Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries

Shapiro, Harold T.; Meslin, Eric M.

doi:10.1056/nejm200107123450212

Cited by 204Ethics in Clinical ResearchEthics and bioethics in healthcareBiomedical Ethics and Regulation

The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.

Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries

Shapiro, Harold T., Meslin, Eric M.·2001·New England Journal of Medicine

DOI 10.1056/nejm200107123450212

Open this paper in CoChat — free account

Abstract

There has been considerable controversy about the ethics of clinical trials that are sponsored or conducted by groups in industrialized countries but carried out in developing countries.18 The National Bioethics Advisory Commission, of which we serve as chairman and executive director, respectively, has recently addressed these and related issues.9 International collaborative research covers a broad spectrum of methods, topics, and research strategies. In this essay, we discuss ethical issues in the design and conduct of clinical trials in developing countries. In particular, we focus on phase 3 and other drug trials that, if successful, can lead to the use . . .

Integrity signals

Registry

Crossref · 10.1056/nejm200107123450212

Cites

13 of 13 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

The literature on conducting clinical trials in low resource countries mostly relates to ethical issues.
“Even within the paucity of literature on conducting clinical trials in low resource countries, the literature mostly relates to ethical issues [19, 26–28].”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [27]

Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment
Connor, E. M., SPERLING, R. S., Gelber, R. D., Kiselev, P., Scott, G. B., O’Sullivan, M. J., VanDyke, R., Bey, M., Shearer, W. T., Jacobson, R. L., et al. (1994) · New England Journal of Medicine · doi:10.1056/nejm199411033311801 · Cited by 3,685
Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries
Lurie, P. G., & Wolfe, S. M. (1997) · New England Journal of Medicine · doi:10.1056/nejm199709183371212 · Cited by 884
The Ethics of Clinical Research in the Third World
Angell, M. (1997) · New England Journal of Medicine · doi:10.1056/nejm199709183371209 · Cited by 863
Ethical Complexities of Conducting Research in Developing Countries
VARMUS, H. E., & Satcher, D. S. (1997) · New England Journal of Medicine · doi:10.1056/nejm199710023371411 · Cited by 424
A new look at international research ethics
Benatar, S. R. (2000) · BMJ · doi:10.1136/bmj.321.7264.824 · Cited by 326
Investigators' Responsibilities for Human Subjects in Developing Countries
Angell, M. E. (2000) · New England Journal of Medicine · doi:10.1056/nejm200003303421309 · Cited by 175
Research in Developing Countries: Taking "Benefit" Seriously
Glantz, L. H., Annas, G. J., Grodin, M. A., & Mariner, W. K. (1998) · The Hastings Center Report · doi:10.2307/3528268 · Cited by 165
Operational guidelines for ethics committees that review biomedical research
Eckstein, S. (2003) · Cambridge University Press eBooks · doi:10.1017/cbo9780511550089.069 · Cited by 149
Research and Informed Consent in Africa — Another Look
IJsselmuiden, C., & Faden, R. (1992) · New England Journal of Medicine · doi:10.1056/nejm199203193261212 · Cited by 141
Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS)
Guenter, D., Esparza, J., & Macklin, R. (2000) · Journal of Medical Ethics · doi:10.1136/jme.26.1.37 · Cited by 107
Is Ethical Research Feasible in Developed and Developing Countries?
del Rı́o, C. (1998) · Bioethics · doi:10.1111/1467-8519.00122 · Cited by 25
Ethical issues facing medical research in developing countries
(1998) · The Lancet · doi:10.1016/s0140-6736(97)12306-6 · Cited by 23
Research Bioethics in the Ugandan Context II: Procedural and Substantive Reform
Loue, S., & Okello, D. (2000) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2000.tb00006.x · Cited by 10

Flagged first, then by citations

Research works printed but not linked: 1

Office of the Inspector General. Institutional review boards: a time for reform. Washington, D.C.: Department of Health and Human Services, 1998.

