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With limited understanding of most new biotechnologies, how do citizens form their opinion and what factors influence their attitudes about these innovations? In this study, we use gene drive biotechnology in agricultural pest management as an example and theoretically propose that given low levels of knowledge and awareness, citizens' acceptance of, or opposition to, gene drive is significantly shaped by two predisposition factors: individuals' general orientation toward science and technology, and their specific benefit-risk assessment frame. Empirically, we employ data collected from a recent US nationally representative public opinion survey (N = 1220) and conduct statistical analyses to test the hypotheses derived from our theoretical expectations. Our statistical analyses, based on various model specifications and controlling for individual-level covariates and state-fixed effects, show that citizens with a more favorable general orientation toward science and technology are more likely to accept gene drive. Our data analyses also demonstrate that citizens' specific gene drive assessment frame-consisting of a potential benefit dimension and a potential risk dimension, significantly shapes their attitudes as well-specifically, people emphasizing more on the benefit dimension are more likely to accept gene drive, whereas those who place more importance on the risk dimension tend to oppose it. We discuss contributions of our study and make suggestions for future research in the conclusion., (© 2023 Society for Risk Analysis.)

Objective: The primary objective of this study was to determine whether Healthy Eating Index (HEI) and Alternative Healthy Eating Index (AHEI) scores were associated with incident metabolic syndrome., Design: This study is a secondary analysis of data from the Jackson Heart Study. HEI and AHEI scores were divided into quintiles and Cox proportional hazards regression models were analysed for 1864 African American adults free from metabolic syndrome at Exam 1 to examine the incidence of metabolic syndrome by quintile of dietary quality score., Setting: Hinds, Madison and Rankin counties, Mississippi, USA., Participants: African American adults, ages 21-94 years, 60·9 % female., Results: Over a mean follow-up time of 6·7 years, we observed 932 incident cases of metabolic syndrome. After adjusting for multiple covariates, a higher HEI score at Exam 1 was not associated with the risk of incident metabolic syndrome, except when looking at the trend analysis for the subgroup of adults with two metabolic syndrome components at Exam 1 ( P -trend = 0·03). A higher AHEI score at Exam 1 was associated with the risk of incident metabolic syndrome (hazard ratio for those in the highest quintile compared to the lowest: 0·80 (95 % CI: 0·65, 0·99), P -trend = 0·03)., Conclusion: These findings suggest that a dietary pattern that scores higher on the AHEI may help reduce the risk of metabolic syndrome, even for adults who already have two of the minimum of three components required for a diagnosis of metabolic syndrome.

Background: Artificial intelligence (AI) and machine learning (ML) technology design and development continues to be rapid, despite major limitations in its current form as a practice and discipline to address all sociohumanitarian issues and complexities. From these limitations emerges an imperative to strengthen AI and ML literacy in underserved communities and build a more diverse AI and ML design and development workforce engaged in health research., Objective: AI and ML has the potential to account for and assess a variety of factors that contribute to health and disease and to improve prevention, diagnosis, and therapy. Here, we describe recent activities within the Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD) Ethics and Equity Workgroup (EEWG) that led to the development of deliverables that will help put ethics and fairness at the forefront of AI and ML applications to build equity in biomedical research, education, and health care., Methods: The AIM-AHEAD EEWG was created in 2021 with 3 cochairs and 51 members in year 1 and 2 cochairs and ~40 members in year 2. Members in both years included AIM-AHEAD principal investigators, coinvestigators, leadership fellows, and research fellows. The EEWG used a modified Delphi approach using polling, ranking, and other exercises to facilitate discussions around tangible steps, key terms, and definitions needed to ensure that ethics and fairness are at the forefront of AI and ML applications to build equity in biomedical research, education, and health care., Results: The EEWG developed a set of ethics and equity principles, a glossary, and an interview guide. The ethics and equity principles comprise 5 core principles, each with subparts, which articulate best practices for working with stakeholders from historically and presently underrepresented communities. The glossary contains 12 terms and definitions, with particular emphasis on optimal development, refinement, and implementation of AI and ML in health equity research. To accompany the glossary, the EEWG developed a concept relationship diagram that describes the logical flow of and relationship between the definitional concepts. Lastly, the interview guide provides questions that can be used or adapted to garner stakeholder and community perspectives on the principles and glossary., Conclusions: Ongoing engagement is needed around our principles and glossary to identify and predict potential limitations in their uses in AI and ML research settings, especially for institutions with limited resources. This requires time, careful consideration, and honest discussions around what classifies an engagement incentive as meaningful to support and sustain their full engagement. By slowing down to meet historically and presently underresourced institutions and communities where they are and where they are capable of engaging and competing, there is higher potential to achieve needed diversity, ethics, and equity in AI and ML implementation in health research., (©Rachele Hendricks-Sturrup, Malaika Simmons, Shilo Anders, Kammarauche Aneni, Ellen Wright Clayton, Joseph Coco, Benjamin Collins, Elizabeth Heitman, Sajid Hussain, Karuna Joshi, Josh Lemieux, Laurie Lovett Novak, Daniel J Rubin, Anil Shanker, Talitha Washington, Gabriella Waters, Joyce Webb Harris, Rui Yin, Teresa Wagner, Zhijun Yin, Bradley Malin. Originally published in JMIR AI (https://ai.jmir.org), 06.12.2023.)

