PMI_IRB_SoW_-_Final.docx

STATEMENT OF WORK

SUPPORT SERVICES FOR PMI IRB

1.0 Introduction

Launched with a $215 million investment in the President’s 2016 Budget, the Precision Medicine Initiative (PMI) will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients. A critical part of PMI is the PMI Cohort Program led by the National Institutes of Health (NIH).

This program seeks to extend precision medicine to all diseases by building a national research cohort of one million or more U.S. participants. Many factors have converged to make now the right time to begin a program of this scale and scope — Americans are engaging in improving their health and participating in health research more than ever before, electronic health records have been widely adopted, genomic analysis costs have dropped significantly, data science has become increasingly sophisticated, and health technologies have become mobile. The PMI Cohort Program will be a participant-engaged, data-driven enterprise supporting research at the intersection of human biology, behavior, genetics, environment, data science and computation, and much more to produce new knowledge with the goal of developing more effective ways to prolong health and treat disease. The cohort will broadly reflect the diversity of the U.S. population by including participants from diverse social, racial/ethnic, and ancestral populations living in a variety of geographies, social environments, and economic circumstances, and from all age groups and health statuses. Information from the cohort will be a broad, powerful resource for researchers working on a variety of important health questions.

2.0 General Requirements

NIH is seeking an organization that is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) to perform the following work.

It is anticipated approximately at least 20-30 protocols are estimated per year.

Current protocols will be transferred to this new requirement.

All research protocols submitted to the PMI Cohort Program will go through review by a newly convened Institutional Review Board (IRB). The PMI Cohort Program IRB will serve as the IRB of record for all protocols received. This Statement of Work sets forth the management, administrative and regulatory support needed for the PMI IRB. Specifically:

A. Manage and provide administrative and regulatory support for scheduled and occasional unscheduled, ad-hoc PMI IRB meetings, including all administrative tasks involved in the preparation, conduct, and follow-up of meeting actions (includes managing expedited review). These tasks include, but are not limited to, the following:

B. Begin development of regulatory compliant SOPs for the core functions of the PMI IRB including, for example, SOPs pertaining to: initial review of research, review of changes in research, continuing review of research, and review of unanticipated problems and serious or continuing noncompliance.

C. Knowledge Acquisition and Analysis of PMI IRB program:

1. Identify, review and advise on any policies or documentation previously developed to support the PMI IRB;

2. Identify and interview key stakeholders (NIH Staff, IRB members, institutions likely to rely on the PMI IRB) to assess current activities, roles, responsibilities and scope of IRB support required;

3. Provide an analysis of the current status of PMI IRB support and documentation; and

4. Provide prioritized recommendations for development of additional documentation.

D. Provide support to the NIH in identifying and selecting PMI IRB members, including tracking tenure and categories of PMI IRB Board members in the Member Activity Tracking Database. Maintain a listing of potential/future appointees.

E. Gather short bio sketches and CV’s for each PMI IRB members.

F. Purchase and hold professional liability insurance for PMI IRB members without gaps in coverage at time of renewal.

G. AAHRPP Accreditation support.

H. Advise and propose best practices for a model for centralized PMI IRB activities including:

· Development of processes to address local context considerations,

· Creation of an Authorization Agreement,

· Helpdesk support for future research sites, and

· Advise on potential IT solutions to support the PMI IRB such as utilization of an integrated software suite to support virtual IRB meetings and IRB records tracking.

3.0 Management and Reporting Requirements

The offeror shall provide one (1) electronic copy each of the following information to the Project Officer. The address for the Project Officer shall be provided at the time of the award.

1. By the tenth (10th) calendar day of each month a brief monthly status report shall be provided. These reports shall include, but are not limited to, a description of work accomplishments during the period, including a list of all activities, the status of each task, problems encountered and any corrective action taken, planned activities for the upcoming period, any available deadlines, and any problems that are anticipated during the upcoming period.

2. Complete Meeting Report. This report shall contain a summary of all work performed as identified by the SOW. This report shall discuss in detail any problems encountered and the successful resolution of those problems in addition to any recommendations and conclusions the offeror has based upon experience and the results obtained.

4.0 Reporting Requirements

All reports required herein shall be submitted in electronic format. In addition, one (1) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified.