Sorted by citations

Ethical and Scientific Implications of the Globalization of Clinical Research
Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., & Schulman, K. A. (2009) · New England Journal of Medicine · doi:10.1056/nejmsb0803929 · Cited by 710
Barriers for conducting clinical trials in developing countries—A systematic review
Alemayehu, C., Mitchell, G., & Nikles, J. (2018) · International Journal for Equity in Health · doi:10.1186/s12939-018-0748-6 · Cited by 406
The Ethics of Placebo-Controlled Trials — A Middle Ground
Emanuel, E. J., & Miller, F. G. (2001) · New England Journal of Medicine · doi:10.1056/nejm200109203451211 · Cited by 354
Fair Benefits for Research in Developing Countries
(2002) · Science · doi:10.1126/science.1076899 · Cited by 200
Multinational corporations' economic and human rights impacts on developing countries: a review and research agenda
Giuliani, E., & Macchi, C. (2013) · Cambridge Journal of Economics · doi:10.1093/cje/bet060 · Cited by 151
Public Health Ethics: Cases Spanning the Globe
Barrett, D. H., Ortmann, L., Dawson, A., Saénz, C., Reis, A. A., & BOLAN, G. A. (2016) · Public health ethics analysis · doi:10.1007/978-3-319-23847-0 · Cited by 113
The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries’ Health Needs?
Wendler, D. S., Emanuel, E. J., & Lie, R. K. (2004) · American Journal of Public Health · doi:10.2105/ajph.94.6.923 · Cited by 104
ecancermedicalscience
Nardini, C. (2016) · ecancermedicalscience · doi:10.3332/ecancer.2014.387 · Cited by 98
Placebo-controlled trials and the Declaration of Helsinki
Lewis, J. A., Jönsson, B., Kreutz, G., Sampaio, C., & van Zwieten‐Boot, B. (2002) · The Lancet · doi:10.1016/s0140-6736(02)08277-6 · Cited by 96
Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?
Nyika, A., Kilama, W. L., Chilengi, R., Tangwa, G. B., Tindana, P. O., Ndebele, P., & Ikingura, J. K. (2009) · Journal of Medical Ethics · doi:10.1136/jme.2008.025189 · Cited by 94
Quality of life among patients receiving palliative care in South Africa and Uganda: a multi-centred study
Selman, L. E., Higginson, I. J., Agupio, G., Dinat, N., Downing, J. D., Gwyther, L., Mashao, T., Mmoledi, K. C., Moll, T., Sebuyira, L. M., et al. (2011) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-9-21 · Cited by 93
Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries
Mystakidou, K., Panagiotou, I. E., Katsaragakis, S., Tsilika, E., & Parpa, E. (2009) · SAHARA-J Journal of Social Aspects of HIV/AIDS · doi:10.1080/17290376.2009.9724930 · Cited by 86
Meeting information needs of patients with incurable progressive disease and their families in South Africa and Uganda: multicentre qualitative study
Selman, L. E., Higginson, I. J., Agupio, G., Dinat, N., Downing, J. D., Gwyther, L., Mashao, T., Mmoledi, K. C., Moll, A. P., Sebuyira, L. M., et al. (2009) · BMJ · doi:10.1136/bmj.b1326 · Cited by 86
Why Patients Continue to Participate in Clinical Research
Wendler, D. S. (2008) · Archives of Internal Medicine · doi:10.1001/archinte.168.12.1294 · Cited by 81
Human Subjects Protections, Institutional Review Boards, and Cultural Anthropological Research
Marshall, P. A. (2003) · Anthropological Quarterly · doi:10.1353/anq.2003.0028 · Cited by 81
Ethical issues in international environmental health research.