Medical futility is an ancient and yet consistent challenge in clinical medicine. The means of balancing conflicting priorities and stakeholders' preferences has changed as much as the science that powers the understanding and treatment of disease. The introduction of patient self-determination and choice in medical decision-making shifted the locus of power in the physician-patient relationship but did not obviate the physician's responsibilities to provide benefit and prevent harm. As we have refined the process in time, new paradigms, specialists, and tools have been developed to help navigate the ever-changing landscape., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Religious institutions have been responsive to the needs of Black men and other marginalized populations. Religious service attendance is a common practice that has been associated with stress management and extended longevity. The objective of this study was to examine the relationship between religious service attendance and all-cause mortality among Black men 50 years of age and older. Data for this study were from NHANES III (1988-1994). The analytic sample (n = 839) was restricted to participants at least 50 years of age at the time of interview who self-identified as Black and male. Mortality was the primary outcome for this study and the NHANES III Linked Mortality File was used to estimate race-specific, non-injury-related death rates using a probabilistic matching algorithm, linked to the National Death Index through December 31, 2015, providing up to 27 years follow-up. The primary independent variable was religious service attendance, a categorical variable indicating that participants attended religious services at least weekly, three or fewer times per month, or not at all. The mean age of participants was 63.6±0.3 years and 36.4% of sample members reported that they attended religious services one or more times per week, exceeding those attending three or fewer times per month (31.7%), or not at all (31.9%). Cox proportional hazard logistic regression models were estimated to determine the association between religious service attendance and mortality. Participants with the most frequent religious service attendance had a 47% reduction of all-cause mortality risk compared their peer who did not attend religious services at all (HR 0.53, CI 0.35-0.79) in the fully adjusted model including socioeconomic status, non-cardiovascular medical conditions, health behaviors, social support and allostatic load. Our findings underscore the potential salience of religiosity and spirituality for health in Black men, an understudied group where elevated risk factors are often present., Competing Interests: The authors have declared that no competing interests exists.

Gene drive is an experimental technique that may make it possible to alter the genetic traits of whole populations of a species through the genetic modification of a relatively small number of individuals. This technology is sufficiently new that literature on the understanding and views of stakeholders and the public regarding the use of gene drive organisms in agricultural pest management is just beginning to emerge. Our team conducted a 2-pronged engagement process with Texas gene drive agricultural stakeholders to ascertain their values, beliefs, and preferences about the efficacy, safety, and risk management considerations of gene drive technology as a potential tool for agricultural pest management. We found that a majority of stakeholders support gene drive research and its potential use for managing agricultural pests. Our work with stakeholders confirms both their willingness to be engaged and the importance they place on stakeholder and public engagement regarding these issues, as well as the need to address these issues before use of gene drive as a pest management mechanism will be accepted and trusted.

