The Ethics of Clinical Research in the Third World

Angell, Marcia

doi:10.1056/nejm199709183371209

Cited by 863Ethics in Clinical ResearchEthics and bioethics in healthcareBiomedical Ethics and Regulation

The Ethics of Clinical Research in the Third World

Angell, Marcia·1997·New England Journal of Medicine

DOI 10.1056/nejm199709183371209

Open this paper in CoChat — free account

Abstract

An essential ethical condition for a randomized clinical trial comparing two treatments for a disease is that there be no good reason for thinking one is better than the other.1,2 Usually, investigators hope and even expect that the new treatment will be better, but there should not be solid evidence one way or the other. If there is, not only would the trial be scientifically redundant, but the investigators would be guilty of knowingly giving inferior treatment to some participants in the trial. The necessity for investigators to be in this state of equipoise2 applies to placebo-controlled trials, as . . .

Integrity signals

Registry

Crossref · 10.1056/nejm199709183371209

Cites

31 of 31 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 [26]

Clozapine for the Treatment-Resistant Schizophrenic: A Double-blind Comparison With Chlorpromazine
Kane, J. (1988) · Archives of General Psychiatry · doi:10.1001/archpsyc.1988.01800330013001 · Cited by 4,156 · see citing works
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 · see citing works
Equipoise and the Ethics of Clinical Research
Freedman, B. (1987) · New England Journal of Medicine · doi:10.1056/nejm198707163170304 · Cited by 2,339 · see citing works
A history and theory of informed consent
Kapp, M. B. (1986) · Journal of Legal Medicine · doi:10.1080/01947648609513478 · Cited by 2,328 · see citing works
Effect of Chlorpromazine or Haloperidol on Formation of 3‐Methoxytyramine and Normetanephrine in Mouse Brain
Carlsson, A., & Lindqvist, M. (1963) · Acta Pharmacologica et Toxicologica · doi:10.1111/j.1600-0773.1963.tb01730.x · Cited by 2,156 · see citing works
International Ethical Guidelines for Biomedical Research Involving Human Subjects
Cioms (1993) · Cited by 1,309 · see citing works
Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children. American Thoracic Society and the Centers for Disease Control and Prevention
Bass, J. B., Farer, L. S., Hopewell, P. C., O'Brien, R., Jacobs, R. F., Ruben, F. L., Snider, D. E., & Thornton, G. F. (1994) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/ajrccm.149.5.8173779 · Cited by 1,190 · see citing works
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 · see citing works
Maternal Viral Load, Zidovudine Treatment, and the Risk of Transmission of Human Immunodeficiency Virus Type 1 from Mother to Infant
SPERLING, R. S., Shapiro, D. E., Coombs, R. W., Todd, J. A., Herman, S. A., McSherry, G., O’Sullivan, M. J., Dyke, R. B. V., Jiménez, E., Rouzioux, C., et al. (1996) · New England Journal of Medicine · doi:10.1056/nejm199611283352201 · Cited by 800 · see citing works
Olanzapine versus Placebo and Haloperidol
Beasley, C. M., Tollefson, G. D., Tran, P., SATTERLEE, W. G., Sanger, T. M., & Hamilton, S. H. (1996) · Neuropsychopharmacology · doi:10.1016/0893-133x(95)00069-p · Cited by 777 · see citing works
A Comparison of Clozapine and Haloperidol in Hospitalized Patients with Refractory Schizophrenia
Rosenheck, R. A., Cramer, J. A., Xu, W., Thomas, J. V., Henderson, W., Frisman, L. K., Fye, C. L., & Charney, D. S. (1997) · New England Journal of Medicine · doi:10.1056/nejm199709183371202 · Cited by 516 · see citing works
Effect of isoniazid prophylaxis on incidence of active tuberculosis and progression of HIV infection
Pape, J. W., JEAN, S. S., Ho, J. L., Hafner, A., & Johnson, W. D. (1993) · The Lancet · doi:10.1016/0140-6736(93)91817-6 · Cited by 440 · see citing works
Statistical Tables for the Design of Clinical Trials.
Wickham, C. A. C., Machin, D., & Campbell, M. J. (1988) · Journal of the Royal Statistical Society Series A (Statistics in Society) · doi:10.2307/2982784 · Cited by 429 · see citing works
A Trial of Three Regimens to Prevent Tuberculosis in Ugandan Adults Infected with the Human Immunodeficiency Virus
Whalen, C. C., Johnson, J. L., Okwera, A., Hom, D. L., Huebner, R. E., Mugyenyi, P. N., Mugerwa, R. D., Ellner, J. J., Nsubuga, P., Vjecha, M. J., et al. (1997) · New England Journal of Medicine · doi:10.1056/nejm199709183371201 · Cited by 396 · see citing works
The Nazi Doctors and the Nuremberg Code Human Rights in Human Experimentation
Annas, G. J., & Grodin, M. A. (1992) · Oxford University Press eBooks · Cited by 337 · see citing works
Perinatal HIV Infection and the Effect of Zidovudine Therapy on Transmission in Rural and Urban Counties
Fiscus, S. A. (1996) · JAMA · doi:10.1001/jama.1996.03530430027034 · Cited by 162 · see citing works
Paediatric HIV infection
Scarlatti, G. (1996) · The Lancet · doi:10.1016/s0140-6736(95)11030-5 · Cited by 145 · see citing works
Ethical Imperialism?
Angell, M. (1988) · New England Journal of Medicine · doi:10.1056/nejm198810203191608 · Cited by 143 · see citing works
Self-citation
Patients’ Preferences in Randomized Clinical Trials
Angell, M. E. (1984) · New England Journal of Medicine · doi:10.1056/nejm198405243102111 · Cited by 142 · see citing works
Self-citation
Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths
Freedman, B., Weijer, C., & Glass, K. C. (1996) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.1996.tb01859.x · Cited by 119 · see citing works
When Evil Intrudes
Caplan, A. L. (1992) · The Hastings Center Report · doi:10.2307/3562946 · Cited by 90 · see citing works
Preventive therapy for tuberculosis
Bess, M. (1993) · Medical Clinics of North America · doi:10.1016/s0025-7125(16)30192-4 · Cited by 84 · see citing works
Tuberculosis : back to the future
Porter, J. D. H., & McAdam, K. P. W. J. (1994) · Wiley eBooks · Cited by 69 · see citing works
Preventive therapy for tuberculosis in HIV-infected persons: international recommendations, research, and practice
Cock, K. M. D., Grant, A. D., & Porter, J. D. H. (1995) · The Lancet · doi:10.1016/s0140-6736(95)92967-3 · Cited by 68 · see citing works
Timing of mother-to-child HIV-1 transmission depends on maternal status
Rouzioux, C., Costagliola, D. G., Burgard, M., Blanche, S., Mayaux, M. J., Griscelli, C., & Valleron, A. (1993) · AIDS · doi:10.1097/00002030-199311002-00011 · Cited by 65 · see citing works
Twenty Years After The Legacy of the Tuskegee Syphilis Study
(1992) · The Hastings Center Report · doi:10.2307/3562945 · Cited by 62 · see citing works
Ethical, Behavioral, and Social Aspects of HIV Vaccine Trials in Developing Countries
Lurie, P. G. (1994) · JAMA · doi:10.1001/jama.1994.03510280057033 · Cited by 60 · see citing works
Directly observed therapy for tuberculosis in rural South Africa, 1991 through 1994.
Wilkinson, D. J. C., Davies, G., & Connolly, C. A. (1996) · American Journal of Public Health · doi:10.2105/ajph.86.8_pt_1.1094 · Cited by 56 · see citing works
The Nazi Hypothermia Experiments and Unethical Research Today
Angell, M. E. (1990) · New England Journal of Medicine · doi:10.1056/nejm199005173222011 · Cited by 56 · see citing works
Self-citation
The Double Burden of HIV Infection and Tuberculosis in Sub-Saharan Africa
Msamanga, G., & Fawzi, W. W. (1997) · New England Journal of Medicine · doi:10.1056/nejm199709183371210 · Cited by 40 · see citing works
Effect of vitamin-enriched bread on the vitamin status of an isolated rural community--a controlled clinical trial.
Bishop, W. B., Laubscher, I., Labadarios, D., Rehder, P., Louw, M. E., & Fellingham, S. A. (1996) · PubMed · Cited by 6 · see citing works

