RFP.AMENDMENT1.W81XWH19R0094.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this RFP Amendment (Amendment 1) is to provide the Government's response to vendor questions as w ell as a amended RFP. In addition, the proposal submission date is changed from NLT 13 September 2019 at 12PM ET to NLT 24 September 2019 at 12PM ET.

See RFP Amendment 1 attachments (Q's and A's, and Amended Supplemental Pricing Sheet).

1. CONTRACT ID CODE PAGE OF PAGES

S 1 81

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 06-Sep-2019

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81XWH19R0094

X 9B. DATED (SEE ITEM 11)

23-Aug-2019

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

06-Sep-2019

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81XWH19R0094

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 13-Sep-2019 12:00 PM to 24-Sep-2019 12:00 PM.

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

BASE PERIOD ON-SITE PROGRAM MANAGER (PM) SUPPORT SERVICES IAW PWS SECTION 2 - 1 FTE (DHPe)

To:

BASE PERIOD ON-SITE PROGRAM MANAGER (PM) / HSPS III SUPPORT SERVICES IAW PWS SECTION 2 - 1 FTE (DHPe)

CLIN 1001

OPTION PERIOD 1 ON-SITE PROGRAM MANAGER (PM) SUPPORT SERVICES IAW PWS SECTION 2 - 1 FTE (DHPe)

OPTION PERIOD 1 ON-SITE PROGRAM MANAGER (PM) / HSPS III SUPPORT SERVICES IAW PWS

SECTION 2 - 1 FTE (DHPe)

CLIN 2001

OPTION PERIOD 2 ON-SITE PROGRAM MANAGER (PM) SUPPORT SERVICES IAW PWS SECTION 2 - 1

OPTION PERIOD 2 ON-SITE PROGRAM MANAGER (PM) / HSPS III SUPPORT SERVICES IAW PWS

CLIN 3001

OPTION PERIOD 3 ON-SITE PROGRAM MANAGER (PM) SUPPORT SERVICES IAW PWS SECTION 2 - 1

OPTION PERIOD 3 ON-SITE PROGRAM MANAGER (PM) / HSPS III SUPPORT SERVICES IAW PWS

CLIN 4001

OPTION PERIOD 4 ON-SITE PROGRAM MANAGER (PM) SUPPORT SERVICES IAW PWS SECTION 2 - 1

OPTION PERIOD 4 ON-SITE PROGRAM MANAGER (PM) / HSPS III SUPPORT SERVICES IAW PWS

CLIN 5001

TRANSITION OUT PERIOD ON-SITE PROGRAM MANAGER (PM) SUPPORT SERVICES (DHPe)

TRANSITION OUT PERIOD ON-SITE PROGRAM MANAGER (PM) / HSPS III SUPPORT SERVICES (DHPe)

The following have been added by reference:

252.219-7004 Small Business Subcontracting Plan (Test Program) MAY 2019

The following have been modified:

PERFORMANCE WORK STATEMENT

Title: Human Subjects Protection (HSP) Personnel Management and Support Services

Requiring Activity Name: Headquarters, US Army Medical Research and Development Command (HQ USAMRDC), Office of Research Protections (ORP), Fort Detrick Maryland

1.0 SCOPE

The Contractor shall provide all personnel, training, materials, supervision, and non-personal services necessary to provide Human Subjects Protection Personnel (HSPS) Management and Support.

1.0.1 Background

Human subjects research funded, conducted, or supported by the USAMRDC is governed by DoD Instruction (DoDI) 3216.02, Army Regulation (AR) 70-25, January 1990; Army Regulation 40-7, January 2009, 32 Code of Federal Regulations (CFR) 219 as effective 21 January 2019; 45 CFR 46 Subparts B, C, and D as effective 21 January 2019; 45 CFR 160; and 45 CFR 164. The USAMRDC also adheres to the Food and Drug Administration (FDA) Regulations 21 CFR 11 (Electronic Records; electronic signatures), 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), 312 (Investigational New Drug Application), 314 (Applications for FDA Approval to Market a New Drug or Antibiotic Drug), 601 (Licensing), 812 (Investigational Device Exemptions), and 814 (Pre-Market Approval of Medical Devices) for research involving investigational drugs or devices. FDA “Guidance for Industry” publications provide additional directions in the research, development, test, and evaluation of regulated products. All research involving cadaver specimens must comply with the Department of Army (DA) policy, “Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education or Training,” 20 April 2012. All research conducted outside of the continental United States (OCONUS) must comply with host nation laws and regulatory requirements.