Lavery, J., Upshur, R., Sharp, R., & Hofman, K. (2003) · International Journal of Hygiene and Environmental Health · doi:10.1078/1438-4639-00242 · Cited by 45
Hydroxychloroquine Controversies: Clinical Trials, Epistemology, and the Democratization of Science
Berlivet, L., & Löwy, I. (2020) · Medical Anthropology Quarterly · doi:10.1111/maq.12622 · Cited by 76
The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial
Mbuagbaw, L. C. E., Thabane, L., Ongolo‐Zogo, P., & Lang, T. A. (2011) · Trials · doi:10.1186/1745-6215-12-145 · Cited by 73
Ethics of placebo-controlled clinical trials in multiple sclerosis
Polman, C. H., Reingold, S. C., Barkhof, F., Calabresi, P. A., Clanet, M., Cohen, J. A., Cutter, G., Freedman, M. S., Kappos, L., LUBLIN, F. D., et al. (2008) · Neurology · doi:10.1212/01.wnl.0000306410.84794.4d · Cited by 70
A qualitative study using traditional community assemblies to investigate community perspectives on informed consent and research participation in western Kenya
Vreeman, R., Kamaara, E. K., Kamanda, A., Ayuku, D., Nyandiko, W. M., Atwoli, L., Ayaya, S., Gisore, P., Scanlon, M., & Braitstein, P. K. A. (2012) · BMC Medical Ethics · doi:10.1186/1472-6939-13-23 · Cited by 67
Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-poor Settings
Marshall, P. A. (2007) · Medical Entomology and Zoology · Cited by 67
Impact Assessment: Measuring & Communicating
Global, N., & Kazanskaia, A. N. (2025) · doi:10.64357/impact-assessment-2025 · Cited by 62
Why do people refuse to take part in biomedical research studies? Evidence from a resource-poor area
Mfutso-Bengo, J. M., Masiye, F., Molyneux, M. E., Ndebele, P., & Chilungo, A. (2008) · Malawi Medical Journal · doi:10.4314/mmj.v20i2.10958 · Cited by 59
Attitudes, understanding, and concerns regarding medical research amongst Egyptians: A qualitative pilot study
Khalil, S., SILVERMAN, H. J., Raafat, M., El‐Kamary, S. S., & El‐Setouhy, M. (2007) · BMC Medical Ethics · doi:10.1186/1472-6939-8-9 · Cited by 58
Global Aspects of Cardiothoracic Surgery with Focus on Developing Countries
Pezzella, A. T. (2010) · Asian Cardiovascular and Thoracic Annals · doi:10.1177/0218492310370060 · Cited by 57
Clinical trials in low and middle-income countries — Successes and challenges
Grover, S., Xu, M. J., Jhingran, A., Mahantshetty, U. M., Chuang, L. T., Small, W. C., & Gaffney, D. K. (2016) · Gynecologic Oncology Reports · doi:10.1016/j.gore.2016.11.007 · Cited by 56
Hidden risks associated with clinical trials in developing countries
Lorenzo, C., Garrafa, V., Solbakk, J. H., & Vidal, S. (2010) · Journal of Medical Ethics · doi:10.1136/jme.2009.031708 · Cited by 58
Conducting Research in Developing Countries: Experiences of the Informed Consent Process from Community Studies in Peru
Creed‐Kanashiro, H., Oreé, B., de Scurrah, M. M., Gil, A. M., & Penny, M. E. (2005) · Journal of Nutrition · doi:10.1093/jn/135.4.925 · Cited by 54
See no evil?
Dearden, A. (2012) · International Conference on Information and Communication Technologies and Development (ICTD) · doi:10.1145/2160673.2160680 · Cited by 53
‘Peace’ and ‘life worthwhile’ as measures of spiritual well-being in African palliative care: a mixed-methods study
Selman, L. E., Speck, P. W., Gysels, M., Agupio, G., Dinat, N., Downing, J. D., Gwyther, L., Mashao, T., Mmoledi, K. C., Moll, T., et al. (2013) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-11-94 · Cited by 51
