This project evaluates the impact of the National Science Foundation's policy to promote education in the responsible conduct of research. 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 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. (shrink)

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. (shrink)

This is the second edition of a highly successful and well-received textbook on the responsible conduct of biomedical and health science research. It is aimed at faculty and graduate students in health science and biomedical science programs. In addition those on National Institute of Health research grants, administrators at universities, academic health centers, and medical and graduate schools will find the book a useful resource. The structure of the book remains the same as the first edition. Each chapter offers an (...) overview together with important primary documents and case studies concerned with core ethical issues underlying responsible research. The major changes from the first edition include new chapters providing overviews of each topic, several new published articles added to the readings, revised case studies along with an essay on how they can be used, as well as further readings and web addresses that will serve as invaluable sources of reference. (shrink)

This is the first systematically organized anthology on responsible conduct in scientific research aimed at students and practicing researchers in the biological sciences. It has been designed in response to the increasing concern to teach graduate students about ethical issues in the biological sciences. The book contains classic essays and other published material and is carefully structured to explore a range of subjects: the qualifications for authorship; plagiarism; the use of human beings and animals in research; the norms of ethical (...) conduct in science; scientific honesty and its relationship to gullibility and self-deception; ethical issues in laboratory work; the relation between science and society; the ethics of teaching and learning. The volume also provides insights into issues often not formally considered in graduate science education such as methods of scientific investigation, scientific paradigms, and the creative process. (shrink)

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 encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine of University Eduardo Mondlane and the Maputo Central Hospital established a joint Institutional Committee on Bioethics for Health. This study examines the experience of the first 4 years of the CIBS FM (...) & MCH. 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. 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. Descriptive cross-sectional studies were the most frequently reviewed research. The majority were prospective and used quantitative methodologies. 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. 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. (shrink)

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. (shrink)