the computers need to be brought to the help desk for repair. Off-site support cannot be provided.
- In the event of a network tasking order mandating compliance, e.g. validating users face-to-face, the user needs to report to the help desk upon request. If the computers becomes overdue with patches/updates or needs to be updated, user is required to report to help desk.
- Nothing (flash drives, hard drives, and printers) may be connected to computers without AFRL IT approval. Policy questions should be directed to the IAO.
- The Contractor shall assume responsibility for all Government Furnished Equipment/Property in their possession. Government-issued badges, identification cards, passes, and vehicle registration media are accountable forms and, as such, are U.S. Government property to be accounted for, protected, and returned to the Government. This responsibility shall extend to any subcontractors.
GENERAL INFORMATION:
Work will be accomplished as telework beginning 30 May 2025.
4=Work schedule is normally 7:30 a.m. to 4:30 p.m., Monday through Friday, however, there may be times when it is necessary for the contractor to work after duty hours or weekends in support of specific taskings. There may be times where the hours may be flexible depending on fluctuating workload volume. Although schedule may be flexible, it will not exceed 40 hours per week.
U.S. Citizenship:
Employee must be a U.S. citizen. For the purpose of base and network access, possession of a permanent resident card (“Green Card”) does not equate to U.S. citizenship.
TRAVEL:
No travel is anticipated for this effort.
SECURITY:
Position of Trust. All contractor personnel require a minimum of a Tier 1 background check (T1)/SF85 for any position that requires access to the internet, use of automated information systems to cover standalone computers or unescorted entry into restricted or controlled areas prior to reporting for duty in support of any requirement. The investigation is not for a security clearance; it is for a position of trust. This is a mandatory requirement set forth in DoDM 5200.02_AFMAN 16-1405, Air Force Personnel Security Program.
The contractor shall provide OPSEC protection for all sensitive/critical information and indicators involved in execution of this contract/Task Order, as defined by AFI 10-701 (Operations Security). 711 HPW Critical Information and Indicators are protected under the 711 HPW Operations Security Program and the 711 HPW Critical Information and Indicators List (CIIL). Contractor employees granted access to critical information and indicators shall be provided initial OPSEC training by the 711 HPW OPSEC Coordinator upon in-processing and prior to being granted access to CIIL items related to the contract/Task Order. The contractor shall also participate in 711 HPW’s annual OPSEC training and education programs, which includes periodic updates and refresher training on CIIL items applicable to the contract/Task Order. The 711 HPW OPSEC coordinator shall evaluate the OPSEC posture of AF contract activities and operations.
DELIVERABLE:
Contractor Progress, Status and Management Report (PSMR).
On a monthly basis, the contractor shall provide a status report. The information will be on project status and describe the work accomplished. The contractor shall also identify any issues/problems anticipated in schedule or cost ceiling during the next reporting period.
The report shall have five sections:
- Project Title, Time Period of report, Date
- Performance: Current status of deliverables, measured against project expectations.
- Schedule: Have scheduled activities and milestones been completed on or before time, and impact of delays.
- Costs: Are there any actual or significant deviations, are significant costs adequately explained in terms of project plans? (i.e., large initial equipment purchase, followed by labor related costs.)
- Risk: Are there known or anticipated opportunities or events that will or can affect project.
Technical Report – Study/Services:
- All reports and data shall be submitted in a non-proprietary, easily transferrable format.
- All reports, data, findings and literature shall be property of the 711 HPW/RH. The contractor shall not reuse or distribute project information without the express permission of 711 HPW/RH and shall retain all 711 HPW/RH origin markings.
Point of Contact for Immediate Consideration:
Art Mata
amata@reef-sys.com