Obesity as a public health problem among adult women in rural Tanzania
Keding, G. B., Msuya, J. M., Maass, B. L., & Krawinkel, M. B. (2013) · Global Health Science and Practice · doi:10.9745/ghsp-d-13-00082 · Cited by 49
Ethical issues for collaborative research in developing countries
Caballero, B. H. (2002) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/76.4.717 · Cited by 49
Informed Consent in Cross-cultural Perspective: Clinical Research in the Tibetan Autonomous Region, PRC
Adams, V., Miller, S., Craig, S. R., Sonam, S., Nyima, Droyoung, Le, P. V., & Varner, M. W. (2007) · Culture Medicine and Psychiatry · doi:10.1007/s11013-007-9070-2 · Cited by 48
Research Involving Human Subjects in Developing Countries
Koski, G., & Nightingale, S. L. (2001) · New England Journal of Medicine · doi:10.1056/nejm200107123450211 · Cited by 47
Globalization of Pediatric Research: Analysis of Clinical Trials Completed for Pediatric Exclusivity
Pasquali, S. K., Burstein, D. S., Benjamin, D. K., Smith, P. B., & Li, J. S. (2010) · PEDIATRICS · doi:10.1542/peds.2010-0098 · Cited by 46
Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in western Kenya
Shaffer, D. N., Yebei, V. N., Baliddawa, J., Sidle, J. E., Greene, J. Y., Meslin, E. M., Kimaiyo, S., & Tierney, W. M. (2005) · Journal of Medical Ethics · doi:10.1136/jme.2004.011106 · Cited by 45
Self-citation
Drug Development in Low- and Middle-Income Countries: Opportunity or Exploitation?
Jalali, R., Nogueira‐Rodrigues, A., Das, A., Sirohi, B., & Panda, P. K. (2022) · American Society of Clinical Oncology Educational Book · doi:10.1200/edbk_10033 · Cited by 45
Abnormal pelvic response to cough in women with stress urinary incontinence
Deffieux, X., Hubeaux, K., Porcher, R., Ismaël, S. S., Raibaut, P., & Amarenco, G. (2007) · Neurourology and Urodynamics · doi:10.1002/nau.20506 · Cited by 44
Volunteerism and Humanitarian Efforts in Surgery
Pezzella, A. T. (2006) · Current Problems in Surgery · doi:10.1067/j.cpsurg.2006.09.002 · Cited by 44
Research in Developing Countries
Shann, F. (2002) · New England Journal of Medicine · doi:10.1056/nejm200202213460817 · Cited by 44
Pelvic Floor Muscle Activity During Coughing: Altered Pattern in Women with Stress Urinary Incontinence
Deffieux, X., Hubeaux, K., Porcher, R., Ismaël, S. S., Raibaut, P., & Amarenco, G. (2007) · Urology · doi:10.1016/j.urology.2007.03.084 · Cited by 42
What Egyptians think. Knowledge, attitude, and opinions of Egyptian patients towards biobanking issues
Abdelhafiz, A. S., Sultan, E. A., Ziady, H. H., Ahmed, E., Khairy, W. A., Sayed, D. M., Zaki, R., Fouda, M. A., & Labib, R. M. (2019) · BMC Medical Ethics · doi:10.1186/s12910-019-0394-6 · Cited by 42
Audiovisual documentation of oral consent: a new method of informed consent for illiterate populations
Benitez, O. M., Devaux, D., & Dausset, J. B. (2002) · The Lancet · doi:10.1016/s0140-6736(02)08361-7 · Cited by 41
Ethics of clinical research in the developing world
Killen, J., Grady, C., Folkers, G. K., & Fauci, A. S. (2002) · Nature reviews. Immunology · doi:10.1038/nri745 · Cited by 39
Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis
Catalá-López, F., Aleixandre-Benavent, R., Caulley, L., Hutton, B., Tabarés-Seisdedos, R., Moher, D., & Alonso-Arroyo, A. (2020) · Trials · doi:10.1186/s13063-019-3944-9 · Cited by 38
Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries
