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Tremblay YDN, Thomassin JL. Overheard at a conference: an in-class activity to foster classroom discussion on ethics and experimental systems in microbiology research. JOURNAL OF MICROBIOLOGY & BIOLOGY EDUCATION 2025; 26:e0014724. [PMID: 39772646 PMCID: PMC12020794 DOI: 10.1128/jmbe.00147-24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/26/2024] [Accepted: 12/08/2024] [Indexed: 01/11/2025]
Abstract
Responsible conduct of research and ethics are key components of microbiology and are carefully considered at all steps from project conception, design, data analysis to publication, and post-publication use of samples. Yet stand-alone courses covering these topics are not always core components of undergraduate biomedical education curricula. Here, we describe a classroom activity for undergraduate students designed to promote increased understanding of ethics and experimental design in biomedical research.
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Affiliation(s)
- Yannick D. N. Tremblay
- Department of Biochemistry, Microbiology and Immunology, University of Saskatchewan, Saskatoon, Canada
| | - Jenny-Lee Thomassin
- Department of Biochemistry, Microbiology and Immunology, University of Saskatchewan, Saskatoon, Canada
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2
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Walker TM, Watson JA, Moore DAJ, Frick M, Jamrozik E. Tuberculosis preventive therapy: scientific and ethical considerations for trials of ultra-short regimens. THE LANCET. INFECTIOUS DISEASES 2025:S1473-3099(25)00083-0. [PMID: 40127669 DOI: 10.1016/s1473-3099(25)00083-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/08/2025] [Revised: 01/31/2025] [Accepted: 02/03/2025] [Indexed: 03/26/2025]
Abstract
Preventive therapy remains key to the elimination of tuberculosis and is typically offered to people with presumptive Mycobacterium tuberculosis infection to prevent active disease. Although the duration of tuberculosis preventive therapy has been reduced substantially over time, it remains long in absolute terms, and uptake remains low. Treatment-shortening trials using non-inferiority designs have so far led to the implementation of effective regimens of 1-4 months' duration. Such regimens are a substantial improvement on the previous 6-9 months' duration standard of care but still far too long given potential toxicity and the very low baseline risk of disease for most individuals. The efficacy of even shorter tuberculosis preventive therapy regimens, including ultra-short regimens shorter than 2 weeks' duration, is yet to be explored, but optimal public health outcomes might be achieved even if the efficacy of such regimens is lower than that of the standard of care. Greater acceptability could lead to higher population uptake, and, potentially, to more cases of tuberculosis avoided. Nonetheless, the optimal duration of ultra-short tuberculosis preventive therapy regimens cannot be explored through classic two-arm non-inferiority trials. Instead, the relationship between different durations and efficacy of tuberculosis preventive therapy will need to be characterised, requiring some participants to be randomly assigned to no (or delayed) therapy in order to characterise the number of tuberculosis cases averted by the shortest options. We argue that such trials are needed to identify the optimal trade-off between efficacy and acceptability and would be ethically acceptable provided there were appropriate risk mitigation measures for participants, including careful monitoring for the development of active disease. In this Personal View, we discuss some of the scientific and ethical considerations around the investigation of ultra-short-course preventive therapy for tuberculosis.
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Affiliation(s)
- Timothy M Walker
- Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, Oxford, UK.
| | - James A Watson
- Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, Oxford, UK; Infectious Diseases Data Observatory, Oxford, UK
| | - David A J Moore
- Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK
| | - Mike Frick
- Treatment Action Group, New York, NY, USA
| | - Euzebiusz Jamrozik
- Ethox and Pandemic Sciences Institute, University of Oxford, Oxford, UK; Department of Infectious Diseases & Royal Melbourne Hospital Department of Medicine, University of Melbourne, Melbourne, VIC, Australia
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3
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Wogu E, Ogoh G, Filima P, Nsaanee B, Caron B, Pestilli F, Eke D. FAIR African brain data: challenges and opportunities. Front Neuroinform 2025; 19:1530445. [PMID: 40098921 PMCID: PMC11911527 DOI: 10.3389/fninf.2025.1530445] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/18/2024] [Accepted: 02/12/2025] [Indexed: 03/19/2025] Open
Abstract
Introduction The effectiveness of research and innovation often relies on the diversity or heterogeneity of datasets that are Findable, Accessible, Interoperable and Reusable (FAIR). However, the global landscape of brain data is yet to achieve desired levels of diversity that can facilitate generalisable outputs. Brain datasets from low-and middle-income countries of Africa are still missing in the global open science ecosystem. This can mean that decades of brain research and innovation may not be generalisable to populations in Africa. Methods This research combined experiential learning or experiential research with a survey questionnaire. The experiential research involved deriving insights from direct, hands-on experiences of collecting African Brain data in view of making it FAIR. This was a critical process of action, reflection, and learning from doing data collection. A questionnaire was then used to validate the findings from the experiential research and provide wider contexts for these findings. Results The experiential research revealed major challenges to FAIR African brain data that can be categorised as socio-cultural, economic, technical, ethical and legal challenges. It also highlighted opportunities for growth that include capacity development, development of technical infrastructure, funding as well as policy and regulatory changes. The questionnaire then showed that the wider African neuroscience community believes that these challenges can be ranked in order of priority as follows: Technical, economic, socio-cultural and ethical and legal challenges. Conclusion We conclude that African researchers need to work together as a community to address these challenges in a way to maximise efforts and to build a thriving FAIR brain data ecosystem that is socially acceptable, ethically responsible, technically robust and legally compliant.
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Affiliation(s)
- Eberechi Wogu
- Department of Anatomy, University of Port Harcourt, Port Harcourt, Nigeria
| | - George Ogoh
- School of Computer Science, University of Nottingham, Nottingham, United Kingdom
| | - Patrick Filima
- Department of Anatomy, University of Port Harcourt, Port Harcourt, Nigeria
| | - Barisua Nsaanee
- Department of Anatomy, University of Port Harcourt, Port Harcourt, Nigeria
| | - Bradley Caron
- Department of Psychology and Neuroscience, The University of Texas at Austin, Austin, TX, United States
| | - Franco Pestilli
- Department of Psychology and Neuroscience, The University of Texas at Austin, Austin, TX, United States
| | - Damian Eke
- School of Computer Science, University of Nottingham, Nottingham, United Kingdom
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Lindholm O, Karjalainen S, Launis V. Chasing 'vulnerability' across six decades of the Declaration of Helsinki. Monash Bioeth Rev 2025:10.1007/s40592-025-00235-4. [PMID: 40000556 DOI: 10.1007/s40592-025-00235-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/10/2025] [Indexed: 02/27/2025]
Abstract
The year 2024 marked the 60th anniversary of the World Medical Association's Declaration of Helsinki (DoH). Coincidentally, the WMA published the 8th revision of this landmark document guiding medical research involving human subjects. One of the key changes in this latest revision concerns the notion of vulnerability, which has always been central to the DoH's ethos. The term 'vulnerability' was explicitly introduced in the 5th revision, published in 2000, which lists five vulnerable groups. Subsequent revisions have significantly altered how vulnerability is portrayed and understood within the document. This article traces the conceptualisation of vulnerability across the various versions of the DoH, culminating in its recently published 8th revision. We explore the underlying principles of each revision and examine how these principles have both influenced and been influenced by broader ethical discourses. Lastly, we address some of the challenges that future revisions must meet to ensure that the document remains internally coherent and practically applicable for researchers and research ethics committees alike.
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Tyagi A, Bajaj SS, Nayeu EN, Stanford FC. No person left behind: Understanding vaccine hesitancy in low- and middle-income countries. Vaccine 2025; 44:126446. [PMID: 39419730 DOI: 10.1016/j.vaccine.2024.126446] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/14/2022] [Revised: 06/16/2024] [Accepted: 10/09/2024] [Indexed: 10/19/2024]
Affiliation(s)
| | | | - Esther Njinembo Nayeu
- Department of Health Promotion, World Health Organization Africa Regional Office, Brazzaville, Republic of Congo
| | - Fatima Cody Stanford
- Massachusetts General Hospital, MGH Weight Center, Department of Medicine-Division of Endocrinology-Neuroendocrine, Department of Pediatrics-Division of Endocrinology, Nutrition Obesity Research Center at Harvard (NORCH), Harvard Medical School, Boston, MA, USA.
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Kurihara C, Greco D, Dhai A, Matsuyama K, Baroutsou V. Vulnerability, social value and the equitable sharing of benefits from research: beyond the placebo and access debates. Front Med (Lausanne) 2024; 11:1432267. [PMID: 39355849 PMCID: PMC11442373 DOI: 10.3389/fmed.2024.1432267] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2024] [Accepted: 08/28/2024] [Indexed: 10/03/2024] Open
Abstract
The vulnerability of research participants is a critical topic for the 2024 revision of the Declaration of Helsinki, with the proposal to include "social value. " However, this proposal has been withdrawn and the relationship between the two concepts has not been clarified. This paper attempts to clarify: (1) the recent reform for the ethical inclusion of vulnerable study participants to promote diversity; (2) the social value, prerequisite for everyone, especially for those who are vulnerable and the most in need; (3) the requirements for promoting the inclusion of vulnerable participants, in particular the review of the norms for placebo-controlled trials and post-trial access; (4) finally, the direction of research ethics reform to achieve social value and equitable global health.
