Results for 'Human challenge vaccine trials'

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  1. The Ethics of Human Challenge Trials Using Emerging SARS-CoV-2 Virus Variants.Abie Rohrig & Nir Eyal - manuscript
    The world’s first COVID-19 human challenge trial using the D614G strain of SARS-CoV-2 is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta variant (B.1.351) for a follow-up human challenge trial, and researchers at Imperial College London are considering conducting that trial. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. While vaccine resistance (...)
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  2. COVID-19 Human Challenge Trials – What Research Ethics Committees Need to Consider.Lisa Tambornino & Dirk Lanzerath - 2020 - Research Ethics 16 (3-4):1-11.
    To reduce the global burden of the COVID-19 pandemic, there is an urgent need to develop a safe vaccine. Vaccine development usually takes many years as it goes through several different phases. To hasten COVID-19 vaccine development, it has been suggested that the final stage could be replaced with a human challenge trial. Volunteers would be intentionally infected with SARS-CoV-2 to see how the vaccine candidate works. To intentionally infect a healthy human being (...)
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  3.  55
    Convergent Ethical Issues in HIV/AIDS, Tuberculosis and Malaria Vaccine Trials in Africa: Report From the WHO/UNAIDS African AIDS Vaccine Programme's Ethics, Law and Human Rights Collaborating Centre Consultation, 10-11 February 2009, Durban, South Africa. [REVIEW]Nicole Mamotte, Douglas Wassenaar, Jennifer Koen & Zaynab Essack - 2010 - BMC Medical Ethics 11 (1):3-.
    BackgroundAfrica continues to bear a disproportionate share of the global HIV/AIDS, tuberculosis (TB) and malaria burden. The development and distribution of safe, effective and affordable vaccines is critical to reduce these epidemics. However, conducting HIV/AIDS, TB, and/or malaria vaccine trials simultaneously in developing countries, or in populations affected by all three diseases, is likely to result in numerous ethical challenges.MethodsIn order to explore convergent ethical issues in HIV/AIDS, TB and malaria vaccine trials in Africa, the Ethics, (...)
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  4. Severe Acute Respiratory Syndrome Coronavirus 2 Human Challenge Trials: Too Risky, Too Soon.Liza Dawson, Jake Earl & Jeffrey Livezey - 2020 - Journal of Infectious Diseases 222 (3):514-516.
    Eyal et al have recently argued that researchers should consider conducting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) human challenge studies to hasten vaccine development. We have conducted (J. L.) and overseen (L. D.) human challenge studies and agree that they can be useful in developing anti-infective agents. We also agree that adults can autonomously choose to undergo risks with no prospect of direct benefit to themselves. However, we disagree that SARS-CoV-2 challenge studies are (...)
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  5. Ethical Considerations for International Recruitment in COVID-19 Human Challenge Trials.Kaleem Ahmid, Abie Rohrig, Paul Ndebele, Zacharia Kafuko & Josh Morrison - manuscript
    Ongoing and anticipated COVID-19 human challenge studies in the UK may advance our understanding of COVID-19 and facilitate the licensure of safe, effective, and easily deployable next-generation COVID-19 vaccines and boosters. We argue that international volunteer recruitment for COVID-19 human challenge trials can help promote diversity in these trials and ensure a sufficient number of eligible volunteers, both of which will increase the benefits of challenge research. We explore the ethical ramifications of dealing (...)
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  6.  15
    Ethics, Human Rights and HIV Vaccine Trials in Low-Income Settings: Table 1.Leslie London, Ashraf Kagee, Keymanthri Moodley & Leslie Swartz - 2012 - Journal of Medical Ethics 38 (5):286-293.
    The massive growth in global health research in past decades has posed many challenges for its effective ethical oversight, not least of which is how best to provide effective protection of research participants. The extent of the HIV epidemic in sub-Saharan Africa in particular makes research into prevention technologies for HIV, including HIV vaccine research, a global priority. However, the need for vaccine research must be considered in conjunction with the individual's right to informed consent, which is based (...)
