NHBLI-ECB-HV-2017-03-TK_Amend__2_11.16.15.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

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Prescribed by GSA FAR (48 CFR) 53.243

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11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

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IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

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Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

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Previous edition unusable

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT CONTINUATION PAGE Page 2 of 4

Note to Offerors: For clarification purposes, the term “Cohort Visit 6” refers to the contract supported exam intended to occur during these revised dates: 1/01/2018 – 9/30/2019.

Item 1. Questions received on or before November

1. For the past renewal, we were allowed to put appendices on a CD. Can we do the same this time?

Response:

No, the technical proposal and appendices should be on 1 cd per the instructions provided and within the page limitations outlined in the RFP.

2. Task 4 (field center) relates to mentoring through diversity supplements. Section B.3. says "The

Contractor shall be reimbursed by the Government in an amount not less than a total of $500 (minimum) nor more than a total of $5,770,000 (maximum) per field center for successful performance of this contract. The maximum includes potential funding through diversity supplements."

The question is whether any diversity supplement funds really come out of the contract total? That is, are they a line item in this budget, or do we try to get supplements later? Typically supplements are additional money, because mentoring a junior person is not as efficient as having an experienced investigator.

Your response: "In response to your question regarding the diversity supplements. They are included in the maximum, but they will be in a separate line item to the total estimated cost of the contract."

Follow-up question: If I include an investigator for diversity, his/her cost comes out of the total cost allocated and is not really a "supplement?"

Response:

The funds for diversity supplements will not be added to the maximum of $5,770,000 per field center.

It is at the discretion of the offeror if an estimate for diversity supplement is needed and those funds should be a separate line item. If you plan to apply for diversity supplements and have had them in the past you may use historical figures for the diversity supplement estimate.

3. The RFP requests field centers continue semi-annual calls. Yet, the suggested FTEs for follow-up interviewers is 1/2 to 1/3 lower than we have needed in the current contract period. Can you explain how we can do the same amount of work with less staff? If the staff is fixed, should we drop semi-annual calls and return to annual calls?

As stated in Attachment #6 of the solicitation package, Additional Proposal Instructions, page 2, “The personnel and levels of effort listed below are for information only and are not to be considered restrictive for proposal purposes. The levels were formulated by NHLBI staff based on prior operations

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT CONTINUATION PAGE Page 3 of 4 of the ARIC field centers.” The levels provided are guidelines, but may differ based on your current institutional needs to achieve the follow-up objectives.

4. Stroke events are listed as an endpoint in the Field Center RFP. Yet, the Field Center RFP lists no stroke abstractor (for Minnesota), nor does either RFP list effort for MMCC stroke reviewers. Please advise.

The personnel and levels of effort listed are for information only and are not to be considered restrictive for proposal purposes. The levels provided are guidelines, but may differ based on your current institutional needs to achieve the stated objectives.

5. To do stroke surveillance the Field Centers will need to continue to receive H-lists (or similar) information from hospitals for identification of cohort events, because we identify a non-negligible proportion of CVD events through hospital surveillance. The suggested Field Center personnel does not include a programmer to verify the accuracy of the H-lists. Furthermore, a key part of Task 1 is continued analysis, and the Field Center RFP does not have programmers or research assistants to do data analysis. We have also already pointed out, in a previous question, that follow-up staff is too low.

May we budget for these seemingly missing staff?

Response:

The personnel and levels of effort listed are for information only and are not to be considered restrictive for proposal purposes. The levels provided are guidelines, but may differ based on your current institutional needs to achieve the stated objectives.

6. Alternatively, can some of the substantial funds available to the Coordinating Center be used as subcontracts to the Field Centers to offset some of these needs?

Some of the Coordinating Center (CC) funds can be used as subcontracts to the field centers to offset some needs, but this would be at the discretion of the CC.

7. More broadly, can a substantial amount of the Coordinating Center funds be used propose sub-contracts to the field centers for components of the EHR feasibility and calibration study?