Within the USAMRDC, the authority to determine and approve that human and cadaver research protocols meet applicable human research protections and cadaver use regulatory requirements is vested in the USAMRDC Office of Research Protections (ORP). The ORP Human Research Protections Office (HRPO) provides the unique DoD-required administrative human subjects protection regulatory reviews and determinations for USAMRDC-supported research conducted by non-DoD organizations and certain categories of DoD-conducted research supported by the USAMRDC. The ORP HRPO provides post-approval compliance oversight of these human research protocols until study completion or conclusion of DoD funding or other support, whichever comes first. The ORP HRPO provides or ensures that the Army-required review and approval for cadaver use is completed for USAMRDC supported research. The ORP HRPO also provides reviews for USAMRDC-supported studies involving cadaver use, and categories of cadaver use conducted or supported by the DA.

The HRPO federal staff consists of a Director, Deputy Director, a Special Projects Human Subjects Protection Scientist (HSPS), and two HSPSs. The federal staff serve as Governmental HRPO Approval Authorities (AA) for review and approval of regulatory actions that are Inherently Governmental. The HRPO also includes a Research Administrative Support Team, three Human Subjects Protection Scientist Reviewer Teams and one contractor Program Manager. Each Team provides review support to the HRPO AAs and is staffed solely by the contractor personnel with functions described in this PWS. Two of the Human Subjects Protection Scientist Reviewer teams shall consist of one HSPS I contractor, three HSPS II contractors, and three HSPS III contractors. The third Human Research Protection Review team consists of one HSPS I contractor, two HSPS II contractors, and four HSPS III contractors. The contractor will designate a Team Leader for each team with functions described in this PWS.

Each team is aligned to USAMRDC managed programs of research and are assigned projects for review in accordance with the research portfolio assigned to the reviewing team.

The ORP Institutional Review Board Office (IRBO) supports the activities of the HQ USAMRDC IRB to provide federally required IRB review, approval, and oversight for human research conducted by customers of the HQ USAMRDC IRB. The IRBO staff consists of a federal Director, Deputy Director, an administrative assistant, and two contract HSPS III contractor personnel with functions described in this PWS.

The contractor will provide an on-site Contract Program Manager (PM). The PM provides daily supervision for contractors and also performs HRPO human research protection review activities.

This contract must have a surge capability in the event the ORP workload in HRPO and/or IRBO increases and additional contract personnel are required to meet mission requirements.

1.0.2 Objectives

Support is requested for the USAMRDC Human Research Protection Program (HRPP), specifically for HQ USAMRDC ORP HRPO and IRBO activities. Research protocols funded, conducted or supported by the USAMRDC must be reviewed for compliance with DoD, federal (to include Department of Health and Human Services, FDA, Environmental Protection Agency), state, host national, and local human subjects protection regulations and human research ethical standards. This contract shall provide HSPS support for the HRPO and the IRBO. This contract shall also provide HSPS Subject Matter Expert and program management support for HRPO and IRBO operations, including workload management and administrative support, operating procedure development, quality assurance, and process improvement initiatives. This contract shall provide HSPS onsite supervision for personnel that support the

HQ USAMRDC ORP.

1.1 Non-Personal Services

This award identifies services that are strictly non-personal in nature.

1.2 Severable / Non-Severable Services

This award identifies services that are severable in nature.

1.3 Inherently Governmental Functions

This requirement has been reviewed and contains no services that include Inherently Governmental functions.

1.4 Organizational Conflict of Interest (OCI) Category

US Army Medical Research and Development Command has categorized all its non-purchased care requirements into three broad categories, as defined below, for purposes of identifying, avoiding, or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories are defined as follows:

• Category 1: USAMRDC Internal Support: Services that, by their very nature, give the

Contractor access to potential requirements and extensive data about Category 2 and Category 3 contractors.

• Category 2: Program Management Support: Services which assist USAMRDC in planning and managing its activities and programs. This includes, for example:

requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support.

