Attachment 1 - Statement of Work.pdf

STATEMENT OF WORK

1.0 TITLE

Centralized Institutional Review Board (CIRB) to Review Minimal Risk Registry Linkage Studies

2.0 BACKGROUND

The Surveillance, Epidemiology, and End Results (SEER) Program is one of the premier cancer surveillance programs in the world being currently composed of population-based cancer registries covering 35% of the total US population. SEER receives approximately 500,000 pathology reports/records annually, and the information collected on each, and every cancer patient in SEER coverage areas includes demographics, a description of their cancer, treatment, and patient follow-up including cause of death for deceased patients. Periodic reports on various aspects of the cancer burden on the population including incidence, survival, treatment, and mortality using the SEER database are made available to the general research community and the public and are routinely cited in the medical literature and the media.

The SEER Program is managed by the Surveillance Research Program (SRP) within the Division of Cancer Control and Population Studies (DCCPS) at the National Cancer Institute (NCI). SRP currently contracts directly with 16 central registries within the U.S. responsible for the collection of pathology reports.

Registry staff annotates the required elements into local systems that are then passed into the SEER Data Management System (SEER*DMS). In addition to the contracts directly with registries, SRP also works in a collaborative fashion with The North American Association of Central Cancer Registries (NAACCR) which is the professional organization that develops and promotes uniform data standards for cancer registration and promotes the use of cancer surveillance data and systems.

Over the past 15 years, unprecedented capacity and opportunity for large scale epidemiologic research has emerged, but a significant barrier still exists. Researchers who seek to efficiently perform a linkage with multiple state cancer registries must submit applications to each individual registry resulting in significant expenditure of time and fiscal resources. This is compounded by the fact that there is no consistency among states in the application, approval and linkage procedures. To address this barrier and continue to improve the opportunities for linkages, NCI and NAACCR are working together to develop and implement a Virtual Pooled Registry Cancer Linkage System (VPR-CLS).

VPR-CLS will provide a streamlined and efficient process for multi-state cancer linkages and IRB approval.

Implementation of such an integrated system to link and provide cancer registry data would benefit the NCI with potential cost savings and enhanced efficiency of current linkage processes for cohort studies and follow-up on NCI sponsored clinical trials. Currently NCI DCCPS funds cohorts that annually follow more than 1.2 million individuals. For most of those, follow up information on the development of cancer, as well as survival and cause of death are essential components. In addition to DCCPS, DCP and DCEG also have large cohort studies that would benefit from cost-efficient methods to acquire follow up information.

Establishing use of a CIRB is a key component of the VPR-CLS approach. It is bolstered by the NIH policy, effective May 25, 2017 (Notice Number NOT-OD-16-094), which set the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried on at more than one site in the United States. While the minimal risk studies that will be submitted will initially be through the VPR-CLS workflow, it is expected that the CIRB will also be used for other DCCPS funded studies utilizing or linking or requesting SEER data where there may be some risk of re-identifiability. These studies will also meet the definition of minimal risk and multi-site research, so the NIH policy is applicable regardless of sponsor.

The CIRB will not only streamline and speed up the review process but will also eliminate duplicative local IRB review, minimize locally driven modifications to the study protocol, and ensure a standard high-quality patient protection review.

3.0 PURPOSE

The purpose of this SOW is to contract with a commercial IRB to serve as a Central IRB (CIRB) for the intake, processing and review of multi-state/site minimal risk registry linkage studies. The CIRB is intended to streamline the IRB application and review process, thereby saving time and resources associated with multiple local IRB approval processes and is a component of the VPR-CLS workflow. The requesting investigator must provide evidence of Institutional IRB review and approval (or exemption) to initiate the VPR-CLS linkage request process. Aside from VPR-CLS multi-site studies, the CIRB is also intended to review studies funded by and conducted by NCI staff within DCCPS or other NCI divisions with a related need for a CIRB review for those studies meeting the definition of minimal risk and eligible for expedited review. The term minimal risk registry linkage study will be used regardless of submission source (VPR- CLS or DCCPS).