Some of the Coordinating Center (CC) funds can be used to propose subcontracts to the field centers for certain components of the study, but this would be at the discretion of the CC.

8. On page 107 of the field center RFP, the due date is Nov 13, 2015, but on page 1 is Dec 18, 2015. I believe the coordinating center RFP has a similar inconsistency. Is Dec 18, 2015 the correct due date?

Please see the October 1, 2015 solicitation Amendment. The due dates on both pages were corrected to December 18, 2015.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT CONTINUATION PAGE Page 4 of 4

9. On page 12, Article F.1., please explain, "The period of performance of this contract shall be from

November 15, 2016 through November 14, 2022. This is a six (6) year contract with a five (5) year ordering period of November 15, 2016 through November 14, 2021."

We are unclear what is expected in the sixth year and whether we should budget something.

Response:

The sixth year is to allow adequate time to deliver the final deliverables prior to the expiration of the contract.

10. Article B.3 on page 5 also says, "The costs set forth in this ARTICLE will cover the contract period

November 15, 2016 through November 14, 2022." Yet, there is no task listed in year 6.

Response:

The sixth year is to allow adequate time to deliver the final deliverables prior to the expiration of the contract. No funding should be anticipated in the sixth year.

Item 2. Section F, Article F.2. DELIVERIES, part a. will be modified to have the Task Area 2’s column heading dates to be 8/15/17 to 9/30/19.

Item 3. Section J, Revisions to Attachment #3, “Statement of Work.” See highlighted text.

ATTACHMENT #3

STATEMENT OF WORK – Attachment #3

STATEMENT OF WORK

The Atherosclerosis Risk in Communities (ARIC) Study Field Centers

RFP: NHLBI-ECB-HV-2017-03-TK

I. Background The Atherosclerosis Risk in Communities (ARIC) Study was initiated in 1985 with two components: community-based surveillance and a prospective cohort study. The community surveillance aimed to monitor trends in hospitalized myocardial infarction (MI), fatal coronary heart disease (CHD) in four U.S. communities: Forsyth County, NC; Jackson, MS; suburbs of Minneapolis, MN; and Washington County, MD. Surveillance for hospitalized heart failure (HF) events was added in 2005. The communities were selected to provide data across four (4) geographic locations with a range of mortality rates, in urban, suburban, and rural settings. The cohort study aimed to investigate the risk factors for and natural history of atherosclerosis and development of clinical atherosclerosis in middle-aged white or African American adults from the same communities. The study recruited in 15,792 white or African American participants initially aged 45-64 years and selected participants received triennial clinical exams over the first ten years of the study (1987-1989, 1990-1992, 1993-1995, and 1996-1998), with a fifth clinical exam in 2011-2013, providing a rich set of data on physical, behavioral, genetic, and psychosocial factors. Since 1988, the cohort has been contacted annually and in 2011 semiannual follow-up was initiated. Findings have been presented in over 1,400 publications as of 2014.

Participants were examined for evidence of subclinical atherosclerosis using B-mode ultrasound in carotid and popliteal arteries, ankle-brachial index measurement, and retinal photography and, in subsets, abdominal aortic CT, and hemostatic factors; established and putative laboratory risk markers; socioeconomic, psychological, behavioral, and environmental characteristics; and genetic factors. Examinations included a variety of components, with a grant-funded detailed cognitive function testing component added in the most recent exam during 2011-2013. Blood samples have been assayed for putative biochemical risk factors and stored for case-control studies. DNA has been extracted and lymphocytes cryopreserved (for possible immortalization) for study of candidate genes, genome-wide scanning, expression, and other –omics investigations. Participation of the surviving cohort was 91, 82, 74, and 65% at each of the respective follow-up examinations. Since baseline, cohort members have also been contacted every 12 months to obtain information on vital status, current residence, major illness or injury, and hospitalizations occurring between contacts to identify clinical Cardiovascular Disease (CVD) events. Cohort retention was 84% at the last completed follow-up ending on December 31, 2013.

