Nancy Kass

Nancy Kass
Johns Hopkins University | JHU · Berman Institute of Bioethics

About

217
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Publications

Publications (217)
Article
This commentary responds to the article "Compulsory Research in Learning Health Care: Against a Minimal Risk Limit," by Robert Steel. Steel acknowledges that our ethics framework for a learning health care system, published in the 2013 special report Ethical Oversight of Learning Health Care Systems , includes an obligation on the part of patients...
Article
Aim: Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights. Materials & methods: 2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntarine...
Chapter
Public health ethics considers moral dimensions of public health practice and research. While medical ethics dates back hundreds of years, and bioethics writings emerged in the 1960s and 1970s, ‘public health ethics’, articulated as such, did not appear significantly in the literature for several more decades. There has been great interest recently...
Article
Background/aims: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing c...
Article
Pragmatic clinical trials (PCTs) may improve the efficiency, relevance, and representativeness of research. While prior research has indicated that willingness to join a PCT is high, it is not universal among those asked in surveys exploring attitudes toward hypothetical PCTs. The objective of this study was to examine what factors predict willingn...
Article
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In many settings, and perhaps especially in low-middle income countries, training institutions do not adequately prepare their students for the ethical challenges that confront them in professional life. We conducted a survey to assess the training needs in research ethics among the faculty at the University of Zambia, School of Medicine (UNZASoM)...
Preprint
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Background Previous studies have shown that participants in emergency research may not understand the research and therefore may not make informed decisions to participate. Little is documented about motivation for research participation in randomized clinical trials in emergency obstetric and newborn care. Conducted among survivors of severe obste...
Book
Public health is fundamentally concerned with promoting the health of populations through the prevention of disease and injury. It is, at its core, a moral endeavor, because the end it seeks is the advancement of human well-being. Vexing ethics issues are inherent in all aspects of public health practice and policy. They exist in top-of-the-news st...
Chapter
This chapter, which grew out of a Greenwall Foundation–funded working group of a dozen or so ethicists, lawyers, and public health practitioners, provides a rough conceptual map of the terrain of public health ethics. It examines the nature of public health and public health interventions, and it identifies a number of general moral considerations...
Article
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Research ethics remains a cornerstone of the scientific enterprise as it defines the boundaries of responsible conduct of research. Our aim was to systematically identify, review and test online training courses in research ethics which could be considered most appropriate for future training at the University of Botswana (UB). We used an evaluativ...
Article
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The amount of biomedical research being conducted around the world has greatly expanded over the past 15 years, with particularly large growth occurring in low- and middle-income countries (LMICs). This increased focus on understanding and responding to disease burdens around the world has brought forth a desire to help LMIC institutions enhance th...
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Post-abortion care (PAC) research is increasingly being conducted in low- and middle-income countries (LMICs) to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitativ...
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Extraordinary innovation in medicine promises vast improvements to the health of individuals and communities. Yet it is a lost opportunity that data from most medical care is never aggregated or analyzed. Even when data are aggregated and analyzed, most of this “learning” is never translated into improved practice. The Learning Health Care System (...
Article
Purpose: Advanced cancer patients (ACPs) who participate in phase I clinical trials often report a less-than-ideal understanding of the required elements of informed consent (IC) and unrealistic expectations for anticancer benefit and prognosis. We examined phase I clinical trial enrollment discussions and their associations with subsequent ACP un...
Article
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IntroductionAn increase in post abortion care (PAC) research with adolescents, particularly in low- and middle-income countries, has brought to attention several associated research ethics challenges. In order to better understand the ethics context of PAC research with adolescents, we conducted a scoping review of published literature. Methods Fol...
Article
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Introduction: Traditional informed consent approaches, involving separate discussions and lengthy consent forms, may be an imperfect fit for comparative effectiveness research (CER) that is integrated into usual care and compares non-investigational treatments. However, systematic efforts to collect broad stakeholder perspectives about alternative...
Article
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Recently, there has been a remarkable increase in biomedical research being conducted in low and middle-income countries. This increase has brought attention to the need for high quality research ethics systems within these countries and a greater focus on research ethics training. Though most programs tend to concentrate on training individuals, l...
Article
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There is growing emphasis on eliciting and incorporating stakeholder perspectives into health research and public policy development. The deliberative engagement session (DES) method provides one approach to elicit informed preferences from patients and other stakeholders on policy issues. DES involves day-long interaction with participants, includ...
Chapter
Public health research often involves human participants. Although some authors have argued that there are significant moral differences between public health research and public health practice, few have claimed that public health research presents unique ethical issues from other types of human participant research. Definitions of public health r...
Article
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Most countries, including Botswana, have established Institutional Review Boards (IRBs) to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low- and middle-income count...
Chapter
Public health research often involves human participants. Although some authors have argued that there are significant moral differences between public health research and public health practice, few have claimed that public health research presents unique ethical issues from other types of human participant research. Definitions of public health r...
