RFP NHLBI-HV-13-06 Attachments 1-4 and 14.pdf

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RFP No. NHLBI-HV-13-06 Attachment 3 – Statement of Work 05/08/2012 HCHS-SOL – Field Centers Page 1 of 31

HISPANIC COMMUNITY HEALTH STUDY – STUDY OF LATINOS (HCHS-SOL)

RFP No.: NHLBI-HV-13-06

STATEMENT OF WORK – Field Centers

BACKGROUND

The Hispanic Community Health Study-Study of Latinos (HCHS-SOL) began in 2006, and a baseline examination was conducted between 2008 and 2011 among over 16,000 Hispanics/Latinos, ages 18-74 years, living in four U.S. communities: San Diego, CA; Chicago, IL;

Miami, FL; and the Bronx, NY. The cohort includes Hispanics/Latinos who self-identified their origin or heritage as Mexican (41%), Puerto Rican (17%), Cuban (15%), Dominican (9%), and Central or South American (18%). The baseline examination aimed to estimate the prevalence of major cardiovascular and pulmonary diseases (CVPD) and their risk (or protective) factors, and the prevalence of other chronic conditions including hypertension, diabetes, obesity, hearing impairment, neurocognitive disorders, dental and periodontal disease, and sleep disorders, among others. Since 2009, the cohort has been contacted annually (retention rate = 85%) to ascertain clinical CVPD events. The cohort has been prospectively followed to assess changes in health status (new diagnoses and CVPD risk factors), and visits to the emergency room, hospitalizations and deaths due to CVPD, and all-cause mortality. Preliminary baseline cross-sectional analyses (based on 2/3 of the cohort) have been presented in several scientific meetings. Publications of final cross-sectional analyses are underway. Study protocols and manuals of operations implemented during the last contract period can be found in the study website www.cscc.unc.edu/hchs, under “About the Study/Public Manuals and Docs”. The study design and sampling design publications are attached under Section III - References.

Preliminary analyses from the baseline examination disclosed: (1) less than 40% of Hispanics with hypertension have it well controlled; (2) a higher overall prevalence of diabetes mellitus than previously reported among Hispanics in the U.S.; (3) within the cohort, a higher prevalence of diabetes among Puerto Ricans, and a lower prevalence among Cubans; (4) greater than 30% prevalence of pre-diabetes across groups; (5) 50% prevalence of cigarette smoking among Puerto Rican men and women, the highest across groups; (6) higher prevalence of asthma and COPD among Puerto Ricans; and (7) no relationship between years living in the U.S. (whether a lifetime or first generation immigrant) and prevalence of diabetes. In addition, sleep apnea across groups is associated with obesity, diabetes mellitus, hypertension and chronic lung diseases.

Given the high prevalence of specific cardiovascular and pulmonary risk factors and disease, and the differences across groups, further study of the relationships between risk (or protective) factors and disease onset, morbidity, and mortality among Hispanics is needed. A larger number of CVPD events that will result from a longer period of follow-up will increase the statistical power for analyses in age- and gender-specific subgroups. Additional data collection will explore how acculturation changes overtime (in this primarily first generation immigrant http://www.cscc.unc.edu/hchs

RFP No. NHLBI-HV-13-06 Attachment 3 – Statement of Work 05/08/2012 HCHS-SOL – Field Centers Page 2 of 31 cohort) and how this change interacts with health status in Hispanic groups with such distinct migratory histories. Finally, further study of this cohort will increase understanding of the impact of socioeconomic factors, including access to and utilization of health care services in the U.S. and outside of the U.S., on changes in CVPD risk and incidence.

I. INTRODUCTION

This contract will extend the Hispanic Community Health Study – Study of Latinos (HCHS- SOL) from June 1, 2013 through May 31, 2019. The scientific aims of the renewal of the HCHS-SOL are to: (1) further investigate the apparent paradox of high socioeconomic adversity, substantial cardiovascular and pulmonary disease (CVPD) risk factor burden, and low CVPD prevalence and mortality in Hispanics; (2) identify putative causes for diseases and conditions highly prevalent in Hispanics (e.g. diabetes, asthma, chronic obstructive pulmonary disease (COPD), left ventricular hypertrophy, and gestational diabetes mellitus);

(3) describe the transformation of health-related risk and protective factors related to migration, acculturation, and length of time living in the U.S.; and (4) assess the impact of changes in socioeconomic factors, cultural values, risk behaviors, and medical care access on health in Hispanics.

The aims stated above will be accomplished through contracts by the National Heart, Lung, and Blood Institute (NHLBI) with four Field Centers, one Coordinating Center and an Echocardiography Reading Center. The Coordinating Center will provide the services for a Central Laboratory and other Reading Centers as needed. Study protocols will be directed by a Steering Committee consisting of the Principal Investigator of each Field Center, the Coordinating Center, the Echocardiogram Reading Center and the NHLBI Contracting Officer’s Representative (COR). Offerors will submit a proposal based on their assessment of the optimal methods. However, after award, standardized protocols will be established by the study Steering Committee, which may be similar or different from those proposed by individual Offerors.