Denburg, A., Galindo, C. R., & Joffe, S. (2016) · The American Journal of Bioethics · doi:10.1080/15265161.2016.1170230 · Cited by 38
Perspectives of Egyptian Research Ethics Committees regarding Their Effective Functioning
Matar, A., & SILVERMAN, H. J. (2013) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2013.8.1.32 · Cited by 37
Ethical Issues in Outsourcing: The Case of Contract Medical Research and the Global Pharmaceutical Industry
Adobor, H. (2011) · Journal of Business Ethics · doi:10.1007/s10551-011-0964-0
Rethinking the Bioethical Enactment of Medically Drugged Bodies: Paradoxes of Using Anti-HIV Drug Therapy as a Technology for Prevention
Rosengarten, M., & Michael, M. (2009) · Science as Culture · doi:10.1080/09505430902885565 · Cited by 34
Rethinking the responsiveness requirement for international research
Wolitz, R. E., Emanuel, E. J., & Shah, S. K. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60320-2 · Cited by 33
Safeguarding children's rights in psychopharmacological research: ethical and legal issues.
Kölch, M., Ludolph, A., Plener, P., Fangerau, H., Vitiello, B., & Fegert, J. (2010) · Current pharmaceutical design · doi:10.2174/138161210791959881 · Cited by 31
The ethics of clinical research in low- and middle-income countries
Lahey, T. (2013) · Handbook of clinical neurology · doi:10.1016/b978-0-444-53501-6.00025-1 · Cited by 31
Institutional Review Board Approval
Parvizi, J., Tarity, T. D., Conner, K., & Smith, J. B. (2007) · Journal of Bone and Joint Surgery · doi:10.2106/00004623-200702000-00030 · Cited by 30
Landscape of Oncology Clinical Trials in Africa
Odedina, F. T., Shamley, D. R., Okoye, I. J., Ezeani, A., Ndlovu, N., Dei‐Adomakoh, Y., Meza, K. S., Agaba, R., Fathi, P., & Askins, N. (2020) · JCO Global Oncology · doi:10.1200/jgo.19.00189 · Cited by 29
A Case Study of Research Ethics Capacity Development in Africa
Hyder, A. A., Harrison, R. A., KASS, N. E., & Maman, S. (2007) · Academic Medicine · doi:10.1097/acm.0b013e3180674484 · Cited by 28
Subjects’ views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study
Sofaer, N., Thiessen, C., Goold, S. D., Ballou, J. M., Getz, K. A., Koski, G., Krueger, R. A., & Weissman, J. S. (2009) · Journal of Medical Ethics · doi:10.1136/jme.2008.024711 · Cited by 28
Impact, Challenges, and Future Projections of Vaccine Trials in Africa
Idoko, O. T., Kochhar, S., Agbenyega, T., Ogutu, B. R., & Ota, M. O. C. (2013) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.12-0576 · Cited by 27
Three Steps to Protecting Pediatric Research Participants from Excessive Risks
Wendler, D. S. (2006) · PLoS Clinical Trials · doi:10.1371/journal.pctr.0010025 · Cited by 26
Participant understanding of informed consent in a multidisease community-based health screening and biobank platform in rural South Africa
Ngwenya, N. B., Luthuli, M., Gunda, R., Gumede, N. A., Adeagbo, O., Nkosi, B., Gareta, D., Koole, O., Siedner, M. J., Wong, E. B., et al. (2020) · International Health · doi:10.1093/inthealth/ihaa072 · Cited by 26
International Cardiac Surgery: A Global Perspective
Pezzella, A. T. (2002) · Seminars in Thoracic and Cardiovascular Surgery · doi:10.1016/s1043-0679(02)70002-6 · Cited by 26
Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings
Mtove, G. A., Kimani, J., Kisinza, W. N., Makenga, G., Mangesho, P. E., Duparc, S., Nakalembe, M., Phiri, K. S., Orrico, R., Rojo, R., et al. (2018) · Trials · doi:10.1186/s13063-018-2563-1 · Cited by 25
