Public health and research ethics education: the experience of developing a new cadre of bioethicists at a Ugandan institution.

Research ethics education is critical to developing a culture of responsible conduct of research. Many countries in sub-Saharan Africa (SSA) have a high burden of infectious diseases like HIV and malaria; some, like Uganda, have recurring outbreaks. Coupled with the increase in non-communicable diseases, researchers have access to large populations to test new medications and vaccines. The need to develop multi-level capacity in research ethics in Uganda is still huge, being compounded by the high burden of disease and challenging public health issues. Only a few institutions in the SSA offer graduate training in research ethics, implying that the proposed ideal of each high-volume research ethics committee having at least one member with in-depth training in ethics is far from reality. Finding best practices for comparable situations and training requirements is challenging because there is currently no "gold standard" for teaching research ethics and little published information on curriculum and implementation strategies. The purpose of this paper is to describe a model of research ethics (RE) education as a track in an existing 2-year Master of Public Health (MPH) to provide training for developing specific applied learning skills to address contemporary and emerging needs for biomedical and public health research in a highly disease-burdened country. We describe our five-year experience in successful implementation of the MPH-RE program by the Mbarara University Research Ethics Education Program at Mbarara University of Science and Technology in southwestern Uganda. We used curriculum materials, applications to the program, post-training and external evaluations, and annual reports for this work. This model can be adapted and used elsewhere in developing countries with similar contexts. Establishing an interface between public health and research ethics requires integration of the two early in the delivery of the MPH-RE program to prevent a disconnect in knowledge between research methods provided by the MPH component of the MPH-RE program and for research in ethics that MPH-RE students are expected to perform for their dissertation. Promoting bioethics education, which is multi-disciplinary, in institutions where it is still "foreign" is challenging and necessitates supportive leadership at all institutional levels.

Trust in Medical Research: A Comparative Study among Patients at a Regional Referral Hospital and Community Members in Lira District, Northern Uganda.

Events such as the Tuskegee syphilis study shaped how the public perceives and trusts medical research globally. However, few studies have examined trust in medical research in developing countries. We tested the hypothesis that levels of trust may be lower among community members compared to hospitalized persons in Uganda. We enrolled 296 participants in rural northern Uganda, and 148(50%) were from the community, 192(65%) were female. Mean level of trust for medical research was higher among hospitalized persons compared to community members (p = 0.0001). Previous research participation (p = 0.03), and willingness to participate in future research (p = 0.001) were positively associated with trust. Medical personnel should engage more with the communities in which they practice fostering trust in medical research.

The CARE (Curiosity, Attentiveness, Respect and Responsiveness, and Embodiment) Model: Operationalizing Cultural Humility in the Conduct of Clinical Research.

Cultural competence training has been criticized for reinforcing existing stereotypes, ignoring intersectionality and inadvertently marginalizing some individuals and groups. In contrast, cultural humility offers the possibility of transformational learning, requiring individuals to pursue a lifelong course of self-examination. This approach makes authentic engagement with others possible. We review the premises underlying cultural competence and cultural humility, as well as proposed models for the integration of cultural humility into the clinical context. We propose a new model for the integration of cultural humility into clinical research: CARE, signifying Curiosity, Attentiveness, Respect and Responsiveness, and Embodiment. We conclude that the concept of cultural humility can be integrated into the conduct of clinical research.

Teaching and Practicing Humanism and Empathy through Embodied Engagement.

Concerns have been raised regarding medicine's dehumanization of patients and providers and regarding the need to include, in the medical school curriculum, components that encourage the development of empathy and humanistic practice. This essay suggests that the development of humanistic practice requires attention to not only the cognitive and affective/emotive aspects of humanism, but also to the nurturing of intersubjectivity between the provider and the patient through strategies designed to promote embodied awareness. Several approaches to the development of embodied awareness are discussed, including puppetry pedagogy, drama, and virtual reality applications.

EVANGELICALISM IN UGANDA: IMPLICATIONS FOR PUBLIC HEALTH AND BIOETHICS.

Considered attention is needed to the interplay between evangelical and charismatic religions and legislation in Uganda and their implications for public health, bioethics, and medical education. This manuscript examines the growth of the evangelical and charismatic movements in Uganda during the past several decades, concurrent trends in the formulation and implementation of law and public policy, and implications for the prevention and treatment of sexually transmitted infections, family violence, physician-patient communication, and medical and health education. The article concludes with suggested strategies to address the adverse consequences stemming from the interjection of religious perspectives into the domains of public health, clinical care, and health education.

