SOURCES SOUGHT
R -- Human Research Protection Program
- Notice Date
- 10/9/2019
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- N00189 NAVSUP Fleet Logistics Center Norfolk Philadelphia Office 700 Robbins Avenue, Building 2B Philadelphia, PA
- ZIP Code
- 00000
- Solicitation Number
- N000182020019
- Response Due
- 10/11/2019
- Archive Date
- 10/26/2019
- Point of Contact
- John Lowney
- E-Mail Address
-
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- Small Business Set-Aside
- N/A
- Description
- Performance Work Statement Human Research Protection Program (DON HRPP) Support Services 1.Purpose: To provide applied research ethics support services for the Department of Navy ™s Human Research Protection Program (DON HRPP) in order to minimize human subject risk in research conducted or supported by the Navy and Marine Corps. 2.Background: The Surgeon General (SG) of the Navy serves as the sole authority for the execution and oversight of the Department of the Navys (DON) Human Research Protection Program (HRPP). The DON HRPP is responsible for ensuring that DON-sponsored and DON-conducted research involving human subjects complies with applicable Federal regulations, Department of Defense (DoD) directives, DON instructions, and policies. The DON HRPP is responsible for oversight of approximately 2,000 human subjects research protocols for studies being conducted in world-wide locations within the DON and in the civilian sector. 3.Scope: The contractor shall provide support services to DON HRPP in applied research ethics and human research protection programs in military, government and civilian settings in order to minimize human risk and to ensure compliance with Federal, DoD, and DON requirements. Tasks include: assessing DON commands, institutions, and extramural collaborators for compliance with applicable Federal regulations, DoD instructions, and DON instructions in regards to Navy and Marine Corps research; continually developing and maintaining DON HRPP guidance documentation of DON HRPP policies and procedures; conducting training on emerging issues and changes to regulatory requirements; and providing administrative, program management and additional support on tasks such as analysis, budget, travel, and information system support. In performing the contract, the contractor will have access to classified (up to secret) information and have access to classified/secret secured spaces. When contactors are working at the Skyline site, the facility will be open from 0600 to 1800 M-F. Contractors providing support on OCONUS travel will be issued a DoN phone to ensure mission coordination and safety. 4. Summary of Requirements 4.1. Review and assess DON commands, institutions, and extramural collaborators for compliance with applicable Federal regulations, DoD instructions, DON instructions, and policies on the protection of human subjects in research, and the level of knowledge of the command/institution HRPP staff and IRB members. 4.1.1. In accordance with the DON HRPP Site Inspection Standard Operating Procedure (SOP), lead, provide subject matter expertise, and support, approximately four Site Inspections per year to evaluate human research protection programs at DoD Medical Treatment Facilities (MTFs) outside the continental United States (OCONUS), Operational Forces, Training Commands, Research and Development (R and D) Laboratories, and System Commands (SYSCOMs), located within the continental United States (CONUS) and OCONUS. Site Inspections will be conducted every four years for all DON Commands and Institutions. OCONUS travel will occur approximately twice per year. Each SI Team generally consist of 1-3 contractor support staff. 4.1.1.1. Compliance Analysts leading a Site Inspection are to complete pre-Site Inspection HRPP documentation, as outlined in the DON HRPP SOPs to be provided to the government four-weeks out from Site Inspection so as to refine final preparations prior to Site Inspection. Government provided checklists and guidance documents will guide the contractor in developing documentation. 4.1.1.2. During Site-Inspections, conduct interviews with key HRPP personnel; review a representative sample of 10 to 25 percent of HRPP documents during on-site record reviews; identify and recommend areas for improvements or required corrective actions; write Site Inspection reports in MS Word with input from the Site Inspection Team. Deliver completed draft to DON HRPP, Director no later than 40 business days from completion of the inspection, in accordance with the DON HRPP Site Inspection SOP. 4.1.2. In accordance with the DON HRPP Assist Visit Standard Operating Procedure (SOP), lead, or participate in, approximately four Assist Visits per year to human research protection programs at DoD OCONUS Medical Treatment Facilities (MTFs), Operational Forces, Training Commands, Research and Development (R and D) Laboratories, and System Commands (SYSCOMs) at CONUS and OCONUS locations. The focus of the Assist Visit is to establish rapport with the command or institution, discuss and become oriented to command/institution ™s HRPP, review and provide suggestions on human research protection matters at the request of the command, and provide training on HRPP matters as identified in 4.3.1 Training and Education. Each AV Team generally consist of 1-3 contractor support staff. 4.1.2.1. Compliance Analysts leading an Assist Visit complete pre-visit preparation documents to be provided to the government two weeks out from Assist Visit so as to refine final preparations prior Assist Visit. Government provided checklists and guidance documents will guide the contractor in process of developing documentation. 