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Affiliation(s)
- Chieko Kurihara
- Kanagawa Dental University, Yokosuka, Japan
- Ethics Working Group of International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), Woerden, Netherlands
| | - Dirceu Greco
- School of Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil
| | - Ames Dhai
- School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa
| | - Kotone Matsuyama
- Ethics Working Group of International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), Woerden, Netherlands
- Department of Health Policy and Management, Nippon Medical School, Tokyo, Japan
| | - Varvara Baroutsou
- Ethics Working Group of International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), Woerden, Netherlands
- International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) President, Woerden, Netherlands
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Erceg D, Jakirović M, Prgomet L, Madunić M, Turkalj M. Conducting Drug Treatment Trials in Children: Opportunities and Challenges. Pharmaceut Med 2024; 38:179-204. [PMID: 38730200 DOI: 10.1007/s40290-024-00523-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/20/2024] [Indexed: 05/12/2024]
Abstract
Children were often referred to as "therapeutic orphans" in the past due to different reasons such as ethical, regulatory, economic, scientific, etc., ones. They were exposed to avoidable risks while missing out on therapeutic advances. Pediatric patients have suffered from a lack of scientific and regulatory standards (e.g., proper drug testing, authorization of medicines for their use, etc.), although the pharmaceutical legislative framework, which ensures the high standards of safety, quality, and efficacy of medicinal products for use in adults, was developed primarily in response to past "drug disasters," mainly involving children. The adoption of pediatric regulatory initiatives first in the USA and then in Europe and other countries and regions has significantly changed the worldwide frameworks and permanently changed pediatric drug research and development. This article tries to give various perspectives with historical context, a review of the different challenges and opportunities as well as important stakeholders in pediatric drug development. The pediatric trial networks are probably the most important stakeholder that enables efficient patient recruitment, access to better resource utilization, and global collaboration of different stakeholders necessary for performing quality and well-designed clinical trials.
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Affiliation(s)
- Damir Erceg
- "Srebrnjak" Children's Hospital, Clinical Trials Unit, 10000, Zagreb, Croatia.
- School of Medicine, Catholic University of Croatia, 10000, Zagreb, Croatia.
- Faculty of Dental Medicine and Health, University of Osijek, "Josip Juraj Strossmayer", 31000, Osijek, Croatia.
- Medical School, University of Osijek "Josip Juraj Strossmayer", 31000, Osijek, Croatia.
| | - Marina Jakirović
- "Srebrnjak" Children's Hospital, Clinical Trials Unit, 10000, Zagreb, Croatia
| | - Luka Prgomet
- Institute of Emergency Medicine of Zagreb County, 10410, Velika Gorica, Croatia
| | - Marina Madunić
- Emergency Department, General Hospital Zabok, 49210, Zabok, Croatia
| | - Mirjana Turkalj
- "Srebrnjak" Children's Hospital, Clinical Trials Unit, 10000, Zagreb, Croatia
- School of Medicine, Catholic University of Croatia, 10000, Zagreb, Croatia
- Medical School, University of Osijek "Josip Juraj Strossmayer", 31000, Osijek, Croatia
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Kiwanuka GN, Bajunirwe F, Alele PE, Oloro J, Mindra A, Marshall P, Loue S. Public health and research ethics education: the experience of developing a new cadre of bioethicists at a Ugandan institution. BMC MEDICAL EDUCATION 2024; 24:1. [PMID: 38172860 PMCID: PMC10763195 DOI: 10.1186/s12909-023-04974-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/16/2023] [Accepted: 12/13/2023] [Indexed: 01/05/2024]
Abstract
Research ethics education is critical to developing a culture of responsible conduct of research. Many countries in sub-Saharan Africa (SSA) have a high burden of infectious diseases like HIV and malaria; some, like Uganda, have recurring outbreaks. Coupled with the increase in non-communicable diseases, researchers have access to large populations to test new medications and vaccines. The need to develop multi-level capacity in research ethics in Uganda is still huge, being compounded by the high burden of disease and challenging public health issues. Only a few institutions in the SSA offer graduate training in research ethics, implying that the proposed ideal of each high-volume research ethics committee having at least one member with in-depth training in ethics is far from reality. Finding best practices for comparable situations and training requirements is challenging because there is currently no "gold standard" for teaching research ethics and little published information on curriculum and implementation strategies. The purpose of this paper is to describe a model of research ethics (RE) education as a track in an existing 2-year Master of Public Health (MPH) to provide training for developing specific applied learning skills to address contemporary and emerging needs for biomedical and public health research in a highly disease-burdened country. We describe our five-year experience in successful implementation of the MPH-RE program by the Mbarara University Research Ethics Education Program at Mbarara University of Science and Technology in southwestern Uganda. We used curriculum materials, applications to the program, post-training and external evaluations, and annual reports for this work. This model can be adapted and used elsewhere in developing countries with similar contexts. Establishing an interface between public health and research ethics requires integration of the two early in the delivery of the MPH-RE program to prevent a disconnect in knowledge between research methods provided by the MPH component of the MPH-RE program and for research in ethics that MPH-RE students are expected to perform for their dissertation. Promoting bioethics education, which is multi-disciplinary, in institutions where it is still "foreign" is challenging and necessitates supportive leadership at all institutional levels.
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Affiliation(s)
- Gertrude N Kiwanuka
- Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda.
| | - Francis Bajunirwe
- Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda
| | - Paul E Alele
- Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda
| | - Joseph Oloro
- Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda
| | - Arnold Mindra
- Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda
| | - Patricia Marshall
- School of Medicine, Case Western Reserve University, Cleveland, OH, USA
| | - Sana Loue
- School of Medicine, Case Western Reserve University, Cleveland, OH, USA
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Rao E, Taylor J, Kaytes A, Concha-Garcia S, Riggs PK, Smith DM, Dubé K, Gianella S. Vulnerability in Biomedical Research: A Historical Reflection and Practical Implications for HIV Cure-Related Research. AIDS Res Hum Retroviruses 2024; 40:22-27. [PMID: 37227023 PMCID: PMC10790546 DOI: 10.1089/aid.2022.0136] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/26/2023] Open
Abstract
The concept of vulnerability in bioethics was first referenced in 1979, when the Belmont Report highlighted the need for special consideration of certain populations in the application of its general principles of respect for persons, beneficence, and justice in research with human participants. Since then, a body of literature has emerged regarding the content, status, and scope, as well as ethical and practical implications of vulnerability in biomedical research. The social history of HIV treatment development has at various points reflected and actively influenced bioethics' debate on vulnerability. In the late 1980s and early 1990s, people with AIDS activist groups drafted landmark patient empowerment manifestos like The Denver Principles, fighting to have greater involvement in the design and oversight of clinical trials related to HIV treatment, and in doing so, pushed against research ethics protocols created with the intention of protecting vulnerable populations. The determination of appropriate benefit/risk profiles in clinical trials was no longer limited to the purview of clinicians and scientists, but began to include the perspectives of people with HIV (PWH) and affected communities. In contemporary HIV cure-related research, where participants often risk health for no personal clinical benefit, the community's voiced motivations and objectives for participation continue to challenge population-based accounts of vulnerability. While the development of a framework for discussion and the establishment of clear regulatory requirements are necessary to support the practical and ethical conduct of research, they risk distraction from the fundamental value of voluntary participation and potentially overlook the unique history and perspectives of PWH in their participation in the quest toward an HIV cure.
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Affiliation(s)
- Emily Rao
- School of Medicine, University of California San Diego (UCSD), San Diego, California, USA
| | - Jeff Taylor
- AntiViral Research Center (AVRC) Community Advisory Board (CAB), UCSD, San Diego, California, USA
- HIV+Aging Research Project-Palm Springs (HARP-PS), Palm Springs, California, USA
- RID-HIV Delaney Collaboratory, San Diego, California, USA
| | - Andy Kaytes
- AntiViral Research Center (AVRC) Community Advisory Board (CAB), UCSD, San Diego, California, USA
| | - Susanna Concha-Garcia
- HIV Neurobehavioral Research Program (HNRP), California NeuroAIDS Tissue Network, UCSD, San Diego, CA, USA
| | - Patricia K. Riggs
- Department of Medicine, Division of Infectious Diseases and Global Public Health, UCSD, La Jolla, CA, USA
| | - Davey M. Smith
- Department of Medicine, Division of Infectious Diseases and Global Public Health, UCSD, La Jolla, CA, USA
| | - Karine Dubé
- RID-HIV Delaney Collaboratory, San Diego, California, USA
- Department of Medicine, Division of Infectious Diseases and Global Public Health, UCSD, La Jolla, CA, USA
| | - Sara Gianella
- Department of Medicine, Division of Infectious Diseases and Global Public Health, UCSD, La Jolla, CA, USA
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Berger A, Rennie S, Aijaz J, Johnson LM, Antillon F, Roberts MC, Chitsike I, Kambugu J, Saha V, Bhakta N, Davis AM, Alexander TB. The role of relative advantage for development of sequencing-based diagnostics for pediatric cancer in low- and middle-income countries. Cancer 2024; 130:173-178. [PMID: 37843081 DOI: 10.1002/cncr.35065] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/17/2023]
Abstract
Efforts to address limitations in cancer diagnostics in low‐ and middle‐income countries should follow an approach that avoids two extremes: unproductive attempts to require implementation of high‐income country gold standards or acquiescence to the diagnostic status quo. The relative advantage of implementing new diagnostic tests (including sequencing‐based approaches) should be determined through comparison to local standards of care, with context‐specific clinical utility determined using locally available therapeutic options.