Effect of micronutrients on morbidity and duration of hospital stay in childhood pneumonia.
Wahed, M. A., Islam, M. A., Khondakar, P., & Haque, M. A. (2008) · PubMed · Cited by 25
The MVQOLI successfully captured quality of life in African palliative care: a factor analysis
Selman, L. E., Siegert, R. J., Higginson, I. J., Agupio, G., Dinat, N., Downing, J. D., Gwyther, L., Mashao, T., Mmoledi, K. C., Moll, T., et al. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2010.12.013 · Cited by 24
Ethical coherency when medical students work abroad
Bhat, S. B. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61461-0 · Cited by 24
Post-trial Access to Tested Interventions: The Views of IRB/REC Chair, Investigators, and Research Participants in a Multinational HIV/AIDS Study
Pace, C. A., Grady, C., Wendler, D. S., Bebchuk, J. D., Tavel, J. A., McNay, L. A., Forster, H. P., Killen, J., & Emanuel, E. J. (2006) · AIDS Research and Human Retroviruses · doi:10.1089/aid.2006.22.837 · Cited by 24
International Collaborative Research Partnerships: Blending Science with Management and Diplomacy
Orsega, C. W. S. (2014) · Journal of AIDS & Clinical Research · doi:10.4172/2155-6113.1000385 · Cited by 22
Regulamentações, conflitos e ética da pesquisa médica em países em desenvolvimento
Cabral, M. M. L., Schindler, H. C., & Abath, F. G. C. (2006) · Revista de Saúde Pública · doi:10.1590/s0034-89102006000300022 · Cited by 21
The Ethics of Placebo in Studies with Fracture End Points in Osteoporosis
Stein, C. M., & Ray, W. A. (2010) · New England Journal of Medicine · doi:10.1056/nejmsb1006120 · Cited by 20
Pediatric oncology research in low income countries: Ethical concepts and challenges
Denburg, A., Joffe, S., Gupta, S., Howard, S. C., Ribeiro, R. C., Antillón‐Klussmann, F., Vásquez, R., & Sung, L. (2011) · Pediatric Blood & Cancer · doi:10.1002/pbc.23419 · Cited by 20
Marking Shifts in Human Research Ethics in the Development of Biobanking
Chalmers, D., Burgess, M., Edwards, K., Kaye, J. S., Meslin, E. M., & Nicol, D. (2014) · Public Health Ethics · doi:10.1093/phe/phu023 · Cited by 19
Self-citation
Establishment of ethical oversight of human research in El Salvador: lessons learned
Caniza, M. A., Clara, A. W., Marón, G. M., Navarro-Marin, J. E., Rivera, R., Howard, S. C., CAMP, J. W., & Barfield, R. C. (2006) · The Lancet Oncology · doi:10.1016/s1470-2045(06)70977-9 · Cited by 18
In Defense of the Hopkins Lead Abatement Studies
Ross, L. F. (2002) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2002.tb00719.x · Cited by 18
Ethical Issues in Measuring Biomarkers in Children’s Environmental Health
Sly, P. D., Eskenazi, B., Pronczuk, J., Šrám, R. J., Díaz‐Barriga, F., Machín, D. G., Carpenter, D. O., Surdu, S., & Meslin, E. M. (2009) · Environmental Health Perspectives · doi:10.1289/ehp.0800480 · Cited by 20
Self-citation
CLINICAL TRIALS IN DEVELOPING COUNTRIES - ETHICAL CONSIDERATIONS
Pašić, M. B., Vidrih, B., Šarac, H., Pašić, H., Vujević, L., Koruga, A. S., & Rajič, F. (2018) · Psychiatria Danubina · doi:10.24869/psyd.2018.285 · Cited by 16
The case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries
Kapiriri, L., Lavery, J. V., SINGER, P. A., Mshinda, H., Babiuk, L. A., & Daar, A. S. (2011) · BMC Public Health · doi:10.1186/1471-2458-11-811 · Cited by 17