Modifiable, behavioral risk factors like occupational sitting may contribute to inflammation, an important cardiovascular risk factor. This study evaluated the association of self-reported occupational sitting with changes in c-reactive protein (CRP) and the role of sex. We examined occupational sitting and baseline CRP levels for 2889 African American participants in the Jackson Heart Study. Four multivariable linear regression models were estimated to determine the association of occupational sitting and CRP. Analyses were conducted in 2020. The mean age was 50.8 years and 61% were female. Participants who reported occupational sitting as "often/always" had CRP levels of 4.9±6.8 mg/L, "sometimes" had levels of 4.8±8.1 mg/L, and "never/seldom" had levels of 4.3±6.8 mg/L. In the unadjusted model, "often/always" engaging in occupational sitting was significantly associated with higher levels of CRP when compared to "never/seldom" ( P < .05). This differed by sex with female participants who reported "often/always" occupational sitting had CRP levels of 6.0±7.6 mg/L compared to only 5.1±6.9 mg/L for "never/seldom." Neither the overall association nor the female-specific association remained statistically significant in the adjusted models. We found an association between occupational sitting and inflammation, measured by CRP. This association varied by sex but did not remain significant after fully adjusting for covariates., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2021 The Author(s).)

Background: African American children and adolescents make up a disproportionately large segment of those classified as overweight and obese. The purpose of this study was to examine social and behavioral factors associated with accelerated accumulation of weight and adiposity among this group., Methods: The data for this cross-sectional study were drawn from the Jackson Heart KIDS Pilot Study - an offspring cohort study comprising 12- to 19-year-old descendants of Jackson Heart Study participants (N=212). Body mass index (BMI) and waist circumference were the outcomes of interest. Daily hassles, fruit and vegetable consumption, physical activity, television watching, parent/grandparent weight status and participant birth weight, age and sex were the independent variables included in the analyses., Results: Males and females were equally represented in the study and the mean BMI and waist circumference for adolescents in the study was 25.81±7.78 kg/m 2 and 83.91 ± 19.81 cm, respectively. Fully adjusted linear regression models for the total sample produced results indicating that age, television viewing, weight control, and parental weight status were positively associated with BMI and waist circumference, respectively. Findings from sex-stratified models for BMI and waist circumference indicated that the significance of coefficients for age, television viewing, and parent/grandparent weight status varied by sex., Conclusions: Knowledge is limited about how sex or gender interact with social and behavioral factors to influence African Americans' health and additional studies are needed to specify how these factors interact to accelerate weight gain and adipose tissue accumulation over the life course., Competing Interests: Competing Interests: None declared., (Copyright © 2021, Ethnicity & Disease, Inc.)

As COVID-19 continues to challenge the practice of head and neck oncology, clinicians are forced to make new decisions in the setting of the pandemic that impact the safety of their patients, their institutions, and themselves. The difficulty inherent in these decisions is compounded by potentially serious ramifications to the welfare of patients and health-care staff, amid a scarcity of data on which to base informed choices. This paper explores the risks of COVID-19 incurred while striving to uphold the standard of care in head and neck oncology. The ethical problems are assessed from the perspective of the patient with cancer, health-care provider, and other patients within the health-care system. While no single management algorithm for head and neck cancer can be universally implemented, a detailed examination of these issues is necessary to formulate ethically sound treatment strategies., (© 2020 Wiley Periodicals, Inc.)

The COVID- 19 pandemic is a critical test for the already overburdened and mostly underfunded public healthcare systems of Latin America. In a region that suffers from severe inequalities, public healthcare systems are the only source of medical care for a large sector of the population who work in the informal economy or are unemployed. State-run hospitals and clinics are already overstressed by continuous demand for treatment of vector-borne diseases and community-acquired infections as well as high rates of non-communicable diseases. Ideological misconceptions and denial among Latin America's political leaders prevented timely preparations for the pandemic and added to chronic governance problems. As ethical expertise in Latin America focuses on research ethics, few hospitals in the region have functioning clinical ethics committees or clinical ethics policy, forcing healthcare personnel to make excruciating treatment decisions in an environment dominated by material scarcity and public distrust. This essay examines the emergence of COVID-19 in Latin America and the serious challenge that it poses for Latin America's public healthcare systems., (© 2020 John Wiley & Sons Ltd.)

