SisterStudy_SOW_Draft_Presolicitation.pdf

DRAFT

STATEMENT OF WORK

THE SISTER STUDY: ENVIRONMENTAL AND GENETIC RISK FACTORS FOR BREAST CANCER

A. Background and Objectives

The Epidemiology Branch, Division of Intramural Research, National Institute of Environmental Health Sciences, National Institutes of Health, Department of Health and Human Services (EB, DIR, NIEHS, NIH, DHHS) will utilize this contract to continue an epidemiological study of environmental and genetic risk factors for breast cancer. This R&D Support services contract is intended to provide the support needed to manage and maintain a cohort of more than 50,000 women, most of whom were enrolled between 2003-2009, from throughout the United States and Puerto Rico, who were between the ages of 35 and 74 at enrollment, and had a sister who had breast cancer. Also included in the cohort follow-up are ~1300 participants in a smaller ancillary study of the sisters with breast cancer. Beginning in 2003, prospective data, including biological and environmental specimens, have been collected to address a wide range of research questions related to women’s health.

The Contractor shall work successfully with diverse and challenging populations, including working with community groups and using best practices for collecting information from and sharing research results with community groups and study participants. The Contractor shall use best practices for recruiting and maintaining high retention rates with diverse populations in long-term studies.

The Contractor shall support the Government by administering, managing, and providing operational support in the conduct of the epidemiological research study designed and supervised by the NIH Principal Investigator (PI) alone or in collaboration with other scientists inside or outside of the NIH, and shall carry out directed analyses of data and biological and environmental samples for ultimate publication by NIH investigators in scientific journals. Contractor activities are described in this Statement of Work and shall include the following areas: maintaining high response and retention rates over follow-up years, collecting, handling, analysis, and tracking of environmental and human biological samples; conducting annual updates of contact information, health and vital status or cause of death;

collecting detailed follow-up data triennially; acquiring medical records or physician verification and pathological details to complement questionnaire data; abstracting, keying, editing, updating and recording data; creating the framework with which to address environmental hypotheses through linkage with geographically-based data systems; assuring the quality, integrity and security of data and samples, facilitating data analysis and collaborative studies, and providing statistical analysis support.

Technical support for this epidemiological research study has been provided under contract HHSN291200445525C, awarded on 23 August 2004 and expiring 22 August 2018. This contract is to continue support of this epidemiological research at the NIH. Data and specimens collected under this contract are the property of the US Government. Data and specimen management responsibilities will be transferred from the current contract to this new contract and/or subsequent contract(s). The data and specimens shall be handled according to the Privacy Act, 5 U.S.C. Subsection (e), within the Epidemiology Branch system of records.

B. Core Task Order Requirements

Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, facilities, and equipment (other than those specified herein) to perform the Statement of Work.

B.1. Continuity of Service

The work to be performed under this contract is a continuation of work presently conducted under contract HHSN291200445525C. In the event of a new contractor, the Contractor shall ensure the orderly, efficient, and safe transition of all contract activities and materials within the first 60 days of contract award. The Contractor shall develop a transition plan to transition all ongoing study activities from the current contract, and assume all responsibilities to conduct the ongoing management of a cohort of up to 60,000 participants.

The Contractor shall be required to integrate or adapt, in accordance with the NIH PI, all study materials and public presence developed and utilized during the prior conduct of the study. The Contractor shall have substantial interaction with the NIEHS Data and Specimen Repository contractor and agrees to exercise best efforts and cooperation in specimen and archive handling responsibilities (see B.2.23).

The continuation of activities under this contract without interruption is important. Upon the expiration of this contract, a successor, either the Government or another Contractor, will continue the study. The Contractor agrees to exercise best efforts and cooperation to effect an orderly and efficient transition to a successor, generally during the final 60 days of the contract.

The Contractor shall, upon the Contracting Officer's or delegate's written (email) notice, (a) furnish phase-in/phase-out services during the last year of the contract period, and (b) negotiate in good faith a plan with a successor to determine the nature and extent of the phase-in/phase-out services required.

The plan shall specify a date for transferring responsibility of each division of work described in the plan, and shall be subject to the Contracting Officer's approval. The Contractor shall provide sufficient experienced personnel during the phase-in/phase-out period to ensure that the services required by this contract are maintained at a high level of proficiency.