The CIRB is expected to provide a consistent, high quality and expert review process and have the expertise and understanding of issues and challenges specific to central cancer registries. The CIRB will primarily be responsible for the review and adjudication of linkage protocols defined as minimal risk studies. Under 45 CFR 46, the Department of Health and Human Services, Office for Human Research Protections specifies that minimal risk studies may be reviewed under an expedited review process (http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.110).

Under this SOW, the CIRB will be a critical partner in the implementation of the VPR-CLS effort and will work with the NCI, NAACCR and registry participants on the VPR-CLS leadership team as well the registries that will accept a CIRB as the sIRB of record. Success with the CIRB effort within the VPR-CLS will help facilitate and increase use of this valuable and high-quality resource which is meticulously collected, managed and guarded. Simultaneously it will help the cancer surveillance community and researchers address the myriad of scientific questions related to the cancer problem within the United States.

4.0 TASKS

Independently and not as an agent of the Government, the Contractor shall furnish all of the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform this Statement of Work.

4.1 Develop, Implement, and Maintain CIRB Review Procedures (Labor Hours)

The contractor shall:

1. Establish a process to contact, discuss, develop and execute with each central cancer registry and their IRB, following the kick-off meeting but prior to accepting any researcher applications, outlining –

a. the requirements of each registry defining a minimal-risk study (meeting registry criteria VPR-CLS submission with expedited review);

http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.110

b. when a study request is required to undergo local IRB review (for example if registry staff are involved in the study, state requirements, etc.);

c. type of agreement necessary for the local IRB to accept the CIRB as the IRB of record. The NCI seeks to enter into agreements that address groups or classifications of studies (minimal-risk, multi-site linkage studies) as compared to agreements which must be addressed with each study request;

d. Local context issues that must be addressed by the CIRB during the review process;

e. for IRBs which have not accepted the CIRB as the IRB of record, note those exceptions and ensure that communications for any particular linkage is addressed appropriately.

2. Fully execute required agreements with local IRB and revise such agreements as necessary.

3. Develop and implement a plan as part of the CIRB review process for addressing local context issues as applicable. Local context issues are defined as issues pertaining to the review of a study application by a registries local IRB not included in the CIRB review which may require reconciliation before approval. The definition of local context issues may vary by state and the contractor shall work with each entity to ensure it is defined and agreed upon when resolving.

4. Work with the COR, the DCCPS IT contractor and NAACCR as needed to understand the VPR- CLS workflow and any associated tools (ex. Match*Pro database) used in the VPR-CLS process.

5. Develop and execute SOPs for expedited review, adjudication and communication of minimal risk studies. This will include:

a. utilization of existing systems and services such as the VPR-CLS online system for the retrieval of the templated application and supporting documents needed to review and adjudicate;

b. review submission of minimal risk protocols for central cancer registry linkages with cohort studies, clinical trials or other research applications;

c. review processes and timelines, process for requesting changes to a reviewed minimal risk registry linkage study protocol;

d. the process and timelines for the re-review of modified minimal risk registry linkage study protocol; and

e. The process and timelines for continuing review activities as required.

Submissions will be reviewed for completeness and the contractor shall work with the submitting party to resolve any issues around completeness.

6. Maintain and update annually the CIRB SOPs related to the review of minimal risk registry linkage studies. SOPs for new or revised processes may be drafted/updated more frequently as required. The contractor shall ensure that all applicable CIRB SOPs are in compliance with Federal laws and regulations. The contractor shall consider VPR-CLS workflows for incorporation into CIRB SOPs.

7. Establish a secure system for the storage of study documents including those downloaded from the VPR-CLS online system to be used in the review process. The system shall restrict access to CIRB members based on role (to be identified by the CIRB). This includes all associated study documents but not limited to:

a. the protocol,

b. correspondence between stakeholders, and

c. any supporting documentation required to render a review and decision.

8. The contractor shall recommend tracking statistics for assessing the performance of the CIRB for submitted studies, identifying how and what elements the contractor can provide.

9. The contractor shall track CIRB activity related to minimal risk registry linkage studies and provide regular updates to the VPR-CLS leadership team or as requested. The contractor shall provide such information with the understanding that the government or VPR-CLS leadership will use it when presenting on minimal risk registry linkage study activity to relevant stakeholders at public meetings.

10. Promote or otherwise post information regarding minimal risk registry linkage study activity on the CIRB’s organizational web site. The contractor shall work with the COR to determine what information shall be presented on the web site.