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  7. Exploring the Ethics of Tuberculosis Human Challenge Models.Abie Rohrig, Josh Morrison, Jonathan Pugh, Julian Savulescu & Helen McShane -
    TB human challenge studies could accelerate TB vaccine development by reducing uncertainty in early-stage vaccine testing, selecting promising vaccine candidates for large-scale field trials, and identifying an immune correlate of protection. However, ethical concerns regarding the exposure of trial participants and bystanders to significant risk have been a limiting factor for TB human challenge models. We analyze the expected social value and risks of different types of TB human challenge models, (...)
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  8.  47
    Ethical Tradeoffs in Trial Design: Case Study of an HPV Vaccine Trial in HIV‐Infected Adolescent Girls in Lower Income Settings.J. C. Lindsey, S. K. Shah, G. K. Siberry, P. Jean-Philippe & M. J. Levin - 2013 - Developing World Bioethics 13 (2):95-104.
    The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in (...)
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  9.  67
    Why Continuing Uncertainties Are No Reason to Postpone Challenge Trials for Coronavirus Vaccines.Robert Steel, Lara Buchak & Nir Eyal - 2020 - Journal of Medical Ethics 46 (12):808-812.
    To counter the pandemic caused by severe acute respiratory syndrome coronavirus 2, some have proposed accelerating SARS-CoV-2 vaccine development through controlled human infection trials. These trials would involve the deliberate exposure of relatively few young, healthy volunteers to SARS-CoV-2. We defend this proposal against the charge that there is still too much uncertainty surrounding the risks of COVID-19 to responsibly run such a trial.
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  10.  7
    Human HIV Vaccine Trials: Does Antibody-Dependent Enhancement Pose a Genuine Risk?Donald S. Burke - 1991 - Perspectives in Biology and Medicine 35 (4):511-530.
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  11.  14
    Payment of COVID-19 Challenge Trials: Underpayment is a Bigger Worry Than Overpayment.Jennifer Blumenthal-Barby & Peter Ubel - 2021 - Journal of Medical Ethics 47 (8):585-586.
    One way to test vaccines is through human challenge trials in which participants are intentionally infected with a contagious organism to expedite the process of assessing the vaccine’s effectiveness. Some experts believe challenge trials may play an important role in fighting COVID-19, especially if the vaccines under current study do not demonstrate sufficient efficacy, if spread of COVID-19 is controlled to a point that radically slows down traditional trials, or if new vaccines need (...)
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  12.  34
    Uncertainty, Error and Informed Consent to Challenge Trials of COVID-19 Vaccines: Response to Steel Et Al.Arnon Keren & Ori Lev - 2020 - Journal of Medical Ethics 46 (12):813-814.
    In a recent article, Steel, Buchak and Eyal argue that current levels of uncertainty do not present a good reason to bar controlled human infection trials of COVID-19 vaccines from proceeding. We argue that their argumentation for this conclusion is flawed. SBE are mistaken about the effects which different forms of ignorance have on participants’ ability to provide valid informed consent. Decision-makers considering whether to allow such trials, we argue, must ultimately consider the likelihood that consent to (...)
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  13.  90
    Justifying the Risks of COVID-19 Challenge Trials: The Analogy with Organ Donation.Athmeya Jayaram, Jacob Sparks & Daniel Callies - 2022 - Bioethics 36 (1):100-106.
    In the beginning of the COVID pandemic, researchers and bioethicists called for human challenge trials to hasten the development of a vaccine for COVID. However, the fact that we lacked a specific, highly effective treatment for COVID led many to argue that a COVID challenge trial would be unethical and we ought to pursue traditional phase III testing instead. These ethical objections to challenge trials may have slowed the progress of a COVID (...), so it is important to evaluate their merit. One common way of doing so is to make an analogy to other social practices that are relevantly similar and which we currently sanction. We submit that non-directed live organ donation (NDLOD) is a promising analogy. After arguing that the risks to volunteers for each activity appear similar, we explore potential disanalogies that would undermine the comparison. We note that there are differences in both the kind and certainty of benefit secured by NDLOD compared to challenge trials. We conclude these differences are insufficient to make NDLOD permissible and challenge trials impermissible. Ultimately, if we think the risks associated with NDLOD are ethically permissible, then we should think the same of the risks associated with COVID challenge trials. (shrink)
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  14.  15
    Coronavirus Human Infection Challenge Studies: Assessing Potential Benefits and Risks.Euzebiusz Jamrozik, George S. Heriot & Michael J. Selgelid - 2020 - Journal of Bioethical Inquiry 17 (4):709-715.