4.1.2.2. During Assist Visits, meet key HRPP personnel from the command or institution; work with key HRPP personnel to improve on practices based on findings identified in Headquarters-level review (HQR) or concerns of the command or institution; provide training as outlined in write visit reports in MS Word with input from the Assist Visit Team and deliver completed draft to Director, DON HRPP within 25 business days of completion of the visit, in accordance with the DON HRPP Assist Visit SOP. 4.1.3. In accordance with the DON HRPP Courtesy Visit SOP, lead, provide subject matter expertise, and support, approximately two Courtesy Visits per year to human research protection programs at non-Assured Department of Navy Commands or Institutions, DoD OCONUS MTFs, Operational Forces, Training Commands, Research and Development (R and D) Laboratories, and SYSCOMs at CONUS and OCONUS locations. The focus of the courtesy visit is to establish rapport with the command or institution, assist with the possible development of the command or institution ™s HRPP, to potentially include establishment of an Exemption Determination Official (EDO) at the HRPP. 4.1.3.1. Compliance Analysts leading a Courtesy Visit complete pre-visit preparation documents to be provided to the government two weeks out from Courtesy Visit so as to refine final preparations prior Courtesy Visit. Government provided checklists and guidance documents will guide the contractor in process of developing documentation. 4.1.3.2. During Courtesy Visits, meet key HRPP personnel and provide regulatory guidance to meet the needs of the HRPP; write Trip Report and deliver completed draft to Director, DON HRPP within 10 business days of completion of the visit. 4.1.4. Conduct Headquarters-level review (HQR) of 100% of all IRB Meeting Minutes Submissions (Approximately 160 submissions per year) to monitor DON compliance with Federal, DoD, and DON requirements within 14 business days of posting to DON HRPP system: 4.1.4.1. As part of the HQR, perform administrative review to determine completeness of documentation and key information; and regulatory review to determine compliance with Federal regulations, DoD instructions, and DON instructions. Document HQR using DON HRPP provided guidance checklists. 4.1.4.2. Write a summary of the findings and archive into DON HRPP system. 4.1.4.3. Communicate results of findings to DON commands and institutions after government approval, as appropriate. 4.1.5. Conduct Headquarters-level review (HQR) of 80% of all research protocol submissions (approximately 600 submissions per year) with a risk level of œGreater Than Minimal Risk and 100% of reports of Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) to monitor DON compliance to Federal, DoD, and DON requirements within 14 business days of posting to DON HRPP system (except for UPIRTSOs which must be processed in accordance with the DON HRPP Reportable Events SOP). 4.1.5.1. For UPIRTSO, contractor must notify the Director, DON HRPP, immediately upon receipt of submission before proceeding to the following actions. 4.1.5.2. For all protocol submissions, perform administrative review to determine completeness of documentation and key information; and, (2) Regulatory review to determine compliance with Federal regulations, DoD instructions, and DON instructions. Document HQR using DON HRPP provided guidance checklists. 4.1.5.3. Write a summary of the findings and archive into DON HRPP system. 4.1.5.4. Prepare and send email notification to Director, DON HRPP to communicate results of findings via email to DON Commands, as appropriate. 4.1.6. Conduct Headquarters-level review (HQR) of approximately 20 percent of all research protocol submissions with a risk level of œMinimal Risk and all other protocol submissions (approximately 900 submissions per year) to include Continuing Reviews, Completion Reports, and Amendments to monitor DON compliance to Federal, DoD, and DON requirements. 4.1.6.1. Perform Administrative review to determine completeness of: 1) documentation and key information; and, 2) Regulatory Review to determine compliance with Federal regulations, DoD directives, and DON instructions. Document HQR using DON HRPP standard criteria-based review guides. 4.1.6.2. Write a summary of the findings for each review and archive into DON HRPP system. 4.1.6.3. Communicate results of findings to DON commands and institutions after government approval, as appropriate. 4.1.7. Conduct review (averages fewer than 10 submissions per year) for allegations of non-compliance, research misconduct, or complaints, and provide report and recommendations to Director, DON HRPP. Prepare an electronic report in MS Word for each preliminary review summarizing the incident or complaint, references, and recommendations in accordance with the DON HRPP Reportable Events SOP. 4.1.8. Prepare and conduct quality assurance and quality improvement activities quarterly. Review Assist Visit reports and Site Inspection reports and identify trends of misinterpretations of requirements and gaps in fulfilling the requirements. Provide written report of trends of misinterpretations and gaps; and recommendations on how to decrease misinterpretations and close the gaps. Findings may be presented at yearly conferences (such as the Military Health Systems Research Symposium (MHSRS)) by contractor support staff. 