The ARIC Study has supported a large number and variety of independently funded ancillary studies that have contributed to the data repository a unique set of data, including major ancillary studies on venous thrombosis, aortic aneurysm, cognitive impairment, and genetics. A wealth of data and biological samples has been collected since the study’s inception. Data from the fifth clinical exam conducted in 2011-2013 provide a new baseline for further scientific discoveries. For a list of all phenotypic data documentation and protocols, refer to the ARIC website: https://www2.cscc.unc.edu/aric/ . The ARIC data are available to qualifying investigators directly from the study and also through dbGaP (http://www.ncbi.nlm.nih.gov/gap) and BioLINCC (https://biolincc.nhlbi.nih.gov). A variety of stored biospecimens, including DNA, serum, plasma, and urine are also available to qualifying researchers.

https://www2.cscc.unc.edu/aric/ http://www.ncbi.nlm.nih.gov/gap https://biolincc.nhlbi.nih.gov/

The incumbent contractors for ARIC are presented in Table 1.

Table 1. ARIC Incumbent Contractors for the period 11/15/2010-11/14/2016

Institution Role Contract Number

University of North Carolina at Chapel Hill Coordinating Center HHSN268201100005C

University of North Carolina at Chapel Hill Field Center HHSN268201100007C

University of Mississippi Medical Center Field Center HHSN268201100010C

University of Minnesota Field Center HHSN268201100008C Johns Hopkins University Field Center HHSN268201100009C Baylor College of Medicine Central Laboratory HHSN268201100006C Brigham and Women’s Hospital Echocardiography Reading

Center HHSN268201100011C

University of North Carolina at Chapel Hill

Cardiovascular Outcomes Research Center HHSN268201100012C

This acquisition is for up to four (4) contracts for ARIC field centers. A parallel acquisition is being released for one contract for the ARIC coordinating center with subcontracts or other mechanisms to accomplish all necessary work, including maintenance of existing biological samples.

II. Study Objectives

The goal of this acquisition is to enhance statistical power to perform analyses of predictors of clinical events, particularly in informative subgroups and study the progression of subclinical to clinical CVD, including identification of new risk factors or interactions among factors. The operational goals are to (1) conduct continued cohort follow-up and data collection on clinical events; (2) continue to foster scientific collaborations; and (3) conduct a limited clinical examination of the ARIC participants as a platform for ancillary study examination components.

ARIC will continue to serve as a platform for in-depth ancillary studies that are funded outside of the ARIC contract. These ancillary studies will be operationally integrated into the main study, and the data will be shared per ARIC and NIH data sharing policies. The studies’ data will be provided to qualified investigators through a defined process that encourages maximum data utilization but that protects participant confidentiality.

III. Task Areas, Timeline, and Technical Requirements

A. Task Areas and Technical Requirements/Activities

Task Area 1 shall encompass conduct of core study operations, data analysis, manuscript preparation, and cohort follow-up for morbidity and mortality. [Note to Offerors: For planning purposes, assume approximately 8,150 surviving participants in 2016.] The field center contractors shall contact all surviving and willing members of the ARIC cohort approximately every 6 months throughout the contract period to ascertain hospitalizations and other changes in health status, including changes in medications. The field centers shall obtain hospitalization records to ascertain, review, and classify new clinical events and other changes in health status.

Task Area 2, if funded, will involve a limited examination of the ARIC cohort during 2017-2019.

It is estimated that up to approximately 5,300 participants will be examined. Study closeout activities will comprise Task Area 3. Task Area 4 will include mentoring early stage investigators through diversity supplements. See Table 2 below for a summary of the technical requirements and activities within each Task Area and Figure 1 for a project timeline.