II. SCOPE AND REQUIREMENTS

[Note: The term CVPD is used to refer to CVD (coronary artery disease, heart failure and stroke) and pulmonary disease (asthma or COPD). Peripheral vascular disease will not be assessed in this contract.]

A. Overall Study Tasks, Timeline, Components and Requirements

1. The Program schedule is estimated as follows:

Task Area A – Protocol Development for twelve (13) months

Task Area B - Study Development, Training, and Pilot Testing (12) months

Task Area C – Visit 2, Cohort Follow-up, Data Analyses, and Publications for sixty-six

(66) months

Task Area D – Final Data Analyses, Publications, and Closeout for six (6) months

RFP No. NHLBI-HV-13-06 Attachment 3 – Statement of Work 05/08/2012 HCHS-SOL – Field Centers Page 3 of 31

2. The timeline of the study activities is illustrated below:

Table 1. Overall timeline of study activities

Activities Time Period

Protocol Development Task Area A June 1, 2013 – August 30, 2014 (13 months)

Study Development, Training and Pilot Testing Task Area B December 1, 2013 – September 30, 2014 (12 months)

Office of Management and Budget (OMB) clearance package preparation and submission

December 1, 2013 – December 31, 2013 (1 month)

NIH Project Clearance and OMB review and approval

January 1, 2014 – July 31, 2014 (7 months)

Protocol review by NHLBI and HCHS-SOL Observational Study Monitoring Board (OSMB)

August 1, 2014 – August 22, 2014 (3 weeks)

Staff training and certification August 23 , 2014 – September 12, 2014 (3 weeks)

Pilot testing September 13, 2014 – September 30, 2014 (2 weeks)

Visit 2 Task Area C October 1, 2014 – September 30, 2017 (36 months)

Cohort follow-up, data analyses, & publications June 1, 2013 – November 30, 2018 (66 months)

Final data analyses, publications and close-out Task Area D December 1, 2018 – May 31, 2019 (6 months)

Note: Timeline is accurate to within 2 months. The contract will be funded using Task Orders (See Table 2).

RFP No. NHLBI-HV-13-06 Attachment 3 – Statement of Work 05/08/2012 HCHS-SOL – Field Centers Page 4 of 31

Table 2. Timeline of activities according to the Tasks Area and Funding Schedule

3. Overall study tasks -The scientific aims of this new 6-year contract will be accomplished through eight specific tasks:

a. Continue annual cohort follow-up to identify potential new fatal and non-fatal CVPD events, fatal and non-fatal exacerbations of asthma or COPD, and all-cause fatality events since the last annual follow-up contact; and continue review and adjudication of identified potential fatal and non-fatal CVPD events.

b. Re-examine (Visit 2) the HCHS-SOL cohort to assess changes from baseline (Visit

1) in: (a) cardiovascular risk profile; (b) pulmonary function and respiratory quality of life; (c) neurocognitive function; and (d) socioeconomic and sociocultural factors and acculturation. In addition, at Visit 2, assess cardiac structure and function of participants 45 years of age and older through an echocardiogram.

c. Ascertain at Visit 2 incident gestational diabetes mellitus (GDM) and pre-eclampsia/eclampsia diagnoses occurring since the baseline examination (Visit 1) and adjudicate these events; commence identifying potential new GDM, hypertension during pregnancy and pre-eclampsia /eclampsia cases through annual cohort follow-up contacts, and conduct ongoing review and adjudication of identified potential cases.

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d. Continue providing a platform for ancillary studies funded by other mechanisms and publicizing the potential for these opportunities within the research community.

e. Implement a mentorship program for early career investigators (ECI) from underrepresented groups, especially Hispanics.

f. Continue providing education and information from HCHS-SOL findings to study participants, their communities and the U.S. Hispanic/Latino community at large.

g. Develop innovative hypotheses, perform data analysis, and produce publications from the study.

h. Ensure opportunities for collaborative publication of results with investigators outside the HCHS-SOL.

4. Visit 2 components

Data to be collected through Visit 2 are approximated by the following list of components, which may be modified during protocol development. Unless there is a strong rationale, procedures for repeat measures should be similar to those used for previous data collections in HCHS-SOL. The final protocol as approved by the NHLBI in consultation with the OSMB shall constitute the final content and schedule of the data to be collected. NHLBI anticipates the administration of core questionnaires will take 2 ½ hours and the core clinical procedures will take 2 ½ hours, for an overall Visit 2 duration under 5 hours. See Appendix I for specific components of Visit 2 ..\..\Appendix I Hispanic Community Health Study FC.pdf

5. Collaborating centers

The primary collaborating centers will include six centers: four Field Centers, a Coordinating Center, and the Echocardiography Reading Center. The Coordinating Center will establish an Electrocardiogram (ECG) Reading Center (for digitalized ECG), a Neurocognitive Reading Center, a Pulmonary Reading Center and a Central Laboratory via subcontract. The work scope for each of the other participating centers is specified in the attached Statements of Work (Section III -References).