    Human infection challenge studies have been proposed as a means to accelerate SARS-CoV2 vaccine development and thereby help to mitigate a prolonged global public health crisis. A key criterion for the ethical acceptability of SARS-CoV2 HCS is that potential benefits outweigh risks. Although the assessment of risks and benefits is meant to be a standard part of research ethics review, systematic comparisons are particularly important in the context of SARS-CoV2 HCS in light of the significant potential benefits (...)
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  15.  60
    Stakeholder Perspectives on Ethical Challenges in Hiv Vaccine Trials in South Africa.Zaynab Essack, Jennifer Koen, Nicola Barsdorf, Catherine Slack, Michael Quayle, Cecilia Milford, Graham Lindegger, Chitra Ranchod & Richard Mukuka - 2010 - Developing World Bioethics 10 (1):11-21.
    There is little published literature on the ethical concerns of stakeholders in HIV vaccine trials. This study explored the ethical challenges identified by various stakeholders, through an open-ended, in-depth approach. While the few previous studies have been largely quantitative, respondents in this study had the opportunity to spontaneously identify the issues that they perceived to be of priority concern in the South African context. Stakeholders spontaneously identified the following as ethical priorities: informed consent, social harms, collaborative relationships between (...)
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  16.  28
    Hiv Vaccine Trials: Reconsidering the Therapeutic Misconception and the Question of What Constitutes Trial Related Injuries.Udo Schüklenk & Richard Ashcroft - 2007 - Developing World Bioethics 7 (3):ii–iv.
    The ethical challenge is squarely focused on the question of what is owed to participants of vaccine trials who happen to become infected during the course of the trial. Not surprisingly, given the prominence of HIV/AIDS in many parts of the developing world, HIV vaccine trials have become the focal point of this debate. It is worth noting from the outset, however, that the same arguments that apply to HIV vaccines would apply to any number (...)
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  17.  23
    Ethical Considerations for Epidemic Vaccine Trials.Joshua Teperowski Monrad - 2020 - Journal of Medical Ethics 46 (7):465-469.
    Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an (...)
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  18.  7
    Payment in Challenge Studies From an Economics Perspective.Sandro Ambuehl, Axel Ockenfels & Alvin E. Roth - 2020 - Journal of Medical Ethics 46 (12):831-832.
    We largely agree with Grimwade et al ’s1 conclusion that challenge trial participants may ethically be paid, including for risk. Here, we add further arguments, clarify some points from the perspective of economics and indicate areas where economists can support the development of a framework for ethically justifiable payment. Our arguments apply to carefully constructed and monitored controlled human infection model trials that have been appropriately reviewed and approved. Participants in medical studies perform a service. Outside the (...)
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  19.  71
    'It Looks Like You Just Want Them When Things Get Rough': Civil Society Perspectives on Negative Trial Results and Stakeholder Engagement in HIV Prevention Trials.Jennifer Koen, Zaynab Essack, Catherine Slack, Graham Lindegger & Peter A. Newman - 2012 - Developing World Bioethics 12 (3):138-148.
    Civil society organizations (CSOs) have significantly impacted on the politics of health research and the field of bioethics. In the global HIV epidemic, CSOs have served a pivotal stakeholder role. The dire need for development of new prevention technologies has raised critical challenges for the ethical engagement of community stakeholders in HIV research. This study explored the perspectives of CSO representatives involved in HIV prevention trials (HPTs) on the impact of premature trial closures on stakeholder engagement. Fourteen respondents from (...)