• Category 3: Product Support. Services or end items required to meet the mission requirements of USAMRDC’s non-purchased care activities and programs. This includes, for example: concept exploration and development; system design; system development and integration; Commercial Off-The-Shelf (COTS) procurement and integration; internal development testing; deployment; installation; operations; and maintenance.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that USAMRDC presumes that award of a contract or order in the subject category will give rise to real or perceived OCIs with respect to requirements in the other two categories; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in USAMRDC requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all USAMRDC requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying, avoiding, and/or mitigating against OCIs, USAMRDC will examine all its non-purchased care requirements and acquisitions regardless of the cognizant contracting activity or the type of contract vehicle used.

Each USAMRDC non-purchased care solicitation will therefore be designated as falling within one of the three above defined categories. The work called for under this contract/order has been determined by USAMRDC to fall within the following non-purchased care OCI category:

Category 2: Program Management Support

2.0 TASKS

2.1 Task Management

The Contractor shall provide sufficient management to ensure that this task is performed efficiently, accurately, on time, and in compliance with the requirements of this document.

Specifically, the Contractor shall designate a single manager to oversee this task and supervise staff assigned to this task. The Contractor shall ensure that a Monthly Progress Report is submitted outlining the expenditures, billings, progress, status, and any problems/ issues encountered in the performance of this task.

2.1.1 Monthly Progress Report (MPR)

The Contractor shall ensure that a MPR (Deliverable 2) is submitted detailing the progress, vice review tasks target completion, as specified below. In addition, the MPR shall detail the expenditures, billings, and any problems/issues encountered in the performance of the PWS tasks. Initial MPR is due NLT 45 days after contract award (DACA).

The Contractor shall require all subcontractors to provide input to the MPR where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and Contractor.

2.1.2 Subcontractor Expenditures Plan

The Contractor shall prepare and deliver a Subcontract Expenditures Report (Deliverable 3) that discloses actual subcontract expenditures by company name, business size standard (e.g., Woman Owned Business, Veteran Owned Business, etc.), and other socioeconomic programs (e.g., Indian Incentive Program, Historically Black Colleges and Universities and Minority Institutions, etc.).

2.1.3 Transition Support

2.1.3a Incoming Transition

The Contractor shall provide a plan (Deliverable 4) for fifteen (15) days Incoming Transition from contract to contract, with the proposal. The Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. The Government will designate a transition period for the incoming Contractor to coordinate and work with the incumbent Contractor. This incoming transition plan shall include, but is not limited to:

• Coordination with Government representatives,

• Review, evaluation and transition of current support services,

• Transition of any applicable data to new Contractor,

• Government-approved training and continuing education and certification processes,

• Transfer of hardware warranties and software licenses (if applicable),

• Transfer of all necessary business and/or technical documentation, accreditation reports

• Transfer of compiled and uncompiled source code, to include all versions, maintenance updates and patches (if applicable),

• Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes,

• Distribution of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.,

• Transfer of Government Furnished Equipment (GFE) and Government Furnished

Information (GFI), and GFE inventory management assistance,

• Applicable USAMRDC briefing and personnel in-processing procedures,

• Coordinate with the Government to account for government keys, ID/access cards, and security codes.

The incoming transition plan shall be submitted with Contractor’s initial proposal.

2.1.3b Option Item: Outgoing Transition Plan

The Contractor shall provide an Outgoing Transition Plan (Deliverable 5) for 30 days outgoing transition for transitioning work from an active contract to a follow-on contract/order or Government entity. This transition may be to a Government entity, another Contractor, or to the incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract and/or orders issued under this Contract to a successful provider.

This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required metrics and statistics. This transition plan shall include, but is not limited to:

• Coordination with Government representatives

• Review, evaluation, and transition of current support services

• Government-approved training and certification process

• Transfer of all necessary business and/or technical documentation

• Transfer of GFE and GFI, and GFE inventory management assistance

• Applicable USAMRDC debriefing and personnel out-processing procedures

• Turn-in of all Government keys, ID/access cards, and security codes

2.1.4 Program Management/Staffing Plans

2.1.4a Program Management Plan

The Contractor shall develop a Program Management Plan (Deliverable 6a) that shall require Government approval. It shall be used to manage, track, and evaluate the Contractor’s performance. The Program Management Plan shall consist of control policies and procedures in accordance with standard industry practices for project administration, execution, and tracking.