Table 2. Task Areas

Tasks Activities

Task Area 1 November 15, 2016 – November 14, 2021 (60 months)

• Participant follow-up

• Clinical events investigation and classification

• Core study operations

• Data analysis, manuscript writing

Task Area 2 August 15, 2017 – September 30, 2019 (25.5 months)

Cohort Visit 6 (contract-supported visit)

Task Area 2.A August 15, 2017 – December 31, 2017 (4.5 months)

Visit 6 preparation:

• Protocol development and review

• Staff training and certification

• Pilot testing

Task Area 2.B January 1, 2018 – September 30, 2019 (21 months)

• Examination of up to approximately 5,300 ARIC participants

• Visit 6 closeout

Task Area 3 November 15, 2020 – November 14, 2021 (12 months)

Study closeout

Task Area 4 November 15, 2016 – November 14, 2021 (60 months)

Mentoring through diversity supplements

Figure 1. Project Timeline (See changes in timeline for Task Areas 2.A and 2.B.)

11/15/2016 to 11/14/2017

11/15/2017 to 11/14/2018

11/15/2018 to 11/14/2019

11/15/2019 to 11/14/2020

11/15/2020 to 11/14/2021

Task Area 1 Task Area 2 Task Area 2.A Exam protocol development Training, certification Pilot testing Task Area 2.B Visit 6 Exam closeout Task Area 3 Task Area 4

B. General Description of the Overall Technical Requirements: Throughout the period of performance, the Contractor shall provide appropriate senior personnel with expertise in cardiovascular disease epidemiology, clinical cardiovascular disease, longitudinal studies management, biostatistics, and administrative management. The Contractor shall:

1. Conduct regular follow-up contacts of participants. (Task Area 1)

2. Investigate participants’ self-reported clinical events by collecting supporting medical records, death certificates, and other relevant materials; perform abstraction of data from such records required for events ascertainment; and conduct expert review and classification thereof. (Task Area 1)

3. Conduct a re-examination of ARIC participants. (Task Area 2) [Note to Offerors: The NHLBI will determine later whether to award this Task Area.]

4. Conscientiously participate in Steering Committee and appropriate subcommittee meetings to develop and implement a coordinated plan to achieve study objectives. The Principal Investigator shall serve on the ARIC Executive Committee and the Steering Committee. Participate collaboratively in study committees to provide a transparent committee process, open access to study documents, clear policies for study conduct and access to data and materials, and an approval process for proposed manuscripts and ancillary studies that is fair and balanced. (Task Area 1)

5. Conduct statistical analyses and prepare scientific abstracts and manuscripts for presentations and publications. (Task Area 1)

6. Prepare and submit technical and financial reports. (Task Areas 1 and 3)

7. Perform activities related to study closeout as directed by the NHLBI Project Office.

(Task Area 3)

8. Work cooperatively with all study investigators and staff, the NHLBI Project Office, and any subcontractors and consultants in all relevant aspects of the study. (Task Areas 1, 2, and 3)

9. Mentor early stage investigators from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds by providing formal and/or informal training opportunities for junior or inexperienced investigators (assistant professors, fellows, and students). (Task Area 4)

Note to Offerors:

For all years, costs incurred to prepare and distribute analytic data sets and/or biological samples to approved outside investigators must be covered by the investigators and not the contract. Furthermore, when new exam procedures, assays or genotyping in ancillary studies reveal potentially clinically actionable conditions, the costs associated with participant notifications must come from the ancillary studies and not the contract.

C. Detailed Description of Technical Requirements in Each Task Area

1. Task Area 1: During the period November 15, 2016 to November 14, 2021

During this period, the Contractor shall:

A. Conduct participant interviews by phone or other method approximately every 6 months throughout the period to obtain information on hospitalizations for cardiovascular outcome ascertainment and selected exposures of interest to ARIC. To that end:

1. Implement the protocol and procedures for participant follow-up. (See the ARIC

Participant Follow-Up Manual of Operations at https://www2.cscc.unc.edu/aric/annual-follow-up-manuals)

a. Conduct follow-up phone interviews with all surviving ARIC participants (excluding hard refusals) for updated contact information, proxy information, outcomes ascertainment and selected exposures of interest to ARIC.

b. Search state databases of deaths to locate matches for ARIC participants.