GLOBAL PANDEMICS: CONSIDERATIONS OF PUBLIC HEALTH, HUMAN RIGHTS, AND BIOETHICS.

Pandemics threaten the health and lives of peoples worldwide, sometimes requiring the imposition of numerous, restrictive public health measures to diminish their impact and preserve health and life. Such measures, however well-intended, have the potential to contravene human rights and raise significant ethical questions at the individual, community, national, and international levels. This article explores the impact of public health measures adopted in an effort to ameliorate the transmission of COVID-19 on access to care, the right to privacy, protection of marginalized communities from discrimination, and violence against women. The discussion of bioethical concerns focuses on resource allocation, the presumed obligation of healthcare workers to provide care, and governmental obligations in the face of a pandemic. The discussion concludes with a review of lessons learned: the need for a coordinated response across levels of government and the private sector, attention to existing structural inequalities that may exacerbate the impact of the pandemic and/or the public health measures adopted to contain the pandemic, the protection of vulnerable and marginalized persons, a clear delineation of and support for workers deemed to be essential, and the provision of relevant training to law enforcement personnel.

The New Wallet Biopsy and Involuntary Patient Transfers Abroad: How Physicians Can Help Protect Patients.

The Emergency Medical Treatment and Active Labor Act in 1986 was intended to bring an end to incidents of "patient dumping." However, due to the conflation of various federal legislative provisions, hospitals faced with the prospect of long-term unreimbursed care of an immigrant patient, whether legally present in the United States or not, are in some cases having such patients transported to another country. These transfers are often being effectuated without patient consent. After an overview of the flaws in the legal system that have effectively encouraged such patient transfers, this essay uses a clinical case to demonstrate how physicians can collaborate with an interdisciplinary team and with family members to ensure that the best interests of immigrant patients are met. Finally, the essay calls on physicians to advocate for the development of hospital policies and practices that will protect patients from international patient dumping.

Manualized cognitive behavioral group therapy to treat vasomotor symptoms for women diagnosed with mood disorders.

OBJECTIVE: This 6-week, prospective, single-arm study examined the feasibility, acceptability, and preliminary efficacy of cognitive behavioral group therapy in peri- and postmenopausal women with mood disorders (major depression or bipolar) and problematic vasomotor menopausal symptoms. METHODS: 59 participants from an outpatient clinic with mood disorders and problematic vasomotor symptoms were enrolled. The primary outcomes were change from baseline to 6 weeks in Hot Flush Night Sweat Problem Rating, Hot Flash Related Daily Interference, and Quality of Life. Secondary outcomes were change in Hot Flush Frequency, depression, anxiety, perceived stress, anhedonia, beliefs and cognitive appraisals of menopause. ClinicalTrials.gov [identifier: NCT02860910]. RESULTS: On the Hot Flush Night Sweat Problem Rating, 39.3% improved 2 or more points, which was clinically relevant. Changes in Quality of Life (p = .001) and the Hot Flash Related Daily Interference Scale were also significant (p < .001). Significant results were found on most secondary outcomes (hot flush frequency on the Hot Flush Daily Diary, depression, anxiety, perceived stress (p < .001) and anhedonia (p = .001). One of six subscales (control subscale) on the cognitive appraisal of menopause significantly improved (p < .001). Three subscales on the beliefs measure did not change significantly (p = .05, p = .91, and p = .14). Six-week study retention was robust (N = 55, 93%) and 94.2% of individuals reported that cognitive behavioral group therapy sessions were useful. CONCLUSION: This exploratory study suggests that CBGT is acceptable, feasible, and efficacious in women with mood disorders and problematic menopause vasomotor symptoms. Further studies are needed using more rigorous and controlled methods.

Teaching Vulnerability in Research: A Study of Approaches Utilized by a Sample of Research Ethics Training Programs.

This article reports the outcomes of qualitative research on the teaching of "vulnerability in research" undertaken with principal investigators of international bioethics training programs funded by the Fogarty International Center of the National Institutes of Health (NIH) of the United States. To properly contextualize this research, we begin with an overview of the various ways in which vulnerability has been conceptualized both by writers and by ethical guidance from low-, middle-, and high-income countries. We conclude with some preliminary suggestions for best practice and recommendations for further research. To the best of our knowledge, this is the first time research of this kind has been carried out.

