Nancy Kass
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View article: Experiences of participants in ETEC controlled human infection model studies
Experiences of participants in ETEC controlled human infection model studies Open
Background Controlled human infection model (CHIM) studies raise ethical issues due to intentional exposure of healthy volunteers to a pathogen. In this study we examine the experiences of participants who have chosen to participate in ent…
View article: Health Research Ethics in Southern Africa: Building Capacity and Cultivating Excellence.
Health Research Ethics in Southern Africa: Building Capacity and Cultivating Excellence. Open
The health research landscape in southern Africa is becoming increasingly complex as research efforts intensify to address the region's significant disease burden. The increasing volume and complexity of health research in low- and middle-…
View article: Health Research Ethics in Southern Africa: Building Capacity and Cultivating Excellence
Health Research Ethics in Southern Africa: Building Capacity and Cultivating Excellence Open
The health research landscape in southern Africa is becoming increasingly complex as research efforts intensify to address the region's significant disease burden. The increasing volume and complexity of health research in low- and middle-…
View article: Advancing Doctoral and Postdoctoral International Bioethics Training Programs Supported by the D43 National Institutes of Health (NIH) Fogarty Mechanism
Advancing Doctoral and Postdoctoral International Bioethics Training Programs Supported by the D43 National Institutes of Health (NIH) Fogarty Mechanism Open
Advancing doctoral and postdoctoral international bioethics training in low-and-middle income countries (LMICs) is essential to address the emerging and reemerging healthcare needs of local populations. The COVID-19 pandemic underscored th…
View article: Optimizing Informed Consent—A Call to Action
Optimizing Informed Consent—A Call to Action Open
This Viewpoint discusses the US Food and Drug Administration’s proposal for a collaborative approach toward clarifying the informed consent process for potential clinical trial participants.
View article: Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries
Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries Open
Background Use of adaptive clinical trials, particularly adaptive platform trials, has grown exponentially in response to the coronavirus disease (COVID-19) pandemic. Implementation of these trials in low- and middle-income countries (LMIC…
View article: 386. Participant Reflections on Their Experiences Participating in Phase 1 and 2 Inpatient Vaccine Trials and Human Challenge Studies
386. Participant Reflections on Their Experiences Participating in Phase 1 and 2 Inpatient Vaccine Trials and Human Challenge Studies Open
Background Volunteers are critical for the success of clinical trials but there is still debate on the ethics surrounding recruitment and enrollment of healthy human subjects who are paid for their participation in such research. This stud…
View article: Ethics of Adaptive Designs for Randomized Controlled Trials
Ethics of Adaptive Designs for Randomized Controlled Trials Open
Over recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such tri…
View article: Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries
Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries Open
Background: Use of adaptive clinical trials, particularly adaptive platform trials, has grown exponentially in response to the coronavirus disease (COVID-19) pandemic. Implementation of these trials in low- and middle-income countries (LMI…
View article: Managing community engagement in research in Uganda: insights from practices in HIV/AIDS research
Managing community engagement in research in Uganda: insights from practices in HIV/AIDS research Open
Background Community engagement (CE) in research is valuable for instrumental and intrinsic reasons. Despite existing guidance on how to ensure meaningful CE, much of what it takes to achieve this goal differs across settings. Considering …
View article: Managing community engagement in research in Uganda: insights from practices in HIV/AIDS research
Managing community engagement in research in Uganda: insights from practices in HIV/AIDS research Open
Background: Community engagement (CE) in research is valuable for instrumental and intrinsic reasons. Despite existing guidance on how to ensure meaningful CE, much of what it takes to achieve this goal differs across settings. Considering…
View article: Randomized comparison of two interventions to enhance understanding during the informed consent process for research
Randomized comparison of two interventions to enhance understanding during the informed consent process for research Open
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 …
View article: Immunity certification for COVID-19: ethical considerations
Immunity certification for COVID-19: ethical considerations Open
Restrictive measures imposed because of the coronavirus disease 2019 (COVID-19) pandemic have resulted in severe social, economic and health effects. Some countries have considered the use of immunity certification as a strategy to relax t…
View article: ACCESS TO TREATMENT IN HIV PREVENTION TRIALS: PERSPECTIVES FROM A SOUTH AFRICAN COMMUNITY: Access to Treatment: Community Perspectives
ACCESS TO TREATMENT IN HIV PREVENTION TRIALS: PERSPECTIVES FROM A SOUTH AFRICAN COMMUNITY: Access to Treatment: Community Perspectives Open
Access to treatment, in HIV vaccine trials (HVTs), remains ethically controversial. In most prevention trials, including in South Africa, participants who seroconvert are referred to publicly funded programmes for treatment. This strategy …
View article: Perceptions of motivation and willingness to participate in randomized clinical trials in emergency obstetric and newborn care among survivors of severe obstetric complications
Perceptions of motivation and willingness to participate in randomized clinical trials in emergency obstetric and newborn care among survivors of severe obstetric complications Open
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 i…
View article: Assessing training needs in health research ethics: a case study from the University of Zambia School of Medicine
Assessing training needs in health research ethics: a case study from the University of Zambia School of Medicine Open
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…
View article: The features and qualities of online training modules in research ethics: a case study evaluating their institutional application for the University of Botswana
The features and qualities of online training modules in research ethics: a case study evaluating their institutional application for the University of Botswana Open
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 co…
View article: Improving institutional research ethics capacity assessments: lessons from sub-Saharan Africa
Improving institutional research ethics capacity assessments: lessons from sub-Saharan Africa Open
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…
View article: Ethical challenges in research on post-abortion care with adolescents: experiences of researchers in Zambia
Ethical challenges in research on post-abortion care with adolescents: experiences of researchers in Zambia Open
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…
View article: Ethics and Learning Health Care: The Essential roles of engagement, transparency, and accountability
Ethics and Learning Health Care: The Essential roles of engagement, transparency, and accountability Open
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 …
View article: Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials
Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials Open
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 prog…
View article: Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research
Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research Open
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‐invest…
View article: Rapid assessment of institutional research ethics capacity: a case study from Zambia
Rapid assessment of institutional research ethics capacity: a case study from Zambia Open
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…
View article: A case study of researchers’ knowledge and opinions about the ethical review process for research in Botswana
A case study of researchers’ knowledge and opinions about the ethical review process for research in Botswana Open
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…
View article: What allows a health care system to become a learning health care system: Results from interviews with health system leaders
What allows a health care system to become a learning health care system: Results from interviews with health system leaders Open
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 alternat…