Elizabeth Heitman

Precaution and governance of emerging technologies

Precaution can be consistent with support of science Precautionary approaches to governance of emerging technology call for constraints on the use of technology whose outcomes include potential harms and are characterized by high levels of complexity and uncertainty. Although articulated in a variety of ways, proponents of precaution often argue that its essential feature is to require more evaluation of a technology before it is put to use, which increases the burden of proof that its overall effect is likely to be beneficial. Critics argue that precaution reflects irrational fears of unproven risks—“risk panics” (1)—and would paralyze development and use of beneficial new technologies (1, 2). Advocates give credence to this view when they suggest that precaution leads necessarily to moratoria (3). Progress in the debate over precaution is possible if we can reject the common assumption that precaution can be explained by a simple high-level principle and accept instead that what it requires must be worked out in particular contexts. The 2016 report from the U.S. National Academies of Science, Engineering, and Medicine (NASEM) on gene drive research (4) illustrates this position. The report shows both that precaution cannot be rejected out of hand as scaremongering and that meaningful precaution can be consistent with support for science.

Cross-Cultural Considerations in U.S. Research Ethics Education

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.

Gene drives on the horizon: Issues for biosafety

In June 2016, the National Academies of Sciences, Engineering, and Medicine published a 220-page report from its multidisciplinary Committee on Gene Drive Research in Non-Human Organisms, which addressed the state of the science of gene drive research and related governance, as well as an array of ethical, social, and legal considerations. Gene drive research is scientifically intriguing and ethically daunting because, unlike other applications of new gene-editing technologies, an effective gene drive is intended to cause the spread of a specific genetic modification through a population and potentially throughout an entire species. This technology holds promise for addressing complex and persistent challenges in public health and ecology but also raises the threat of unintended consequences. Biosafety specialists will have an important role in defining and meeting the need for effective containment, mitigation, and governance strategies for gene drive research. This article reviews the conclusions and recommendations of the committee and recent commentary from leading gene drive researchers, with emphasis on issues in biosafety.

Twelve Years of Fogarty-Funded Bioethics Training in Latin America and the Caribbean: Achievements and Challenges

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.

Training Basic, Clinical and Translational Investigators

Publisher Summary This chapter focuses on advanced training for clinical and translational investigators, including physician-scientists and other doctorally trained clinical and translational researchers. Translating recent advances into better health requires the training of scientists equipped to make discoveries in humans, to develop and test new diagnostic tools and treatments safely in people, to evaluate the effectiveness of clinical interventions, and to implement the most effective approaches to improve health. The optimal training of clinical and translational scientists shares many characteristics with the training of other biomedical scientists. Clinical and translational researchers, however, also require a unique knowledge base and skill set. Whether dealing with individual human subjects or populations, clinical and translational investigators must understand how to study complex and integrated systems, in which there is considerable variability. Clinical and translational research spans a wide spectrum from first-in-human studies conducted in a small number of subjects to health outcomes research conducted in large populations. The skills required to conduct these types of research differ, as does the infrastructural support. The study also discusses the training of successful clinical and translational investigators, including participation in a core didactic curriculum, immersion in a scientific field through a mentored research apprenticeship, participation in formal career development, and leadership development activities.

Engaging Actively with Issues in the Responsible Conduct of Science: Lessons from International Efforts Are Relevant for Undergraduate Education in the United States

This Feature describes a National Research Council project centered on educating faculty in the Middle East/North Africa and Asia to use active learning when teaching responsible conduct of science (RCS). It provides insights for faculty in the United States as they engage students in the intricacies of RCS or establish “train-the-trainer” programs at their home institutions.

America COMPETES at 5 years: An Analysis of Research-Intensive Universities’ RCR Training Plans

This project evaluates the impact of the National Science Foundations (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 Initiatives 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.

Ethical issues in the use of SMS messaging in HIV care and treatment in low- and middle-income countries: case examples from Mozambique

Abstract 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.

Human rhinovirus C infections in pediatric hematology and oncology patients.

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.

Assessment of Parents’/Guardians’ Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia

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.