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Affiliation(s)
- Anissa Berger
- Department of Social Medicine, University of North Carolina, Chapel Hill, North Carolina, USA
| | - Stuart Rennie
- Department of Social Medicine, University of North Carolina, Chapel Hill, North Carolina, USA
| | - Javeria Aijaz
- Department of Pathology, Indus Health and Hospital Network, Karachi, Pakistan
| | - Liza-Marie Johnson
- Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA
| | | | - Megan C Roberts
- Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA
| | | | | | - Vaskar Saha
- Tata Translational Cancer Research Center, Kolkata, India
| | - Nickhill Bhakta
- Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, Tennessee, USA
| | - Arlene M Davis
- Department of Social Medicine, University of North Carolina, Chapel Hill, North Carolina, USA
| | - Thomas B Alexander
- Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina, USA
- Department of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, North Carolina, USA
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11
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Tankwanchi AS, Asabor EN, Vermund SH. Global Health Perspectives on Race in Research: Neocolonial Extraction and Local Marginalization. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2023; 20:6210. [PMID: 37444057 PMCID: PMC10341112 DOI: 10.3390/ijerph20136210] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 04/14/2023] [Revised: 06/17/2023] [Accepted: 06/21/2023] [Indexed: 07/15/2023]
Abstract
Best practices in global health training prioritize leadership and engagement from investigators from low- and middle-income countries (LMICs), along with conscientious community consultation and research that benefits local participants and autochthonous communities. However, well into the 20th century, international research and clinical care remain rife with paternalism, extractive practices, and racist ideation, with race presumed to explain vulnerability or protection from various diseases, despite scientific evidence for far more precise mechanisms for infectious disease. We highlight experiences in global research on health and illness among indigenous populations in LMICs, seeking to clarify what is both scientifically essential and ethically desirable in research with human subjects; we apply a critical view towards race and racism as historically distorting elements that must be acknowledged and overcome.
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Affiliation(s)
- Akhenaten Siankam Tankwanchi
- Department of Health Systems and Population Health, University of Washington School of Public Health, Seattle, WA 98195, USA
| | - Emmanuella N. Asabor
- Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA; (E.N.A.); (S.H.V.)
| | - Sten H. Vermund
- Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA; (E.N.A.); (S.H.V.)
- Department of Pediatrics, Yale School of Medicine, New Haven, CT 06510, USA
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12
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Affiliation(s)
- Meghan N Cichocki
- From the Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School
| | - William T Chung
- From the Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School
| | - Kevin C Chung
- From the Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School
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13
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Johnson AM. Pandemic HIV and its legacy for medicine and global health. Clin Med (Lond) 2023; 23:106-114. [PMID: 36921987 PMCID: PMC11046497 DOI: 10.7861/clinmed.ed.23.2.harv] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/17/2023]
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14
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Różyńska J. Taking the principle of the primacy of the human being seriously. MEDICINE, HEALTH CARE, AND PHILOSOPHY 2021; 24:547-562. [PMID: 34318429 PMCID: PMC8557179 DOI: 10.1007/s11019-021-10043-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 07/23/2021] [Indexed: 06/13/2023]
Abstract
This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about the meaning and role of the principle. Several authors note that the principle is vogue, ambiguous and apparently conflicting with the accepted practice of conducting non-beneficial research on individuals unable to give consent. There are opinions that it is just "a vacuous figure of speech" and should be abandoned. This paper argues that the primacy principle is far from being "a vacuous figure of speech", rather it should be seen as a threefold concept: a fundamental interpretative rule, a procedural rule, and a substantive rule aimed at protecting research subjects from instrumental treatment and unacceptable risks. This interpretation tracks back to the principle regulatory and normative origins in the Declaration of Helsinki of 1975, but also acknowledges changes in research ethics and practice, which took place at the turn on the twentieth and twenty-first centuries. Thus, the proposed reading of the principle is not only original, but also historically grounded and normatively fruitful. It provides a fresh and ethically rich perspective on extensively debated, but still controversial problem of an upper limit of permissible risks in non-beneficial studies.
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Affiliation(s)
- Joanna Różyńska
- Center for Bioethics and Biolaw, Faculty of Philosophy, University of Warsaw, Krakowskie Przedmiescie 3, 00-047, Warsaw, Poland.
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15
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Shah SK, London AJ, Mofenson L, Lavery JV, John-Stewart G, Flynn P, Theron G, Bangdiwala SI, Moodley D, Chinula L, Fairlie L, Sekoto T, Kakhu TJ, Violari A, Dadabhai S, McCarthy K, Fowler MG. Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial. Clin Trials 2021; 18:681-689. [PMID: 34524048 DOI: 10.1177/17407745211045734] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Research in rapidly evolving policy contexts can lead to the following ethical challenges for sponsors and researchers: the study's standard of care can become different than what patients outside the study receive, there may be political or other pressure to move ahead with unproven interventions, and new findings or revised policies may decrease the relevance of ongoing studies. These ethical challenges are considerable, but not unprecedented. In this article, we review the case of a multinational, randomized, controlled perinatal HIV prevention trial, the "PROMISE" (Promoting Maternal Infant Survival Everywhere) study. PROMISE compared the relative efficacy and safety of interventions to prevent mother to child transmission of HIV. The sponsor engaged an independent international ethics panel to address controversy about the study's standard of care and relevance as national and international guidelines changed. This ethics panel concluded that continuing the PROMISE trial as designed was ethically permissible because: (1) participants in all arms received interventions that were effective, and there was insufficient evidence about whether one intervention was more effective or safer than the other, and (2) data from PROMISE could be useful for a diverse range of stakeholders. In general, trials designed to inform rapidly evolving policy issues should develop mechanisms to revisit social value while recognizing that the value of research varies for diverse stakeholders with legitimate reasons to weigh evidence differently. We conclude by providing four reasons that trials may depart from the standard of care after a change in policy, while remaining ethically justifiable, and by suggesting how to improve existing trial oversight mechanisms to address evolving social value.
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Affiliation(s)
- Seema K Shah
- Department of Pediatrics, Northwestern Feinberg School of Medicine, Mary Ann & J. Milburn Smith Child Health Outcomes, Research, and Evaluation (SCHORE) Center, Stanley Manne Children's Research Institute, Lurie Children's Hospital, Northwestern Pritzker School of Law, by courtesy, Chicago, IL, USA
| | - Alex John London
- Center for Ethics and Policy, Carnegie Mellon University, Pittsburgh, PA, USA
| | - Lynne Mofenson
- Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, USA
| | - James V Lavery
- Global Health Ethics, Rollins School of Public Health, Emory University, Atlanta, GA, USA
| | | | - Patricia Flynn
- Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA
| | - Gerhard Theron
- Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa
| | | | - Dhayendre Moodley
- Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa
| | | | - Lee Fairlie
- Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, Johannesburg, South Africa
| | - Tumalano Sekoto
- Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana
| | - Tebogo J Kakhu
- Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana
| | - Avy Violari
- Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, Johannesburg, South Africa
| | - Sufia Dadabhai
- Johns Hopkins Bloomberg School of Public Health, Blantyre, Malawi
| | | | - Mary Glenn Fowler
- Johns Hopkins University Research Collaboration, Makerere University, Kampala, Uganda
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16
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Mielke D, Rohde V. Randomized controlled trials-a critical re-appraisal. Neurosurg Rev 2021; 44:2085-2089. [PMID: 33025186 PMCID: PMC8338869 DOI: 10.1007/s10143-020-01401-4] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/05/2020] [Revised: 08/31/2020] [Accepted: 09/22/2020] [Indexed: 10/28/2022]
Abstract
Randomized controlled trials (RCTs) are considered to represent the gold standard of scientific studies and paved the way for evidence-based medicine (EBM). Besides the initial aim to improve the quality of patient care, EBM is used in the meanwhile for political and economic decision-making and legal issues as well. A review of the literature was performed, followed by a search using links and references of the detected articles. Additionally, homepages for German institutions of public health were screened. Substantial limitations of RCTs and EBM health care could be identified. Based on the selected literature, 80% of the medical treatments have low evidence. RCTs are expensive and are mainly performed by the industry nowadays. A publication bias for positive results exists. Some RCTs are of low external validity. Many studies have a low fragility index. Nonetheless, negative RCTs could be of benefit for the patients. The results of RCTs, gained in a distinct patient population, are partially generalized. RCTs should be analyzed critically before adopting the results to daily clinical routine. It is not really justified to use RCTs and EBM for political and economic decision-making and legal issues as seen today.
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Affiliation(s)
- Dorothee Mielke
- Department of Neurosurgery, Georg-August-University Göttingen, Robert-Koch-Strasse 40, D-37075, Göttingen, Germany.
- Osnabrück University of Applied Science, Caprivistraße 1, Osnabrück, 49076, Germany.
| | - Veit Rohde
- Department of Neurosurgery, Georg-August-University Göttingen, Robert-Koch-Strasse 40, D-37075, Göttingen, Germany
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17
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Salhia B, Olaiya V. Historical Perspectives on Ethical and Regulatory Aspects of Human Participants Research: Implications for Oncology Clinical Trials in Africa. JCO Glob Oncol 2021; 6:959-965. [PMID: 32614729 PMCID: PMC7392783 DOI: 10.1200/jgo.19.00196] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
Clinical trials research involving human participants has led to numerous medical advances. Historically, however, clinical trials research was the source of major concerns for the safety and welfare of the human participants taking part in these studies. The ethical principles of autonomy, beneficence, and justice came about in response to medical atrocities, and regulations were ultimately put in place to protect the rights and welfare of human participants and to maintain the public trust in the research enterprise. Today, clinical trials are one of the most heavily regulated practices in the world, and yet still not all people are provided the same oversights and protections, with improprieties disproportionately affecting poor-resource nations and vulnerable populations. As Africa approaches the post-communicable disease era, cancer is set to take the lead as the most burdensome disease, making the need for oncology clinical trials in Africa greater than ever before. Africa represents a heterogeneous market with 55 countries, most with their own National Regulatory Agency (NRA) and each with varying levels of regulatory maturity. This diversity creates a highly complex regulatory environment and causes challenges when bringing drugs to market. There is a large need for harmonization and increased collaboration between the African nations' NRAs. In addition, many African countries need to be better equipped to handle research ethics committees and/or learn how to rely on neighboring countries with more established ethics committees. Well-run clinical trials offer solutions to national health care problems, and all people deserve equal access to their benefits.