4.2. Provide subject matter expertise and administrative support in the development and maintenance of DON HRPP guidance documentation of DON HRPP policies and procedures in applied research ethics and human research protection. 4.2.1. Recommend in writing guidance about Assurances, collaborations, or agreements; protocol-specific or issue-specific guidance; and, general HRPP guidance for DON Commands and institutions and DON collaborators to the government to maintain DON HRPP in compliance with Federal, DoD, DON requirements. 4.2.2. Prepare new and revised draft DON HRPP policies, guidance, and procedures when revisions of Federal or DoD regulations occur and submit to Director, DON HRPP. 4.2.3. Monitor changes in Federal and DoD policies and recommend in writing updates to DON policies and procedures as a result of these changes. 4.2.4. Provide annual review of all developed DON HRPP policies, guidance checklists, and DON HRPP SOPs and provide to Director, DON HRPP recommendations for updates or changes to such material to ensure compliance with all Federal, DoD, DON requirements and current DON HRPP practices. 4.2.5. Attend annual conferences, including the Public Responsibility in Medicine and Research (PRIM and R) Advancing Ethical Research (AER) and the Military Health Systems Research Symposium (MHSRS) to provide support to DON HRPP and to maintain currency of subject matter expertise; ensure awareness of potential changes in Government and DoD Regulations that guide human subject research protections. 4.3. Continually develop and conduct education and training for DON HRPP internal staff and DON commands, institutions, and extramural performers conducting human subjects research. 4.3.1. Continually develop, implement, coordinate, and maintain an education and training program by developing courses, seminars, and instructional programs, for DON HRPP intramural performers. Government will supply facilities and audio video support. Education and training topics will include DON HRPP Handbook; emergent topics based upon headquarters-level reviews, site inspections, Assist Visits and changes in regulations. The Director, DON HRPP is responsible for approving recommendations for training topics; however contractor should provide topics for consideration. Training will be conducted onsite at the command or institution being visited during Site Inspections, Assist Visits, or via video teleconferences/webinars from DON HRPP home location. There will be six to twelve (30 to 90 minutes) training and education sessions offered annually. Of the six to twelve training and education sessions, up to four may be video teleconferences/webinars. Training sessions will typically be attended by command HRPP personnel of one to twenty people. Teleconferences/webinars may be attended by up to 50 or more personnel. 4.3.2. Continually develop, implement, coordinate, and maintain an education and training program by developing courses, seminars, and instructional programs, for DON HRPP staff employees to maintain DON HRPP staff core skills and competencies; emergent topics based upon headquarters-level reviews, Site Inspections, Assist Visits and changes in regulations. Education and training topics will cover DON HRPP guidance and policy. The Director, DON HRPP is responsible for approving recommendations for training topics; however contractor should provide topics for consideration. Training will be conducted onsite within DON HRPP office spaces. There will be four 30 minute training and education sessions offered annually. Training will be attended by DON HRPP staff members. DON HRPP staff personnel attending will be up to 20 personnel. 4.3.3. Provide an annual assessment of content on a DON-provided web-based training tool (currently CITI). This assessment will provide DON HRPP Training and Education Specialists an evaluation of the curriculums ™ currency and relevancy to current DON HRPP practices and current regulations. Provide customer service to DON personnel and extramural performers in accessing and using the system. Annual assessment due annually on August 31 to Director, DON HRPP. 4.3.4. Prepare and conduct program evaluation. The quality of training will be evaluated by requesting trainees and conference attendees to complete an evaluation form rating the education and training provided. Training feedback data will be provided by contractor to the DON HRPP Training and Education Specialist for evaluation at the completion of each training session. 4.3.5. Develop and conduct Command or Institution specific training needed to close gaps identified in section 4.1.7 in government requested format. 4.3.6. Develop a yearly Training and Education plan and provide final draft of proposed training plan to Director, DON HRPP. 4.3.7. Create a quarterly edition of the Research Protections Update and forward final draft to Director, DON HRPP for final review and approval before dissemination to all DON-Assured Commands and Institutions. 4.4. Provide administrative support to DON HRPP. 4.4.1. Using Microsoft Office products, DON Research Protection Information Technology Management System (RPITMS), or other DON HRPP provided software, track assurances and IRB registration records; review assurance applications; track and respond to requests for information. 4.4.2. Review all Assurance applications (there are 31 assurances currently approved by the Navy Surgeon General) and prepare packages for approval process: 4.4.2.1. Review Assurance applications for completeness of all key information. Work with Institution to correct omissions prior to processing the package. 