Introduction: The current hypercompetitive extramural funding environment in the United States emphasizes the critical need for effective research training programs that focus not only on grantsmanship, but on skill development across the full range of research activities, culminating in writing research results for publication. Using Writing Accountability Groups (WAG), the National Heart, Lung, and Blood Institute (NHLBI) funded Obesity Health Disparities (OHD) PRIDE is one of the few research training and mentoring programs that places an equal focus on scientific writing and grant writing. This article reports on the utility of WAGs for OHD PRIDE mentees., Method: Participants included 14 of 26 individuals who were fellows in the OHD PRIDE research training and mentoring program. A typical WAG has between four and eight members who meet for one hour each week over a 10-week period and commit a priori to attend at least 70% of the sessions. Summary statistics were produced to characterize number of peer-reviewed publications, grants, years in academic rank, and category of current academic rank, barriers to frequency of writing, and duration of writing. Results from pre- and post-WAG surveys were compared to determine the overall impact of the WAG. The study period discussed in this article took place between January and December 2017 and included data from three 10-week cycles beginning in February, May, and September., Results: Fifty-three percent of OHD PRIDE participants successfully completed at least one 10-week WAG cycle. The WAGs did not have a statistically significant impact on either the frequency of writing or the duration of writing. However, the majority of the participants who successfully completed at least one WAG cycle reported that they either maintained or increased their frequency or duration of writing., Conclusion: By providing a structured approach to developing and/or enhancing a practice of consistent writing, time management skills, and collaborative relationships, the WAG has promise for enhancing scientific writing skills for many trainees and early-career faculty. Longer term follow-up is needed to more fully assess the potential impact of WAGs., Competing Interests: Competing Interests: None declared., (Copyright © 2020, Ethnicity & Disease, Inc.)

The development of research training opportunities for investigators from the untapped pool of traditionally underrepresented racial/ethnic groups has gained intense interest at the National Institutes of Health (NIH). The significant and persistent disparity in the likelihood of R01 funding between African American and Whites was highlighted in the groundbreaking 2011 report, Race, Ethnicity, and NIH Research Awards . Disparities in funding success were also shown to exist at the institutional level, as 30 institutions receive a disproportionate share of federal research funding. Historically Black Colleges and Universities (HBCUs) have a dual commitment to education and research; however, the teaching loads at HBCUs may present challenges for research-oriented faculty. Few research training and mentoring programs have been specifically designed for this group. During 2015 and 2016, we held three conversation cafés with 77 participants in Jackson, Mississippi and Baltimore, Maryland. The purpose of this article is to describe findings from these conversation cafés regarding barriers and facilitators to building robust research careers at HBCUs, and to illustrate how these data were used to adapt the conceptual framework for the NHLBI-funded Obesity Health Disparities (OHD) PRIDE program. Identified barriers included teaching and advising loads, infrastructures, and lack of research mentors on campus. The benefit of incorporating research into classroom teaching was a noted facilitator., Competing Interests: Competing Interests: None declared., (Copyright © 2020, Ethnicity & Disease, Inc.)

When scholars express concern about trust in science, they often focus on whether the public trusts research findings. This study explores a different dimension of trust and examines whether and how frequently researchers misrepresent their research accomplishments when applying for a faculty position. We collected all of the vitae submitted for faculty positions at a large research university for 1 year and reviewed a 10% sample for accuracy. Of the 180 applicants whose vitae we analyzed, 141 (78%) claimed to have at least one publication, and 79 of these 141 (56%) listed at least one publication that was unverifiable or inaccurate in a self-promoting way. We discuss the nature and implications of our findings, and suggest best practices for both applicants and search committees in presenting and reviewing vitae.

Participants' understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study's aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study's informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans' informed, voluntary participation in clinical trials.

Background: Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH., Methods: This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions., Results: A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS., Conclusions: Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens.

Mentoring has been consistently identified as an important element for career advancement in many biomedical and health professional disciplines and has been found to be critical for success and promotion in academic settings. Early-career faculty from groups underrepresented in biomedical research, however, are less likely to have mentors, and in general, receive less mentoring than their majority-group peers, particularly among those employed in teaching-intensive institutions. This article describes Obesity Health Disparities (OHD) PRIDE, a theoretically and conceptually based research training and mentoring program designed for early-career faculty who trained or are employed at Historically Black Colleges and Universities (HBCUs)., Competing Interests: Competing Interests: None declared.