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  20.  21
    Ethical Implications in Vaccine Pharmacotherapy for Treatment and Prevention of Drug of Abuse Dependence.Anna Carfora, Paola Cassandro, Alessandro Feola, Francesco La Sala, Raffaella Petrella & Renata Borriello - 2018 - Journal of Bioethical Inquiry 15 (1):45-55.
    Different immunotherapeutic approaches are in the pipeline for the treatment of drug dependence. “Drug vaccines” aim to induce the immune system to produce antibodies that bind to drugs and prevent them from inducing rewarding effects in the brain. Drugs of abuse currently being tested using these new approaches are opioids, nicotine, cocaine, and methamphetamine. In human clinical trials, “cocaine and nicotine vaccines” have been shown to induce sufficient antibody levels while producing few side effects. Studies in humans, determining (...)
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  21.  6
    Expérimentation clinique des vaccins contre le VIH: Dilemmes scientifiques et éthiques.Marc Lallemant & Sophie Le Coeur - 1995 - History and Philosophy of the Life Sciences 17 (1):151-169.
    Developing a vaccine against HIV is one of the greatest challenges the scientific community faces today. Several vaccine candidates have undergone preliminary safety and immunogenicity studies in humans. Research teams are ready to test these vaccines in the field, yet the scientific community is divided as to whether efficacy trial should begin. This paper addresses the complex scientific and ethical issues raised by clinical trials. Considering the pressure to act rapidly to solve the crisis, scientists need to (...)
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  22.  38
    Working with C Ommunity H Ealth W Orkers as ‘ V Olunteers’ in a Vaccine Trial: Practical and Ethical Experiences and Implications.Vibian Angwenyi, Dorcas Kamuya, Dorothy Mwachiro, Vicki Marsh, Patricia Njuguna & Sassy Molyneux - 2013 - Developing World Bioethics 13 (1):38-47.
    Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in trial (...)
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  23.  46
    Ethical Considerations in International HIV Vaccine Trials: Summary of a Consultative Process Conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS).D. Guenter - 2000 - Journal of Medical Ethics 26 (1):37-43.
    Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered “developing” countries. Safeguarding the rights and welfare of individuals (...)
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  24.  23
    Views of the Process and Content of Ethical Reviews of Hiv Vaccine Trials Among Members of Us Institutional Review Boards and South African Research Ethics Committees.Robert Klitzman - 2008 - Developing World Bioethics 8 (3):207-218.
    ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to (...)
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  25. Pandemic Ethics: 8 Big Questions of COVID-19.Ben Bramble - 2020 - Sydney: Bartleby Books.
    A clear and provocative introduction to the ethics of COVID-19, suitable for university-level students, academics, and policymakers, as well as the general reader. It is also an original contribution to the emerging literature on this important topic. The author has made it available Open Access, so that it can be downloaded and read for free by all those who are interested in these issues. Key features include: -/- A neat organisation of the ethical issues raised by the pandemic. An exploration (...)
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  26.  45
    Public Engagement with Science? Local Understandings of a Vaccine Trial in the Gambia.James Fairhead, Melissa Leach & Mary Small - 2006 - Journal of Biosocial Science 38 (1):103-116.
    This paper considers how parents engage with a large, internationally supported childhood pneumococcal vaccine trial in The Gambia. Current analysis and professional reflection on public engagement is strongly shaped by the imperatives of public health and research institutions, and is thus couched in terms of acceptance and refusal, and . In contrast Gambian parents in the extreme, of free medical treatment, versus onepublic engagement with science’ in a globalized context might be recast, with implications for debates in biomedical ethics, (...)
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  27.  20
    Live Attenuated Vaccine Trials in Medically Informed Volunteers: A Special Case?A. J. Pinching - 2000 - Journal of Medical Ethics 26 (1):44-46.
    A group of activist clinicians have offered to volunteer for clinical trials of live attenuated HIV vaccines. This has provided an important conceptual challenge to medical ethics, and to work on the development of HIV vaccines. In exploring these issues, this article highlights how the HIV field has altered the content as well as the tone of ethical discourse. The balance of expertise and authority between research subjects and triallists is profoundly changed, raising questions about the limits of (...)