Article
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Introduction: The US health care system faces pressure to improve quality while managing complexity, curbing costs, and reducing inefficiency. These shortcomings have sparked interest in the Learning Health Care System (LHCS) as an alternate approach to organizing research and clinical care. Although diverse stakeholders have expressed support for...
Article
Background/aims: Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to...
Article
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Objectives: Our primary aim was to evaluate the impact of US National Institutes of Health (NIH)-funded bioethics training programmes (Fogarty bioethics training programmes, FBTPs) that trained individuals from Africa over the programme's first 10 years to examine changes between pretraining and post-training in individual achievement and to docum...
Article
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Introduction: There is increased interest in transitioning to a "learning health care system" (LHCS). While this transition brings the potential for significant benefits, it also presents several ethical considerations. Identifying the ethical issues faced by institutions in this transition is critical for realizing the goals of learning health ca...
Article
Background: Informed consent requirements generally require a lengthy process and signed documentation for patients to participate in clinical research. With growing interest in comparative effectiveness research (CER), whereby patients receive approved (non-experimental) medicines for their medical condition, questions have been raised whether the...
Article
Background: Comparative effectiveness research (CER) and pragmatic clinical trials commonly test interventions that are in routine use and pose minimal incremental risk or burdens to patients who participate in this research. The objective of this study was to elicit the range of patients' views and opinions regarding a variety of different types...
Article
As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with pa...
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Determining how clinicians should meet their professional obligations to treat patients with Ebola virus disease in nonepidemic settings necessitates considering measures to minimize risks to clinicians, the context of care, and fairness. Minimizing risks includes providing appropriate equipment and training, implementing strategies for reducing ex...
Article
Recently, there have been increasing numbers of activities labeled as either quality improvement (QI) or comparative effectiveness research (CER), both of which are designed to learn what works and what does not in routine clinical care settings. These activities can create confusion for researchers, Institutional Review Board members, and other st...
Article
Background: The increasing globalization of research drives a need for greater research ethics capacity in low resource countries. Several programs have attempted to expand research ethics capacity by training individuals, but few have focused on broader research ethics systems and institutions. This study describes and applies an institutional re...
Article
Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness...
Article
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Background: Priority setting is at the core of resource allocation. In recent years, priority setting in public health has occurred in the context of a difficult authorizing environment, one in which politicians have shown increasing interest in reducing the footprint of government, even during times of increased demand for social services. In thi...
Article
In Reply Our proposed approach does not call for abandoning research protections for all comparative effectiveness research; instead, we argued for a more tailored application of the protections based on a research activity’s degree of risk, the expectations of patients, and the norms of clinical practice. In the bathing regimens example, the regim...
Article
Background The Clinical and Translational Science Award (CTSA) program has raised the profile and the available funding for engagement in biomedical research. Such increased funding and attention may address known barriers to engagement. However, little work has been done to describe experiences across multiple CTSAs, especially how the CTSA struct...
Article
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Unhealthy eating can have value for individuals and groups, even while it has disvalue in virtue of being unhealthy. In this paper, we discuss some ways in which unhealthy eating has value and draw out implications for the ethics of policies limiting access to unhealthy food. Discussing the value and disvalue of unhealthy eating helps identify oppo...
Article
Ebola virus disease has ignited some of our worst fears in a globalized world. The disease spreads quickly, with high mortality, and is crossing borders. More than half of infected persons have died (1). The confirmed cases include 2 Americans who have become the focus of public attention because of their heroism and for the extraordinary measures...
Article
The increasing conduct of health systems research (HSR) in low- and middle-income countries (LMICs) has not been matched by concurrent work to clarify the field's ethical dimensions. To begin to address this gap, a two-day workshop on the ethics of HSR in LMICs was convened at Johns Hopkins University in June 2013. Participants included health syst...
Article
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Objectives: We examined critical budget and priority criteria for state health agencies to identify likely decision-making factors, pressures, and opportunities in times of austerity. Methods: We have presented findings from a 2-stage, mixed-methods study with state public health leaders regarding public health budget- and priority-setting proce...
Article
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The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards' documents and annual reports su...
Article
The US national institutes of health, Fogarty International Center (NIH-FIC) has, for the past 13 years, been a leading funder of international research ethics education for resource-limited settings. Nearly half of the NIH-FIC funding in this area has gone to training programs that train individuals from sub-Saharan Africa. Identifying the impact...
Article
Obesity and overweight prevalence soared to unprecedented levels in the United States, with 1 in 3 adults and 1 in 6 children currently categorized as obese. Although many approaches have been taken to encourage individual behavior change, policies increasingly attempt to modify environments to have a more positive influence on individuals' food an...
Article
The US health care system is poised to learn more about preventing, diagnosing, and treating illness than has ever been possible. This change is powered by the increasing commitment to comparative effectiveness research, increases in practice-based research, and the increasing availability of data arising from electronic health information systems...
Article
As many as 1 in 10 patients is harmed while receiving hospital care in wealthy countries. The risk of health care-associated infection in some developing countries is as much as 20 times higher. In response, in many global regions, increased attention has turned to the implementation of a broad program of safety research, encompassing a variety of...