4.4.2.2. Prepare approval package using BUMED approval process procedures for the Surgeon General ™s signature and approval. 4.4.2.3. Track Assurance packages through approval process. 4.4.2.4. Prepare emails and letter correspondence to Command or Institution with the results of the application, including mailing the approved Assurance to applicant. 4.4.3. Maintain the DON HRPP email account, which includes receipt of approximately 1,600 emails monthly in and out of the. Respond, or appropriately route general inquiries to DON HRPP. Coordinate internal DON HRPP email discussions, and archive emails as needed. 4.4.4. Post 100% of incoming protocol submissions, IRB Minutes, initial reviews, continuing reviews, amendments, UPIRTSOs and Serious Adverse Events, Final Reports, and others into DON HRPP DON HRPP IT management System for tracking and headquarters-level reviews. 4.5. Provide program management, analysis, and information system support: 4.5.1. Maintain DON HRPP Oversight and Monitoring database or other DON HRPP IT management System. Provide support for electronic IRB submission system. Attend committee meetings or teleconferences along with Government representative, as needed. 4.5.2. Maintain DON HRPP budgets for submission to resource sponsors and for use within the office. Track expenditures against those budgets and funding authorizations received by DON HRPP. 4.5.3. Develop annual travel resource projections for government staff members. 4.5.4 Develop annual proposed travel plan to all DoN-Assured Commands or Institutions and provide to Director, DON HRPP for review and approval. 4.5.5. Develop and maintain record retention policy, to include process for annual review of the shared drive. Recommendations to remove, retain, or archive files should be provided to Director, DON HRPP on annual basis for consideration and approval. 4.5.6. Maintain DON HRPP website up to date with most current documentation. 4.5.7.Schedule and maintain weekly update meeting with Director, DON HRPP. 4.5.8. Provide to Director, DON HRPP a monthly report of activities the contractor has performed in relationship to the current contract tasks and deliverables. 5.Deliverables Performance ObjectiveReferencesMethodMeasurement Required Performance Standard Site Inspections Assist Visits4.1.1 4.1.2Written reports using DON HRPP report format in accordance with DON HRPP SOPs. Reports must be complete and have all elements covered.Written report includes summary of finding with actions and recommendations of Site Inspection or Assist Visit Team95% Headquarters level review: 100% of all IRB Minutes, 80%of Greater than Minimum Risk Protocol Submissions, 100% of UPIRTSOs and other non-compliance reports4.1.3 4.1.4 4.1.6HQR reviews and assessments archived in DON HRPP IT management System within 14 days of posting. Report must be complete and have all element covered.Written report includes summary of finding with actions and recommendations of reviewer.90% Headquarters level review: Representative sample of Protocol Submission risk level œMinimum Risk 4.1.5HQR reviews and assessments archived in DON HRPP IT management System. Report must be complete and have all element covered.Written report includes summary of finding with actions and recommendations of reviewer.75% Quality Assurance and Quality Improvement 4.1.7Written report by due dateReport encompasses recommendations75% Recommendations to change DON HRPP Guidance4.2.2 Adoption by DON HRPP Written reports encompasses recommendations for changes75% DON HRPP Internal Training, Staff Training, Extramural Training 4.3.1 4.3.2 4.3.4Evaluation Report within 2 weeks post eventParticipant evaluation of program95% Annual CITI Assessment4.3.3Written report of assessment by due dateReport encompasses recommendations95% Quality Assurance and Quality Improvement Training 4.3.5Training in government requested formatTraining is based on gaps identified in section 4.1.790% Review, Process and track Assurances 4.4.2 Time to process from receipt to mailing out must be tracked with an average time to complete less than 60 days to completion.Documents must conform to BUMED correspondence requirements95% Monthly Activities Report4.5.6Written ReportWritten report includes summary of activities associated with the tasks, sub-tasks, and deliverables of the contract. 95% 6.0 Medical Contractor Access to Federally Controlled Facilities and/or Unclassified Sensitive Information or Unclassified IT Systems (DEC 2011) This clause applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to Privacy Act information on a DoD computer/network. It is the responsibility of the command/facility where the work is performed to ensure compliance. Each contract health care worker providing services at a Navy command under this contract is required to obtain a Common Access Card. Additionally, depending on the level of computer/network access, that contract health care worker will also require a successful investigation as detailed below. CONTRACTOR ™S SECURITY REPRESENTATIVE The contractor shall designate an employee to serve as the Contractor ™s Security Representative. Within three work days after contract award, the contractor shall provide to the Navy Command ™s Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the Contractor ™s Security Representative. The Contractor ™s Security Representative shall be the primary point of contact on any security matter. The Contractor ™s Security Representative shall not be replaced or removed without prior notice to the Contracting Officer. ACCESS TO FEDERAL