Pediatric Assent for a Study of Antiretroviral Therapy Dosing for Children in Western Kenya: A Case Study in International Research Collaboration
Vreeman, R., Nyandiko, W. M., & Meslin, E. M. (2009) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2009.4.1.3 · Cited by 16
Self-citation
Human Rights,Cultural Pluralism, and International Health Research
Marshall, P. A. (2005) · Metamedicine · doi:10.1007/s11017-005-2199-5 · Cited by 16
Estudios Experimentales 1 Parte: El Ensayo Clínico
Manterola, C., & Otzen, T. (2015) · International Journal of Morphology · doi:10.4067/s0717-95022015000100054 · Cited by 15
A pragmatic analysis of vulnerability in clinical research
Wendler, D. S. (2017) · Bioethics · doi:10.1111/bioe.12367 · Cited by 15
Altruism, Scepticism, and collective decision-making in foreign-born U.S. residents in a tuberculosis vaccine trial
Craig, S. R., Lahey, T., Dixit, A., & von Reyn, C. F. (2018) · BMC Public Health · doi:10.1186/s12889-018-5460-3 · Cited by 15
Study of laboratory staff’ knowledge of biobanking in Côte d’Ivoire
Kintossou, A. K., N’Dri, M. K., MONEY, M. E., Cissé, S., Doumbia, S., Soumahoro, M.-K., Coulibaly, F. A., Djaman, J. A., & Dosso, M. B. (2020) · BMC Medical Ethics · doi:10.1186/s12910-020-00533-y · Cited by 14
Use and abuse of empirical knowledge in contemporary bioethics
Solbakk, J. H. (2004) · Medicine Health Care and Philosophy · doi:10.1023/b:mhep.0000021845.28818.e2 · Cited by 14
Ethics of International Research: What Does Responsiveness Mean?
Grady, C. (2006) · The AMA Journal of Ethic · doi:10.1001/virtualmentor.2006.8.4.pfor2-0604 · Cited by 14
HIV/AIDS and Bioethics: Historical Perspective, Personal Retrospective
Bryan, C. S. (2002) · Health Care Analysis · doi:10.1023/a:1015634125917 · Cited by 14
Understanding of research: a Sri Lankan perspective
Sumathipala, A., Siribaddana, S., Hewage, S. N., Lekamwattage, M., Athukorale, M., Siriwardhana, C., Munasinghe, K., Sumathipala, K., Murray, J., & Prince, M. J. (2010) · BMC Medical Ethics · doi:10.1186/1472-6939-11-7 · Cited by 14
Universality and its Limits: When Research Ethics Can Reflect Local Circumstances
Orentlicher, D. (2002) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2002.tb00409.x · Cited by 14
Involving Communities in Deciding What Benefits They Receive in Multinational Research
Wendler, D. S., & Shah, S. K. (2015) · The Journal of Medicine and Philosophy A Forum for Bioethics and Philosophy of Medicine · doi:10.1093/jmp/jhv017 · Cited by 13
Challenges and opportunities in setting up a phase III vaccine clinical trial in resource limited settings: Experience from Nepal
Saluja, T., Giri, B. R., Chaudhary, S., Tamrakar, D., Kanodia, P., Palkar, S. H., Vemula, S., Chinaworapong, S., Kim, B., Gupta, B. P., et al. (2021) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2020.1855955 · Cited by 15
Human dignity as a basis for providing post-trial access to healthcare for research participants: a South African perspective
Andanda, P., & Wathuta, J. (2017) · Medicine Health Care and Philosophy · doi:10.1007/s11019-017-9782-1 · Cited by 15
Clinical trials in low‐resource settings: the perspectives of caregivers of paediatric participants from Uganda, Tanzania and Kenya
van den Berg, M., Ogutu, B. R., Sewankambo, N. K., Merten, S., Biller‐Andorno, N., & Tanner, M. (2019) · Tropical Medicine & International Health · doi:10.1111/tmi.13281 · Cited by 13