11. Identify CIRB and respond to educational needs of review board members, VPR-CLS/DCCPS leadership, local IRBs/registries or Study personnel related to the CIRB and its activities and processes. The contractor shall appraise the government of such educational needs and work with the government to develop, implement, or otherwise share such educational material so as to enhance the effectiveness of the CIRB submission and review process.

12. Utilize electronic systems and tools to facilitate and conduct the tasks in this SOW. The Government will not be providing such tools nor will the Government fund for the development of new tools for these tasks.

13. Participate in VPR related project calls/meetings

14. Maintain AAHRPP accreditation for the duration of this contract.

15. Within the first six months following contract award, the Contractor shall develop and submit a draft transition plan which will describe the Contractor’s strategy for transferring work form this contract to a successor contract, in the event a final transition would be required. The plan must include information on the transfer of policies and procedures;

transfer of relevant files, records, materials and data; transition of all activities as appropriate. The draft transition plan will be revised, if necessary, and the draft transition plan will become the final transition plan upon approval of the COR. The approved final transition plan shall be followed to ensure an orderly, secure, efficient and expedited transition of all contract activities by the contract completion date.

4.2 Conduct CIRB Reviews (Fixed Unit Price)

1. Create and maintain a review board for the review of minimal risk registry linkage studies.

This will include:

a. identification of a Chair,

b. listing of review board members,

c. process steps and timeline for action by the review board for the initial review and,

d. any subsequent re-review of minimal risk registry linkage studies.

The contractor shall ensure that the review board membership has adequate expertise to review submitted studies. The contractor shall appropriately assign reviewers for each review to be conducted including initial review, amendment review, continuing review, etc. While this is not required to be a standing board, the CIRB shall ensure that appropriately qualified members are available without delaying the review.

2. Coordinate, prepare and distribute meeting packets including agenda and related review materials to CIRB members (which may include members of the VPR-CLS and/or DCCPS leadership teams) in a timely fashion. Timelines to be established with the COR. This shall include but not be limited to:

a. recording attendance,

b. completion of reviewer assignments,

c. review board members conflict of interest, recusal and meeting quorum per the

CIRB SOPs.

3. Document all aspects of the review meetings and prepare minutes of review meetings. The

Contractor shall make review meetings and related documentation available to the COR at the COR’s request.

4. Prepare all correspondence related to CIRB meeting review outcomes, including, but not limited to, drafting outcome letters and sending the drafted letters to the Chair for signature, distributing the letters to the appropriate Study personnel (Study Chair, PI, etc.), copying all relevant staff per request or CIRB SOPs. The contractor shall also utilize the VPR- CLS online system to upload relevant review documents (outcome letters, changes to protocols, etc.) which will facilitate the information being disseminated to all necessary parties.

5. Upload study specific documents to the secure system for storage, including those downloaded from the VPR-CLS online system to be used in the review process. This includes all associated study documents but not limited to:

a. the protocol,

b. correspondence between stakeholders, and

c. any supporting documentation required to render a review and decision.

6. Develop a plan to accommodate fluctuations in the number of minimal risk studies submitted for CIRB review each year. For estimating purposes only, the NCI anticipates the number of studies may increase by at least 25% per year above a starting estimate of 25 studies. Given uncertainty in demand, it’s also possible that the volume of studies falls below this estimate. The contractor should plan for this potential variation.

5.0 OTHER UNIQUE REQUIREMENTS OR CONSIDERATIONS

The Contractor shall maintain full accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) for the duration of this contract.

6.0 PERIOD OF PERFORMANCE

12-months, plus two 12-month Option Periods. See 11.2 “Option to Extend the Term of the Contract”.

7.0 PLACE OF PERFORMANCE

All work shall be performed at the Contractor’s facility.

8.0 CONTRACT TYPE

Time and Materials (T&M)

9.0 PAYMENT SCHEDULE

Task 4.1 “Develop, Implement, and Maintain CIRB Review Processes” will be reimbursed on a Labor Hour basis following the terms of FAR Clause 52.232-7 “Payments under Time-and-Materials and Labor- Hour Contracts.” The Contractor shall invoice monthly pursuant to the Invoice Instructions in the contract.