The introduction of mobile communication technologies in health care in low- and middle-income countries offers an opportunity for increased efficiencies in provision of care, improved utilization of scarce resources, reductions in workload, and increased reach of services to a larger target population. Short message service (SMS) technologies offer promise, with several large-scale SMS-based implementations already under way. Still largely lacking in the research literature are evaluations of specific ethical issues that arise when SMS programs are implemented and studied in resource-limited settings. In this paper, we examine the ethical issues raised by the deployment of SMS messaging to support patient retention in HIV care and treatment and in the research conducted to evaluate that deployment. We use case studies that are based in Mozambique and ground our discussion in the ethical framework for international research proposed by Emanuel et al., highlighting ethical considerations needed to guide the design and implementation of future SMS-based interventions. Such guidance is increasingly needed in countries such as Mozambique, where the local capacity for ethical study design and oversight is still limited and the scale-up and study of mHealth initiatives are still driven predominantly by international collaborators. These issues can be complex and will need ongoing attention on a case-by-case basis to ensure that appropriate protections are in place, while simultaneously maximizing the potential benefit of new mHealth technologies.

This project evaluates the impact of the National Science Foundation's (NSF) policy to promote education in the responsible conduct of research (RCR). To determine whether this policy resulted in meaningful RCR educational experiences, our study examined the instructional plans developed by individual universities in response to the mandate. Using a sample of 108 U.S. institutions classified as Carnegie "very high research activity", we analyzed all publicly available NSF RCR training plans in light of the consensus best practices in RCR education that were known at the time the policy was implemented. We found that fewer than half of universities developed plans that incorporated at least some of the best practices. More specifically, only 31% of universities had content and requirements that differed by career stage, only 1% of universities had content and requirements that differed by discipline; and only 18% of universities required some face-to-face engagement from all classes of trainees. Indeed, some schools simply provided hand-outs to their undergraduate students. Most universities (82%) had plans that could be satisfied with online programs such as the Collaborative Institutional Training Initiative's RCR modules. The NSF policy requires universities to develop RCR training plans, but provides no guidelines or requirements for the format, scope, content, duration, or frequency of the training, and does not hold universities accountable for their training plans. Our study shows that this vaguely worded policy, and lack of accountability, has not produced meaningful educational experiences for most of the undergraduate students, graduate students, and post-doctoral trainees funded by the NSF.

National Health Data Warehouses (NHDWHs) promise to improve individual and population health. These systems are now increasingly being deployed in low- and middle-income countries (LMICs), given increased recognition of the value of data analytics in informing decision-making. However, ethical issues relevant to implementation of NHDWHs in LMICs remain largely ignored or, at best, inadequately addressed. In this paper, we highlight and critically analyze several of the key ethical issues, including privacy, informed consent and trust, confidentiality and security, secondary data use, sustainability and implementation validity, risk-benefit ratio, governance and conflict of interest, justice, equity, access, and collaborative partnerships. We then provide a set of guiding principles and points to consider for countries and implementers to guide further decision-making around ethics of implementing NHDWHs within LMICs.

Objectives: The aim of this review was to provide an overview of studies conducted to determine the effects of chlorogenic acid (CGA) on cognition and neurological health., Methods: A literature search was conducted using PubMed and various search terms including chlorogenic acid, CGA, memory, neuroscience, cognition, nutrition, antioxidant, pharmacokinetics, neuroprotection, and neurodegeneration., Results: Many studies have linked CGA consumption to a wide range of health benefits, including neuroprotection, cardioprotection, weight loss, chemopreventive properties, anti-inflammatory activity, decreased blood pressure, decreased diet-induced insulin resistance, decreased blood pressure, anxiolytic effects, and antihyperalgesic effects. Pre-clinical and clinical studies both provide evidence that CGA supplementation could protect against neurological degeneration and the resulting diseases associated with oxidative stress in the brain; however, no formal, well-controlled studies have been performed to date., Discussion: Recent research suggests that dietary consumption of CGA could produce a wide range of health benefits and physiological effects. There is also mounting evidence that the consumption of polyphenols, including CGA, in the diet could reduce the risk of developing neurodegenerative conditions. Further studies should be conducted with a focus on the effects of CGA on cognition and the nervous system and employing well-designed clinical studies.