6. Ancillary studies

The study will serve as a platform for in-depth ancillary studies that are funded through Federal and non-Federal funding mechanisms. An ancillary study is one that is not required in the statement of work, and not funded under the negotiated contract.

The existing policy for ancillary studies will continue and is found at www.cscc.unc.edu/hchs, under “About the Study/Ancillary Studies”.

Submission of ancillary studies proposals by early career investigators (ECI) and investigators from minority groups, especially Hispanics, will be encouraged (Refer to Section II.B.4 – Mentoring Plan).

../../Appendix%20I%20Hispanic%20Community%20Health%20Study%20FC.pdf

RFP No. NHLBI-HV-13-06 Attachment 3 – Statement of Work 05/08/2012 HCHS-SOL – Field Centers Page 6 of 31

B. Task Area A - Protocol Development - The service to be provided within this task area include, but are not limited to, the following:

[Note: From this section forward the terms “Contractor” and “Field Center” are used interchangeably. Also note that the terms Hispanic and Latino have been used interchangeably throughout the text].

1. General Requirements

a. Work cooperatively with other study centers, including the other Field Centers, Coordinating Center, Reading Centers, Central Laboratory and the NHLBI Project Office in all relevant aspects of study development and execution.

b. Conscientiously participate in the Steering Committee and other appropriate study Committees to develop and implement a coordinated plan to achieve the study aims and tasks.

i. During the first year of this contract period, the Steering Committee is expected to meet in person 3 times to plan Visit 2 and design all study protocols. During the rest of the contract period, the Steering Committee will meet in person twice a year in the Washington, DC – Bethesda, MD area (refer to Section L of the RFP).

ii. Including the Principal Investigators, up to 4 key personnel from the Coordinating Center and its subcontractors, 2 representatives from the Field Centers, and 1 representative from the Echocardiography Reading Center may attend the in person meetings.

iii. In addition to the in-person Steering Committee meetings, the Principal Investigators of the Coordinating Center, the Echocardiography Reading Center and each Field Center will attend a yearly meeting with the HCHS-SOL Observational Studies Monitoring Board (OSMB) in the Washington, DC- Bethesda, MD area (refer to Section L of the RFP).

iv. Co-Principal Investigators, Co-Investigators and other scientific consultants or advisors listed under key personnel, and who are receiving salary compensation or consultant fees under the contract, shall demonstrate active participation in the appropriate Committees and other study activities commensurate with their percent effort and role in the study (refer to Section L of the RFP).

c. Conduct data analysis, make presentations at scientific meetings, and submit publications to peer-reviewed journals. Submit abstracts and manuscripts proposed for presentation or publication to the HCHS-SOL Publications Committee and the NHLBI Project Office in accordance with the HCHS-SOL Manuals of Operation and current NHLBI policy. Each Contractor is expected to submit to peer-reviewed scientific journals a minimum of 3 manuscripts for publication per year.

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d. Encourage investigators, especially Hispanic researchers, from within and outside the existing HCHS-SOL sites to participate in data analysis and publications both as collaborators with HCHS-SOL investigators and using the NHLBI Data Repository. The NHLBI data sharing guidelines are found at http://www.nhlbi.nih.gov/funding/datasharing.htm.

e. Prepare and submit technical and financial reports as specified herein.

f. Comply with all required standards of protection of humans participating in research, including HIPAA privacy and disclosure requirements in all participant-related activities.

2. Transition Plans

Offerors shall propose a transition plan detailing transition of the incumbents’ responsibilities. The plan includes but is not limited to transition of all data including plans for confidentiality and security of all data, all existing protocols, documents, minutes, and reports, web sites designated for study investigators (www.cscc.unc.edu/hchs) and for participants (www.saludsol.net), demonstration of offerors knowledge, interaction, communication and involvement in the existing community in which the work is proposed.

a. Implement proposed plan for a smooth and seamless transition of Field Center’s responsibilities from the existing Field Center Contractor.

b. Obtain IRB approval with appropriate consideration for conditions that have been established and existing in the original contract. This should include informed consent conditions agreed to by the participants, and existing IRB approved conditions at the original Coordinating Center.

c. Implement proposed plan for transition of all data from the existing Contractor, including plans for confidentiality and security of all data.

d. Implement proposed plan for transition of all existing protocols, documents, minutes, and reports from the current Contractor.

e. Implement proposed plan on interaction, communication and involvement in the existing community in which work is proposed.