B.2. Technical & Research Support

During the course of the contract, the Contractor shall provide the following research support services:

General Research Support

1. Conduct pilot studies, literature reviews, computer searches, or other activities to determine best technologies, state-of-the-art analysis methods and vendors, standard operating procedures, innovations in communication, capabilities of collaborating institutions, and numbers of eligible study subjects; convene focus groups when appropriate; prepare, pretest, evaluate and produce data collection forms and methods.

2. Prepare training programs, operations and procedure manuals, and other required materials for study personnel. Design, develop, modify, standardize, furnish and maintain study forms and documentation and commercial quality materials, such as questionnaires, communications to participants, forms, brochures, shipping kits, media presentations, lab flow sheets, etc. Provide records management, document each step of the study and maintain, in an orderly and accessible manner, all relevant material so that any aspect of the study may be reviewed and evaluated by the PI, COR and other investigators with little or no prior notice.

3. Maintain a log of scientific decisions made during the study that affect the study design, conduct, or analysis. The log may consist of copies of relevant memos and notes from telephone conversations, but must include, at a minimum, a brief explanation and date of the decision and the name of the NIH staff member responsible for the change. All decisions that affect the cost or schedule of the study shall be referred to the COR, in advance, for approval through the CO via appropriate contract procedures.

4. Provide staff or identify consultants with expertise in the conduct of large cohort epidemiology studies, industrial hygiene/occupational exposure coding, medical record abstraction and coding, medication coding, Spanish language translation, participant interviewing, etc. In accordance with the standard practice, during all phases of contact with participants, it is essential that the Contractor match interviewer to participant gender and race whenever possible. This study will collect sensitive data on health outcomes, reproductive history, sexual orientation, and other personal behaviors. Other epidemiology studies have reported that matching interviewers to participants by gender and race significantly improves response rates, particularly among subgroups that are typically under-represented in population research studies.

a. Moorman PG, Newman B, Millikan RC, Tse C-KJ, Sandler DP. Participation rates in a case-control study: The impact of age, race, and race of interviewer. Ann. Epidemiol. 1999; 9:188-95.

b. Catania, J; Binson, D; Canchola, J, Pollack, L, Hauk, W; and Coates, T. Effects of Interviewer Gender, Interviewer Choice, and Item Context on Responses to Questions Concerning Sexual Behavior. Public Opinion Quarterly 60:3:345-370, 1996.

c. Pollner, M. The effects of interviewer gender in mental health interviews. J Nerv Ment Dis. 1998, Jun;

186(6):369-73.

d. Delamater J. Methodological issues in the study of pre-marital sexuality. Social Methods Res. 1974; 3:30–61.

5. Conduct, document and ensure proper study protocol training for and provide oversight of abstractors, interviewers, coders, and others who will acquire and assemble data, records and samples; provide contract staff with required and applicable safety, certification, privacy and ethics training with regard to human subjects research, Health Insurance Portability and Accountability Act (HIPAA) issues, good practices and standard operating procedures for safe handling of personal and private information, and biological and environmental specimens.

6. Provide administrative support and prepare required materials for Institutional Review Board, Certificates of Confidentiality, and other clearances.

7. Provide relevant/affected personnel to attend weekly, monthly and ad hoc staff meetings and to communicate regularly with NIH investigators, and with agents for parties whose cooperation or approval is needed. Maintain the ability to attend frequent in-person, face-to-face single-site meetings with the COR, NIH Principal Investigators, and NIH and multiple other Contractor staff to monitor activities of the study activities being simultaneously conducted. Face-to-face meetings are crucial to ensure that the study protocol and procedures are being carefully followed and modified when problems develop and will ensure the scientific quality of the study. Since many study activities will be receiving support simultaneously, in-person meetings will occur often/weekly with little warning. The following categories of Contractor staff must be able to meet this requirement: Directors, Managers, Analysts and Specialists as needed.

8. Provide administrative support for necessary travel of contract staff to subcontractor and/or collaborator sites for training, meetings, audits, and other travel as required; prior approval by the CO and COR is required. Provide administrative and travel support for ad hoc advisory meetings and teleconferences of relevant individuals, collaborators, consultants, etc. to aid in study design, logistics, or analysis.

