Research ethics capacity building in Sub-Saharan Africa: a review of NIH Fogarty-funded programs 2000–2012

The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards' documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees' leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees' background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program

Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa

<p>Abstract</p> <p>Background</p> <p>South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality.</p> <p>Discussion</p> <p>This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research.</p> <p>Summary</p> <p>This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance.</p

Smoking disparities by level of educational attainment in the United States, 1966 to 2015

Background Previous studies in the U.S. show higher smoking rates among those with lower levels of education attainment. Less is known about how these smoking patterns vary by birth cohort or how they may be driven by different demographic profiles across education groups. Furthermore, limited attention has been given to differences in smoking behaviors between those with less than a high school degree and those with 8th grade education or less. Methods Data from the National Health Interview Survey 1966-2015 were utilized to obtain smoking-related information for U.S. adults aged 25 years or older. We developed age-period-cohort models with constrained natural splines to estimate smoking prevalence in groups categorized with five education levels: ≤8th grade, 9-11th grade, high school graduate or GED, some college, and at least a college degree. Annual probabilities of smoking initiation, cessation and intensity by age, birth cohort (1890-1990), gender, and education level were also estimated by the models. Additional regression analyses were conducted to identify sociodemographic factors that may explain smoking disparities across education subgroups. Results The probability of smoking initiation was highest among individuals with 9-11 th grade education and lowest among those with a college degree or more. The initiation probability among those with ≤8 th grade education decreased by birth cohort, resulting in this group having the second lowest smoking prevalence after those with a college degree or more in more recent birth cohorts. The smoking cessation probability was highest among those with a college degree or more. Additional analyses suggest that the low smoking rates among those with ≤8 th grade education may be driven by the increasing proportion of non-US born Hispanics in this group. Conclusions This study identifies population characteristics that may be driving smoking disparities between levels of educational attainment, providing detailed insights into change in smoking patterns by education for different U.S. birth cohorts

Sociodemographic Patterns of Exclusive, Dual, and Polytobacco Use Among U.S. High School Students: A Comparison of Three Nationally Representative Surveys

Purpose This study examines sociodemographic patterns of exclusive/dual/polytobacco use among U.S. high school students using multiple national surveys. Methods Using three national youth surveys (Population Assessment of Tobacco and Health [PATH] Wave 4 [2016–2017], 2017 Youth Risk Behavior Survey, and 2017 National Youth Tobacco Survey), we classified tobacco products into four groups: (1) electronic nicotine delivery systems (ENDS), (2) conventional cigarettes (CCs), (3) other combustible tobacco products, and (4) smokeless tobacco products. We created 16 categories of non/exclusive/dual/polytobacco use within the past 30 days using the four product groups and calculated weighted population prevalence by sex and race/ethnicity (all surveys) and parental education and income (PATH), based on variable availability. Results The results from 9,331, 12,407, and 9,699 high school students in PATH, Youth Risk Behavior Survey, and National Youth Tobacco Survey, respectively, largely agreed and pointed to similar conclusions. ENDS was the most prevalent exclusive use product (3.8%–5.2% across surveys), with CCs falling to second or third (1.2%–2.0% across surveys). By sex, exclusive, dual, and poly smokeless tobacco product use were more common for males, whereas exclusive CC use was more common for females. By race/ethnicity, non-Hispanic Whites had a higher prevalence of exclusive ENDS use and ENDS/CC dual use than non-Hispanic Blacks. As income and parental education levels increased from low to high, the prevalence of exclusive CC use decreased, whereas the prevalence of exclusive ENDS use increased. Conclusion Understanding sociodemographic patterns of tobacco use can help identify groups who may be at greater risk for tobacco-related health outcomes