A. Technical Progress Reports. Deliveries in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award.

B. Monthly Progress Reports shall contain two main sections as indicated below and should be submitted with the monthly invoice:

Financial Status Report—The following will be provided in Section 1 of the Quarterly Progress Report:

a) Hours expended during the reporting period by individual

b) Cumulative hours expended throughout the reporting period by job category

c) Contract funds expended during the reporting period

d) Schedule of activities planned and estimated hours for the next reporting period and number of remaining hours to complete activities.

Progress Report—The following will be provided in Section II of the Quarterly Progress Report:

a) Descriptive information about the activities undertaken during the reporting period

b) Planned activities for future reporting periods

c) Summary of work accomplished during the previous month

d) Milestones and deliverables, if applicable

e) Any issues or problems impacting project progress along with their ultimate resolution The Offeror shall provide a Progress Report to the Project Officer on the 15th day of each month.

5.0 Deliverables and Delivery Schedule

A. Pre-Meeting Deliverables for Planning and Support

· Secure meeting space (minimum of 6 meetings/year) 6 months to a year ahead of time

· Meeting summary (minimum of 6 meetings/year) within 2 weeks after the meeting

· Pre-meeting materials prepared one month prior to the meeting including, but not limited to the following:

· Draft letters of invitation, agenda and administrative letter to acceptances

· Updated agendas

· Updated participant lists and mailing lists

· Development of attendee lists

· Status report of meeting facilities, hotel accommodations, airline reservations and meeting registration

· Meeting announcement, including confirmation that Federal Register Notice has been sent, and deadline

· Pre-meeting mailings

· Arrange NIH campus cable and video taping of meeting at least one month prior to the meeting.

· Some meetings may require the preparation and distribution of background materials and reports 2 weeks to 1 month prior to the meeting. This will be accomplished by the development and upkeep of a PMI-IRB share file site for meeting materials.

B. On-Site Meeting Deliverables:

Provide the necessary on-site staff (a minimum of 2) for performing conference service functions the day(s) of the meeting(s). These functions include, but are not limited to, the following: administrative support, message handling, registration, information desk, audio-visual projection and/or recording, and transcription assistance. Provide set up of meeting materials to include: logistical packets, participant lists, biographical sketches, handouts, agendas, nametags, table tents, directional signs, and refreshments, etc.

C. Post Meeting Deliverables:

· Plan for prompt delivery of meeting transcripts (7 to 9 business days after meeting), meeting summary (5 to 10 days after meeting), meeting minutes (7 to 10 days after minute taker gets transcript.)

· Update PMI-IRB web-site using past tense for meeting description and dates.

· Thirty days following each meeting, and subsequently every thirty days until a meeting is closed out, the offeror shall provide a detailed status report to include:

· Status of payment of participants

· Status of summary and transcript

· Meeting expenses incurred

· Status of contract funds

D. Travel and Hotel Arrangements In accordance with current Federal Travel Regulations (FTR).

· Travel orders, itineraries, expense tracking for members and guests

· Hotel arrangements for members and guests

· Transportation to and from the hotel and meeting each day for all PMI-IRB members

· Transportation arrangements to the airport/train stations at the conclusion of the meeting for all PMI-IRB members.

6.0 Period of Performance

A twelve month base year September 1, 2016 to August 31, 2017 plus 4 twelve month option Years

7.0 Performance Location

All work will be performed on site at an NIH designated location or remotely at the discretion of NIH.

8.0 Government Property

All equipment and supplies needed to perform outlines tasks and activities will be supplied by the offeror.

9.0 Skill and Labor Categories

The following skills and labor categories will be needed throughout this contract.

Project Management IRB Administrator/Coordinator Accreditation and Local Context Administrator Document Control Specialist Outreach/QA Administrator Outreach Specialist QA/QC Specialist Client Services Specialist - Helpdesk IT Support

10. Basis for Award The Government shall award a contract resulting from this quotation to the responsible offeror whose quote conforming to the statement of Work will be the most advantageous to the Government, price and other factors considered. Evaluation factors other than price, when combined, are significantly more important than price.

11. Evaluation of Offers

The following evaluation factors shall be used to evaluate the prospective contractors and are listed in order of importance:

1. Technical Evaluation (40%)

2. Management/Staffing (30%)

3. Key Personnel (30)

Total points 100% Past Performance (reviewed but not scored with above criteria) Price (evaluated, but not scored)

12. Format and Information for Submitting a Quotation:

The technical proposal should clearly and fully demonstrate the offeror’s capabilities, knowledge, and experience regarding the technical requirements described below. Failure to respond explicitly to each of the categories and subcategories listed below may result in the offeror’s quotation being deemed technically unacceptable Pricing quotation and technical quotation should be submitted as two (2) separate files.

