Lessons learned obtaining informed consent in research with vulnerable populations in community health center settings

<p>Abstract</p> <p>Background</p> <p>To improve equity in access to medical research, successful strategies are needed to recruit diverse populations. Here, we examine experiences of community health center (CHC) staff who guided an informed consent process to overcome recruitment barriers in a medical record review study.</p> <p>Methods</p> <p>We conducted ten semi-structured interviews with CHC staff members. Interviews were audiotaped, transcribed, and structurally and thematically coded. We used NVivo, an ethnographic data management software program, to analyze themes related to recruitment challenges.</p> <p>Results</p> <p>CHC interviewees reported that a key challenge to recruitment included the difficult balance between institutional review board (IRB) requirements for informed consent, and conveying an appropriate level of risk to patients. CHC staff perceived that the requirements of IRB certification itself posed a barrier to allowing diverse staff to participate in recruitment efforts. A key barrier to recruitment also included the lack of updated contact information on CHC patients. CHC interviewees reported that the successes they experienced reflected an alignment between study aims and CHC goals, and trusted relationships between CHCs and staff and the patients they recruited.</p> <p>Conclusions</p> <p>Making IRB training more accessible to CHC-based staff, improving consent form clarity for participants, and developing processes for routinely updating patient information would greatly lower recruitment barriers for diverse populations in health services research.</p

Biomeasures of Insulin Resistance, Central Adiposity, and Cardiovascular Inflammation among Women and Men in the Jackson Heart Study Prevalence Ratios and (95% Confidence Intervals).

<p>Figures estimate associations with elevated insulin resistance (HOMA-IR) greater than or equal to 3.31, elevated waist circumference greater than 88 cm, and elevated C-reactive protein greater or equal to 3.0 mg/L. Prevalence ratios estimated via binomial log regression with multiple imputations for missing covariates performed in PROC GENMOD, with repeated statement for neighborhood census tracts. Analysis excludes all diabetics (self-reported, use of diabetic medications, elevated fasting plasma glucose equal or greater than126 mg/dL, or hemoglobin A1C greater or equal to 6.5%), individuals with ≤400 kcal daily energy intake and individuals with HOMA-IR <0. Analyses are fully adjusted for listed covariates plus age, neighborhood stability, dietary intake (meeting USDA recommendations regarding the percentage of calories in carbohydrate and fat consumed, exceeding 15% of calories as protein, dietary fiber intake, and percentage of calories consumed as alcohol), scaled family household income, and less than high school educational attainment. Reference categories: Lives in most advantaged neighborhoods, does not perceives neighborhood as unsafe, former or never smoker. Active Living Index modeled as a continuous variable.</p

Neighborhood Socioeconomic Disadvantage and Selected Characteristics of Jackson Heart Study Participants, 2000–2004.

<p>Numbers are N(%) unless otherwise noted. Chi-squared tests for associations among categorical values. Kruskal-wallis statistic used to test for associations between classes for continuous outcome variables.</p>a<p>USDA recommended percentage of calories as carbohydrates is ≤65%.</p>b<p>USDA recommended percentage of calories as fat is ≤35%.</p

Unadjusted Percentage of Cardiometabolic Risk Factors between Neighborhood Socioeconomic Disadvantage among Women and Men in the Jackson Heart Study, 2000–2004.

<p>Excludes diabetics consistent with ATP III consensus guidelines and individuals with ≤400 kcal daily energy intake. Diabetes is defined as self-reported type I or II diabetes; taking diabetes medications; having a measured fasting plasma glucose equal to or greater than 126 mg/dL; measured hemoglobin A1C of 6.5% or greater. Elevated glucose (“pre-diabetes”) is defined as a measured fasting plasma glucose between 100–125 mg/dL, consistent with American Diabetes Association recommendations. Sex specific norms are used to define elevated waist circumference and low HDL measurement. Elevated blood pressure is defined as systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg. Elevated triglycerides are defined as ≥150 mg/dL. Elevated hsCRP is defined as hsCRP≥3.0 (mg/L), elevated insulin resistance is defined as HOMA-IR greater than or equal to 3.31. *p≤0.05 **p≤0.01.</p

Correlates of Metabolic Syndrome in the Jackson Heart Study Prevalence Ratios and (95% Confidence Intervals).

<p>Figures estimate age-adjusted associations with metabolic syndrome via binomial log regression with multiple imputations for missing covariates performed in PROC GENMOD, with repeated statement for neighborhood census tracts. Reference categories: Lives in most advantaged neighborhoods, does not perceives neighborhood as unsafe. Analysis for metabolic syndrome excludes all diabetics (self-reported, use of diabetic medications, elevated fasting plasma glucose equal or greater than 126 mg/dL, or hemoglobin A1C greater or equal to 6.5%) and individuals with ≤400 kcal daily energy intake.</p>a<p>Models estimate the prevalence ratios associated with neighborhood socioeconomic disadvantage and perceived neighborhood safety adjusted for active living index, current smoking status, meeting USDA diet recommendations for percentage of calories as carbohydrate, fat, greater than 15% of daily calories as protein, daily dietary fiber intake, and percentages of calories as alcohol.</p>b<p>Adjusts for age, health behaviors, lives in most disadvantaged neighborhoods, perceives neighborhood as unsafe, neighborhood stability, family household income scaled for family size, and less than high school educational attainment.</p