The Program Management Plan shall include the following:

• Identification of milestones where Government information/activity is required and timeline dependencies for subsequent Contractor activities.

• An Integrated Master Management Plan describing the Contractor’s overall management approaches, policies and procedures including suggested project metrics.

2.1.4b Staffing and Retention Plan

The Contractor shall develop and maintain a Staffing and Retention Plan (Deliverable 6b) to ensure qualified staff as well as staffing levels in place throughout the life of the contract.

This Staffing and Retention Plan shall explain offeror’s staffing and retention (i.e. hiring and retention of personnel) practices and how they will contribute to program success.

2.1.5 Quality Control Plan

The contractor shall develop and maintain an effective Quality Control Plan (QCP) to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The QCP shall be submitted 15 days after contract award for review/acceptance. (Deliverable 7) The contractor’s QCP is the assurance that the work products comply with the requirement of the contract. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor shall use to maintain quality, timeliness, responsiveness, and customer satisfaction. After acceptance of the quality control plan, the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to the QC system.

2.1.6 Key/Essential Personnel

2.1.6a Key Personnel

a. The Contractor agrees to utilize the following Key Personnel on this contract:

Program Manager HSPS III (All Positions)

b. The above Key Personnel shall be utilized as critical to fulfill the requirements of this contract.

Key Personnel shall have the knowledge, skills, and experience to interpret and apply federal human subjects protection requirements and make regulatory review recommendations to the HRPO AA as described in this PWS. Due to the complex nature of the research reviewed in HRPO, at least one Contractor Key Person (HSPS III) in HRPO must have clinical patient care experience and experience with clinical trials in hospital settings.

c. The contractor must provide thorough and detailed documentation of the experience, abilities, and background for Key Personnel under this contract in the form of resumes.

d. Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have qualifications equal to or greater than the individuals proposed. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Substitution or replacement of these personnel shall be replaced within 30 days of the Key Person vacancy.

2.1.6b Essential Personnel

a. The Contractor agrees to utilize the following Essential Personnel on this contract:

HSPS II (All Positions)

b. The above Essential Personnel shall be utilized as necessary to fulfill the requirements of this contract. Essential Personnel must have the knowledge, skills, and experience to interpret and apply federal human subjects protection requirements and make regulatory review recommendations to the HRPO AA as described in this PWS.

c. The contractor must provide thorough and detailed documentation of the experience, abilities, and background for Essential Personnel under this contract in the form of resumes.

d. Substitutions of proposed Essential Personnel shall not be allowed for a period of three months after award, except under extreme circumstances. Any substitution or replacement Essential Personnel shall have qualifications equal to or greater than the individuals proposed. For temporary and/or permanent replacement of Essential Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Essential Personnel. Substitution or replacement of these personnel shall be replaced within 30 days of the Essential Person vacancy.

e. If any of the listed Essential Personnel are subcontractor personnel, the contractor shall include the substance of this clause in any subcontract which he awards under this contract.

2.1.7 Post Award Conference/Periodic Progress Meetings

The Contractor agrees to attend any post-award conference convened by the contracting activity or contract administration office. The contracting officer, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor’s performance. At these meetings, the contracting officer will apprise the contractor of how the government views the contractor’s performance and the contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

2.2 Specific Tasks – HRPO

Tasks 2.2.2 - 2.2.4 are the primary support tasks of HSPS I-III. Other HRPO tasks (subsequent to tasks 2.2.2 – 2.2.4) in this section run concurrently with the primary tasks, however the Government may direct additional contractor emphasis and focus on secondary tasks to address HRPO operational needs.

2.2.1 Team Leading

Each of the three HRPO review teams shall have one contractor HSPS designated as Team Leader. In addition to serving as a HSPS III (see below), the Team Leader HSPS contractor shall train and mentor new personnel, and serve an immediate expert resource for all team members, and collaborate with the On-Site PM to manage team workload. The Team Leader must be an expert in applying human subjects protections requirements to propose potential solutions to facilitate investigators’ conduct of compliant research with consideration for the DoD supported projects perfomance schedule.

2.2.2 Human Subjects Protection Scientist (HSPS) III – Initial Administrative Review of Proposal and Protocol Submissions

Using Government-provided policies, procedures, checklists, and information systems, the HSPS III contractor shall accelerate an investigator’s pursuit of HRPO approval through timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to the USAMRDC to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection regulatory and cadaver use requirements.