Empirical assessment of the practice of clinical ethics is made difficult by the limited standardization of settings, structures, processes, roles, and training for ethics consultation, as well as by whether individual ethics consultants or hospital ethics committees (HECs) provide consultation. Efforts to study the relationship between theory and practice in the work of HECs likewise require the spelling out of assumptions and definition of key variables, based in knowledge of the core concepts of clinical ethics and logistics of clinical consultation. The survey of HEC members reported by Wasserman and colleagues illustrates the difficulty of such research and calls attention to need for studies of real-time, complex decision making to inform conclusions about how theory affects practice., (Copyright 2015 The Journal of Clinical Ethics. All rights reserved.)

Children with cancer and HSCT recipients are at high risk for common viral infections. We sought to define the viral etiology of ARI and identify risk factors. Nasal wash samples were collected from pediatric hematology-oncology patients and HSCT recipients with ARI during the 2003-2005 winter seasons. Real-time RT-PCR was performed to detect Flu A, influenza B, RSV, PIV 1-3, human MPV, and HRV. HRV specimens were sequenced and genotyped. Seventy-eight samples from 62 children were included. Viruses were detected in 31 of 78 samples (40%). HRV were detected most frequently, in 16 (52%) including five HRVC; followed by seven (22%) RSV, five (16%) Flu A, four (13%) MPV, and two (6%) PIV2. There was a trend toward higher risk of viral infection for children in day care. Only 8% of the study children had received influenza vaccine. HRV, including the recently discovered HRVC, are an important cause of infection in pediatric oncology and HSCT patients. Molecular testing is superior to conventional methods and should be standard of care, as HRV are not detected by conventional methods., (© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Demand among graduate and postdoctoral trainees for international research experience brings together students and investigators from increasingly diverse cultural backgrounds around the world. Educators in research ethics and scientific integrity need to address the cultural aspects of both science and ethics to help all trainees learn ethical practices for effective collaboration with a diverse array of partners. NIH and NSF's mandates for instruction in the responsible conduct of research do not specifically address the needs of international trainees or U.S. trainees who undertake research projects abroad. Nonetheless, research ethics educators' typical focus on policy and professional standards can offer trainees and faculty investigators helpful insights into differing ethical values and priorities in research. Examination of linguistic differences can also reveal important conceptual frameworks that shape ethical practice. New resources for teaching research integrity in cross-cultural settings can be a valuable addition to the development of shared understanding of the goals of scientific research.

The landscape in research ethics has changed significantly in Latin America and the Caribbean over the past two decades. Research ethics has gone from being a largely foreign concept and unfamiliar practice to an integral and growing feature of regional health research systems. Four bioethics training programs have been funded by the Fogarty International Center (FIC) in this region in the past 12 years. Overall, they have contributed significantly to changing the face of research ethics through the creation of locally relevant training materials and courses (including distance learning), academic publications, workshops, and conferences in Spanish, and strengthening ethics review committees and national systems of governance. This paper outlines their achievements and challenges, and reflects on current regional needs and what the future may hold for research ethics and bioethics training in Latin America and the Caribbean.

Data analysis is essential to translational medicine, epidemiology, and the scientific process. Although recent advances in promoting reproducibility and reporting standards have made some improvements, the data analysis process remains insufficiently documented and susceptible to avoidable errors, bias, and even fraud. Comprehensively accounting for the full analytical process requires not only records of the statistical methodology used, but also records of communications among the research team. In this regard, the data analysis process can benefit from the principle of accountability that is inherent in other disciplines such as clinical practice. We propose a novel framework for capturing the analytical narrative called the Accountable Data Analysis Process (ADAP), which allows the entire research team to participate in the analysis in a supervised and transparent way. The framework is analogous to an electronic health record in which the dataset is the "patient" and actions related to the dataset are recorded in a project management system. We discuss the design, advantages, and challenges in implementing this type of system in the context of academic health centers, where team based science increasingly demands accountability.