3. Visit 2 Protocol Development

a. Participate in development of the study protocol for Visit 2. See Appendix I for specific components of Visit 2 ..\..\Appendix I Hispanic Community Health Study FC.pdf

b. Ensure that the protocol specifies comparability of repeat measures with those previously collected where trend analysis is planned, including but not limited to http://www.nhlbi.nih.gov/funding/datasharing.htm http://www.cscc.unc.edu/hchs http://www.saludsol.net/

RFP No. NHLBI-HV-13-06 Attachment 3 – Statement of Work 05/08/2012 HCHS-SOL – Field Centers Page 8 of 31 blood pressure, body weight, BMI, percent body fat, waist and hip circumference, glucose and lipid metabolism, pulmonary function, neurocognitive tests and kidney function.

c. Collaborate with the other HCHS-SOL Field Centers and the Coordinating Center in the development of an informed consent template with common language for all Field Centers and that complies with all required standards.

d. Obtain provisional IRB approval of the study protocol and consent form.

e. Assist the Coordinating Center as necessary in identifying reading center and expert teams for the ECG; pulmonary function; neurocognitive function; GDM, and pre-eclampsia/eclampsia; sociocultural; and other examination components.

f. Provide one facility and qualified bilingual staff necessary for conduct of Visit 2.

Visit 2 should take place at only one facility per Field Center.

g. Identify one or more physicians to be available for consultation regarding findings of potentially abnormal clinically relevant (especially urgent findings) derived from any of the study procedures.

h. Obtain equipment needed to conduct Visit 2 as specified in the Visit 2 protocol.

i. Echocardiogram machines will be provided by NHLBI. Warranty and maintenance fees for the echocardiogram machines shall be included in the Field Center’s budget.

ii. For other exam components, utilize equipment previously used during Visit 1.

iii. The Offeror shall include the purchase or transfer of necessary equipment from an original Field Center in the budget, as necessary.

4. Mentoring of Early Career Investigators (ECI)

a. Design and execute a plan for mentorship of a minimum of 3-4 early career investigators (ECI).

i. ECI (especially investigators of Hispanic origin) can be at different stages of training or career development, including graduate school, medical school, post-doctoral and junior faculty levels.

ii. The ECI could be affiliated with the Field Center’s academic institution or outside institutions.

iii. Mentoring of outside ECI is strongly encouraged.

iv. Mentoring can be performed by the Field Center Principal Investigator and/or other Co-Investigators and other appropriate research faculty.

RFP No. NHLBI-HV-13-06 Attachment 3 – Statement of Work 05/08/2012 HCHS-SOL – Field Centers Page 9 of 31

v. The plan should describe:

1. The projected number and level of ECI that will be mentored during this contract period.

2. The content, format, and duration of mentoring.

3. Potential mentors in the Field Center and their areas of expertise.

4. Metrics of success (for example, proposal of ancillary studies and their submission as grant applications for funding, proposal of specific analyses and publications, number of publications, thesis proposal, faculty appointment, presentations at regional or national scientific meetings leading toward manuscript development and publication, active leadership in regional or national organizations).

b. Submit a report on the progress of the mentoring plan and each mentee to the Career Development Committee as requested, and to the COR as part of the annual Progress Report (Deliverables).

5. Community Relations

a. Design and execute a plan to continue community relations to enhance communication of study progress and findings to study participants, their communities and the U.S. Hispanic/Latino population at large.

i. Describe objectives, strategies, a specific timeline for the activities proposed, and an evaluation of the effectiveness of the proposed activities.

ii. Where possible, engage participation or input from local community leaders and/or organizations.

iii. Provide letters of endorsement or support from local community organizations and/or leaders, which state the specific activity endorsed or supported.

iv. Include rationale and justification for proposed purchases or activities that will require subcontracts (e.g. public relations campaign, retention video, printing of banners or posters, purchase of phone cards, etc). Include at least 3 quotes for each purchase or subcontract proposed.

b. Submit a report on the progress of the proposed community relations plan to the Community Relations Committee as requested, and to the COR as part of the deliverables.

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6. Operational and Scientific Coordination

a. Participate fully as a member of the Steering Committee and other study Committees in developing and implementing the new study protocols and data collection instruments required for this renewal, providing expertise in cardiovascular epidemiology and other disciplines needed for the work scope described herein.

b. Cooperate with the Coordinating Center requests for information and communications concerning publications or study decisions.

c. Provide information to the Coordinating Center for HCHS-SOL OSMB reports and deliver presentations to the HCHS-SOL OSMB as directed by the COR.

7. Data Entry, Transmittal, and Management

a. Send at intervals specified in the study protocol to be agreed upon and approved by the Steering Committee, all cohort data to the Coordinating Center. Perform local computer data entry for these data, using only systems provided by the Coordinating Center.

b. Use the system recommended or provided and maintained by the Coordinating Center for participant data entry and transfer from Field Centers to the Coordinating Center or Reading Centers (when appropriate).

c. Cooperate with the Coordinating Center to ensure installation and proper operation of any microcomputer hardware and software.

d. Cooperate with the Coordinating Center quality control and quality assurance activities, including pursuing missing data and correctable errors. The Contractor shall implement corrective action as needed and maintain logs of problems and their solutions.

Use of locally designed and/or alternative software that interferes with the data transmission to the Coordinating Center will not be allowed. Transmission of study data to the Coordinating Center takes precedence over locally designed or alternative technology, and shall follow the guidelines described in the Data Management Manual of Operations (to be developed by the Coordinating Center).