Active Learning on Center Stage: Theater as a Tool for Medical Education.

Introduction: Knowledge and skill development related to communication must incorporate both affective and behavioral components, which are often difficult to deliver in a learning activity. Using theater techniques and principles can provide medical educators with tools to teach communication concepts. Methods: This 75-minute faculty development workshop presents a variety of techniques from theater and adapts them for use in medical education. Using examples related to diversity and inclusion, this session addresses general educational and theater principles, role-play, sociodrama, applied improvisation, and practical aspects of involving theater partners. The session materials include a PowerPoint presentation with facilitator notes, interactive activities to demonstrate each modality, and an evaluation. The sessions can be extended to longer formats as needed. Results: Forty-five participants at Learn Serve Lead 2016: The AAMC Annual Meeting attended the 75-minute session. We emailed 32 participants 5 months after the conference, and eight responded. Participants reported that their confidence level in using theater techniques as a tool for medical education increased from low-to-medium confidence presession to high confidence postsession. All survey respondents who were actively teaching said they had made changes to their teaching based on the workshop. All commented that they appreciated the active learning in the session. Many indicated they would appreciate video or other follow-up resources. Discussion: Principles and techniques from theater are effective tools to convey difficult-to-teach concepts related to communication. This workshop presents tools to implement activities in teaching these difficult concepts.

Linking the Heart and the Head: Humanism and Professionalism in Medical Education and Practice.

BACKGROUND: This paper articulates a practical interpretive framework for understanding humanism in medicine through the lens of how it is taught and learned. Beginning with a search for key tensions and relevant insights in the literature on humanism in health professions education, we synthesized a conceptual model designed to foster reflection and action to realize humanistic principles in medical education and practice. The resulting model centers on the interaction between the heart and the head. The heart represents the emotive domains of empathy, compassion, and connectedness. The head represents the cognitive domains of knowledge, attitudes, and beliefs. The cognitive domains often are associated with professionalism, and the emotive domains with humanism, but it is the connection between the two that is vital to humanistic education and practice. The connection between the heart and the head is nurtured by critical reflection and conscious awareness. Four provinces of experience nurture humanism: (1) personal reflection, (2) action, (3) system support, and (4) collective reflection. These domains represent potential levers for developing humanism. Critical reflection and conscious awareness between the heart and head through personal reflection, individual and collective behavior, and supportive systems has potential to foster humanistic development toward healing and health.

HIV-Risk Related Attitudes and Behaviors Among Older Impoverished Women Living in Puerto Rico.

HIV has increasingly impacted older adults regarding sero-prevalence and sero-incidence as long-term survivors of HIV/AIDS are living longer. This study examines the relationship between age and HIV-related attitudes and risk behaviors among female public housing residents in Puerto Rico. Using a self-administered survey instrument, 1,138 female public housing residents were surveyed between April and August 2006. Bivariate results showed that older women (aged 50+ years) were significantly less likely to report HIV testing and to discuss safer sex with their most recent "steady" sex partner than women under the age of 50 years. Older women were also more likely to express anxiety associated with condoms and more barriers to using condoms. The older versus younger groups did not significantly differ regarding condom use, which was extremely low across the groups. In the past three and 12 months, older women were less likely than younger women to report having (a) multiple sex partners and; (b) oral and anal sex with their most recent steady sex partner; (c) oral sex with their most recent non-steady sex partner and, (d) engaging in sexual activity in the previous three and 12 months. Age-specific messages concerning their increased risk of HIV among other interventions would likely curtail the increase in the number of new HIV cases being reported among members of this sub-population.

Breast Cancer Stage and Treatment Among Ohio Medicaid Beneficiaries With and Without Mental Illness.