Numerous studies are demonstrating that engaging undergraduate students in original research can improve their achievement in the science, technology, engineering, and mathematics (STEM) fields and increase the likelihood that some of them will decide to pursue careers in these disciplines. Associated with this increased prominence of research in the undergraduate curriculum are greater expectations from funders, colleges, and universities that faculty mentors will help those students, along with their graduate students and postdoctoral fellows, develop an understanding and sense of personal and collective obligation for responsible conduct of science (RCS). This Feature describes an ongoing National Research Council (NRC) project and a recent report about educating faculty members in culturally diverse settings (Middle East/North Africa and Asia) to employ active-learning strategies to engage their students and colleagues deeply in issues related to RCS. The NRC report describes the first phase of this project, which took place in Aqaba and Amman, Jordan, in September 2012 and April 2013, respectively. Here we highlight the findings from that report and our subsequent experience with a similar interactive institute in Kuala Lumpur, Malaysia. Our work provides insights and perspectives for faculty members in the United States as they engage undergraduate and graduate students, as well as postdoctoral fellows, to help them better understand the intricacies of and connections among various components of RCS. Further, our experiences can provide insights for those who may wish to establish "train-the-trainer" programs at their home institutions.

Community engagement is increasingly becoming an integral part of research. "Community-engaged research" (CEnR) introduces new stakeholders as well as unique challenges to the protection of participants and the integrity of the research process. We--a group of representatives of CTSA-funded institutions and others who share expertise in research ethics and CEnR--have identified gaps in the literature regarding (1) ethical issues unique to CEnR; (2) the particular instructional needs of academic investigators, community research partners, and IRB members; and (3) best practices for teaching research ethics. This paper presents what we know, as well as what we still need to learn, in order to develop quality research ethics educational materials tailored to the full range of stakeholder groups in CEnR.

Statistical analysis is a cornerstone of the scientific method and evidence-based medicine, and statisticians serve an increasingly important role in clinical and translational research by providing objective evidence concerning the risks and benefits of novel therapeutics. Researchers rely on statistics and informatics as never before to generate and test hypotheses and to discover patterns of disease hidden within overwhelming amounts of data. Too often, clinicians and biomedical scientists are not adequately proficient in statistics to analyze data or interpret results, and statistical expertise may not be properly incorporated within the research process. We argue for the ethical imperative of statistical standards, and we present ten nontechnical principles that form a conceptual framework for the ethical application of statistics in clinical and translational research. These principles are drawn from the literature on the ethics of data analysis and the American Statistical Association Ethical Guidelines for Statistical Practice., (Copyright © 2011 John Wiley & Sons, Ltd.)

Instruction in the responsible conduct of research (RCR) is required for all trainees funded by the National Institues of Health (NIH) or National Science Foundation (NSF). A recent Delphi study identified 53 key topics in 7 core areas that RCR education experts felt should be included in this instruction, which is required of many trainees in clinical and translational research. We performed a content analysis of major textbooks and online resources used in RCR instruction to determine the extent to which the 53 key topics identified in the Delphi study are covered by these resources. Textbooks and online resources used in RCR education at Clinical and Translational Science Award institutions were identified via survey. These resources were subjected to a content analysis. The 53 key topics identified in the Delphi study formed the basis of these analyses. We identified 10 textbooks and 1 online resource currently in use. Of the 53 key topics, only 4 were included in all 11 resources, and another 12 were included in 10. Twenty-three topics were covered in fewer than 65% of the resources, and two topics were absent from nearly all. Educators in clinical and translational research should be aware of key topics that are not covered in the RCR textbooks and online resources they may use and should consider augmenting discussion of such topics with other materials.

In the increasingly global community of biomedical science and graduate science education, many US academic researchers work with international trainees whose views on scientific writing and plagiarism can be strikingly different from US norms. Although a growing number of countries and international professional organizations identify plagiarism as research misconduct, many international trainees come from research environments where plagiarism is ill-defined and even commonly practiced. Two research-ethics educators consider current perspectives on plagiarism around the world and contend that US research-training programs should focus on trainees' scientific writing skills and acculturation, not simply on preventing plagiarism., (Copyright © 2011 Elsevier Inc. All rights reserved.)

The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium's Clinical Research Ethics Key Function Committee (CRE-KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8-item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.