8. Data Analysis and Publications

a. Contribute to the analysis, interpretation, presentation and publication of research results from the study.

i. Provide both scientific and methodological expertise for analyzing and publishing important findings related to HCHS-SOL study objectives in peer-

RFP No. NHLBI-HV-13-06 Attachment 3 – Statement of Work 05/08/2012 HCHS-SOL – Field Centers Page 11 of 31 reviewed journals, sharing the leadership for these manuscripts in collaboration with both other HCHS-SOL investigators and outside investigators.

b. Lead the writing and submission for publication to peer-reviewed scientific journals of a minimum of three (3) manuscripts per year.

NOTE: For proposal purposes, the offeror shall provide the estimated costs for the first task order (Task Order 1) for the work described in Task Area A. Task Area A will be 13 months in duration. Note that the minimum order requirement under the resulting contract will be for the negotiated amount of Task Order 1. See Section

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C. Task Area B - Study Development, Training, and Pilot Testing - The service to be provided within this task area include, but are not limited to, the following:

[Note: General Requirements item a – f are the same as in Task Area A and additional items g – k are required to be completed as well. Items g – k are bolded.]

1. General Requirements

a. Work cooperatively with other study centers, including the other Field Centers, Coordinating Center, Reading Centers, Central Laboratory and the NHLBI Project Office in all relevant aspects of study development and execution.

b. Conscientiously participate in the Steering Committee and other appropriate study Committees to develop and implement a coordinated plan to achieve the study aims and tasks.

i. The Steering Committee will meet in person twice a year in the Washington, DC – Bethesda, MD area (refer to Section L of the RFP).

ii. Including the Principal Investigators, up to 4 key personnel from the Coordinating Center and its subcontractors, 2 representatives from the Field Centers, and 1 representative from the Echocardiography Reading Center may attend the in person meetings.

iii. In addition to the in-person Steering Committee meetings, the Principal Investigators of the Coordinating Center, the Echocardiography Reading Center and each Field Center will attend a yearly meeting with the HCHS-SOL Observational Studies Monitoring Board (OSMB) in the Washington, DC- Bethesda, MD area (refer to Section L of the RFP).

iv. Co-Principal Investigators, Co-Investigators and other scientific consultants or advisors listed under key personnel, and who are receiving salary compensation or consultant fees under the contract, shall demonstrate active participation in the appropriate Committees and other study activities commensurate with their percent effort and role in the study (refer to Section L of the RFP).

c. Conduct data analysis, make presentations at scientific meetings, and submit publications to peer-reviewed journals. Submit abstracts and manuscripts proposed for presentation or publication to the HCHS-SOL Publications Committee and the NHLBI Project Office in accordance with the HCHS-SOL Manuals of Operation and current NHLBI policy. Each Contractor is expected to submit to peer-reviewed scientific journals a minimum of 3 manuscripts for publication per year.

d. Encourage investigators, especially Hispanic researchers, from within and outside the existing HCHS-SOL sites to participate in data analysis and publications both as collaborators with HCHS-SOL investigators and using the

RFP No. NHLBI-HV-13-06 Attachment 3 – Statement of Work 05/08/2012 HCHS-SOL – Field Centers Page 13 of 31

NHLBI Data Repository. The NHLBI data sharing guidelines are found at http://www.nhlbi.nih.gov/funding/datasharing.htm.

e. Prepare and submit technical and financial reports as specified herein.

f. Comply with all required standards of protection of humans participating in research, including HIPAA privacy and disclosure requirements in all participant-related activities.

g. Collaborate with the other HCHS-SOL Field Centers to finalize the informed consent form with common language for all Field Centers and that complies with all required standards, including HIPAA privacy and disclosure requirements.

h. Obtain approval from the Institutional Review Board to conduct the study.

i. Plan and participate in central training sessions for clinical staff, based on draft protocols developed and approved by the Steering Committee.

i. Work cooperatively with the Reading Centers, Central Laboratory and Coordinating Center in technician training activities.

ii. Ensure that certified clinical staff and technicians are available to perform all Visit 2 components.

j. Perform pilot testing for Visit 2 after training is complete, consisting of performing all of Visit 2 components according to the Manuals of Operations, including volunteers at each Field Center who are not study participants.

i. The pilot tests shall include shipping blood and urine samples to the Central Laboratory and transmitting images and data to the Reading Centers, Central Laboratory, and Coordinating Center.

k. Inform participants about Visit 2 through the quarterly newsletter (refer to www.saludsol.net for examples) already established by the Retention and Follow-Up Committee, and other retention strategies proposed by the Field Center and/or the Retention and Follow-Up Committee.

2. Cohort Follow Up and Event Classification

a. Contact all surviving HCHS-SOL cohort members annually beginning in April 2013 to update personal information, and ascertain vital status, changes in health status, fatal and non-fatal CVPD, GDM, pre-eclampsia and eclampsia events following the established (or updated) protocol and annual follow-up (AFU) procedures www.cscc.unc.edu/hchs, under “About the Study/Public Manuals and Docs /Manual 3 – Retention, and Manual 16 - Follow-Up”.

http://www.nhlbi.nih.gov/funding/datasharing.htm http://www.saludsol.net/

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i. Develop a local plan to maintain an annual cohort retention rate as high as possible throughout the period but over 80% at a minimum.

