23 results on '"Eyal, Nir"'
Search Results
2. Risk to Nonparticipants in HIV Remission Studies With Treatment Interruption: A Symposium
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Eyal, Nir and Deeks, Steven G
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Medical Microbiology ,Biomedical and Clinical Sciences ,Sexually Transmitted Infections ,HIV/AIDS ,Infectious Diseases ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Infection ,Adult ,Aged ,Aged ,80 and over ,Anti-Retroviral Agents ,Biomedical Research ,Duration of Therapy ,Female ,Guidelines as Topic ,HIV Infections ,Humans ,Male ,Middle Aged ,Remission Induction ,Research Design ,Risk Factors ,Sexual Partners ,HIV ,research ethics ,analytic treatment interruption ,HIV cure-related studies ,immunotherapy ,pre-exposure prophylaxis ,Biological Sciences ,Medical and Health Sciences ,Microbiology ,Biological sciences ,Biomedical and clinical sciences ,Health sciences - Abstract
Ethical guidelines and recommendations for human subjects research typically focus on protecting the individuals who directly participate in that research. However, additional people, including sex partners of research participants, can also face harms and burdens from medical studies. In human immunodeficiency virus (HIV) cure-related research, a persistent ethical and practical challenge surrounds the use of analytical antiretroviral treatment interruptions. The challenge is usually discussed in relation to risks to study participants, but serious dangers accrue to nonparticipants, including sex partners of study participants. This multidisciplinary supplement relays the risks for nonparticipating sex partners in HIV cure-related studies and addresses the ethical dilemmas raised by these studies, with recommendations for researchers, advocates, sponsors, and oversight bodies.
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- 2019
3. Ethical issues in HIV remission trials
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Eyal, Nir, Holtzman, Lisa G, and Deeks, Steven G
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Minority Health ,Women's Health ,Clinical Research ,Infectious Diseases ,Sexually Transmitted Infections ,Behavioral and Social Science ,Clinical Trials and Supportive Activities ,HIV/AIDS ,8.3 Policy ,ethics ,and research governance ,Health and social care services research ,Infection ,Clinical Trials as Topic ,Ethics ,Medical ,Guidelines as Topic ,HIV ,HIV Infections ,Humans ,Remission Induction ,analytic treatment interruption ,HIV cure-related studies ,human subjects research ,immunotherapy ,research ethics ,Public Health and Health Services ,Virology ,Clinical sciences ,Medical microbiology ,Epidemiology - Abstract
Purpose of reviewSeveral promising experimental pathways exist for long-term control of HIV in the absence of antiretroviral therapy (HIV 'remission') and are now being tested in early clinical studies. These studies can be invasive and pose a host of distinctive risks to participants, as well as to nonparticipants, especially to participants' fetuses, and sexual partners.Recent findingsEthical analyses of these studies have mainly focused on the risks to study participants. They recommend, and some investigators implement, procedures to mitigate risks for participants or to offset them with direct, indirect, and nonmedical benefits. They also suggest ways to keep participants' consent highly voluntary and informed. Rarely do ethicists propose keeping the social value of studies high. Of these recommended responses, only the latter, rarer proposals help address the risk to nonparticipants, as would some novel ways to address that risk.SummaryHIV remission studies pose a number of ethical dilemmas. Many current investigative approaches put the participant at significant risk, but well established guidelines exist for mitigating this risk. Ethical issues that are not being fully addressed include risk to nonparticipants and the need to consider the societal value of studies, for example, their prospective impact on the global HIV burden. VIDEO ABSTRACT.
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- 2018
4. Ethical Questions in Medical Electronic Adherence Monitoring
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Campbell, Jeffrey I., Eyal, Nir, Musiimenta, Angella, and Haberer, Jessica E.
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- 2016
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5. Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions.
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Berner-Rodoreda, Astrid, McMahon, Shannon, Eyal, Nir, Hossain, Puspita, Rabbani, Atonu, Barua, Mrittika, Sarker, Malabika, Metta, Emmy, Mmbaga, Elia, Leshabari, Melkizedeck, Wikler, Daniel, and Bärnighausen, Till
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INFORMED consent (Medical law) ,RISK perception ,HEALTH policy ,COVID-19 pandemic ,HUMAN experimentation ,INDIVIDUAL differences - Abstract
Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs. Health experts across all countries favored a strong evidence base, prior information to the affected populations, and individual consent for 'risky' HPEs. Differences pertained to individual risk perception, how and when consent by group representatives should be obtained and whether HPEs could be treated as health policies. The study adds to representative consent options for HPEs, yet shows that more research is needed in this field – particularly in the present Covid-19 pandemic which has highlighted the need for HPEs nationally and globally. [ABSTRACT FROM AUTHOR]
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- 2022
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6. The Ethics of Human Challenge Trials Using Emerging Severe Acute Respiratory Syndrome 2 Variants.