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  28.  39
    COVID-19 and the Ethics of Human Challenge Trials.Bert Gordijn & Henk ten Have - 2021 - Medicine, Health Care and Philosophy 24 (1):1-2.
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  29.  17
    Ensuring Access to HIV Prevention Services in South African HIV Vaccine Trials: Correspondence Between Guidelines and Practices.Zaynab Essack - 2014 - Public Health Ethics 7 (2):195-206.
    Researchers and sponsors are required to assist HIV prevention trial participants to remain HIV-uninfected by ensuring access to prevention services. Ethics guidelines require that these HIV risk-reduction services be state of the art. This and related ethics recommendations have been intensely debated. This descriptive study aimed to identify actual HIV prevention practices for two HIV vaccine trials at five South African sites, to explore whether actual practices meet guideline recommendations and to discuss implications for practices and ethics guidelines. (...)
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  30.  65
    Ethical Criteria for Human Challenge Studies in Infectious Diseases: Table 1.Ben Bambery, Michael Selgelid, Charles Weijer, Julian Savulescu & Andrew J. Pollard - 2016 - Public Health Ethics 9 (1):92-103.
    Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised (...)
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  31.  10
    Resource and Needs of Research Ethics Committees in Africa: Preparations for HIV Vaccine Trials.C. Milford, D. Wassenaar & C. Slack - 2005 - IRB: Ethics & Human Research 28 (2):1-9.
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  32. Pandemic Ethics: The Case for Risky Research.Richard Yetter Chappell & Peter Singer - 2020 - Research Ethics 16 (3-4):1-8.
    There is too much that we do not know about COVID-19. The longer we take to find it out, the more lives will be lost. In this paper, we will defend a principle of risk parity: if it is permissible to expose some members of society (e.g. health workers or the economically vulnerable) to a certain level of ex ante risk in order to minimize overall harm from the virus, then it is permissible to expose fully informed volunteers to a (...)
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  33.  35
    Research Benefits for Hypothetical HIV Vaccine Trials: The Views of Ugandans in the Rakai District.Christine Grady, Jennifer Wagman, Robert Ssekubugu, Maria J. Wawer, David Serwadda, Mohammed Kiddugavu, Fred Nalugoda, Ronald H. Gray, David Wendler, Qian Dong, Dennis O. Dixon, Bryan Townsend, Elizabeth Wahl & Ezekiel J. Emanuel - 2008 - IRB: Ethics & Human Research 30 (2):1.
    Controversy persists over the ethics of compensating research participants and providing posttrial benefits to communities in developing countries. Little is known about residents' views on these subjects. In this study, interviews about compensation and posttrial benefits from a hypothetical HIV vaccine trial were conducted in Uganda’s Rakai District. Most respondents said researchers owed the community posttrial benefits and research compensation, but opinions differed as to what these should be. Debates about posttrial benefits and compensation rarely include residents' views like (...)
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  34.  29
    Feedback of Research Findings for Vaccine Trials: Experiences From Two Malaria Vaccine Trials Involving Healthy Children on the K Enyan C Oast.Caroline Gikonyo, Dorcas Kamuya, Bibi Mbete, Patricia Njuguna, Ally Olotu, Philip Bejon, Vicki Marsh & Sassy Molyneux - 2013 - Developing World Bioethics 13 (1):48-56.
    Internationally, calls for feedback of findings to be made an ‘ethical imperative’ or mandatory have been met with both strong support and opposition. Challenges include differences in issues by type of study and context, disentangling between aggregate and individual study results, and inadequate empirical evidence on which to draw. In this paper we present data from observations and interviews with key stakeholders involved in feeding back aggregate study findings for two Phase II malaria vaccine trials among children under (...)
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  35.  22
    Ethical Dilemmas in Malaria Drug and Vaccine Trials: A Bioethical Perspective.M. Barry & M. Molyneux - 1992 - Journal of Medical Ethics 18 (4):189-192.