The HSPS III contractor shall provide comprehensive, timely, professional quality and fully documented initial reviews of research supported by the USAMRDC. The HSPS III shall have the expertise to provide reviews of all types of research supported by the USAMRDC, including, but not limited to, research involving human subjects, cadavers, human data, and biospecimens.

The purpose of these reviews is to assure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection and cadaver use regulatory requirements and to delineate deficiencies and areas of noncompliance. These reviews provide recommendations regarding regulatory and ethical issues for submission that are provided to the Principal Investigator following review and approval by the HRPO Approval Authority. The HSPS III contractor shall provide regulatory-based written initial reviews of protocols using standardized checklists. (Deliverable 8)

The HSPS III contractor shall formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects research and cadaver use. This includes identification and assessment of noncompliance when the research is conducted prior to HRPO approval.

The HSPS III contractor shall provide human subjects protection regulatory consultation on selected proposals and pre-reviews of draft protocols as tasked by the Program Manager. The HSPS III contractor shall conduct pre-reviews of projects submitted to the HRPO for determination of the applicability of the human subjects protection regulations. On an as-needed basis, the Program Manager may task the HSPS III contractor to complete administrative review actions for protocols in post-approval oversight. The HSPS III should interpret and apply federal human subjects protection requirements and make regulatory review recommendations for any HRPO administrative review action required, from initial submission through lifecycle oversight to study closure. The HRPO prioritizes submissions for review in the following order as assigned: review actions requiring approval (e.g. initial reviews and amendments), promptly reportable study events, continuing reviews, and continuations, and closures)

The HSPS III contractor shall provide accurate information, assistance and documents to customers and HRPO federal personnel when requested with appropriate professionalism in a timely manner. This requires active management and updating of the protocol files and the information management systems used to track information related to protocol review. This also requires active backup of HSPS working materials to the HRPO’s shared computer drive to facilitate review of future actions by team members.

The contractor shall responsively engage in email and telephone communication with the Principal Investigator, HRPO Approval Authority, and key study personnel to address questions, concerns, and outstanding issues.

The government may require changes in contractor labor mix to accommodate changes in Federal, Department of Defense, and Army human subjects protection regulatory requirements.

2.2.3 Human Subjects Protection Scientist (HSPS) II - Administrative Review of Protocol Submissions in Post-Approval Oversight and Limited Initial Review Support

The HSPS II contractor shall provide real-time oversight of USAMRDC-supported research protocols through timely documented reviews of protocol lifecycle submissions to assure ongoing compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection regulatory requirements. The contractor provides regulatory-based written review of protocol life cycle submissions using standardized checklists. (Deliverable 9) The HSPS II contractor delineates deficiencies and areas of noncompliance and makes recommendations to the HRPO federal AAs regarding regulatory and ethical issues in HRPO post-approval submissions.

At the request of the Program Manager and/or during times of high volume of protocol submissions, the HSPS II contractor shall provide comprehensive, timely, professional quality and fully documented initial reviews of USAMRDC and DoD-supported protocols limited to the following categories of submissions: research not involving human subjects and exempt human subjets research, HRPO determinations, deferrals, and requests for protocol withdrawal. The purpose of these reviews is to ensure research compliance with all applicable regulatory requirements and to recommend HRPO concurence or nonconcurrence with institutional determinations of exempt human research or research not involving human subjects. These reviews are provided to the Principal Investigator following review and approval by the HRPO Approval Authority. The HSPS II contractor shall provide regulatory-based written initial reviews of protocols using standardized checklists. (Deliverable 10)

The HSPS II contractor shall provide a comprehensive review and evaluation of human subjects research protocol amendments/addenda, continuing review reports, protocol continuations under new USAMRDC awards, reports of unanticipated problems and serious adverse event, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, and final study reports and provide a professional quality written review, as required. The HSPS II contractor shall provide professional quality written review and HRPO determination for the addition of collaborators/sites for HRPO active protocols that are in post-approval oversight. The HRPO prioritizes submissions for review in the following order as assigned: review actions requiring approval (e.g. initial reviews and amendments), promptly reportable study events, continuing reviews, and continuations, and closures)

The HSPS II contractor shall provide accurate information, assistance, and documents to customers and HRPO federal personnel when requested with appropriate professionalism in a timely manner. This shall require active management and updating the protocol files and the information management systems used to track information related to protocol review.