Article
The authors argue that in a learning health care system with ethically robust oversight policies, a streamlined consent process could replace formal written informed-consent procedures for many studies, and patient consent would not be required at all for some trials.
Article
PurposeThe Clinical and Translational Science Award (CTSA) program has highlighted community engagement in research by requiring institutions to develop bidirectional relationships with communities to obtain funding. Little is known about how institutions have operationalized that requirement. This study aimed to describe the strategies proposed by...
Article
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In 1972, the longest running nontherapeutic research study ever conducted by our Public Health Service ended. The Tuskegee Study of Untreated Syphilis in the Negro Male (1932-1972) enrolled 399 poor, African-American men with syphilis, watched as their syphilitic disease progressed, misled them, and denied them treatment. (Am J Public Health. Publi...
Article
Background: Electronic clinical data (ECD) will increasingly serve as an important source of information for comparative effectiveness research (CER). Although many retrospective studies have relied on ECD, new study designs propose using ECD for prospective CER. These designs have great potential but they also raise important ethics questions. A...
Article
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The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of et...
Article
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Context: State health departments across the country are responsible for assuring and improving the health of the public, and yet financial constraints grow only more acute, and resource allocation decisions become even more challenging. Little empirical evidence exists regarding how officials working in state health departments make these tough a...
Article
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To the Editor: We are a group of scholars and leaders in bioethics and pediatrics with extensive experience in ethical and regulatory issues in pediatrics and human subjects research. We urge the Office for Human Research Protections (OHRP) to withdraw its notification to the institutions involved in the Surfactant, Positive Pressure, and Oxygenati...
Article
The rise of quality improvement research and comparative effectiveness research in health care settings constitutes progress toward the goal of what the Institute of Medicine has called a “learning healthcare system,” in which we are “drawing research closer to clinical practice by building knowledge development and application into each stage of t...
Article
Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual impr...
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Joseph Amon and colleagues discuss the challenges of conducting human rights research in settings where local research ethics committees may favor the interests of the state over the interests of research participants.
Article
Motivations and decision-making styles that influence participation in biomedical research vary across study types, cultures, and countries. While there is a small amount of literature on informed consent in non-western cultures, few studies have examined how participants make the decision to join research. This study was designed to identify the f...
Article
The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African...
Article
On July 25, 2011, the Department of Health and Human Services published an advance notice of proposed rule making, outlining potential changes to the federal regulations overseeing human subjects research.1 These regulations, known since 1991 as “the Common Rule,” have been effective in ensuring that most human research in this country is reviewed...
Article
Recent manmade and natural disasters highlight weaknesses in the public health systems designed to protect populations from harm and minimize disruption of the social and built environments. Emergency planning and response efforts have, as a result, focused largely on ensuring populations' physical well-being during and after a disaster. Many publi...
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  Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic research. However, there appears to be very little work conducted with...
Article
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The goal of this project was to develop and validate a new tool to evaluate learners' knowledge and skills related to research ethics. A core set of 50 questions from existing computer-based online teaching modules were identified, refined and supplemented to create a set of 74 multiple-choice, true/false and short answer questions. The questions w...
Conference Paper
Background: Community engagement (CE) in research is gaining attention as a way to improve research and the health of communities, as well as to demonstrate respect for such communities. As more and more community engagement is conducted, and as more funders require this practice, having a clear understanding of the ethical underpinnings of such an...
Conference Paper
Background: In 2005, the NIH announced a funding mechanism, the Clinical and Translational Science Award Program (CTSA), which focuses on facilitating the transfer of research-generated knowledge from the bench to the bedside to the community. Among other things, grant funding is dependent on an institution's plans for community engagement (CE). Th...
Article
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Informed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while eve...
Article
Emily Largent, Steven Joffe, and Franklin Miller offer a stimulating contribution to the literature on integrating medical research and practice. We agree on both the need to move toward what the Institute of Medicine has called a learning health care system and the need for new conceptions for integrating research and practice within it. We also a...
Article
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Informed consent is required in most clinical research with humans. While federal regulations state consent information should be understandable to participants, concerns have been raised that consent forms are overly long and complex. Consent forms from 2006 HIV network trials sponsored by the National Institutes of Health (NIH), Division of AIDS...
Article
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Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance...
Article
Identifying vulnerable groups and ensuring that their needs are met during disasters-whether naturally occurring or manmade-are vital aspects of preparedness planning. Developing preparedness strategies that are responsive to those at greatest risk is a moral mandate, justified by the principles of beneficence, justice, and respect for autonomy. In...
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Serious adverse events in research involving healthy volunteers are rare, but their impact on other volunteers is unknown. We conducted semi-structured interviews with 60 healthy volunteers at an institution where a healthy research volunteer died. Most volunteers (85%) had heard of the event, but few said it changed their thoughts about joining re...
Article
Several highly visible quality improvement (QI) projects led to controversy over their ethical oversight, attracting attention from institutional review boards (IRBs) and the Office for Human Research Protection. While QI research has increased dramatically, there is limited empirical evidence regarding how multiple IRBs review the same study. This...