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Affiliation(s)
- Bodour Salhia
- Department of Translational Research, University of Southern California, Norris Comprehensive Cancer Center, Keck School of Medicine, Los Angeles, CA
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18
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Kakuhikire B, Satinsky EN, Baguma C, Rasmussen JD, Perkins JM, Gumisiriza P, Juliet M, Ayebare P, Mushavi RC, Burns BFO, Evans CQ, Siedner MJ, Bangsberg DR, Tsai AC. Correlates of attendance at community engagement meetings held in advance of bio-behavioral research studies: A longitudinal, sociocentric social network study in rural Uganda. PLoS Med 2021; 18:e1003705. [PMID: 34270581 PMCID: PMC8323877 DOI: 10.1371/journal.pmed.1003705] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/10/2021] [Revised: 07/30/2021] [Accepted: 06/21/2021] [Indexed: 12/22/2022] Open
Abstract
BACKGROUND Community engagement is central to the conduct of health-related research studies as a way to determine priorities, inform study design and implementation, increase recruitment and retention, build relationships, and ensure that research meets the goals of the community. Community sensitization meetings, a form of community engagement, are often held prior to the initiation of research studies to provide information about upcoming study activities and resolve concerns in consultation with potential participants. This study estimated demographic, health, economic, and social network correlates of attendance at community sensitization meetings held in advance of a whole-population, combined behavioral, and biomedical research study in rural Uganda. METHODS AND FINDINGS Research assistants collected survey data from 1,630 adults participating in an ongoing sociocentric social network cohort study conducted in a rural region of southwestern Uganda. These community survey data, collected between 2016 and 2018, were linked to attendance logs from community sensitization meetings held in 2018 and 2019 before the subsequent community survey and community health fair. Of all participants, 264 (16%) attended a community sensitization meeting before the community survey, 464 (28%) attended a meeting before the community health fair, 558 (34%) attended a meeting before either study activity (survey or health fair), and 170 (10%) attended a meeting before both study activities (survey and health fair). Using multivariable Poisson regression models, we estimated correlates of attendance at community sensitization meetings. Attendance was more likely among study participants who were women (adjusted relative risk [ARR]health fair = 1.71, 95% confidence interval [CI], 1.32 to 2.21, p < 0.001), older age (ARRsurvey = 1.02 per year, 95% CI, 1.01 to 1.02, p < 0.001; ARRhealth fair = 1.02 per year, 95% CI, 1.01 to 1.02, p < 0.001), married (ARRsurvey = 1.74, 95% CI, 1.29 to 2.35, p < 0.001; ARRhealth fair = 1.41, 95% CI, 1.13 to 1.76, p = 0.002), and members of more community groups (ARRsurvey = 1.26 per group, 95% CI, 1.10 to 1.44, p = 0.001; ARRhealth fair = 1.26 per group, 95% CI, 1.12 to 1.43, p < 0.001). Attendance was less likely among study participants who lived farther from meeting locations (ARRsurvey = 0.54 per kilometer, 95% CI, 0.30 to 0.97, p = 0.041; ARRhealth fair = 0.57 per kilometer, 95% CI, 0.38 to 0.86, p = 0.007). Leveraging the cohort's sociocentric design, social network analyses suggested that information conveyed during community sensitization meetings could reach a broader group of potential study participants through attendees' social network and household connections. Study limitations include lack of detailed data on reasons for attendance/nonattendance at community sensitization meetings; achieving a representative sample of community members was not an explicit aim of the study; and generalizability may not extend beyond this study setting. CONCLUSIONS In this longitudinal, sociocentric social network study conducted in rural Uganda, we observed that older age, female sex, being married, membership in more community groups, and geographical proximity to meeting locations were correlated with attendance at community sensitization meetings held in advance of bio-behavioral research activities. Information conveyed during meetings could have reached a broader portion of the population through attendees' social network and household connections. To ensure broader input and potentially increase participation in health-related research studies, the dissemination of research-related information through community sensitization meetings may need to target members of underrepresented groups.
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Affiliation(s)
| | - Emily N. Satinsky
- Department of Psychology, University of Southern California, Los Angeles, California, United States of America
- Center for Global Health, Massachusetts General Hospital, Boston, Massachusetts, United States of America
- * E-mail:
| | - Charles Baguma
- Mbarara University of Science and Technology, Mbarara, Uganda
| | - Justin D. Rasmussen
- Department of Psychology, Duke University, Durham, North Carolina, United States of America
| | - Jessica M. Perkins
- Peabody College, Vanderbilt University, Nashville, Tennessee, United States of America
| | | | - Mercy Juliet
- Mbarara University of Science and Technology, Mbarara, Uganda
| | | | - Rumbidzai C. Mushavi
- Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts, United States of America
- Department of Obstetrics and Gynecology, Brigham and Women’s Hospital, Boston, Massachusetts, United States of America
- Harvard Medical School, Boston, Massachusetts, United States of America
| | - Bridget F. O. Burns
- Department of Urban Studies and Planning, Massachusetts Institute of Technology, Boston, Massachusetts, United States of America
| | - Claire Q. Evans
- Peabody College, Vanderbilt University, Nashville, Tennessee, United States of America
| | - Mark J. Siedner
- Center for Global Health, Massachusetts General Hospital, Boston, Massachusetts, United States of America
- Harvard Medical School, Boston, Massachusetts, United States of America
- Mongan Institute, Massachusetts General Hospital, Boston, Massachusetts, United States of America
- Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America
| | - David R. Bangsberg
- Mbarara University of Science and Technology, Mbarara, Uganda
- Oregon Health and Science University - Portland State University School of Public Health, Portland, Oregon, United States of America
| | - Alexander C. Tsai
- Mbarara University of Science and Technology, Mbarara, Uganda
- Center for Global Health, Massachusetts General Hospital, Boston, Massachusetts, United States of America
- Harvard Medical School, Boston, Massachusetts, United States of America
- Mongan Institute, Massachusetts General Hospital, Boston, Massachusetts, United States of America
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19
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Hlaing WM, Kushch NA, Wells AE, Goodman KW. Common topics discerned in ethics in epidemiology and public health syllabi: in-depth review. Ann Epidemiol 2021; 60:31-34. [PMID: 33932571 DOI: 10.1016/j.annepidem.2021.04.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2021] [Revised: 04/11/2021] [Accepted: 04/18/2021] [Indexed: 11/19/2022]
Abstract
This commentary reviews ethics in epidemiology and public health (PH) syllabi collected in 2011 and 2018. The syllabi repository was an American College of Epidemiology (ACE) Ethics Committee project to support institutions and faculty introducing, furthering or improving ethics in epidemiology and public health courses. Of 83 syllabi from 52 accredited public health schools and programs, 80 were reviewed to identify the most common ethics topics. The extracted information was categorized into eight main groups: (1) ethical/moral foundations and theories; (2) case studies in epidemiology/PH; (3) ethical issues in PH practice; (4) ethical issues in general epidemiologic/PH research; (5) ethical issues in specific research areas; (6) ethical issues in information technology; (7) ethical issues in other emerging topics in epidemiology/PH; and (8) others. The frequency of topics in each category was computed, and common topics were presented. Ethical issues absent from the syllabi were inferred. This commentary is intended to promote a dialog among those desiring to elevate epidemiology and public health ethics to an educational level commensurate with its importance.
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Affiliation(s)
- WayWay M Hlaing
- University of Miami Miller School of Medicine, University of Miami School of Med Public Health Sciences, Miami, FL.
| | - Nicholas A Kushch
- University of Miami Miller School of Medicine, University of Miami School of Med Public Health Sciences, Miami, FL
| | - Aidan E Wells
- University of Miami Miller School of Medicine, University of Miami School of Med Public Health Sciences, Miami, FL
| | - Kenneth W Goodman
- University of Miami Miller School of Medicine, University of Miami School of Med Public Health Sciences, Miami, FL
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20
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Gilmore-Bykovskyi A, Jackson JD, Wilkins CH. The Urgency of Justice in Research: Beyond COVID-19. Trends Mol Med 2020; 27:97-100. [PMID: 33277159 PMCID: PMC7855410 DOI: 10.1016/j.molmed.2020.11.004] [Citation(s) in RCA: 27] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2020] [Revised: 11/10/2020] [Accepted: 11/11/2020] [Indexed: 12/15/2022]
Abstract
The striking imbalance between disease incidence and mortality among minorities across health conditions, including coronavirus disease 2019 (COVID-19) highlights their under-inclusion in research. Here, we propose actions that can be adopted by the biomedical scientific community to address long-standing ethical and scientific barriers to equitable representation of diverse populations in research.