The HSPS II shall attend integrated program and project review meetings with HQ USAMRDC customer representatives to assess issues affecting the progression of protocols in post-approval oversight and assist the HRPO Approval Authorities in identifying human subjects protection related problems and associated resolutions.

The HSPS II contractor shall support the HRPO federal personnel in the conduct of noncompliance investigations and compliance inspections of extramural protocols. The contractor shall provide regulatory-based written review of HRPO reportable events.

(Deliverable 11)

The government may require changes in contractor labor mix to accommodate changes in federal, Department of Defense, and Army human subjects protection regulatory requirements.

2.2.4 Human Subjects Protection Scientist (HSPS) I- Administrative Support for the

HRPO

The HSP AS contractor shall provide excellent and timely customer service and support to his/her HRPO Team staff, HRPO Approval Authority, Principal Investigators, and other HRPO customers. Administrative support includes preparing official correspondence related to management of a protocol from the time of its submission to the HRPO until the protocol file’s closure and archive. HSP AS contractor duties include completing HRPO protocol submission reminder correspondence, managing protocol records, updating databases used to track submission information, preparing correspondence related to protocol reviews, and compiling reports on HRPO reviews as requested. The HSP AS shall support request for records and data calls, including retrieving records, scanning and organizaing documents, and generating simple reports from electronic databases as requested. A limited number of HSP AS shall support the organization and maintanance of shared drive resources and electronic archives of HRPO submissions. The HSP AS contractor shall support the HRPO review teams by processing protocol review actions to include continuing review reports, and final study reports submitted to

HRPO.

2.2.5 Human Research Protection Program and DoD-Supported Protocol Compliance Oversight Review Support

The contractor shall provide HSPS support for intramural staff assistance visits and HRPP assessments designed to monitor compliance with human subjects protection regulations and make recommendations for improvement. The contractor shall provide support for compliance assessment of DoD-supported extramural protocols, as requested. This includes assisting with planning, formulation of agenda, and preparation of materials for use during the visit, to include any educational presentations, and visit checkists (Deliverable 12). The contractor shall participate in interviews with investigators, study staff, IRB staff, institutional officials, and research participants, and conduct detailed policy and regulatory record reviews and assist with preparation of after-action reports (Deliverable 13). The HSPS contractor shall travel to sites, as needed, to support HRPO federal personnel in this task.

2.2.6 Human Subjects Protection Policies and Procedures Development Support

The contractor shall assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to research supported by the

USAMRDC.

The contractor shall assist in the development of local procedures and guidance for the HRPO and the USAMRDC in the area of human subjects protection. The contractor shall support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines. The contractor shall assist in development and implementation of internal HRPO operating procedures and review guidelines as requested.

2.2.7 Education/Training

The contractors shall provide routine review and update of all internal orientation and training materials for HRPO staff to ensure they reflect current Federal, DoD, DA, state, host nation, and USAMRDC regulatory requirements related to the protection of human subjects in research and cadaver use. The contractor shall submit changes to the government for approval before use.

Upon request, the contractor shall provide continuing education and training of HRPO reviewer staff in current human subjects protection topics at HRPO staff meetings.

The contractor shall foster regulatory compliance through education and training of investigators, research managers, administrators, and provide assistance to program offices and investigators with interpretation of human subjects protection and cadaver use requirements. The contractor shall provide planning assistance and support for meetings and training/conferences sponsored by the ORP.

The contractor shall acquire and retain knowledge of current Federal, DoD, DA, state, host nation, and USAMRDC regulatory requirements related to the protection of human subjects in research and cadaver use and apply knowledge of these regulations and general ethical principles during HRPO reviews of assigned projects.

The contractor shall interact with colleagues, consultants, investigators, research directors, supervisors, other US Army personnel, etc., to gather or disseminate information or to provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects protection regulations and HRPO requirements.

The contractor shall prepare appropriate training packets and other materials for HRPO conducted training.