PURPOSE: There is a dearth of studies on cancer outcomes in individuals with mental illness. We compared breast cancer outcomes in Medicaid beneficiaries with and without mental illness. METHODS: Using records from the 1996 to 2005 Ohio Cancer Incidence Surveillance System (OCISS) and Medicaid files, we identified fee-for-service women age < 65 years diagnosed with incident invasive breast cancer who had enrolled in Medicaid ≥ 3 months before cancer diagnosis (n = 2,177). We retrieved cancer stage, patient demographics, and county of residence from the OCISS. From Medicaid claims data, we identified breast cancer treatment based on procedure codes and mental illness status based on diagnosis codes, prescription drugs dispensed, and service codes. We developed logistic regression models to examine the association between mental illness, cancer stage, and treatment for locoregional disease, adjusting for potential confounders. RESULTS: Women with mental illness represented 60.2% of the study population. Adjusting for potential confounders, women with mental illness were less likely than those without mental illness to have unstaged or unknown-stage cancer (adjusted odds ratio [OR], 0.61; 95% CI, 0.44 to 0.86; P = .005) or to be diagnosed with distant-stage cancer (adjusted OR, 0.59; 95% CI, 0.40 to 0.85; P = .005). We observed no difference by mental illness status in receipt of definitive treatment (adjusted OR, 1.04; 95% CI, 0.84 to 1.29; P = .08). CONCLUSION: Among Ohio Medicaid beneficiaries, women with mental illness did not experience disparities in breast cancer stage or treatment of locoregional disease. These findings may reflect the equalizing effects of Medicaid through vulnerable individuals' improved access to both physical and mental health care.

Identifying Gaps in the Cultural Competence/Sensitivity Components of an Undergraduate Medical School Curriculum: A Needs Assessment.

Physicians and other health care workers are increasingly being called upon to bridge the cultural differences that may exist between themselves and their patients. Adequate cross-cultural education is essential if existing health care disparities are to be reduced. We conducted a needs assessment to identify gaps in the cultural competence/sensitivity components of the undergraduate medical school curriculum at Case Western Reserve University School of Medicine. The 2011 study was designed (1) to assess how first and second year medical school students perceive the adequacy of the medical school curriculum with respect to issues of diversity and (2) the extent to which first and second year medical students believe that an understanding of issues relating to patient culture are important to the provision of effective patient care. Student perspectives were assessed through a web-based anonymous survey of all first year (n = 167) and all second year (n = 166) medical school students, two focus groups (total n = 14) and a Problem-based Case Inquiry Group exercise (n = 6), both with second year students. A substantial proportion of participating first and second year medical students do not believe that self-reflection regarding one's own cultural biases is important to one's performance as a physician, do not view an understanding of diverse patient cultural beliefs as important or very important in the provision of effective patient care, and are uncomfortable with and unsure about how to approach culture-related issues arising in patient care. The inclusion of specified elements--increased contact with diverse patients, more comprehensive resources, increased opportunities to practice communication skills and engage in self-reflection--may be critical to heighten student awareness of and comfort in interacting with diverse populations. Our findings are relevant to the development of medical school curricula designed to improve physician understanding of and responsiveness to diverse patient populations and efforts to reduce health disparities.

The Impact of a Research Ethics Training Program: Romania as a Case Study.

Case Western Reserve University's (CWRU) Training Program in International Research Ethics, funded by the Fogarty International Center, has been ongoing in Romania since 2000. The program consists of multiple components: a U.S.- based MA degree program for long-term trainees, Romania-based short courses, a U.S.-based opportunity for mid-and senior-level personnel to develop collaborative writing or research projects and present lectures, and a newsletter and various Internet-based activities. We evaluated the impact of the training program on bioethics in Romania through a survey of the training program's long-term trainees, a literature search for trainee publications, interviews with key informants, and identification of key events during the course of the program. Findings indicate that the program has had a considerable impact in the field of bioethics through trainee authorship of peer-reviewed publications, books, and chapters; trainee career trajectories that encompass activities related to research ethics; and the development of a Romania-based master's degree program in bioethics and a Center of Bioethics and Health Policy. We attribute these achievements to the establishment of strong relationships between CWRU in Cleveland and the University of Medicine and Pharmacy Gr. T. Popa in Iasi, Romania, prior to the initiation of the training program; collaboration with key Romania-based institutional partners that are equally invested in the program's success; reliance of the program on a solid theoretical framework; ongoing program responsiveness to trainee and country needs; and a sustained commitment of time, expertise, and funding by the funders, sponsors, and in-country collaborators.

Female migrant sex workers in Moscow: gender and power factors and HIV risk.