Obtain death certificates as appropriate.

2. Propose and implement plans to retain participants and assure participant satisfaction throughout the period of performance.

a. Contribute material for the participant website and the annual participant newsletter

3. Provide participants with answers to participant questions as needed.

4. Maintain security and confidentiality of the data.

5. Maintain and update, as necessary, participant consent and medical authorization forms.

B. Investigate participants’ self-reported clinical events by collecting supporting medical records, death certificates, and other relevant materials; perform abstraction of event data from such records; and provide medical expertise for expert review and classification thereof.

1. Investigate self-reported potential clinical events.

a. Identify, collect, and review records from hospitalizations; physician visits;

death certificates; interviews with family, friends or nursing homes; and any other information used to ascertain the diagnosis of cardiovascular diseases or death in this population. (See the criteria for event ascertainment in the Surveillance Procedures Coronary Heart Disease Manual and the Surveillance Events Heart Failure Manual at https://www2.cscc.unc.edu/aric/surveillance-manuals )

b. Perform abstraction of event-related data from such records.

2. Implement standardized procedures to identify and classify morbid cardiovascular events (including myocardial infarction, angina, stroke, transient ischemic attack (TIA), heart failure, peripheral arterial disease, and atrial fibrillation), cardiovascular interventions, and all mortal events.

a. Each field center shall provide personnel trained and certified to conduct classification and review of events.

3. Maintain confidentiality and security of the data files, and transmit data promptly to the ARIC coordinating center as specified in Study Protocols. Provide data to NHLBI as requested by the Contracting Officer’s Representative.

C. Perform administrative, operational, and technical duties to support productive collaboration among the study personnel, outside researchers collaborating with ARIC, and the NHLBI Project Office.

1. Maintain IRB approval for the study, including cohort follow-up and event investigation.

2. Seek outside investigators to work with ARIC investigators in analyzing the study data, particularly data not yet available through the NHLBI Data Repository. Also, encourage investigators from outside the existing ARIC sites to conduct data analysis and publication of the “public use” data from the NHLBI Data Repository.

Formalize and expand existing plans to facilitate this to include (but not be limited https://www2.cscc.unc.edu/aric/annual-follow-up-manuals https://www2.cscc.unc.edu/aric/surveillance-manuals https://www2.cscc.unc.edu/aric/surveillance-manuals

to) publicizing the ARIC publication policy, the ancillary study mechanisms on the ARIC public website, and the Data Repository data at scientific meetings, or via letters to investigators. Provide data user support and designated staff to respond to inquiries about data or ancillary studies.

Below is for Jackson field center only:

3. Work cooperatively with the Jackson Heart Study investigators in all relevant aspects of study development and execution to minimize the burden to the Jackson participants who enrolled in both ARIC and the Jackson Heart Study and maximize study cost-effectiveness of the study operations.

D. Coordinate and participate collaboratively in study committees to provide a transparent committee process. (See Section IV below for details of the various study committees.)

1. Conscientiously participate in ARIC Steering Committee and appropriate subcommittees to:

a. Optimize study oversight and operations

b. Ensure the safety and privacy of the ARIC participants

E. Prepare and submit technical and financial reports.

1. Submit annual progress reports that include descriptive information about the activities undertaken during the reporting period. Report on:

a. Main operational activities

b. Problems encountered and how they were resolved

c. Modifications to any subcontracts or consulting agreements

d. Scientific productivity, including but not limited to the following metrics:

i. Number of publications

ii. Number of publications in high-profile journals

iii. Number of citations garnered by publications

iv. Number of different first authors on manuscripts and authors from non-ARIC institutions

v. Number of funded ancillary studies

vi. Number of collaborative papers published

vii. Use of data in clinical guidelines or other clinical applications, or to stimulate or guide clinical trials or basic investigations

2. Submit quarterly staffing reports that include for each staff member:

a. Area of responsibility

b. Study-related activities in the previous quarter

c. Proposed and actual levels of effort

d. Explanations of any changes during the period

3. Submit monthly financial invoices, as required by NIH.

F. Work cooperatively with all study investigators and staff, the NHLBI Project Office, and any subcontractors and consultants in all relevant aspects of the tasks listed above. Provide timely responses to specific requests from the NHLBI, Steering Committee, and Observational Study Monitoring Board (OSMB).