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Affiliation(s)
- Andrea Gilmore-Bykovskyi
- University of Wisconsin-Madison, School of Nursing, School of Medicine and Public Health, Madison, WI, USA.
| | - Jonathan D Jackson
- Community Access, Recruitment, and Engagement (CARE) Research Center, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
| | - Consuelo H Wilkins
- Office of Health Equity, Vanderbilt University Medical Center, Nashville, TS, USA; Department of Internal Medicine, Meharry Medical College, Nashville, TS, USA
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21
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Price JT, Mabula-Bwalya CM, Freeman BL, Carda-Auten J, Phiri WM, Chibwe K, Kantumoya P, Vwalika B, Stringer JSA, Golin CE. Acceptability of a trial of vaginal progesterone for the prevention of preterm birth among HIV-infected women in Lusaka, Zambia: A mixed methods study. PLoS One 2020; 15:e0238748. [PMID: 32970697 PMCID: PMC7514015 DOI: 10.1371/journal.pone.0238748] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Accepted: 08/21/2020] [Indexed: 11/18/2022] Open
Abstract
Antenatal progesterone prevents preterm birth (PTB) in women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively. Neither has been tested for the indication of maternal HIV, which is associated with an elevated risk of PTB. The Vaginal Progesterone (VP) Trial was a pilot feasibility study of VP to prevent HIV-related PTB in Lusaka, Zambia. Using mixed methods, we concurrently evaluated the acceptability of the trial and the study product among participants. Over a 1-year period, we enrolled 140 pregnant women living with HIV into a double-masked, placebo-controlled, randomized trial of daily self-administered VP or placebo. We administered an endline questionnaire to all participants and conducted in-depth interviews with 30 participants to assess barriers and facilitators to uptake and retention in the trial and to study product adherence. All interviews were audiotaped, transcribed, translated into English as needed, and independently coded by two analysts to capture emerging themes. Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product. When given a hypothetical choice between vaginal and injectable progesterone, 97 (74%) chose vaginal, 31 (24%) injectable, and 3 (2%) stated no preference. Most interviewees reported no difficulties with using the study product; others cited minor side effects and surmountable challenges. Strategies that supported adherence included setting alarms, aligning dosing with antiretrovirals, receiving encouragement from friends and family, sensing a benefit to their unborn baby, and positive feedback from study staff. Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit. Those who would prefer weekly injections cited fewer doses to remember. Perceived barriers to study participation included mistrust about the motivations behind research, suspicion of Satanism, and futility or possible harm from a placebo. We report key influences on acceptability of a randomized trial of VP to prevent PTB among HIV-infected women in Zambia, which should inform methods to promote uptake, adherence, and retention in a full-scale trial.
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Affiliation(s)
- Joan T. Price
- Division of Global Women’s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
- Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia
| | | | - Bethany L. Freeman
- Division of Global Women’s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
| | - Jessica Carda-Auten
- Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
| | | | | | | | - Bellington Vwalika
- Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia
| | - Jeffrey S. A. Stringer
- Division of Global Women’s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
| | - Carol E. Golin
- Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
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22
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Bitter CC, Ngabirano AA, Simon EL, Taylor DM. Principles of research ethics: A research primer for low- and middle-income countries. Afr J Emerg Med 2020; 10:S125-S129. [PMID: 32837877 PMCID: PMC7423570 DOI: 10.1016/j.afjem.2020.07.006] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/13/2019] [Revised: 06/17/2020] [Accepted: 07/11/2020] [Indexed: 12/15/2022] Open
Abstract
Ethical oversight in the form of review boards and research ethics committees provide protection for research subjects as well as guidance for safe conduct of studies. As the number of collaborative emergency care research studies carried out in low- and middle-income countries increases, it is crucial to have a shared understanding of how ethics should inform choice of study topic, study design, methods of obtaining consent, data management, and access to treatment after closure of the study. This paper describes the basic principles of Western research ethics - respect for persons, beneficence, and justice - and how the principles may be contextualized in different settings, by researchers of various backgrounds with different funding streams. Examples of lapses in ethical practice of research are used to highlight best practices.
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Affiliation(s)
- Cindy C. Bitter
- Saint Louis University School of Medicine, Division of Emergency Medicine, St. Louis MO, USA
| | - Annet Alenyo Ngabirano
- Aga Khan University, Kampala, Uganda
- Makerere University College of Health Sciences, Kampala, Uganda
| | - Erin L. Simon
- Cleveland Clinic Akron General, Department of Emergency Medicine, Akron, OH, USA
- Northeast Ohio Medical University, Rootstown, OH, USA
| | - David McD. Taylor
- University of Melbourne, Department of Medicine, Parkville, Victoria, Australia
- Austin Health, Heidelburg, Victoria, Australia
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23
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Opinion: It's ethical to test promising coronavirus vaccines against less-promising ones. Proc Natl Acad Sci U S A 2020; 117:18898-18901. [PMID: 32699147 DOI: 10.1073/pnas.2014154117] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/18/2022] Open
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Valentine GC, Perez K, Weiss EM. Community Empowerment Through Education: The Inherent Foundation of Promoting Solidarity in Global Health Research. THE AMERICAN JOURNAL OF BIOETHICS : AJOB 2020; 20:77-79. [PMID: 32364481 DOI: 10.1080/15265161.2020.1745941] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/11/2023]
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Das AK, Okita T, Enzo A, Asai A. The Ethics of the Reuse of Disposable Medical Supplies. Asian Bioeth Rev 2020; 12:103-116. [PMID: 33717332 PMCID: PMC7747311 DOI: 10.1007/s41649-020-00114-6] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2018] [Revised: 03/05/2020] [Accepted: 03/09/2020] [Indexed: 11/28/2022] Open
Abstract
The use of single-use items (SUDs) is now ubiquitous in medical practice. Because of the high costs of these items, the practice of reusing them after sterilisation is also widespread especially in resource-poor economies. However, the ethics of reusing disposable items remain unclear. There are several analogous conditions, which could shed light on the ethics of reuse of disposables. These include the use of restored kidney transplantation and the use of generic drugs etc. The ethical issues include the question of patient safety and the possibility of infection. It is also important to understand the role (or otherwise) of informed consent before reuse of disposables. The widespread practice of reuse may bring down high healthcare costs and also reduce the huge amount of hospital waste that is generated. The reuse of disposables can be justified on various grounds including the safety and the cost effectiveness of this practice.
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Affiliation(s)
- Anjan Kumar Das
- School of Medicine, Faculty of Health and Medical Sciences, Taylor’s University, Subang Jaya, Selangor Malaysia
| | - Taketoshi Okita
- Department of Medical Ethics, Tohoku University Graduate School of Medicine Sendai, Sendai, Japan
| | - Aya Enzo
- Department of Medical Ethics, Tohoku University Graduate School of Medicine Sendai, Sendai, Japan
| | - Atsushi Asai
- Department of Medical Ethics, Tohoku University Graduate School of Medicine Sendai, Sendai, Japan
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26
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Sullivan K, Mtande T, Jaffe E, Rosenberg N, Zimba C, Hoffman I, Little M, Faden R, Lyerly AD. Views among Malawian women about joining HIV prevention clinical trials when pregnant. AIDS Res Ther 2020; 17:27. [PMID: 32460804 PMCID: PMC7251879 DOI: 10.1186/s12981-020-00271-6] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/26/2019] [Accepted: 05/04/2020] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women's views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population. METHODS We conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women's perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach. RESULTS A majority of women accepted participation in all trials. Women's views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions. CONCLUSIONS The majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.
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Affiliation(s)
- Kristen Sullivan
- Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA.
| | - Tiwonge Mtande
- UNC Project Malawi, Tidziwe Centre, Private Bag A-104, Lilongwe, Malawi
| | - Elana Jaffe
- Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA
| | - Nora Rosenberg
- Department of Health Behavior, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 170 Rosenau Hall, 135 Dauer Drive, Chapel Hill, NC, 27599, USA
| | - Chifundo Zimba
- UNC Project Malawi, Tidziwe Centre, Private Bag A-104, Lilongwe, Malawi
| | - Irving Hoffman
- Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Bioinformatics Building, 130 Mason Farm Road, Chapel Hill, NC, 27599, USA
| | - Maggie Little
- The Kennedy Institute of Ethics, Georgetown University, 3700 O Street Northwest, Washington, DC, 20057, USA
| | - Ruth Faden
- Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Avenue, Baltimore, MD, 21205, USA
| | - Anne Drapkin Lyerly
- Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA
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27
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Scheiner A, Rickard JL, Nwomeh B, Jawa RS, Ginzburg E, Fitzgerald TN, Charles A, Bekele A. Global Surgery Pro-Con Debate: A Pathway to Bilateral Academic Success or the Bold New Face of Colonialism? J Surg Res 2020; 252:272-280. [PMID: 32402397 DOI: 10.1016/j.jss.2020.01.032] [Citation(s) in RCA: 26] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2019] [Revised: 01/27/2020] [Accepted: 01/31/2020] [Indexed: 02/03/2023]
Abstract
Global surgery, especially academic global surgery, is of tremendous interest to many surgeons. Classically, it entails personnel from high-income countries going to low- and middle-income countries and engaging in educational activities as well as procedures. Academic medical personnel have included students, residents, and attendings. The pervasive notion is that this is a win-win situation for the volunteers and the hosts, that is, a pathway to bilateral academic success. However, a critical examination demonstrates that it can easily become the bold new face of colonialism of a low- and middle-income country by a high-income country.