9. Provide all deliverables and reports in accordance with the “Reporting Requirements/Deliverables” section of the contract.

10. Upon completion of the Contract, assemble a compendium of all original questionnaires, forms, procedures, operations manual, analyses and other archival study materials to an electronic form suitable for efficient, secure long-term storage. The Contractor shall prepare archival data files for transfer to a designated location at contract completion.

Cohort Maintenance

11. Develop and implement strategies designed to maintain cohort retention and follow-up response rates with full participation from greater than 90% of living participants in a protocol demanding multiple tasks by participants (e.g., completing and returning follow-up questionnaires, medical records release authorizations and other forms). Particular attention shall be paid to retention of participants from lower socioeconomic backgrounds, racial or ethnic minorities, priority age groups, under-represented regions of the country, and groups with high rates of breast cancer and/or high rates of exposure to environmental contaminants.

12. Assume, adapt and maintain a study information website for participants and researchers, with secure data collection and transmission, adhering to federal government policies and guidance, including, but not limited to, compliance with Section 508 of the Workforce Investment Act of 1998, NIH and NIEHS policies, and Privacy Act 5 USC 552a, Rehabilitation Act of 1973, and which follow HHS IMR Policies for usage of web cookies, HHS web standards for usability, clear language, logos, etc.

13. Assist in the development and production of self-administered forms, and complex interviewer-administered and computer-assisted follow-up questionnaires. In addition, the Contractor shall provide advice on technological or other advances in methods for data collection and to maximize participation. The Contractor shall conduct data collection events during the period of performance, with activities such as a brief 1-to-4-page annual contact information and health status update, triennial detailed follow-up questionnaires, and periodic smaller ancillary collections of questionnaire data and/or medical record information.

14. Provide Spanish translation for all material used to correspond with participants:

questionnaires, letters, forms, instructions, website, etc. Provide visual and hearing disability modifications and accommodations for participants.

15. Assemble medical and death records, industrial hygiene, geocoding, diet, reproductive, occupational, environmental monitoring, etc. data and histories; have records evaluated and coded by appropriate nosologists, pathologists, industrial hygienists, clinicians, or other relevant experts and abstractors. For specialized procedures or knowledge not possessed by Contractor staff, develop and manage subcontracts and consultants. CO and COR approvals are required before any subcontract or consultant is awarded. The Contractor will monitor and document the performance and progress of any work done under subcontract in the performance of the study.

16. Identify and validate all new incident cases (~300 per year) of breast cancer in participants over the performance period.

17. Identify and validate other incident cancers, and major health events/diagnoses as specified by the NIH PI.

18. Utilize participant proxy contact information and other available resources to identify incident cancer cases, cases of incapacitation, and deaths in the cohort, and to update addresses and locate persons otherwise lost to follow-up.

Data Support

19. Following designs and decisions of the NIH PI, provide reproducible epidemiologic, statistical, genetic, bioinformatics, descriptive and other data analyses specified by the EB investigator:

identify sets of participants from among the cohort to serve as appropriate comparisons for analyses of environmental and biological factors; analyze high dimensional data; provide documentation of each step of data analysis, including initial analysis plan, initial archival data set(s), data changes or edits, analysis programs, tabular results, final data set, and evidence of reproducibility of published data; provide support for and facilitate receipt of data for pooling projects and meta-analyses; provide support for analysis and interpretation of high dimensional “omics” and other data.

20. Assist in developing NIH-compliant data sharing policies, provide systems for tracking data requests and data delivery, and uses of study data and samples; produce publication-quality graphics, tables, and figures as required for scientific publication of study analyses and findings.

“Public use data” shall conform to up-to-date conventions of privacy, including US privacy laws, OMB and NIST standards of data/information security, encryption and masking of Personally Identifiable Information (PII) such that distinguishing individual identity is not revealed.