2. Task Area 2: On or about August 15, 2017 – September 30, 2019

During this period, the Contractor shall recruit and perform a limited re-examination of all surviving and willing ARIC participants for Visit 6. The targeted recruitment is up to approximately 5,300 participants. This Task Area will be broken down into two smaller Task Areas (Task Areas 2.A and 2.B; see Table 2 and Figure 1): the first will be for exam preparation activities and the second to conduct the exam and exam closeout. The Contractor shall work collaboratively throughout the period with ancillary study investigators and staff to coordinate exam components from multiple funding sources with those of the contract-funded Visit 6. The Visit 6 components and approximate times are listed in Table 3.

Note to Offerors: The NHLBI will determine later whether to fund this specific Task Area.

The exact dates are also subject to change as determined by NHLBI.

Table 3. Cohort Visit 6 components and approximate times

Component Time

Reception, Consent 20 minutes Demographic information 10 minutes Anthropometry 10 minutes Blood pressure 15 minutes Smoking history 5 minutes Medical history, including medications 25 minutes Phlebotomy 15 minutes

A. Task Area 2.A. On or about August 15, 2017 – December 31, 2017, the Contractor shall:

1. Provide qualified staff to participate in planning and preparing for Visit 6.

2. In collaboration with the ARIC Steering Committee and coordinating center, develop a protocol for re-examination of the ARIC cohort. The protocol will be reviewed by the ARIC OSMB. (The protocol for ARIC Visit 5 can be found on the ARIC website at https://www2.cscc.unc.edu/aric/cohort-manuals .)

3. In collaboration with the ARIC Steering Committee and coordinating center, develop a Visit 6 manual of operations based on the protocol.

a. Unless a strong rationale exists to do otherwise, data collection procedures shall be consistent with those used previously in ARIC.

b. Comparability of measures with those from previous examinations must be assured wherever possible.

4. In collaboration with the ARIC Steering Committee or designated sub-committee and the coordinating center, develop standardized informed consent forms across all field centers. Assure inclusion of all required elements.

a. ARIC has a Certificate of Confidentiality for DHHS Funded Studies, which shall be noted in the informed consent forms.

5. Based on the protocol and manual of operations, collaborate with the ARIC coordinating center to plan and participate in central training for clinic staff.

Complete initial certification of performance capabilities of relevant staff.

6. Plan and conduct pilot testing for the examination, including collecting and shipping blood samples to the biospecimen repository. The results shall be reviewed by the ARIC Operations Committee and Steering Committee.

7. Redesign and implement changes in protocol and manual of operations, as recommended by the Operations Committee and approved by the Steering Committee, based on pilot testing results.

https://www2.cscc.unc.edu/aric/cohort-manuals

8. Obtain IRB approvals to conduct the study and provide documentation of IRB approval to the coordinating center.

B. Task Area 2.B. On or about January 1, 2018 – September 30, 2019, the Contractor shall:

1. Provide qualified staff to conduct Visit 6. (See Table 3 for exam component times.)

2. Recruit, obtain informed consent, and examine all surviving and willing ARIC participants in accordance with the finalized Visit 6 protocol.

a. The final blood volume to be collected per participant will be determined by the

Steering Committee and the NHLBI Project Office.

[Note to Offerors: For planning purposes, assume a blood draw volume of approximately 40 cc.]

3. Perform data entry and collaborate with the coordinating center on verification and correction of entered data.

4. Participate with the coordinating center on quality assurance and quality control activities according to established study procedures, as recommended by the Quality Control Committee to assure high quality data collection.