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Affiliation(s)
- Alyssa Scheiner
- Division of Trauma, Department of Surgery, Stony Brook University Renaissance School of Medicine, Stony Brook, New York
| | | | - Benedict Nwomeh
- Department of Pediatric Surgery, Nationwide Children's Hospital, Ohio State University, Columbus, Ohio
| | - Randeep S Jawa
- Division of Trauma, Department of Surgery, Stony Brook University Renaissance School of Medicine, Stony Brook, New York.
| | - Enrique Ginzburg
- Division of Trauma, Surgical Critical Care and Burns, Dewitt Daughtry Family Department of Surgery, University of Miami, Leonard M. Miller School of Medicine, Miami, Florida
| | | | - Anthony Charles
- Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - Abebe Bekele
- Department of Surgery, Addis Ababa University School of Medicine, Addis Ababa, Ethiopia
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Hellmann F, Williams-Jones B, Garrafa V. COVID-19 and Moral Imperialism in Multinational Clinical Research. Arch Med Res 2020; 51:572-573. [PMID: 32387041 PMCID: PMC7188637 DOI: 10.1016/j.arcmed.2020.04.017] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/17/2020] [Accepted: 04/23/2020] [Indexed: 11/18/2022]
Abstract
A TV debate in April 2020 between two French doctors regarding the benefits of testing a coronavirus vaccine in Africa where there are no masks or treatments available has led to international criticism. This case highlights a problematic ethical double standard in multinational clinical research: trials that would be considered unethical in high income countries (e.g., placebo-controlled where there is an existing treatment) are nonetheless justified in low-and-middle-income countries because the existing standards of care are less (i.e., no access to a treatment). Underlying this ethical double standard in some multinational clinical trials is a moral imperialism and persistent colonialist thinking that must be rejected.
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Affiliation(s)
- Fernando Hellmann
- Department of Public Health, Federal University of Santa Catarina, Campus Universitário Reitor João David Ferreira Lima, Santa Catarina, Brazil.
| | - Bryn Williams-Jones
- Bioethics Program, Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Quebec, Canada
| | - Volnei Garrafa
- UNESCO Chair and Post Graduate Program in Bioethics, University of Brasilia, Brasilia, DF, Brazil
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Abstract
PURPOSE OF REVIEW The aim of this review is to describe the use of usual care arms in randomized trials. RECENT FINDINGS Randomization of patients to an experimental or a control arm remains paramount for the estimation of average causal effects. Selection of the control arm is as important as the definition of the intervention, and it might include a placebo control, specific standards of care, protocolized usual care, or unrestricted clinical practice. Usual care control arms may enhance generalizability, clinician acceptability of the protocol, patient recruitment, and ensure community equipoise, while at the same time introducing significant variability in the care delivered in the control group. This effect may reduce the difference in treatments delivered between the two groups and lead to a negative result or the requirement for a larger sample size. Moreover, usual care control groups can be subject to changes in clinician behavior induced by the trial itself, or by secular trends in time. SUMMARY Usual care control arms may enhance generalizability while introducing significant limitations. Potential solutions include the use of pretrial surveys to evaluate the extent to which a protocolized control arm reflects the current standard of care and the implementation of adaptive trials.
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Lessons from PrEP: A Qualitative Study Investigating How Clinical and Policy Experts Weigh Ethics and Evidence When Evaluating Preventive Medications for Use in Pregnant and Breastfeeding Women. AIDS Behav 2019; 23:1858-1870. [PMID: 30552519 PMCID: PMC6570782 DOI: 10.1007/s10461-018-2361-5] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
This study explored how multinational HIV experts weigh clinical, evidential, and ethical considerations regarding pre-exposure prophylaxis in pregnant/breastfeeding women. Semi-structured interviews were conducted with experts in HIV policy, research, treatment, and implementation from three global regions. A constant comparative approach identified major themes. Experts noted that exclusion of pregnant women from research limits evidence regarding risks/benefits, emphasizing that underinclusion of pregnant women in RCTs shifts the onus of evidence-building to clinical care. Experts discussed approaches for weighing evidence to make decisions, including triangulating evidence from sources other than RCTs. Likelihood and severity of disease strongly influenced decisions. Less effective interventions with limited fetal risk were preferred over interventions of uncertain safety, unless the disease was serious. Experts resisted the dichotomous choice between protecting maternal and fetal interests, arguing that these interests are intertwined and that more holistic approaches to maternal–fetal balance support greater inclusion of pregnant women in research.
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Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials. Lancet HIV 2019; 6:e475-e482. [PMID: 31078451 DOI: 10.1016/s2352-3018(19)30133-x] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/01/2018] [Revised: 02/28/2019] [Accepted: 03/25/2019] [Indexed: 12/12/2022]
Abstract
Despite the recent success of antiretrovirals for HIV prevention, additional, more effective, or more acceptable biomedical interventions will ultimately be needed to end the HIV epidemic. Designing clinical trials to evaluate the efficacy of new products that reduce HIV infection risk is challenging because of the existence of highly effective interventions to prevent HIV. However, the implementation of these interventions is uneven, and the fact that multiple HIV prevention efficacy trials are currently evaluating new products means the field confronts uncertainty in the emerging standard of prevention. In this Viewpoint, we take stock of the current state of HIV prevention, and subsequently discuss the key challenges in designing future trials to evaluate the next generation of HIV prevention products. We also highlight gaps in the knowledge base that need to be addressed to advance the design of research. Future trials are tenable, even in the context of existing and effective interventions, and should involve careful statistical approaches and multidisciplinary collaborative design.
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Mzombwe M, Desderius B, Kapiga S, Smart L, Peck R. The ethical imperative to treat NCDs during research in Africa. Lancet Glob Health 2019; 7:e406-e407. [PMID: 30879500 DOI: 10.1016/s2214-109x(19)30066-x] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/24/2019] [Accepted: 01/30/2019] [Indexed: 12/15/2022]
Affiliation(s)
- Majaliwa Mzombwe
- Vanderbilt University School of Medicine, Nashville, TN 37232, USA.
| | - Bernard Desderius
- Department of Medicine, Catholic University of Health and Allied Sciences, Mwanza, Tanzania
| | - Saidi Kapiga
- London School of Hygiene and Tropical Medicine, Medical Research Council Tropical Epidemiology Group, London, UK; Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania
| | - Luke Smart
- Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
| | - Robert Peck
- Center for Global Health and Department of Medicine, Division of General Internal Medicine, Weill Cornell Medical College, New York, NY, USA; Department of Medicine, Weill Bugando School of Medicine, Mwanza, Tanzania
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Bloria SD, Kataria K, Luthra A, Bloria P. Publications in high impact journals from India in the last two years-A reality check. Indian J Anaesth 2019; 62:994-996. [PMID: 30636804 PMCID: PMC6299759 DOI: 10.4103/ija.ija_494_18] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022] Open
Affiliation(s)
| | - Ketan Kataria
- Department of Anaesthesia, PGIMER, Chandigarh, India
| | - Ankur Luthra
- Department of Anaesthesia, PGIMER, Chandigarh, India
| | - Pallavi Bloria
- Department of Anesthesia, GMC, Jammu, Jammu and Kashmir, India
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34
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Humphreys S. Drip-Feeding: How the Pharmaceutical Industry Influences Research Ethics Committees. RESEARCH ETHICS 2018. [DOI: 10.1177/174701610700300403] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
Whilst research ethics committees (RECs) exist to represent society's interests by placing appropriate checks on the economic power of ‘big pharma’, the political sphere is here seen to have generally acquiesced to economic interests and allowed industry to influence how it is regulated. RECs are accordingly urged to remain vigilant about the prospects of their being the subject of hidden influences.
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Skierka AS, Michels KB. Ethical principles and placebo-controlled trials - interpretation and implementation of the Declaration of Helsinki's placebo paragraph in medical research. BMC Med Ethics 2018; 19:24. [PMID: 29544543 PMCID: PMC5856313 DOI: 10.1186/s12910-018-0262-9] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2017] [Accepted: 03/01/2018] [Indexed: 11/26/2022] Open
Abstract
BACKGROUND In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of Helsinki in favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation. METHODS We distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities' respective approaches to interpretation and implementation of the Declarations' placebo paragraph in the conduct of medical research. RESULTS Our findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of "serious harm" and "methodological reasons" are proposed as well as safeguards to avoid abuse of the option to use placebo-controls. CONCLUSION Leaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki's character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard.
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Affiliation(s)
| | - Karin B Michels
- Institute for Prevention and Cancer Epidemiology, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
- Department of Obstetrics, Gynecology and Reproductive Biology, Obstetrics and Gynecology Epidemiology Center, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
- Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA.
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Cheah PY, Steinkamp N, von Seidlein L, Price RN. The ethics of using placebo in randomised controlled trials: a case study of a Plasmodium vivax antirelapse trial. BMC Med Ethics 2018; 19:19. [PMID: 29510711 PMCID: PMC5840837 DOI: 10.1186/s12910-018-0259-4] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2016] [Accepted: 02/26/2018] [Indexed: 01/12/2023] Open
Abstract
BACKGROUND The use of placebos in randomised controlled trials is a subject of considerable ethical debate. In this paper we present a set of considerations to evaluate the ethics of placebo controlled trials that includes: social value of the study; need for a randomised controlled trial and placebo; standards of care; risks of harm due to administration of placebo and the harm benefit balance; clinical equipoise; and double standards. We illustrate the application of these considerations using a case study of a large ongoing multicentre, placebo-controlled, double-blinded, randomised trial to determine primaquine anti-relapse efficacy in vivax malaria. MAIN BODY There is an urgent need for primaquine anti-relapse studies in order to rationalise the management of a potentially fatal disease. An ethical justification for the use of the placebo arm is provided on the grounds that the actual current applied standard of care in most endemic places does not include primaquine. It has also been argued that there is clinical equipoise among the primaquine study arms and that the risk of harms of being in the placebo arm is the risk of having relapse, which is no more than not being included in the trial, and that there are no double standards. CONCLUSION Based on our set of considerations, we conclude that a placebo arm is not only justified but imperative in this study. We propose that similar considerations should be prospectively applied to other placebo controlled trials and observational control arms where no treatment is offered.