2.2.8 Quality Assurance

The contractor shall actively manage and update protocol files and the information management systems used to track information related to protocol review, i.e., contractor personnel must master entry of protocol-related information into automated information management systems, and keep protocol status and event information complete and up to date. The contractor shall perform quality control and assurance assessments on contractor submissions to the government for accuracy, completeness, timeliness, and adherence to ORP requirements regarding regulatory reviews, electronic information system entries, and use of the shared computer drive. All contractor work products for contract staff completing orientation shall be reviewed for quality before submission to the government. The contractor shall assist in the execution of an internal quality control/assurance program. The contractor shall provide periodic reports of workload management and review throughput in accordance with HRPO guidance.

2.2.9 Performance Improvement

The contractor shall participate in performance improvement activities and shall task contract personnel to participate in specific working groups to improve and streamline the protocol review and approvals processes, and provide support for formulating and writing HRPO standard operating procedures and work instructions. As requested, HSPS work group members shall provide routine review and update of all HRPO review materials and investigator toolkits on shared drive, website, and electronic review systems. Work group recommendations shall be submitted to the government for approval. As tasked by the government, HRPO work group duties run concurrent with other protocol review tasks as described in this PWS.

As requested, the contractor shall task a limited number of contract personnel to generate, review, and analyze routine reports of HRPO workload and HRPO operations, including review turnaround times from submission to approval, and other ORP review time intervals as determined by the government.

The contractor shall provide support for the HRPO peformance improvement activities related to paper and electronic review processes, including recommendation of solutions to electronic review issues, updating HRPO work instructions and user guides related to the use of electronic review systems, and providing ongoing training related to electronic review processes.

2.3 Specific Tasks – IRBO – HSPS III

Tasks 2.3.1 - 2.3.2 are the primary support tasks the contractor staff in IRBO. Other IRBO tasks in this section run concurrently with the primary tasks, however the Government may direct additional contractor emphasis and focus on secondary tasks to address IRBO operational needs.

2.3.1 Comprehensive Research Protocol Pre-review

Using government provided policies, procedures, checklists, guidances and information systems, the IRBO contractor shall facilitate investigator’s pursuit of HQ USAMRDC IRB approval through comprehensive pre-review of protocols submitted to the HQ USAMRDC IRB for expedited or convened IRB review. Working under supervision of the Director, IRBO or Deputy Director, IRBO, the contractor shall provide a comprehensive, timely, professional quality, and fully documented pre-review of each assigned protocol for regulatory compliance before it is sent to the IRB Expedited Review Member or convened IRB for action or consideration of approval. The contractor shall provide regulatory- based written pre-review of new protocols following an IRBO required format using standardized checklists. (Deliverable 14) The IRBO contractor shall provide administrative review of non-DoD collaborators and institutions in each assigned protocol in preparation for Human Research Protecton Offical review and approval.

The IRBO contractor shall conduct pre-reviews of projects submitted to the HQ USAMRDC IRB Office for determination of the applicability of the human subjects protection regulations.

The IRBO contractor shall prepare correspondence, response to customer inquiries to explain and interpret human subjects protection regulations and guidelines to investigators and other customers. (Deliverable 15) The contractor shall attend meetings with HQ USAMRDC IRB customer representatives to address issues affecting the progression of protocols and assist in identifying problems and resolutions to problems.

The IRBO contractor shall formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects research.

The IRBO contractor shall engage in email and telephone communications with the Principal Investigator and key study personnel to address questions, concerns, and outstanding issues.

2.3.2 Post Approval Protocol Monitoring

The IRBO contractor shall provide post-IRB-approval lifecycle management of assigned protocols including, but not limited to, pre-review of amendments/addenda, continuing review reports, reports of unanticipated problems and serious adverse events, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, and final study reports and provide a professional quality written review, as required. The IRB contractor shall provide regulatory-based written pre-review of protocol life cycle actions following a IRBO-required format using standardized checklists. (Deliverable 16)

The IRBO contractor shall provide support for the conduct of site monitoring visits to HQ USAMRDC IRB customer institutions to monitor compliance with HQ USAMRDC IRB-approved protocols and human subjects protection regulations, and assist in the conduct of noncompliance investigations and compliance inspections of HQ USAMRDC IRB protocols.

Support includes preparing, planning, conducting, and reporting on compliance inspections of research for which the HQ USAMRDC IRB has oversight. The IRBO contractor shall provide completed site visit/inspection checklists, written findings from site visit and compliance inspection activities (Deliverable 17). The IRBO contractor shall assist in the preparation of the written report of each compliance inspection that includes written specific findings of the inspection. The IRBO contractor shall travel to sites, as needed, to support IRBO federal personnel in compliance oversight of HQ USAMRDC IRB protocols.