5. Process and transfer collected blood samples to the biospecimen repository for long-term storage.

6. Provide to each participant and, with consent, to his/her health care provider, in a timely fashion (within 4 weeks of examination):

a. A report of clinically relevant exam results

b. An indication of any abnormalities of clinical significance

7. Notify participants of clinically significant abnormalities of that warrant early notification following alert notification procedures established by the Operations and Steering Committees and approved by the OSMB.

8. Report unexpected serious adverse events and other unanticipated problems to IRBs and NHLBI according to NHLBI policy (see the NHLBI Adverse Event and Unanticipated Problem Reporting Policy at https://www.nhlbi.nih.gov/research/funding/human-subjects/adverse-event).

9. Conduct ongoing retraining and recertification of performance capabilities of relevant staff through centralized and/or localized training as needed.

10. Conduct exam closeout and complete data cleaning.

3. Task Area 3: During the period November 15, 2020 – November 14, 2021

A. If required by the NHLBI, participate in transferring the study operations from the incumbent to another entity. To that end, work closely with the new entity to:

1. Provide a smooth and seamless transition of responsibilities to the new entity.

2. Help the new entity to obtain IRB approval with appropriate consideration for conditions that have been established and exist in the current contract, including informed consent conditions agreed to by the participants.

B. Prepare and submit a Final Progress Report and Final Financial Report on or before the completion date of the contract.

1. Summarize the work performed over the entire contract period of performance

2. Include salient results, recommendations and conclusions.

3. Provide sufficient detail to describe comprehensively the results achieved.

https://www.nhlbi.nih.gov/research/funding/human-subjects/adverse-event

4. Task Area 4: During the period November 15, 2016 – November 14, 2021

A. Mentor early stage investigators from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds by providing formal and/or informal training opportunities for junior or inexperienced investigators (assistant professors, fellows, and students), particularly individuals. This includes but is not limited to engaging early stage investigators to work on data analyses and publications and to serve on study committees.

B. The Contractor is encouraged to apply for supplements from available NIH funding opportunities or include ARIC experiences in existing training programs.

IV. ARIC Committee and Management Structure

A. ARIC Steering Committee: This Committee shall consist of the principal investigators from the coordinating center, up to four field centers, the biorepository, as well as the NHLBI Contracting Officer’s Representative. Subcommittees make recommendations to the Steering Committee, which finalizes decisions. The charges to the Steering Committee are to:

1. Develop and approve all aspects of the study protocol.

2. Identify modifications of the study protocol or operational policy as necessary, and recommend changes to NHLBI.

3. Resolve operational problems.

4. Review the coordinating center reports regarding study progress.

5. Advise and assist the study centers and Project Office in the performance of the study.

6. Review ancillary studies for compatibility with ARIC goals, and recommend priorities to the ARIC OSMB and NHLBI.

B. Standing ARIC Sub-Committees: Subcommittees make recommendations to the Steering Committee, which finalizes decisions. The Executive Committee shall comprise at a minimum the principal investigators from the coordinating center, up to four field centers, and the NHLBI Contracting Officer’s Representative; membership in other committees shall be determined by the Steering Committee and the NHLBI Project Office. These committees usually meet monthly by conference call unless otherwise noted. The charges to the specific committees are as follows:

1. Executive Committee:

a. Oversee day-to-day operations of the study as an extension of the Steering Committee to ensure efficient and quality performance.

b. Discuss important issues for presentation, review, and approval by the Steering Committee.

[Note: The Executive Committee holds monthly conference calls, on alternating bi-weekly schedule to monthly Steering Committee calls.]

2. Publications Committee:

a. Develop, disseminate, and enforce policies for proposing and conducting data analyses; establishing authorship and reinforcing responsibilities of authorship; monitoring progress of data analyses; and use of data in abstracts, presentations, and publications.

b. Provide guidance to the coordinating center in the maintenance of the publications data base.

c. Recommend to the Steering Committee priorities for publications and presentations.

d. Review, recommend modifications for, and consider for approval all manuscript proposals and resulting abstracts and manuscripts emanating from the study centers (exclusive of manuscripts resulting from analysis of data obtained via the NHLBI Data Repository).