This study aimed to build formative knowledge regarding HIV risks in female migrant sex workers in Moscow, focusing on gender and power. This was a collaborative ethnographic study, informed by the theory of gender and power, in which researchers conducted minimally structured interviews with 24 female sex workers who were migrants to Moscow and who provided sexual services to male migrant laborers. Overall, the female migrant sex workers engaged in HIV risk behaviors and practiced inadequate HIV protection with their clients. These behaviors were shaped by gender and power factors in the realms of labor, behavior, and cathexis. In the labor realm, because some female migrants were unable to earn enough money to support their families, they were pushed or pulled into sex work providing service to male migrants. In the behavior realm, many female migrant sex workers were intimidated by their male clients, feared violence, and lacked access to women's health care and prevention. In the cathexis realm, many had a sense of shame, social isolation, emotional distress, and lacked basic HIV knowledge and prevention skills. To prevent HIV transmission requires addressing the gender and power factors that shape HIV/AIDS risks among female migrant sex workers through multilevel intervention strategies.

HIV sexual risk behaviors and multilevel determinants among male labor migrants from Tajikistan.

The purpose of this study was to investigate HIV risk behaviors and their multilevel determinants in male labor migrants from Tajikistan to Moscow. In Russia and Central Asia, where AIDS rates are amongst the world's highest, conditions in both sending and receiving countries pose serious challenges to HIV prevention. A survey of Tajik married male seasonal labor migrants in Moscow was completed by 200 workers from 4 bazaars and 200 workers from 18 construction sites as part of a mixed method study. The quantitative results indicated that male labor migrants were at risk for HIV due to higher sexual behaviors including sexual relations with sex workers (92 %), multiple partnering in the past month (86 %), unprotected sex with sex workers (33 %), and reduced frequency of condom use while drinking alcohol (57 %). Multivariate tests indicated the multilevel factors that increased HIV sexual risks including: pre-migration factors (e.g. used sex workers in Tajikistan); migrant work and lifestyle factors (e.g. greater number of times visited Moscow); migrant sexual and relational factors (e.g. regular partner in Moscow); and migrant health and mental health factors (e.g. increased frequency of alcohol use). Qualitative findings from longitudinal ethnographic interviews and observations of a subset of 40 purposively sampled Tajik male migrants demonstrated how these multilevel pre-migration and migration factors account for HIV risk and protective behaviors in context. These findings underscore the seriousness of HIV risk for labor migrants and call both for multilevel approaches to prevention and for further study.

Is there a universal understanding of vulnerability? Experiences with Russian and Romanian trainees in research ethics.

Vulnerability of participants in research and the provision of special protections for vulnerable research participants are key concepts in research ethics. Despite international consensus requiring special protections for vulnerable research participants, both the concept of vulnerability and the nature and adequacy of strategies to reduce vulnerability remain vague and, consequently, are subject to varying interpretations. We report on observations of the challenges faced in understanding this key concept by 20 Russian and Romanian trainees participating in a one-year M.A. training program in research ethics from 2000 through 2011. We describe how trainees' understanding of and appreciation for the need for special protections of vulnerable research participants was nurtured. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.

Building research ethics capacity in post-communist countries: experience of two Fogarty training programs.

The post-Communist countries of Central and Eastern Europe and Central Asia are at various stages of development with respect to their capacity to protect human research participants. We examined the impact of two Fogarty-funded programs in this region, the Union Graduate College-Vilnius University Advanced Certificate Program and the Case Western Reserve University Master's Degree Program, by surveying these programs' graduates and by examining alumni activities. Alumni have served in leadership roles on research ethics committees, developed and taught new courses in research ethics, and contributed to scholarship. However, political, social, and economic challenges impede the ability of graduates to maximize their effectiveness. Additional curricular attention is needed in research methodology, policy development and implementation, and the interplay between research ethics and human rights.

Mentoring international research ethics trainees: identifying best practices.

Mentoring is an important component of training in the basic and clinical sciences due to the increasing complexities associated with establishing a career. Data relating to 466 long-term trainees in research ethics training programs were obtained from the Fogarty International Center's database. Data were supplemented with survey data (n = 17) and telephone interviews (n = 10) of the 21 principal investigators whose programs offered long-term training. The programs most successful with mentoring involved (1) the provision of an orientation for the trainees at the commencement of training; (2) a highly structured process of mentoring that required regular meetings and task achievement timelines; (3) intensive, frequent contact with the PI; and (4) support with personal issues that were troublesome to trainees. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.