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Rohrig, Abie and Eyal, Nir
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COVID-19 , *SARS-CoV-2 Delta variant , *SARS-CoV-2 , *RESEARCH funding - Abstract
The world's first coronavirus disease 2019 human challenge trial using the D614G strain of severe acute respiratory syndrome 2 (SARS-CoV-2) is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta and Delta variant for a follow-up human challenge trial, and researchers at hVIVO are considering conducting these trials. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. We explore 2 specific characteristics of some variants that may initially be thought to make such trials unethical and conclude that SARS-CoV-2 variant challenge trials can remain ethical. [ABSTRACT FROM AUTHOR]
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- 2022
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7. Symposium on risks to bystanders in clinical research: An introduction.
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Eyal, Nir and Holtzman, Lisa
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CLINICAL medicine research , *CONFERENCES & conventions , *DECISION making , *RESEARCH ethics , *BYSTANDER CPR - Abstract
An editorial is presented on the symposium on risks to bystanders in clinical research. Topics include the risks to researchers may become a safety concern and especially for student researchers, the infectious disease studies can place bystanders at risk of acquiring the infection from study participants, and the research assistant may be at risk of assault when interviewing participants.
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- 2020
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8. Study bystanders and ethical treatment of study participants—A proof of concept.
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Eyal, Nir
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EXPERIMENTAL design , *RESEARCH ethics , *RISK assessment , *SAFETY , *HUMAN research subjects - Abstract
The ethics of research on human subjects is often construed as a fine balance between the interests of patients in need of novel health interventions, and those of study participants who should remain safe in the process. But there is a third group in the mix. Some people belong to neither category, yet research can affect or jeopardize them. Call such people "bystanders." This article shows that thinking about bystander protection can question whether there is an upper limit on the risks that studies may legitimately visit upon their participants. Thus, thinking about appropriate bystander protection can shed light on the appropriate protection of study participants. Core research ethics, which focuses on the latter, must consider the former as well. [ABSTRACT FROM AUTHOR]
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- 2020
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9. Why Challenge Trials of SARS‐CoV‐2 Vaccines Could Be Ethical Despite Risk of Severe Adverse Events.
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Eyal, Nir
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VACCINES , *COVID-19 pandemic , *RESEARCH ethics , *RANDOMIZED controlled trials , *VOLUNTEERS - Abstract
Human challenge trials to test the efficacy of vaccine candidates against SARS‐CoV‐2, the novel coronavirus behind Covid‐19, could save considerable time and many lives. But they may initially seem unethical because they expose healthy volunteers to a live virus that is killing many people and for which no cure exists. This article argues that this is not the correct test of their ethics. The correct test is comparative. And in the special circumstances of the Covid‐19 pandemic, human challenge trials meet the correct test better than standard efficacy testing would. [ABSTRACT FROM AUTHOR]
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- 2020
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10. Regulating impact on bystanders in clinical trials: An unsettled frontier.
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Eyal, Nir, Kimmelman, Jonathan, Holtzman, Lisa G, and Lipsitch, Marc
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CLINICAL trials ,SCIENTIFIC observation ,RESEARCH ethics ,UNOBTRUSIVE measures - Abstract
This article informally reviews key research ethics guidelines and regulations, academic scholarship, and research studies and finds wide variety in how they consider risk to bystanders in medical research (namely, non-participants whom studies nevertheless place at risk). Some of these key sources give no or very little consideration to bystanders, while others offer them the utmost protection (greater than they offer study participants). This unsettled frontier would benefit from a deeper investigation of the ethics of protecting research bystanders. [ABSTRACT FROM AUTHOR]
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- 2019
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11. How to Address the Risk of HIV Transmission in Remission Studies With Treatment Interruption: The Low-Hanging Fruit Approach.
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Eyal, Nir
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HIV infection transmission , *THERAPEUTICS , *FRUIT , *SEXUAL partners , *HIV prevention , *ANTI-HIV agents , *VACCINES , *MIXED infections , *STRUCTURED treatment interruption , *RESEARCH funding , *PASSIVE euthanasia , *DISEASE remission - Abstract
Some HIV remission studies include a treatment interruption that seriously risks infecting participants' sex partners with HIV. What, ethically, is owed to these nonparticipants? Until greater certainty emerges on what protections should be afforded nonparticipants of research studies, what I call a "low-hanging fruit" approach may help researchers and review bodies determine how to address infection risks to nonparticipants in these studies. [ABSTRACT FROM AUTHOR]
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- 2019
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12. Ethical complexities of responding to bystander risk in HIV prevention trials.