Task 4.2 “Conduct CIRB Reviews” will be reimbursed on a Fixed Unit Price basis per completed study review For the purposes of FAR Clause 52.232-7 “Payments under Time-and-Materials and Labor-Hour Contracts” costs associated with “Conducting CIRB Reviews” shall be treated as an Other Direct Cost.

The NCI anticipates 25 studies during the first 12-month period. The NCI may increase the number of studies at the unit price specified as described in Section 11.1 “Option for Increased Quantity”.

NET 30 days from date of invoice. Payment shall be made in monthly increments after satisfactory completion and acceptance of the deliverables stated in Section 10.0. The Contractor shall be paid after satisfactory completion and acceptance of work provided. Payment authorization requires submission and approval of invoice to the NCI COR and NIH OFM Commercial Accounts per the attached Invoice and Payment Provisions. A copy of each invoice should be e-mailed to the NCI COR’s contact information on the first page of the order.

10.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

Deliverables shall be sent via e-mail to the NCI Branch B Invoice and Deliverables Mailbox at ncibranchbinvoices@mail.nih.gov and cc’ing the Contracting Officer’s Representative in a Microsoft compatible format.

DELIVERABLE SCHEDULE

SOW

Section Name Description Submission Schedule

4.1.4 CIRB SOPs Provide a written description of the

expedited review process (SOPs) for the review of minimal risk registry linkage studies.

45 days after contract award.

Any modifications or new SOPs are required to be submitted at the time the SOP is completed.

4.1.5 Revisions to

CIRB SOPs

Provide a written description of any changes anticipated to study review activities, processes, operations, etc.

30 days after the release or posting of any draft changes to relevant rules.

mailto:ncibranchbinvoices@mail.nih.gov based on changes to OHRP rules or other applicable rules or laws.

4.1.6 List of CIRB

Review Board Members

Provide a list of potential reviewers that may participate on a review board for minimal risk registry linkage studies, including identification of board chair, along with relevant background or specialty information.

15 days after contract award and when the list of reviewers changes.

4.1.8 Tracking

statistics elements

Provide a written description of the various tracking statistics captured for assessing the performance of the CIRB for submitted studies, identifying how and what elements will be tracked.

15 days after contract award and when the list of elements changes.

4.1.10 Web site plan Provide a written plan for the posting

and promotion of VPR-CLS activities and review statistics on the CIRB’s web site. The web site plan will inform the COR of how the contractor shall post and promote minimal risk registry linkage study activity on its web site.

15 days after contract award or whenever the plan needs to change.

4.1.14 AAHRPP

Accreditation

Provide evidence of current AAHRPP accreditation. The contractor shall also provide a written plan for the re-accreditation effort should the need for re-accreditation occur during the time this contract is in effect.

At time of award for evidence of current accreditation status. Re-accreditation plan shall be submitted when the plan is developed. The contractor shall notify the COR immediately if there is any change in its AAHRPP accreditation status.

4.1.15 Transition Plan To identify and document contractor

succession plan.

Within six months of award.

4.2 Monthly

Report See below. Due on or before the 5th calendar day following each reporting period.

4.2 Final Report See below. Within 30 days of contract

completion. A Monthly Report will not be required for the period when the Final Report is due.

Monthly Report This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. Reports shall be due on or before the 5th calendar day following each reporting period.

The Monthly Report shall include the tracking statistics as well as other pertinent information, to be determined between the COR and the Contractor, representing CIRB activity related to submitted studies on a monthly basis or upon request to the COR. It is expected that this report will include, but not be limited to:

• Program status, to include objectives met, work completed and work outstanding

• Notable achievements

• Issues or obstacles impeding progress and recommended solutions

• Status of deliverables/milestones

• Reporting on tracking statistics and related activity

• Issues and resolutions

• Resource planning/status

• Description of work completed and plans for next month including anticipated travel

Final Report This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved, to be determined between the COR and the Contractor. A Monthly Report will not be required for the period when the Final Report is due.

11.0 OPTION CLAUSES:

1. FAR 52.217-7 Option for Increased Quantity -- Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor at any time during the contract performance. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of Clause)

2. FAR 52.217-9 Option to Extend the Term of the Contract (March 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor prior to contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed three (3) years.

(End of Clause)