SOURCES SOUGHT
99 -- Centralized Institutional Review Board (CIRB) to Review Minimal Risk Registry Linkage Studies under the Surveillance, Epidemiology, and End Results (SEER) program
- Notice Date
- 5/28/2020 4:40:40 PM
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NIH NCI ROCKVILLE MD 20852 USA
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-SBSS-PCPSB-00087-AM
- Response Due
- 6/12/2020 12:30:00 PM
- Archive Date
- 06/27/2020
- Point of Contact
- Angela Moore, Phone: 2402767767, John Turner, Phone: 2402767756
- E-Mail Address
-
Angela.Moore2@nih.gov, john.turner@nih.gov
(Angela.Moore2@nih.gov, john.turner@nih.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E158, Bethesda, MD� 20892, USA. Introduction:�This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This request is to fulfill a need of the National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS) to contract with a commercial Institutional Review Board (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.� The CIRB is also intended to review DCCPS-funded minimal risk studies. 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 30% of the total US population. SEER receives approximately 450,000 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 work flow, it is expected that the CIRB will also be used for other DCCPS-funded studies utilizing or linking 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. Purpose and Objectives: The purpose of this acquisition 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.� The CIRB is also intended to review DCCPS funded minimal risk studies.� 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 acquisition, 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. Project Requirements: 1.� Have a process in place 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) 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 government 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.� Perform and develop 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, and d. � the process and timelines for the re-review of modified minimal risk registry linkage study protocol, Submissions will be reviewed for completeness and the contractor shall work with the submitting party to resolve any issues around completeness. 4.� Have a plan in place to accommodate an anticipated increase in the number of minimal risk studies submitted for CIRB review.� It is possible that the number of studies can increase by at least 25% per year above the starting estimate of 25 studies.� It is also possible that the volume of studies will fall below estimates and the contractor�s plan should account for that as well. 5.� 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. 6.� 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. 7.� 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. 8.� 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.� 9.� Provide 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. 10.� 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 recommend tracking statistics it is capable of providing.� 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. 11.� 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. 12.� 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. 13.� 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. 14.� 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. 15.� Maintain AAHRPP accreditation for the duration of this contract. 16.� 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. 17.� Participate in VPR related project calls/meetings Period of Performance: 12-Months plus two 12-Month Option Periods Other Considerations: Mandatory Qualification Criteria*: Full Accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). *Mandatory Qualification Criteria establishes conditions that must be met prior to proposal evaluation by the Government following the solicitation for proposals. This Source Sought Notices is NOT a solicitation for proposals. Capability Statement - Submission Instructions:�This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement it may submit a capability statement which shall be considered by the agency. �The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. �Responses must be received in the contracting office by 3:30PM ET, June 12, 2020.� All responses and questions must be in writing and emailed to Angela Moore, Contracting Specialist via electronic mail at Angela.Moore2@mail.nih.gov. �In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference Notice # HHS-NIH-NCI-SBSS-PCPSB-00087-AM on all correspondence. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate.� Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization�s qualifications to perform the work.� Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.� After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities.� However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality:�No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/eab4321bf473463481d78de61755ca93/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN05673993-F 20200530/200528230205 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |