implications of inclusion and exclusion criteria As shown in Table 3.1, according to analyses of the National Health and Nutrition Examination Survey (NHANES) data for 1999-2004, approximately 6% of the US population meets the basic eligibility criteria related to age and SBP, and are free of diabetes and previous stroke. Among that group, approximately 70% meet the risk criteria described above. The vast majority of these individuals have an estimated 10- year risk of CVD exceeding 20% and the population average 10-year risk for CVD is approximately 28%. (Note that the use of the FRS in this manner likely underestimates the risk of those individuals with existing CHD and stage 3 CKD.) This analysis provides evidence that the recruitment pool will be large enough to enable us to recruit successfully and to generalize our ultimate results to a reasonably large proportion of the US population. Table 3.1. Distribution of 10-year risk of CVD in NHANES participants who met basic SPRINT eligibility criteria Criteria % of US Population meeting basic eligibility criteria (age, SBP, no DM or stroke) % of those meeting basic eligibility requirements who meet risk criteria 10-year CVD Risk Distribution (%) Mean 10-yr CVD risk (%) 5- 10% 10- 15% 15- 20% 20+% CHD or Stage 3 CKD or FR>15% 6.7 70.3 1.3 3.2 24.3 71.1 28.6 In additional analyses of the NHANES potentially eligible pool, 16.3% had stage 3 CKD (3.6% had eGFR < 45ml/min/1.73m2 ), 15.6% had a history of CVD, 34.6% were 75 years old or older, 8.1% were African Americans, and 49.8% were women. Stage 3a CKD, defined as eGFR 45-59 ml/min/1.73m2 , but a urine albumin-to-creatinine (ACR) ≤ Version 4.0 20 November 1, 2012 10 mg/g, comprised 6.1% of the eligible pool.. These analyses, shown in Table 3.2, provide evidence to support our recruitment targets for participants with CKD, in the SENIOR population, minorities and women. Table 3.2. Characteristics of SPRINT eligible sample based on NHANES data. Eligibility requirements include age>50, SBP>130, eGFR> 20, ACR 10 mg/g 6.6 % Stage 3a + ACR ≤ 10 mg/g 6.1 % Senior (age>75) 34.6 % Female 49.8 % Black 8.1 % Hispanic 7.4 % SBP 130-139 on no BP lowering medications 15.2 % with FRS < 15% per 10 yrs 4.5 3.2 Recruitment: Informed Consent, Screening, Baseline Recruitment The SPRINT recruitment goals are described above. Specific community resources will be used to target women and minority/under-served populations to ensure adequate representation of these groups in SPRINT. Recruitment strategies that have worked well in other trials related to hypertension and CKD will be used. Centralized training for CCN and Clinical Site staffs regarding recruitment issues will be provided before recruitment begins. The goal of participant recruitment is to create a trial population that will ensure adequate event rates for statistical power while maximizing participant safety and generalizability to the population for which the intervention is intended. A multifaceted approach to screening and enrollment is essential to achieve the recruitment goal. For this multicenter trial, recruitment strategies targeting both existing populations within the clinical practice of the research sites as well as individuals from outside these practice settings will be used to identify potentially eligible participants. The Recruitment, Retention and Adherence Subcommittee will play a significant role in monitoring the progress of study-wide recruitment and provide a forum for advising the CCNs and clinical sites on problem identification, goal setting, strategy deployment and evaluation in their efforts to achieve site and study-wide recruitment goals. This may include guidance for enhancing the recruitment of ethnic groups, women and the elderly. The Subcommittee will also contribute to the development of the recruitment tools including culture-, gender- and age-specific materials to promote enrollment among these important subgroups. 3.2.1 Regulatory and Ethical Considerations, including the Informed Consent Process Version 4.0 21 November 1, 2012 The study will be conducted in accordance with Good Clinical Practice (GCP), all applicable subject privacy requirements, and the guiding principles of Helsinki, including but not limited to: 1. Local Institute Review Board (IRB)/Central IRB review and approval of study protocol and any subsequent amendments. 2. Subject informed consent for main trial, SPRINT MIND, genetic testing, and post trial contact, and any ancillary studies. The study consent will contain the six essential elements from GCP guidelines that include: • Research statement, reasonably foreseeable risks or discomforts, reasonably expected benefits to subjects or others, appropriate alternatives, extent of confidentiality, compensation or treatment for injury. • Additional elements where appropriate such as unforeseeable risks to subjects, embryos, or fetuses, investigator-initiated termination of participation, additional costs, significant new findings, authorization for release of protected health Information for research purposes. 3. Investigator reporting requirements. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization must be obtained from each person prior to enrollment into SPRINT. In collaboration with the CCNs, the SPRINT Coordinating Center will provide full details and