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Eyal, Nir and Wikler, Daniel
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HIV prevention ,HIV infection transmission ,PREVENTION of infectious disease transmission ,CLINICAL trials ,PREVENTIVE medicine ,RESEARCH ethics ,PSYCHOSOCIAL factors ,SEXUAL partners - Abstract
Till Bärnighausen points out the medical risks that two categories of contemporary HIV prevention trials, for "treatment-as-prevention" and for "pre-exposure prophylaxis," pose to people who are not study participants. Bärnighausen's compelling case forces reconsideration of the absence of bystanders in the law governing ethical review of health research. It raises the intriguing question: to what legal protection are bystanders morally entitled? The remedy might seem to be to accord bystanders the rights and protections currently accorded to human study participants. We counsel against that remedy on three grounds, inviting colleagues to suggest alternatives. [ABSTRACT FROM AUTHOR]
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- 2019
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13. Risk to bystanders in clinical trials: A symposium.
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Eyal, Nir
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HIV prevention ,ANTIRETROVIRAL agents ,CLINICAL trials ,CONFERENCES & conventions ,HEALTH status indicators ,PUBLIC health ,RESEARCH ethics ,RISK assessment ,PSYCHOLOGY of human research subjects - Abstract
This symposium takes a critical look at the ethics of impact on "bystanders" to clinical research. By that we mean study non-participants who nevertheless are at risk of being affected by the study in some way. This introduction suggests some questions to consider while reading through the symposium contributions, and gives a précis of each. [ABSTRACT FROM AUTHOR]
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- 2019
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14. Reframing Consent for Clinical Research: A Function-Based Approach.
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Dickert, Neal W., Eyal, Nir, Goldkind, Sara F., Grady, Christine, Joffe, Steven, Lo, Bernard, Miller, Franklin G., Pentz, Rebecca D., Silbergleit, Robert, Weinfurt, Kevin P., Wendler, David, and Kim, Scott Y. H.
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AUTONOMY (Psychology) , *CLINICAL medicine research , *INFORMED consent (Medical law) , *LOCUS of control , *RESEARCH ethics , *TRUST , *RULES , *HUMAN research subjects - Abstract
Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. [ABSTRACT FROM PUBLISHER]
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- 2017
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15. A new day for human challenge trials?
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Rohrig, Abie and Eyal, Nir
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Two years into the coronavirus disease 2019 (COVID-19) pandemic and following several hot debates, the world's first COVID-19 human challenge trial has recently been published by Killingley et al. We review its findings and explain why this particular juncture in time makes additional challenge trials for COVID-19 and for other diseases justified and important. [ABSTRACT FROM AUTHOR]
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- 2022
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16. How to keep high-risk studies ethical: classifying candidate solutions.
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Eyal, Nir
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HEALTH risk assessment ,HIV infections ,THERAPEUTICS ,SOCIAL ethics ,VALUES (Ethics) ,HIV-positive persons ,HEALTH ,AIDS vaccines ,CLINICAL trials ,ETHICS ,EXPERIMENTAL design ,INFORMED consent (Medical law) ,MEDICAL research ,READABILITY (Literary style) ,RESEARCH ethics ,SOCIAL responsibility ,DISEASE remission ,PATIENT selection - Abstract
This article lays out a wide spectrum of candidate ethical solutions for the challenge on which this JME symposium focuses: the benefit:risk ratio challenge to some early-phase HIV cure and remission studies. These candidate solutions fall into four categories: ones that seek to reduce risks in early-phase HIV cure and remission studies, ones that enhance the benefits for these studies' participants (or show that those were adequate in the first place), ones that focus on participants' free and informed consent to participate and ones according to whom the large benefits to non-participants can defeat considerations about individual participant net risks. In so doing, this article also structures the rest of the symposium. [ABSTRACT FROM AUTHOR]
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- 2017
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17. Is it ethical to isolate study participants to prevent HIV transmission during trials with an analytical treatment interruption?