There are no page limits or font requirements. However the technical quote should be concise enough to clearly prove the offerors ability to satisfy the requirements in the SOW.

Price will be evaluated separately. Offerors shall provide a separate quote for the base year and each potential option year as well as a total for all five years.

The Evaluation Criteria shall be applied in assessing quotations. The criteria are listed in descending order of importance.

13. Technical Factors Comprehension of the Requirement (40%) The offeror’s response shall demonstrate their understanding of the SOW by clearly showing a grasp of the range and the complexity of the work. Offerors should demonstrate a conceptual understanding of the challenges specific to the Office of the Director for the tasks in this SOW and suggestions for overcoming these. Offerors must demonstrate experience with similar tasks performed in the past three (3) years for audiences and/or user-groups.

Key Personnel Experience (30%) Offerors shall demonstrate experience of key personnel supporting the planning and implementation of activities described in the SOW. Please provide resumes of key staff. Requirements of key personnel are included in the SOW.

Resumes of Key Personnel: Resumes of Key Personnel as identified in HHSAR 352.270-5 KEY PERSONNEL - must be submitted with technical quotations. Technical quotes shall contain sufficient information about the qualifications of the staff of the Offerors, including biographical information about personnel who are to be assigned to work on this contract and any other information that would allow the Government to judge their abilities to perform the requirements of this contract. The names of all key Contractor personnel as well as their qualifications, employment histories (including absence of any criminal records), roles, and commitments to the performance of this contract shall be provided in the contract proposals.

Management/Staffing (30%) Technical quotes should detail how the offeror will provide the necessary project administration, organization, and staff to ensure quality control, compliance with statement of work expectations, and necessary staffing adjustments. In addition, offerors must demonstrate the ability to simultaneously manage multiple tasks within set time periods.

The possession of key personnel with expertise to perform the tasks set in this SOW is deemed almost as important as the technical aspects of the proposal. Responses should describe the key personnel who will be assigned to manage performance and supervise the work for each task and subtask. Responses should also demonstrate how the key personnel are/were involved with work highlighted under the previous “past performance” criteria; and provide resumes which demonstrate how key personnel meet the criteria listed for each key personnel category as described in the SOW. The Government will review these resumes to evaluate whether the individuals possess the required experience to perform the specific tasks. Resumes should be no more than three (3) pages in length.

Past Performance Past Performance shall not be scored as technical evaluation criteria but shall be reviewed.

Offerors should include references to similar work in scope of this SOW as performed in the past three (3) years.

The Government will evaluate the offeror’s past performance based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror’s likelihood of success in performing the acquisition requirements as indicated by that offeror’s record of past performance. The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror’s performance. The lack of a performance record may result in an unknown performance risk assessment, which will neither be used to the advantage of nor disadvantage of the offeror.

Each offeror will be evaluated on its performance under existing and prior contracts for similar products or services. The Government is not required to contact all references provided by the offeror. Also, references other than those identified by the offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the offeror’s past performance.

The past performance sub-factors are listed below in order of relative importance. These sub-factors will be used to evaluate the quality of past performance.

Past Performance Sub-factors:

· Record of conforming to specifications and to standards of excellence in workmanship

· Adherence to contract schedules, including the administrative aspects of performance

· Reputation for reasonable and cooperative behavior and commitment to customer satisfaction

· Business-like concern for the interest of the customer

Past Performance Information:

Offerors shall submit the following information as part of their technical response:

A list of the last three (3) contracts/purchase orders completed during the past five (5) years and the last three (3) contracts/purchase orders awarded currently in process that are similar in nature to the statement of work. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns.

1. Include the following information for each contract or subcontract:

2. Name of Contracting Organization

3. Contract Number (for subcontracts, provide the prime contract number and the subcontract number)

4. Contract type

5. Total Contract Value

6. Description of Requirement

7. Contracting Officer’s Name and Telephone Number

8. Program Manager’s Name and Telephone Number

9. NAICS Code (North American Industry Classification Code

The offeror may provide information on problems encountered on the identified contracts and the offeror’s corrective actions.