FACILITIES Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement Federal security standards for Federal employees and contractors. The Deputy Secretary of Defense Directive-Type Memorandum (DTM) 08-006 “ œDoD Implementation of Homeland Security Presidential Directive “ 12 (HSPD-12) dated November 26, 2008 (or its subsequent DoD instruction) and Navy implementing memorandum dated May 28, 2010 direct implementation of HSPD-12. This clause is in accordance with HSPD-12 and its implementing directives. Per HSPD-12 and implementing guidance, all contract health care workers working at a federally controlled base, facility or activity under this clause will require a Common Access Card. ACCESS TO DOD SYSTEMS In accordance with SECNAV M-5510.30, contractors who require access to DoD networks are categorized as IT-I, IT-II, or IT-III. This clause applies to contractors who require IT-II privileged access to a DoN or DoD unclassified computer/network; the IT-II level, defined in detail in SECNAV M-5510.30, includes positions which require access to information protected under the Privacy Act, to include Protected Health Information (PHI). All contract health care worker positions under this contract require access to Privacy Act protected information and are therefore categorized as no lower than IT-II. PROCEDURES To obtain a favorable determination, each contractor employee must have a favorably completed an interim Secret Clearance to be able to work on this contract. Failure to provide the required documentation at least 30 days prior to the individual ™s start date shall result in delaying the individual ™s start date. To maintain continuing authorization for an employee to access Privacy Act information on a DoD unclassified computer/network, the contractor shall ensure that the individual employee has a current requisite background investigation. The Contractor ™s Security Representative shall be responsible for initiating reinvestigations as required and ensuring that background investigations remain current (not older than 10 years) throughout the contract performance period. When access to IT systems is required for performance of the contractor employee ™s duties, such employees shall in-process with the Navy Command ™s Security Manager and Information Assurance Manager upon arrival to the Navy command and shall out-process prior to their departure at the completion of the individual ™s performance under the contract. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The SAAR-N shall be forwarded to the Navy Command ™s Security Manager at least 30 days prior to the individual ™s start date. Failure to provide the required documentation at least 30 days prior to the individual ™s start date shall result in delaying the individual ™s start date. When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. The Contractor ™s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required. The Contractor ™s Security Representative shall ensure that each individual employee pending assignment shall accurately complete the required forms for submission to the Navy Command Security Manager. The Contractor ™s Security Representative shall screen the investigative questionnaires for completeness and accuracy and for potential suitability/security issues prior to submitting the request to the Navy Command ™s Security Manager. Forms and fingerprint cards may be obtained from the Navy Command ™s Security Manager. These required items, shall be forwarded to the Navy Commands Security Manager for processing at least 30 days prior to the individual employee ™s anticipated date for reporting for duty. The Navy Command ™s Security Manager will review the submitted documentation for completeness and accuracy prior to submitting it to the Office of Personnel Management (OPM). Suitability/security issues identified by the Navy may render the contract employee ineligible for the assignment. An unfavorable determination made by the Navy is final (subject to SF 86 appeal procedures) and such a determination does not relieve the contractor from meeting any contractual obligation under the contract. If contractor employees already possess a current favorably adjudicated investigation, the Navy Command ™s Security Manager will use the Visit Authorization Request (VAR) via the Joint Personnel Adjudication System (JPAS). The contractor shall include the IT Position Category per SECNAV M-5510.30 for each employee designated on a VAR. The VAR requires annual renewal for the duration of the employee ™s performance under the contract. The Navy Command ™s Security Manager will forward the required forms to OPM for processing. Adjudication Facility (CAF) for a eligibility determination. DENIAL OF ACCESS The potential consequences of any requirements under this clause including denial of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have physical access to a federally controlled facility and/or access to a federally-controlled information system/network and/or access to government information. INTERIM ACCESS The Navy Commands Security Manager may authorize issuance of a CAC card and interim access to a DoN or DoD unclassified computer/network upon a favorable review of the SF-86 questionnaire and advance fingerprint results. When the results of the investigation are received and a favorable determination is not made, contractor employees working on the contract under interim access shall be removed immediately and will no longer be authorized to work on the contract.
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