1. Additional contacts and other strategies to maintain a local retention response rate ≥ 80% can be incorporated into the plan. Examples of these strategies include activities that have been implemented in the first contract period (e.g. birthday cards, holiday cards, annual SOL family day, and others). Proposal of other innovative and cost-effective strategies that will maintain the retention across participant age groups and genders is encouraged.

b. Ascertain vital status, changes in health status (including new diagnoses, medication profile, etc), pregnancies and deliveries, emergency room (ER) visits, hospitalizations, and deaths.

i. Obtain copies of medical records of potential events to be adjudicated (named below) and, if necessary, information from physicians, coroner reports, lay informants and other sources, as established by the Endpoints Committee (www.cscc.unc.edu/hchs, under “About the Study/Public Manuals and Docs/Manual 15 – Endpoints”).

1. Obtain discharge diagnosis and procedure codes for all hospitalizations and ER visits, and death certificates for all deaths.

2. Obtain copies of hospital records of fatal and non-fatal MI, heart failure, stroke, exacerbation of asthma or COPD, GDM, pre-eclampsia or eclampsia events that required hospitalization.

3. Obtain copies of medical (outpatient) records of GDM or pre-eclampsia or other events in situations in which these conditions were diagnosed or treated exclusively in outpatient settings.

4. Obtain copies of ER records of exacerbation of asthma or COPD that required ER care.

5. De-identify all collected record copies and forward to the Coordinating Center for record abstraction and event review, adjudication and classification, as per protocol established in the first contract period.

c. Keep participant consent for events investigations (e.g. medical release) current.

d. Provide one or more qualified physicians to participate in the Endpoints Committee to review adjudicate and classify the events mentioned above.

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e. Implement quality control procedures to maintain high quality follow-up, investigation, and validation of events according to the Endpoints Committee protocol and as recommended by the Coordinating Center.

f. Work with the Endpoints Committee and the Coordinating Center (upon approval of the Steering Committee) on any necessary modifications of the contents of the AFU interview and incorporate revisions into the study protocol.

g. Work in collaboration with the Coordinating Center and other Field Centers to complete identification and adjudication of events occurring until September 30, 2018.

h. In the annual progress report, include a description of the Field Center’s Principal Investigator’s efforts and accomplishments on establishing communication with the Office of Medical Records and Privacy Officers of hospitals and clinics from which medical records will be requested.

3. Mentoring of Early Career Investigators (ECI) [Note: Same as described under Task Area A, Section II.B.4]

a. Design and execute a plan for mentorship of a minimum of 3-4 early career investigators (ECI).

i. ECI (especially investigators of Hispanic origin) can be at different stages of training or career development, including graduate school, medical school, post-doctoral and junior faculty levels.

ii. The ECI could be affiliated with the Field Center’s academic institution or outside institutions.

iii. Mentoring of outside ECI is strongly encouraged.

iv. Mentoring can be performed by the Field Center Principal Investigator and/or other Co-Investigators and other appropriate research faculty.

v. The plan should describe:

1. The projected number and level of ECI that will be mentored during this contract period.

2. The content, format, and duration of mentoring.

3. Potential mentors in the Field Center and their areas of expertise.

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4. Metrics of success (for example, proposal of ancillary studies and their submission as grant applications for funding, proposal of specific analyses and publications, number of publications, thesis proposal, faculty appointment, presentations at regional or national scientific meetings leading toward manuscript development and publication, active leadership in regional or national organizations).

b. Submit a report on the progress of the mentoring plan and each mentee to the Career Development Committee as requested, and to the COR as part of the annual Progress Report (Deliverables).

4. Community Relations [Note: Same as described under Task Area A, Section II.B.5]

a. Design and execute a plan to continue community relations to enhance communication of study progress and findings to study participants, their communities and the U.S. Hispanic/Latino population at large.

i. Describe objectives, strategies, a specific timeline for the activities proposed, and an evaluation of the effectiveness of the proposed activities.

ii. Where possible, engage participation or input from local community leaders and/or organizations.

iii. Provide letters of endorsement or support from local community organizations and/or leaders, which state the specific activity endorsed or supported.

iv. Include rationale and justification for proposed purchases or activities that will require subcontracts (e.g. public relations campaign, retention video, printing of banners or posters, purchase of phone cards, etc). Include at least 3 quotes for each purchase or subcontract proposed.

b. Submit a report on the progress of the proposed community relations plan to the Community Relations Committee as requested, and to the COR as part of the deliverables.

5. Operational and Scientific Coordination [Same as described under Task Area A, Section II.B.6]

a. Participate fully as a member of the Steering Committee and other study Committees in developing and implementing the new study protocols and data collection instruments required for this renewal, providing expertise in cardiovascular epidemiology and other disciplines needed for the work scope described herein.

b. Cooperate with the Coordinating Center requests for information and communications concerning publications or study decisions.