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Affiliation(s)
- Phaik Yeong Cheah
- 0000 0004 1937 0490grid.10223.32Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Bangkok, 10400 Thailand ,0000 0004 1936 8948grid.4991.5Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK ,0000 0004 1936 8948grid.4991.5The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
| | - Norbert Steinkamp
- grid.465920.cEthical Foundations of Social-Professional Practice, Catholic University of Applied Social Sciences, Berlin, Germany
| | - Lorenz von Seidlein
- 0000 0004 1937 0490grid.10223.32Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Bangkok, 10400 Thailand ,0000 0004 1936 8948grid.4991.5Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK
| | - Ric N. Price
- 0000 0004 1936 8948grid.4991.5Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK ,0000 0000 8523 7955grid.271089.5Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT Australia
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Dawson L, Strathdee SA, London AJ, Lancaster KE, Klitzman R, Hoffman I, Rose S, Sugarman J. Addressing ethical challenges in HIV prevention research with people who inject drugs. JOURNAL OF MEDICAL ETHICS 2018; 44:149-158. [PMID: 27114469 PMCID: PMC6367727 DOI: 10.1136/medethics-2015-102895] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/14/2015] [Revised: 03/23/2016] [Accepted: 04/04/2016] [Indexed: 05/15/2023]
Abstract
Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs (PWID). Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: (1) Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? (2) Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? (3) When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? (4) Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world.
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Affiliation(s)
- Liza Dawson
- Division of AIDS, NIH/NIAID, Bethesda, Maryland, USA
| | | | | | | | | | - Irving Hoffman
- University of North Carolina, Chapel Hill, North Carolina, USA
| | - Scott Rose
- Family Health International, Durham, North Carolina, USA
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38
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Abstract
The globalization of clinical research is gaining momentum. In particular, emerging countries, such as Brazil, India, Russia and South Africa show a significant increase in clinical trials. This trend is generating various ethical problems, which are examined in the present article. Sometimes, generally accepted ethical rules, such as the evaluation of clinical trials by ethics commissions are not respected and sometimes conflicts are generated which are difficult to resolve. For instance, it is controversial which standard of care researchers and sponsors have to provide in an international study. These conflicts are exacerbated by a fundamental dilemma: more research on diseases prevalent in developing and emerging countries is necessary. At the same time, the protection of study participants in those countries creates particular challenges. In recent years, international commissions and guidelines have achieved significant progress in solving these conflicts; however, the further development has to be analyzed very carefully. Incentives for better research on neglected diseases have to be created. Undesirable developments and abuse have to be prevented by appropriate international ethical standards.
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Affiliation(s)
- H-J Ehni
- Institut für Ethik und Geschichte der Medizin, Universität Tübingen, Gartenstr. 47, 72074, Tübingen, Deutschland
| | - U Wiesing
- Institut für Ethik und Geschichte der Medizin, Universität Tübingen, Gartenstr. 47, 72074, Tübingen, Deutschland.
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Duby J, Sharma R, Bhutta ZA. Opportunities and Challenges in Global Perinatal Research. Neonatology 2018; 114:93-102. [PMID: 29768264 DOI: 10.1159/000488310] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/05/2018] [Accepted: 03/11/2018] [Indexed: 11/19/2022]
Abstract
BACKGROUND The global plight of stillbirths and neonatal mortality is concentrated in low- and middle-income countries. The ambitious targets introduced by the World Health Organization in the Every Newborn Action Plan demand a commitment to research that promotes equitable perinatal outcomes. OBJECTIVES The aim of this review was to understand the opportunities for global perinatal research and the accompanying challenges. METHODS We conducted a literature search to identify research prioritization exercises from 2014 to 2018 pertaining to global perinatal health. The top 50 questions with the highest research prioritization scores were extracted and analyzed. RESULTS The greatest priorities centered on community-based, implementation research targeting major causes of stillbirth and neonatal mortality in low-resource settings. The priorities are saddled with prerequisite conditions, design obstacles, and ethical considerations that require attention. CONCLUSIONS While the challenges are undeniable, the need to make the perinatal period healthier for babies worldwide has never been clearer.
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Affiliation(s)
- Jessica Duby
- Division of Neonatology, University of Toronto, Toronto, Ontario, Canada
| | - Renee Sharma
- Centre for Global Child Health, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - Zulfiqar A Bhutta
- Centre for Global Child Health, The Hospital for Sick Children, Toronto, Ontario, Canada
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40
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Ward CL, Shaw D, Anane-Sarpong E, Sankoh O, Tanner M, Elger B. The Ethics of Health Care Delivery in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania. J Empir Res Hum Res Ethics 2017; 13:26-41. [PMID: 29179625 DOI: 10.1177/1556264617742236] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
This study explores ethical issues raised in providing medical care to participants and communities of low-resource settings involved in a Phase II/III pediatric malaria vaccine trial (PMVT). We conducted 52 key informant interviews with major stakeholders of an international multi-center PMVT (GSK/PATH-MVI RTS,S) (NCT00866619) in Ghana and Tanzania. Based on their stakeholder experiences, the responses fell into three main themes: (a) undue inducement, (b) community disparities, and (c) broad therapeutic misconceptions. The study identified the critical ethical aspects, from the perspectives of stakeholders, of delivering health care during a PMVT. The study showed that integrating research into health care services needs to be addressed in a manner that upholds the favorable risk-benefit ratio of research and attends to the health needs of local populations. The implementation of research should aim to improve local standards of care through building a collaborative agenda with local institutions and systems of health.
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Abstract
Healthcare research is haunted by a history of unethical studies in which profound harm was caused to vulnerable individuals. Official systems for gaining ethical approval for research, designed to prevent a repetition of these shameful examples, can prove bureaucratic and inflexible in practice. The core ethical principles of respect for autonomy, prevention of harm, promotion of benefit, and justice (which form the basis of professional codes of research conduct) must be applied flexibly to take account of contextual, methodological, personal and practical considerations. Ensuring that the design and conduct of all research is ethically sound is the responsibility of all involved-including researchers, research institutions, ethics review committees and regulatory bodies.
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Affiliation(s)
- Anne Slowther
- Ethox Centre Department of Public Health and Primary Care, University of Oxford, Oxford OX3 7LF.
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43
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Kim JU, Oleribe O, Njie R, Taylor-Robinson SD. A time for new north-south relationships in global health. Int J Gen Med 2017; 10:401-408. [PMID: 29158688 PMCID: PMC5683789 DOI: 10.2147/ijgm.s146475] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
The modern concept of globalization in health care and clinical research often carries a positive message for the “Global South” nations of Africa, South America and Southeast Asia. However, bioethical abuse of participants in clinical trials still exists in the Global South. Unethical studies directed by the “Global North”, formed by the medically advanced nations in North America, Western Europe and Japan, have been hugely concerning. The issue between the Global North and South is a well-recognized socioeconomic phenomenon of globalization. Medical exploitation has its roots in the socioeconomic interactions of a postcolonial world, and solutions to reducing exploitation require a deeper understanding of these societal models of globalization. We explore the fundamental causes of imbalance and suggest solutions. Reflecting on the globalization model, there must be an effort to empower the Global South nations to direct and govern their own health care systems efficiently on the basis of equality.
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Affiliation(s)
- Jin Un Kim
- Division of Digestive Health, Department of Surgery and Cancer, Imperial College London, London, UK
| | - Obinna Oleribe
- Excellence and Friends Management Care Centre, Abuja, Nigeria
| | | | - Simon D Taylor-Robinson
- Division of Digestive Health, Department of Surgery and Cancer, Imperial College London, London, UK
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44
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Wendler DS. The Ethics of Research in Lower Income Countries: Double Standards Are Not the Problem. THE JOURNAL OF CLINICAL ETHICS 2017. [DOI: 10.1086/jce2017283239] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
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Macklin R. Challenges Working with Presidential Bioethics Commissions. Hastings Cent Rep 2017; 47 Suppl 1:S39-S41. [PMID: 28543660 DOI: 10.1002/hast.719] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022]
Abstract
Presidential commissions come and go by design, and it is reasonable to wonder about the impact of their recommendations. I have been involved in the work of two presidential commissions: as a member of the Advisory Committee on Human Radiation Experiments (from 1994 to 1995) and as senior consultant to the National Bioethics Advisory Commission (from 1999 to 2000) for its report on multinational research. I continue to reflect on and look for the impact of both these commissions. ACHRE's charter included the review of experiments with ionizing radiation sponsored or conducted by the United States government since the 1940s. The committee was also charged with investigating specific intentional releases of radiation into the environment. ACHRE had a somewhat unique difficulty built into its work: the need to make retrospective ethical judgments. With the National Bioethics Advisory Commission, my main role as senior consultant consisted of writing chapters of the report on multinational research for the commissioners' approval. A more important concern for me as a hired consultant was how to maintain intellectual and moral integrity. Unlike when writing scholarly papers, where I can express my own views, when I was drafting text for a presidential commission, the commissioners' views took precedence over my own when we disagreed. I wondered, how much could I comply with the commissioners' positions without compromising my own integrity?