HIV/AIDS Research Conducted in the Developing World and Sponsored by the Developed World: Reporting of Research Ethics Committee Review in Two Countries
Chin, L. J., Rifai-Bashjawish, H., Kleinert, K. J., Saltman, A., Leu, C., & Klitzman, R. (2011) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2011.6.3.83 · Cited by 12
The Effect of Relationships on Decision-Making Processes of Women in Harare, Zimbabwe
Nyika, A., Wassenaar, D. R., & Mamotte, N. (2009) · Ethics & Behavior · doi:10.1080/10508420902886627 · Cited by 12
The National Bioethics Advisory Commission: Contributing to Public Policy
Eiseman, E. (2003) · DigitalGeorgetown (Georgetown University Library) · Cited by 12
Conduct of clinical trials in developing countries
Kasper, C. K. (2002) · Haemophilia · doi:10.1046/j.1365-2516.2002.00594.x · Cited by 12
Current status of phase I clinical trials in Asia: an academic perspectives.
Louisa, M., Takeuchi, M., Setiabudy, R., Nafrialdi, N., & Takeuchi, M. (2012) · PubMed · Cited by 11
Clinical research in developing countries: recent moral arguments
Lackey, D. P. (2002) · Cadernos de Saúde Pública · doi:10.1590/s0102-311x2002000500038 · Cited by 11
The ethical limits of bungee research in ICTD
Dearden, A., & Tucker, W. D. (2015) · IEEE International Symposium on Technology and Society (ISTAS) · doi:10.1109/istas.2015.7439430 · Cited by 11
Ethical international research on human subjects research in the absence of local institutional review boards
Bhat, S. B., & Hegde, T. T. (2006) · Journal of Medical Ethics · doi:10.1136/jme.2005.013516 · Cited by 11
Issues and Challenges for Clinical Research in International Settings
Olopade, C. O., Olugbile, S. O., & Olopade, O. I. (2012) · Elsevier eBooks · doi:10.1016/b978-0-12-382167-6.00047-3 · Cited by 10
THE REPORTING OF IRB REVIEW IN JOURNAL ARTICLES PRESENTING HIV RESEARCH CONDUCTED IN THE DEVELOPING WORLD
Klitzman, R., Kleinert, K. J., Rifai-Bashjawish, H., & LEU, C. S. (2011) · Developing World Bioethics · doi:10.1111/j.1471-8847.2011.00306.x · Cited by 11

Authors: Shapiro, H. T., & Meslin, E. M.
Affiliations: National Institutes of Health (US)
ORCID: Meslin, Eric M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2001-07-12
Volume: 345
Issue: 2
Pages: 139-142
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm200107123450212
OpenAlex: W2065625460
Cited by: 204
References: 13
Citations by year: 2026: 1 · 2025: 2 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 8 · 2019: 4 · 2018: 5 · 2017: 9 · 2016: 7 · 2015: 6 · 2014: 6 · 2013: 13 · 2012: 8
FWCI: 15.50
Type: journal article
Language: en
Open access: closed
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
DigitalGeorgetown (Georgetown University Library) (submittedVersion)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
Keywords: clinical trial ethics, developing countries, international collaborative research, research ethics oversight, National Bioethics Advisory Commission
MeSH terms: Clinical Trials as Topic, Developing Countries, Ethics, Medical, Helsinki Declaration, Humans, Research Design, United States, Ethical Review, Vulnerable Populations, Internationality

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Claims other papers make about this one

Citations

Cites

Cited by

Related

Metadata

Record

About these checks