21. Receive and fulfill analysis dataset requests from internal NIH and external investigators, and Cohort Consortium projects; provide oversight and guidance for analytic programming for summary variable creation in the format requested by each project, updates to original request and additional data required for analysis. Provide data services such as generating tables for collaborator grant applications. Individual requests may include, for example, 300-2,000 variables. Create outcome event algorithms (e.g., that summarize multiple sources to define prevalent and incident diagnoses), and harmonize data from various sources.

22. Provide a FIPS 199 categorization ‘Moderate’ computing center and network under appropriate NIST, DHHS/NIH, FISMA, OMB, and IRB guidelines, integrating quality assurance and quality control of all data collection systems. Computing system shall have an Information System Security Plan, an updated Plan of Action & Milestones (POA&M) list, and a Certification and Accreditation Program. The Contractor shall complete NIH E-Authentication Threshold Analysis (ETA) and NIH E-Authentication Risk Assessment (ERA), and maintain HHS Privacy Impact Assessment(s) (PIAs) for information system. The computing center shall have capabilities and staffing sufficient for management of a system incorporating existing study data files, new data collections, data management, freezer monitoring, laboratory inventory, telephone and web-assisted interviewing, call center(s) and associated technologies, study management systems, archival data storage, analysis programming including genetic/bioinformatics programming, and analysis of high dimensional data, while adhering to relevant federal government laws, policies, standards and guidance, and in compliance with NIH enterprise architecture, with protections for PII and PHI, and appropriate risk management and risk mitigation systems in place.

Laboratory Support

23. The historical collection of ~4M cohort samples are labeled and tracked using BioSpecimen Inventory System (BSI, Information Management Services, Inc., Silver Spring MD). All samples are transferred for long-term storage at the NIEHS Repository (managed under a separate contract); the Contractor is not responsible for providing long-term storage of samples.

Contractor activities include sample coordination data management, inventory of specimens, receiving and processing of specimens for storage, and tracking specimen movement among Contractor, Repository, subcontractor, and collaborator sites.

24. Provide laboratory capabilities for receipt, inventory, processing, fractioning, bar-code labelling, shipping, and tracking of frozen, refrigerated or ambient samples. The laboratory shall maintain adequate and appropriate cold holding (+4°C, -20°C, -80°C, and LN2) for short-term storage during tasks for receiving, processing, packaging and sending out of study samples, and shall provide and implement a 24-hour-per-day emergency plan for freezer/refrigerator failures, including regular maintenance plan, installed temperature-control back-up systems, and notification of the Contractor staff and COR.

25. Research, evaluate and identify appropriate laboratories for conducting sample analyses; develop and monitor subcontracts with analysis laboratories. Provide assembling, tracking, shipping (and aliquoting if needed) requirements for such analyses. Evaluate quality assurance/quality control of laboratory analyses, coordinate data processing needs for analysis results. CO and COR approvals are required before any subcontract is awarded. The Contractor shall monitor and document the performance and progress of any work done under subcontract in the performance of the study.

B.4. Facilities/Equipment

The Contractor shall provide all facilities and equipment not otherwise provided by the Government.

Study activities are conducted simultaneously, with more than 50,000 participants located throughout the US and Puerto Rico. To ensure project success and facilitate management, the Contractor shall create and maintain a centralized coordination site for performing and managing study activities.

A list of Government owned property in use on the current contract which will be transferred to the Contractor is provided herein. The Contractor shall provide the usual office and laboratory equipment and supplies, including any necessary specialized software. If equipment is required which is of no future value to the Contractor, or if unusual equipment is necessary for compatibility with existing or future government systems, the CO may approve its purchase under the Contract. All such items of equipment will be the property of the US Government.

B.5. Travel Requirements

The Project Director shall be responsible for managing subcontracts, which may involve limited travel, when deemed necessary by the NIH Principal Investigator, at the discretion of the COR and upon approval by the CO. The Project Director, or other staff shall also attend meetings with collaborators/consultants when their expertise is needed on study-related issues. Long distance travel for other than the Project Director, Managers, or Coordinators is not likely to be required. Travel costs pertaining to the management of the study will be covered by the Contract. The Government will not provide travel funds associated with attending any professional meetings or training workshops for Contract employees, without prior COR and CO approval.

B.6. Contractor/Subcontractor Responsibility

The Contractor shall provide documentation and plans regarding security, liability and insurance for facilities and participant contact.