[Note: The Publications and Presentations Committee holds monthly conference calls.]

3. Ancillary Studies Committee:

a. Develop, disseminate, and enforce policies for proposing and conducting ancillary studies.

b. Review, recommend modifications to the science and logistical conduct, and recommend approval or disapproval of ancillary study proposals to the Steering Committee.

4. Laboratory/Genetics Committee:

a. Develop a protocol for Field Center phlebotomists.

b. In conjunction with the Quality Control Committee, recommend a plan for quality assurance, and develop and recommend methods to assess comparability among centers and to investigate reasons for lack of comparability or unacceptable variability among Field Centers or within a Field Center.

c. Review ancillary study proposal biospecimen requests, recommend modifications as needed, and recommend approval or disapproval to the Ancillary Studies and Steering Committees.

5. Operations Committee:

a. Evaluate recommended examination components in terms of participant burden; operationalize approved examination components.

b. Make recommendations to the Steering Committee regarding methods to minimize participant burden and optimize comfort, interest, and satisfaction.

c. Assure that participant concerns are addressed and ensure maximum participation.

d. Develop methods to train examination staff; plan and execute training for examination procedures; develop procedures for exam technicians to obtain and maintain certification to perform study procedures; plan and monitor the pilot study.

e. Develop the Manual of Operations for clinic operations.

f. Develop system of "alert" values and procedures for providing feedback to and referrals for participants and their health care providers. Oversee timely provision of results to participants and their health care providers.

6. Retention and Follow-up Committee

a. Review regular reports on the status of annual and semi-annual follow-up interviews and propose to the Steering Committee any needed modifications to follow-up protocols.

b. Coordinate and disseminate participant information material to keep participants informed about the study and foster good will.

7. CHD and HF Morbidity and Mortality Committees:

a. Maintain and update as needed the protocol for identifying, evaluating, and quantifying, as feasible and appropriate, cardiovascular events, including (1) clinical event manifestations of coronary heart disease, cerebrovascular disease, congestive heart failure, and atrial fibrillation and (2) clinical diagnostic testing and interventions.

b. Participate in the classification of type and severity of cardiovascular events.

8. Quality Control Committee:

a. In conjunction with the Operations Committee, develop methods to assess accuracy and reliability of examination methods and control variability, including collection of quality control data.

b. Evaluate quality control data, report to the Steering Committee on a regular basis, alert the Steering Committee when reliability or variability are unacceptable, and recommend and oversee further investigation and corrective action, as appropriate.

9. Other Committees:

a. The Steering Committee shall constitute other committees and subcommittees as needed.

V. Other Institutions and Federal Offices: The Contractor and/or ARIC Steering Committee shall report to several boards and offices according to the charge and schedule of each.

A. Contractor Institution

1. Institutional Review Board (IRB)

2. Office of Research Administration

B. National Heart, Lung, and Blood Institute

1. Division of Cardiovascular Sciences (DCVS): The DCVS oversees programmatic aspects of the ARIC contract.

2. Office of Acquisitions (OA) within the Office of Management: The OA oversees contractual aspects of the ARIC contract.

3. ARIC Observational Studies Monitoring Board (OSMB): The ARIC OSMB is appointed by the NHLBI and acts as an independent advisory group to the NHLBI Director. It is responsible for safeguarding the interests of study participants, assessing the safety and efficacy of study procedures, and monitoring the overall conduct of the study. The OSMB reviews the protocols and conduct of the ARIC with regard to protection of participants and to scientific merit. The OSMB typically meets on an annual basis.

C. DHHS Office for Human Research Protections (OHRP): OHRP provides guidance in protection of the rights, welfare, and wellbeing of persons involved in research conducted by

DHHS.

D. The United States Office of Management and Budget (OMB): OMB reviews burden of the ARIC contract on the U.S. public (primarily the ARIC participants and the medical community who provides and documents their health care) under the Paper Reduction Act.