2.3.3 Human Subjects Protection Policies and Procedures Development

The IRBO contractor shall assist in development, update, and continuous improvement of the HQ USAMRDC IRB’s human subjects protection policies, procedures, guidelines, templates, and review checklists to ensure regulatory compliance with current laws, regulations, and policies governing human subjects research.

2.3.4 Human Subjects Protection Education and Training

The IRBO contractor shall contribute to the development, coordination, and conduct of innovative human subjects protection regulatory compliance education and training programs targeted at HQ USAMRDC IRB members and the IRB’s customers. The contractor shall prepare appropriate training packets and other materials for training.

The IRBO contractor shall interact with colleagues, HQ USAMRDC IRB members, and the IRB’s customers to gather or disseminate information or to provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects protection regulations and IRBO/HQ USAMRDC IRB requirements.

The IRBO contractor shall acquire and retain knowledge of current Federal, DoD, DA, state, host nation, and USAMRDC regulatory requirements related to the protection of human subjects in research and cadaver use and apply knowledge of these regulations and general ethical principles during IRBO pre-reviews of assigned projects.

2.3.5 Quality Assurance

The IRBO contractor shall actively manage and update protocol files and the information management systems used to track information related to protocol review, i.e., contractor personnel must enter protocol-related information into automated information management systems, and keep protocol status and event information complete and up to date. The contractor shall assess the contractor work products for accuracy, timeliness, and adherence to ORP IRBO requirements regarding regulatory reviews, automated data information system entries and use of the shared computer drive. The contractor shall assist in the execution of an internal quality control/assurance program.

2.3.6 Performance Improvement

The IRBO HSPS contractor shall assist in the conduct of performance improvement activities to include participation in task-specific working groups aimed at improving and streamlining the HQ USAMRDC IRB’s protocol review and approval process.

2.4 Management of On-Site Personnel and Reporting

The contractor shall identify one HSPS subject matter expert to serve as PM and provide on-site supervision of contract personnel assigned to the ORP. The PM shall function as a HSPS and shall manage a small caseload of protocols to ensure he/she remains current on process and can provide appropriate guidance to contract staff.

The on-site supervisor PM contractor shall provide on-site, day-to-day work supervision for the contract personnel employed at the ORP to include assigning work to HRPO contractor personnel.

The on-site supervisor PM contractor at the ORP shall maintain a positive work environment to facilitate staff success in their job performance.

The on-site supervisor PM contractor shall ensure that personnel are adequately oriented to their duties and to the standards and expectations of the ORP within the initial 3 months of employment (with accommodation for Common Access Card issuance delay).

During incoming transition, the contractor shall be afforded 120 days to complete adequate orientation of new employees to duties and ORP procedures.

The on-site supervisor PM contractor shall provide quality assurance oversight for contractor activities and ensure that deliverables meet all timeliness and quality standards.

The on-site supervisor PM contractor at ORP shall coordinate with the HRPO and IRBO senior leadership on matters relating to the contractor’s conduct of all aspects of human subjects protection and cadaver use compliance oversight, to include regulatory reviews, participation in investigators meetings, staff assistance visits, and completion of special projects as requested by the leadership of HRPO and IRBO.

The on-site supervisor PM contractor at ORP shall oversee all aspects of the contractors’ responsibilities for protocol lifecycle management from initial proposal/protocol review through receipt of the final study report, and shall ensure that protocols, amendments, continuing reviews, reportable study events, and final report actions are comprehensively reviewed for compliance with Federal, DoD, DA, state, host nation, and USAMRDC regulations, policies, and guidelines and human research ethical standards.

The on-site PM supervisor contractor at ORP shall ensure that accurate regulatory and procedural guidance are provided in a timely and professional manner.

The on-site PM supervisor contractor at ORP shall ensure contractor support for the HRPO electronic review transition plan to a new electronic review and archive system.

The on-site PM supervisor contractor at the ORP shall ensure that all additional contractor duties are performed in a timely and professional manner. The contractor shall perform supervisory functions for contractor staff. The contractor shall monitor quality of deliverables and workplace performance.

The on-site PM…