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c. Provide information to the Coordinating Center for HCHS-SOL OSMB reports and deliver presentations to the HCHS-SOL OSMB as directed by the Contracting Officer’s Representative.

6. Data Entry, Transmittal, and Management [Same as described under Task Area A, Section

II.B.7]

a. Send at intervals specified in the study protocol to be agreed upon and approved by the Steering Committee, all cohort data to the Coordinating Center. Perform local computer data entry for these data, using only systems provided by the Coordinating Center.

b. Use the system recommended or provided and maintained by the Coordinating Center for participant data entry and transfer from Field Centers to the Coordinating Center or Reading Centers (when appropriate).

c. Cooperate with the Coordinating Center to ensure installation and proper operation of any microcomputer hardware and software.

d. Cooperate with the Coordinating Center quality control and quality assurance activities, including pursuing missing data and correctable errors. The Contractor shall implement corrective action as needed and maintain logs of problems and their solutions.

Use of locally designed and/or alternative software that interferes with the data transmission to the Coordinating Center will not be allowed. Transmission of study data to the Coordinating Center takes precedence over locally designed or alternative technology, and shall follow the guidelines described in the Data Management Manual of Operations (to be developed by the Coordinating Center).

7. Data Analysis and Publications [Same as described under Task Area A, Section II.B.8]

a. Contribute to the analysis, interpretation, presentation and publication of research results from the study.

i. Provide both scientific and methodological expertise for analyzing and publishing important findings related to HCHS-SOL study objectives in peer-reviewed journals, sharing the leadership for these manuscripts in collaboration with both other HCHS-SOL investigators and outside investigators.

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D. Task Area C – Visit 2, Cohort Follow-up, Data Analyses, and Publications - As protocols are approved, task orders will be issued accordingly. The services provided within this task area include, but is not limited to, the following:

1. General Requirements

a. Work cooperatively with other study centers, including the other Field Centers, Coordinating Center, Reading Centers, Central Laboratory and the NHLBI Project Office in all relevant aspects of study development and execution.

b. Conscientiously participate in the Steering Committee and other appropriate study Committees to develop and implement a coordinated plan to achieve the study aims and tasks.

i. The Steering Committee will meet in person twice a year in the Washington, DC – Bethesda, MD area (refer to Section L of the RFP).

ii. Including the Principal Investigators, up to 4 key personnel from the Coordinating Center and its subcontractors, 2 representatives from the Field Centers, and 1 representative from the Echocardiography Reading Center may attend the in person meetings.

iii. In addition to the in-person Steering Committee meetings, the Principal Investigators of the Coordinating Center, the Echocardiography Reading Center and each Field Center will attend a yearly meeting with the HCHS-SOL Observational Studies Monitoring Board (OSMB) in the Washington, DC- Bethesda, MD area (refer to Section L of the RFP).

iv. Co-Principal Investigators, Co-Investigators and other scientific consultants or advisors listed under key personnel, and who are receiving salary compensation or consultant fees under the contract, shall demonstrate active participation in the appropriate Committees and other study activities commensurate with their percent effort and role in the study (refer to Section L of the RFP).

c. Conduct data analysis, make presentations at scientific meetings, and submit publications to peer-reviewed journals. Submit abstracts and manuscripts proposed for presentation or publication to the HCHS-SOL Publications Committee and the NHLBI Project Office in accordance with the HCHS-SOL Manuals of Operation and current NHLBI policy. Each Contractor is expected to submit to peer-reviewed scientific journals a minimum of 3 manuscripts for publication per year.

d. Encourage investigators, especially Hispanic researchers, from within and

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NHLBI Data Repository. The NHLBI data sharing guidelines are found at http://www.nhlbi.nih.gov/funding/datasharing.htm.

e. Prepare and submit technical and financial reports as specified herein.

f. Comply with all required standards of protection of humans participating in research, including HIPAA privacy and disclosure requirements in all participant-related activities.

2. Recruitment

Recruit (contact and schedule visits), obtain signed informed consent, and conduct Visit 2 examination for all available cohort survivors with procedures and questionnaires described in Section II.A.4, and as outlined in the final Visit 2 protocol to be developed by the study.

a. Coordinate entry and transmission of participants’ data according to the guidelines provided by the Coordinating Center and/or Reading Centers.

b. Provide for handling of collected blood and urine specimens, including refrigerated centrifugation, laboratory procedures for sample preparation, temporary storage at low temperature, and shipping with dry ice to the Central Laboratory, according to the approved protocol. Also provide for preparation of samples for long-term storage and future measurements of additional biomarkers at the Central Laboratory according to the approved protocol.

c. During the examination follow the participants’ safety guidelines, as per the Study Protocol that can be found in www.cscc.unc.edu/hchs, under “About the Study/Public Manuals and Docs”/Manual 2 – Field Centers Procedures, Section 27.