    Malaria is a disease of developing countries whose local health services do not have the time, resources or personnel to mount studies of drugs or vaccines without the collaboration and technology of western investigators. This investigative collaboration requires a unique bridging of cultural differences with respect to human investigation. The following debate, sponsored by The Institute of Medicine and The American Society of Tropical Medicine and Hygiene, raises questions concerning the conduct of trans-cultural clinical malaria research. Specific questions are (...)
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  36.  11
    Challenging ‘Girls Only’ Publicly Funded Human Papillomavirus Vaccination Programmes.Victoria G. Law & Diana L. Gustafson - 2017 - Nursing Inquiry 24 (1):e12140.
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  37.  34
    Comprehension of a Simplified Assent Form in a Vaccine Trial for Adolescents: Table 1.Sonia Lee, Bill G. Kapogiannis, Patricia M. Flynn, Bret J. Rudy, James Bethel, Sushma Ahmad, Diane Tucker, Sue Ellen Abdalian, Dannie Hoffman, Craig M. Wilson & Coleen K. Cunningham - 2013 - Journal of Medical Ethics 39 (6):410-412.
    Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. Methods Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. Results 123 youth completed (...)
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  38. Ethical Issues in the Development and Testing of a Preventive Hiv Vaccine.Christine Grady - 1993 - Dissertation, Georgetown University
    This dissertation explores the ethics of human subjects research with particular attention to how clinical research on vaccines differs from research on therapies. The major differences are rooted in the fact that the benefits of vaccines and vaccine research accrue to the community to which vaccines belong by inducing herd immunity and thereby protecting both vaccinated and unvaccinated individuals. Therapeutics have no corresponding benefit to the community, the primary beneficiary is the individual. The ethical justification for conducting (...) research in a given community therefore should include an evaluation of the risks and benefits to the community as well as to involved individuals. Respect for individuals extends to respect for communities and for individuals as members of communities. A three way partnership between investigators, the community, and the community members is suggested as an ethical foundation for vaccine research. ;This model is then applied to the particular and complex case of testing a preventive HIV vaccine. HIV is an unique virus which continues to cause extraordinary devastation worldwide. The characteristics of HIV, its transmission and epidemiology, along with unprecedented scientific possibilities present a formidable challenge to the development and testing of an HIV vaccine. Using the community model, specific suggestions are made for the ethical conduct of clinical efficacy trials of HIV preventive vaccines. (shrink)
     
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  39. Perceived Capacity of Selected African Research Ethics Committees to Review HIV Vaccine Trial Protocols.C. Milford, D. R. Wassenaar & C. M. Slack - 2006 - IRB: Ethics & Human Research 28 (2):1-9.
  40. Job Applicants as Research Subjects: The Case of a Rubella Vaccine Trial.Angela R. Holder - 1980 - IRB: Ethics & Human Research 2 (2):5.
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  41.  25
    A Radical Approach to Ebola: Saving Humans and Other Animals.Sarah J. L. Edwards, Charles H. Norell, Phyllis Illari, Brendan Clarke & Carolyn P. Neuhaus - 2018 - American Journal of Bioethics 18 (10):35-42.
    As the usual regulatory framework did not fit well during the last Ebola outbreak, innovative thinking still needed. In the absence of an outbreak, randomised controlled trials of clinical efficacy in humans cannot be done, while during an outbreak such trials will continue to face significant practical, philosophical, and ethical challenges. This article argues that researchers should also test the safety and effectiveness of novel vaccines in wild apes by employing a pluralistic approach to evidence. There are three (...)
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  42.  7
    Research Ethics and Public Trust in Vaccines: The Case of COVID-19 Challenge Trials.Nir Eyal - forthcoming - Journal of Medical Ethics:medethics-2021-108086.
    Despite their clearly demonstrated safety and effectiveness, approved vaccines against COVID-19 are commonly mistrusted. Nations should find and implement effective ways to boost vaccine confidence. But the implications for ethical vaccine development are less straightforward than some have assumed. Opponents of COVID-19 vaccine challenge trials, in particular, made speculative or empirically implausible warnings on this matter, some of which, if applied consistently, would have ruled out most COVID-19 vaccine trials and many non-pharmaceutical responses.