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Eyal, Nir and Magalhaes, Monica
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HIV infection transmission , *THERAPEUTICS , *DENTAL ethics , *HIV , *HIV prevention , *ANTI-HIV agents , *VACCINES , *MIXED infections , *STRUCTURED treatment interruption , *RESEARCH funding , *ISOLATION (Hospital care) , *PASSIVE euthanasia - Abstract
This commentary considers an extreme idea for protecting against human immunodeficiency virus (HIV) transmission to sex partners of individuals participating in HIV remission studies with an analytical treatment interruption (ATI). Other human challenge studies, such as studies of influenza, commonly isolate participants during the trial, to protect their contacts and the community against infection. Why should HIV studies with a treatment interruption be any different, one might wonder? This article concludes that isolation should not be used in HIV remission studies with an ATI but also shows that the matter is complex. [ABSTRACT FROM AUTHOR]
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- 2019
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18. Vaccine testing for emerging infections: the case for individual randomisation
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Eyal, Nir and Lipsitch, Marc
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Allocation of Health Care Resources ,Clinical trials ,Epidemiology ,Ethics ,Research Ethics - Abstract
During the 2014-2015 Ebola outbreak in Guinea, Liberia and Sierra Leone, many opposed the use of individually randomised controlled trials to test candidate Ebola vaccines. For a raging fatal disease, they explained, it is unethical to relegate some study participants to control arms. In Zika and future emerging infections, similar opposition may hinder urgent vaccine research, so it is best to address these questions now. This article lays out the ethical case for individually randomised control in testing vaccines against many emerging infections, including lethal infections in low-income countries, even when at no point in the trial do the controls receive the countermeasures being tested. When individual randomisation is feasible-and it often will be-it tends to save more lives than alternative designs would. And for emerging infections, individual randomisation also tends as such to improve care, access to the experimental vaccine and prospects for all participants relative to their opportunities absent the trial, and no less than alternative designs would. That obtains even under placebo control and without equipoise-requiring which would undermine individual randomisation and the alternative designs that opponents proffered. Our arguments expound four often-neglected factors: benefits to non-participants, benefits to participants once a trial is over including post-trial access to the study intervention, participants' prospects before randomisation to arms and the near-inevitable disparity between arms in any randomised controlled trial.
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- 2017
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19. The Diverse Ethics of Translational Research.
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Sofaer, Neema and Eyal, Nir
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CLINICAL medicine research , *CLINICAL trials , *CONFLICT of interests , *ENDOWMENT of research , *INFORMED consent (Medical law) , *MEDICAL ethics , *POVERTY , *RESEARCH ethics , *GENOMICS , *GOVERNMENT regulation , *DRUG approval , *RESEARCH , *HUMAN research subjects , *ETHICS , *SAFETY ,DEVELOPING countries - Abstract
Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1). Whether or not T1 has these features, translational research beyond approval (T2: phase IV, health services, and implementation research) is unlikely to and, when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor. [ABSTRACT FROM AUTHOR]
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- 2010
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20. Two Kinds of To-Kind Benefits and Other Reasons Why Shared Vulnerability Can Keep Clinical Studies Ethical.
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Eyal, Nir
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INFORMED consent & ethics , *HUMAN research subjects , *RESEARCH ethics , *AT-risk people , *RELATIVE medical risk , *PSYCHOLOGICAL vulnerability , *ETHICS - Abstract
The author offers comments on the article "Shared vulnerabilities in research," by Eric Chwang which appeared in "American Journal of Bioetics." Topics include shared vulnerability in research as difficulty providing informed consent and as elevated liability to be wronged, the vulnerability of ethnic, racial and economic minorities in being more often wronged than other people in research, and the personalization of reviewers' risk-benefit ration determinations.
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- 2014
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21. Removing One Barrier to Protecting Sex Partners in HIV Remission Studies With a Treatment Interruption.
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Eyal, Nir
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THERAPEUTICS , *SEXUAL partners , *HIV , *HUMAN research subjects , *HIV infection transmission , *HIV prevention , *ANTI-HIV agents , *VACCINES , *MIXED infections , *PSYCHOSOCIAL factors , *STRUCTURED treatment interruption , *RESEARCH funding , *UNSAFE sex , *PASSIVE euthanasia , *DISEASE remission - Abstract
Only a few of the recommendations made in this supplement are implemented in ongoing HIV remission studies that involve an analytical treatment interruption. The absence of these recommendations in protocols puts sexual partners of study participants at serious risk. This paper addresses one possible barrier to implementation: a certain misunderstanding among sponsors and research entities. [ABSTRACT FROM AUTHOR]
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- 2019
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22. Translational Research Beyond Approval: A Two-Stage Ethics Review.
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Sofaer, Neema and Eyal, Nir
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ETHICS committees , *INFORMED consent (Medical law) , *RESEARCH methodology , *MEDICAL research , *POVERTY , *RESEARCH ethics , *COMMUNITY support , *RESEARCH , *HUMAN research subjects , *ETHICS , *LAW , *LEGISLATION , *SAFETY - Abstract
A letter to the editor is presented in response to the article "The Diverse Ethics of Translational Research," by N. Sofaer and N. Eyal.
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- 2010
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23. Afterword: returning to philosophical foundations in research ethics.
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Eyal, Nir
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RESEARCH ethics ,SCIENTIFIC knowledge ,SCIENTIFIC community ,RESEARCH institutes ,SCIENTIFIC method ,HIV prevention ,MEDICAL research ethics ,AIDS vaccines ,MEDICAL ethics ,RESEARCH funding ,RISK assessment ,HUMAN research subjects ,DISEASE eradication - Abstract
This is an afterword to the JME symposium on the benefit/risk ratio challenge in clinical research, and the case of HIV cure. It notes implications of the symposium for research ethics in general. [ABSTRACT FROM AUTHOR]
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- 2017
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