d. Perform local quality assurance and control activities, according to established study procedures to assure high quality data collection (www.cscc.unc.edu/hchs, under “About the Study/Public Manuals and Docs/Manual 12”).

i. Site visits led by a Coordinating Center representative will be conducted as needed in concurrence with the NHLBI COR during Visit 2 period to assure compliance with study standards.

e. A representative from the Echocardiography Reading Center and a representative from one Field Center who is directly involved in Visit 2 examination activities (for example, a Clinic Manager or someone of comparable level of leadership) shall participate in these site visits.

f. Perform data entry and initial verification and correction of the entered data using software provided by the Coordinating Center.

http://www.nhlbi.nih.gov/funding/datasharing.htm

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g. Ensure that data transmission from the Field Centers to the Coordinating Center takes place within the specified timeline and following the same protocol agreed upon and approved by the Steering Committee.

h. Follow the same study protocol as all other Field Centers, as agreed upon and approved by the Steering Committee.

i. Include in the budget a total reimbursement for transportation, childcare and mobile phone charges expenses incurred during Visit 2 and annual follow-up interviews of up to $150 for each participant. This total reimbursement will be made available to HCHS-SOL participants only (not to friends, proxies, relatives or family members) upon completion of Visit 2 procedures, and completion of each annual follow-up interview, and will be divided accordingly. This reimbursement will be exclusive of incentives associated with ancillary studies.

3. Notification of Individual Results and Medical Referrals

a. In collaboration with the Coordinating Center, follow the participants safety guidelines described in the study protocol (Manual 2), and follow recommendations regarding referrals to urgent, emergency or outpatient care accordingly, and as recommended by physicians at the Field Center.

b. In collaboration with the Coordinating Center, Reading Centers, Central Laboratory and relevant Committees, provide clinically relevant results (including genetic research results) and an indication of any abnormalities of clinical significance to the participant and, with his/her consent, to his/her physician.

c. Provide participants referrals for follow-up of medically relevant abnormal findings as appropriate. Identify a local network of health care providers or institutions to which participants (especially those with limited financial resources) can be referred if indicated.

4. Cohort Follow Up and Event Classification [Same as described under Task Area B.2]

a. Contact all surviving HCHS-SOL cohort members annually beginning in April 2013 to update personal information, and ascertain vital status, changes in health status, fatal and non-fatal CVPD, GDM, pre-eclampsia and eclampsia events following the established (or updated) protocol and annual follow-up (AFU) procedures www.cscc.unc.edu/hchs, under “About the Study/Public Manuals and Docs /Manual 3 – Retention, and Manual 16 - Follow-Up”.

i. Develop a local plan to maintain an annual cohort retention rate as high as possible throughout the period but over 80% at a minimum.

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1. Additional contacts and other strategies to maintain a local retention response rate ≥ 80% can be incorporated into the plan. Examples of these strategies include activities that have been implemented in the first contract period (e.g. birthday cards, holiday cards, annual SOL family day, and others). Proposal of other innovative and cost-effective strategies that will maintain the retention across participant age groups and genders is encouraged.

b. Ascertain vital status, changes in health status (including new diagnoses, medication profile, etc), pregnancies and deliveries, emergency room (ER) visits, hospitalizations, and deaths.

i. Obtain copies of medical records of potential events to be adjudicated (named below) and, if necessary, information from physicians, coroner reports, lay informants and other sources, as established by the Endpoints Committee (www.cscc.unc.edu/hchs, under “About the Study/Public Manuals and Docs/Manual 15 – Endpoints”).

1. Obtain discharge diagnosis and procedure codes for all hospitalizations and ER visits, and death certificates for all deaths.

2. Obtain copies of hospital records of fatal and non-fatal MI, heart failure, stroke, exacerbation of asthma or COPD, GDM, pre-eclampsia or eclampsia events that required hospitalization.

3. Obtain copies of medical (outpatient) records of GDM or pre-eclampsia or other events in situations in which these conditions were diagnosed or treated exclusively in outpatient settings.

4. Obtain copies of ER records of exacerbation of asthma or COPD that required ER care.

5. De-identify all collected record copies and forward to the Coordinating Center for record abstraction and event review, adjudication and classification, as per protocol established in the first contract period.

c. Keep participant consent for events investigations (e.g. medical release) current.

d. Provide one or more qualified physicians to participate in the Endpoints Committee to review adjudicate and classify the events mentioned above.

e. Implement quality control procedures to maintain high quality follow-up, investigation, and validation of events according to the Endpoints Committee protocol and as recommended by the Coordinating Center.

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f. Work with the Endpoints Committee and the Coordinating Center (upon approval of the Steering Committee) on any necessary modifications of the contents of the AFU interview and incorporate revisions into the study protocol.

g. Work in collaboration with the Coordinating Center and other Field Centers to complete identification and adjudication of events occurring until September 30, 2018.

h. In the annual progress report, include a description of the Field Center’s Principal Investigator’s efforts and accomplishments on establishing communication with the Office of Medical Records and Privacy Officers of hospitals and…