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Kedoté NM, Salami A, Tsala Tsala JP, Grimaud MA, Bergeron M, Fayomi B. [Researches' Institutional Framework in Three Sub-Saharan African Countries]. ACTA ACUST UNITED AC 2017; 28:63-74. [PMID: 29561119 DOI: 10.3917/jib.281.0063] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Abstract
This paper presents the overview of the legal and institutional frameworks of research with human beings in sub-Saharan Africa, in particular in Benin, Cameroon and Nigeria. Concerning the methodology, a literature review focused on the regulations of institutional frameworks was done. Then, 28 semi-structured interviews were conducted with members of ethics committees to assess their composition and their mode of operation. Finally, we describe the existing courses in research ethics included in programs of first, second and third cycles in major universities from concerned countries.Concerning structures, all countries have normative and functional ethics committees concerned with the basics of ethics in health research. However, these ethics committees face several challenges including the lack of funding, deficiencies in the training of their members and the application of the ethical evaluation to qualitative and mixed researches.
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Crane JT, Rossouw TM. Inequality and ethics in paediatric HIV remission research: From Mississippi to South Africa and back. Glob Public Health 2017; 12:220-235. [PMID: 27458074 PMCID: PMC5455772 DOI: 10.1080/17441692.2016.1211162] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
In 2013, physician-researchers announced that a baby in Mississippi had been 'functionally cured' of HIV [Persaud, D., Gay, H., Ziemniak, C. F., Chen, Y. H., Piatak, M., Chun, T.-W., … Luzuriaga, K. (2013b, March). Functional HIV cure after very early ART of an infected infant. Paper presented at the 20th conference on retroviruses and opportunistic infections, Atlanta, GA]. Though the child later developed a detectable viral load, the case remains unprecedented, and trials to build on the findings are planned [National Institute of Allergy and Infectious Diseases. (2014). 'Mississippi baby' now has detectable HIV, researchers find. Retrieved from http://www.niaid.nih.gov/news/newsreleases/2014/pages/mississippibabyhiv.aspx ]. Whether addressing HIV 'cure' or 'remission', scrutiny of this case has focused largely on scientific questions, with only introductory attention to ethics. The social inequalities and gaps in care that made the discovery possible - and their ethical implications for paediatric HIV remission - have gone largely unexamined. This paper describes structural inequalities surrounding the 'Mississippi baby' case and a parallel case in South Africa, where proof-of-concept studies are in the early stages. We argue that an ethical programme of research into infant HIV remission ought to be 'structurally competent', and recommend that paediatric remission studies consider including a research component focused on social protection and barriers to care.
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Affiliation(s)
- Johanna T Crane
- a Department of Anthropology, School of Interdisciplinary Arts and Sciences , University of Washington-Bothell , Bothell , WA , USA
| | - Theresa M Rossouw
- b Department of Immunology, Institute for Cellular and Molecular Medicine , University of Pretoria , Pretoria , South Africa
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Rattehalli RD, Zhao S, Li BG, Jayaram MB, Xia J, Sampson S, Cochrane Schizophrenia Group. Risperidone versus placebo for schizophrenia. Cochrane Database Syst Rev 2016; 12:CD006918. [PMID: 27977041 PMCID: PMC6463908 DOI: 10.1002/14651858.cd006918.pub3] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/11/2023]
Abstract
BACKGROUND Risperidone is the first new-generation antipsychotic drug made available in the market in its generic form. OBJECTIVES To determine the clinical effects, safety and cost-effectiveness of risperidone compared with placebo for treating schizophrenia. SEARCH METHODS On 19th October 2015, we searched the Cochrane Schizophrenia Group Trials Register, which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. We checked the references of all included studies and contacted industry and authors of included studies for relevant studies and data. SELECTION CRITERIA Randomised clinical trials (RCTs) comparing oral risperidone with placebo treatments for people with schizophrenia and/or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS Two review authors independently screened studies, assessed the risk of bias of included studies and extracted data. For dichotomous data, we calculated the risk ratio (RR), and the 95% confidence interval (CI) on an intention-to-treat basis. For continuous data, we calculated mean differences (MD) and the 95% CI. We created a 'Summary of findings table' using GRADE (Grading of Recommendations Assessment, Development and Evaluation). MAIN RESULTS The review includes 15 studies (N = 2428). Risk of selection bias is unclear in most of the studies, especially concerning allocation concealment. Other areas of risk such as missing data and selective reporting also caused some concern, although not affected on the direction of effect of our primary outcome, as demonstrated by sensitivity analysis. Many of the included trials have industry sponsorship of involvement. Nonetheless, generally people in the risperidone group are more likely to achieve a significant clinical improvement in mental state (6 RCTs, N = 864, RR 0.64, CI 0.52 to 0.78, very low-quality evidence). The effect withstood, even when three studies with >50% attrition rate were removed from the analysis (3 RCTs, N = 589, RR 0.77, CI 0.67 to 0.88). Participants receiving placebo were less likely to have a clinically significant improvement on Clinical Global Impression scale (CGI) than those receiving risperidone (4 RCTs, N = 594, RR 0.69, CI 0.57 to 0.83, very low-quality evidence). Overall, the risperidone group was 31% less likely to leave early compared to placebo group (12 RCTs, N = 2261, RR 0.69, 95% CI 0.62 to 0.78, low-quality evidence), but Incidence of significant extrapyramidal side effect was more likely to occur in the risperidone group (7 RCTs, N = 1511, RR 1.56, 95% CI 1.13 to 2.15, very low-quality evidence).When risperidone and placebo were augmented with clozapine, there is no significant differences between groups for clinical response as defined by a less than 20% reduction in PANSS/BPRS scores (2 RCTs, N = 98, RR 1.15, 95% CI 0.93 to 1.42, low-quality evidence) and attrition (leaving the study early for any reason) (3 RCTs, N = 167, RR 1.13, 95% CI 0.53 to 2.42, low quality evidence). One study measured clinically significant responses using the CGI, no effect was evident (1 RCT, N = 68, RR 1.12 95% CI 0.87 to 1.44, low quality evidence). No data were available for extrapyramidal adverse effects. AUTHORS' CONCLUSIONS Based on low quality evidence, risperidone appears to be benefitial in improving mental state compared with placebo, but it also causes more adverse events. Eight out of the 15 included trials were funded by pharmaceutical companies. The currently available evidence isvery low to low quality.
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Affiliation(s)
| | - Sai Zhao
- Systematic Review Solutions Ltd5‐6 West Tashan RoadYan TaiTianjinChina264000
| | - Bao Guo Li
- Tianjin Medical University Cancer Institute and HospitalInterventional therapy departmentHuan‐Hu‐Xi Road, Ti‐Yuan‐Bei,He Xi DistrictTianjinChina300060
| | - Mahesh B Jayaram
- Melbourne Neuropsychiatry CentreDepartment of PsychiatryUniversity of MelbourneMelbourneAustralia
| | - Jun Xia
- The University of NottinghamCochrane Schizophrenia GroupInstitute of Mental HealthUniversity of Nottingham Innovation Park, Triumph Road,NottinghamUKNG7 2TU
| | - Stephanie Sampson
- The University of NottinghamInstitute of Mental HealthUniversity of Nottingham Innovation Park, Jubilee CampusNottinghamUKNG7 2TU
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Broadhead RL. Reflections on research at the College of Medicine: Excellence yesterday, today, tomorrow. Malawi Med J 2016; 28:79-80. [PMID: 27895836 DOI: 10.4314/mmj.v28i3.3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
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Kass NE, Ali J, Hallez K, Hyder AA. Bioethics training programmes for Africa: evaluating professional and bioethics-related achievements of African trainees after a decade of Fogarty NIH investment. BMJ Open 2016; 6:e012758. [PMID: 27633644 PMCID: PMC5030587 DOI: 10.1136/bmjopen-2016-012758] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/03/2022] Open
Abstract
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 document any associations between individual, training programme and post-training accomplishments. DESIGN We surveyed trainees from the 10 bioethics programmes funded by NIH Fogarty International Center from 2000 to 2011 that included African trainees. McNemar's and Wilcoxon signed rank-sum tests were used to analyse pre-post levels of general and bioethics-related professional achievement. Likelihood of specific post-training achievement outcomes was measured using logistic regression including demographic, pretraining and intratraining variables. SETTING 10 different FBTPs that trained individuals from Africa from 2000 to 2011. PARTICIPANTS Of 253 eligible respondents, 171 completed the survey (response rate 67.6%). PRIMARY OUTCOME MEASURES Pre-post comparisons of professional achievement indicators (eg, serving in leadership roles, teaching, publishing manuscripts); likelihood of specific post-training achievement outcomes. RESULTS Post-training, respondents were significantly more likely to report serving in a leadership role, being an investigator on a research grant, serving on international committees, serving as a mentor, and publishing manuscripts than at pretraining. Post-training, significantly greater numbers of respondents reported bioethics-related achievements including being a bioethics instructor, serving on an Institutional Review Board (IRB), being an investigator on a bioethics grant and publishing bioethics-related manuscripts than pretraining. Controlling for other factors, there were no significant differences by gender in the post-training success of these participants in terms of leadership roles, being instructors, investigators on grants and holding IRB roles. CONCLUSIONS African trainees who participated in FBTPs reported significantly higher levels of professional achievement after training. There was no single factor-either demographic, related to a trainee's professional background, or in programme design-that consistently predicted greater levels of post-training achievement.
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Affiliation(s)
- Nancy E Kass
- Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland, USA
- Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
| | - Joseph Ali
- Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland, USA
| | - Kristina Hallez
- Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland, USA
| | - Adnan A Hyder
- Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland, USA
- Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
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