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  43.  26
    Challenge Trials: What Are the Ethical Problems?Daniel M. Hausman - 2021 - Journal of Medicine and Philosophy 46 (1):137-145.
    If, as is alleged, challenge trials of vaccines against COVID-19 are likely to save thousands of lives and vastly diminish the economic and social harms of the pandemic while subjecting volunteers to risks that are comparable to kidney donation, then it would seem that the only sensible objection to such trials would be to deny that they have low risks or can be expected to have immense benefits. This essay searches for a philosophical rationale for rejecting (...) trials while supposing that they have huge benefits and relatively low risks. Although it finds some force in objections to challenge trials grounded in the obligations of researchers to limit the harms imposed on some individuals for the benefit of others, it argues that there is no compelling objection to challenge trials of vaccines for COVID-19—if they have the benefits and risks that have been claimed. (shrink)
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  44.  88
    Vaccination Policy and Ethical Challenges Posed by Herd Immunity, Suboptimal Uptake and Subgroup Targeting.J. Luyten, A. Vandevelde, P. Van Damme & P. Beutels - 2011 - Public Health Ethics 4 (3):280-291.
    Vaccination policy is an ethically challenging domain of public policy. It is a matter of collective importance that reaches into the most private sphere of citizens and unavoidably conflicts with individual-based ethics. Policy makers need to walk a tight rope in order to complement utilitarian public health values with individual autonomy rights, protection of privacy, non-discrimination and protection of the worst-off. Whether vaccination is voluntary or compulsory, universal or targeted, every option faces complex ethical hurdles because of the interdependence of (...)
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  45.  27
    Controlled Human Infection with SARS-CoV-2 to Study COVID-19 Vaccines and Treatments: Bioethics in Utopia.Søren Holm - 2020 - Journal of Medical Ethics 46 (9):569-573.
    A number of papers have appeared recently arguing for the conclusion that it is ethically acceptable to infect healthy volunteers with severe acute respiratory syndrome coronavirus 2 as part of research projects aimed at developing COVID-19 vaccines or treatments. This position has also been endorsed in a statement by a working group for the WHO. The papers generally argue that controlled human infection is ethically acceptable if the risks to participants are low and therefore acceptable, the scientific quality of (...)
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  46.  25
    Addressing the Ethical Challenges of First in-Human Trials.Audrey R. Chapman - 2011 - Journal of Clinical Research and Bioethics 2 (4).
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  47.  13
    Human Dignity as a Basis for Providing Post-Trial Access to Healthcare for Research Participants: A South African Perspective.Pamela Andanda & Jane Wathuta - 2018 - Medicine, Health Care and Philosophy 21 (1):139-155.
    This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version (...)
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  48.  46
    Uncertain Translation, Uncertain Benefit and Uncertain Risk: Ethical Challenges Facing First-in-Human Trials of Induced Pluripotent Stem (Ips) Cells.Ronald K. F. Fung & Ian H. Kerridge - 2013 - Bioethics 27 (2):89-96.
    The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement therapy. First-in-human (...)
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  49.  38
    Challenge Studies of Human Volunteers: Ethical Issues.T. Hope - 2004 - Journal of Medical Ethics 30 (1):110-116.
    There is a long history of medical research that involves intentionally infecting healthy people in order to study diseases and their treatments. Such research—what might be called “human challenge studies”—are an important strand of much current research—for example, in the development of vaccinations. The many international and national guidelines about the proper conduct of medical research do not specifically address human challenge studies. In this paper we review the guidelines on the risk of harm that healthy (...)
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  50.  21
    Evaluation of the Quality of Informed Consent in a Vaccine Field Trial in a Developing Country Setting.Deon Minnies, Tony Hawkridge, Willem Hanekom, Rodney Ehrlich, Leslie London & Greg Hussey - 2008 - BMC Medical Ethics 9 (1):15-.
    BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality (...)
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