Flagged first, then by citations

Sorted by citations

What Makes Clinical Research Ethical?
Emanuel, E. J. (2000) · JAMA · doi:10.1001/jama.283.20.2701 · Cited by 2,710 · see citing works
What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004) · The Journal of Infectious Diseases · doi:10.1086/381709 · Cited by 966 · see citing works
Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues
Temple, R., & Ellenberg, S. S. (2000) · Annals of Internal Medicine · doi:10.7326/0003-4819-133-6-200009190-00014 · Cited by 871 · see citing works
Non‐inferiority trials: design concepts and issues – the encounters of academic consultants in statistics
D’Agostino, R. B., Massaro, J. M., & SULLIVAN, L. M. (2002) · Statistics in Medicine · doi:10.1002/sim.1425 · Cited by 715 · see citing works
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 · see citing works
Assessing the Gold Standard — Lessons from the History of RCTs
Bothwell, L. E., Greene, J. A., Podolsky, S. H., & Jones, D. S. (2016) · New England Journal of Medicine · doi:10.1056/nejmms1604593 · Cited by 664 · see citing works
Autologous non-myeloablative haemopoietic stem-cell transplantation compared with pulse cyclophosphamide once per month for systemic sclerosis (ASSIST): an open-label, randomised phase 2 trial
Burt, R. K., Shah, S. J., Dill, K. E., Grant, T. H., Gheorghiade, M., Schroeder, J. L., Craig, R. M., Hirano, I., Marshall, K., Ruderman, E., et al. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60982-3 · Cited by 581 · see citing works
Gender equality in science, medicine, and global health: where are we at and why does it matter?
Shannon, G. D., Jansen, M., Williams, K., Cáceres, C. F., Motta, A., Odhiambo, A., Eleveld, A., & Mannell, J. (2019) · The Lancet · doi:10.1016/s0140-6736(18)33135-0 · Cited by 554 · see citing works
Towards a More Inclusive and Dynamic Understanding of Medical Mistrust Informed by Science
Jaiswal, J., & Halkitis, P. N. (2019) · Behavioral Medicine · doi:10.1080/08964289.2019.1619511 · Cited by 495 · see citing works
Efficacy of three short-course regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania, South Africa, and Uganda (Petra study): a randomised, double-blind, placebo-controlled trial
(2002) · The Lancet · doi:10.1016/s0140-6736(02)08214-4 · Cited by 457 · see citing works
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 · see citing works
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 · see citing works
Reflections and recommendations on research ethics in developing countries
Benatar, S. R. (2002) · Social Science & Medicine · doi:10.1016/s0277-9536(01)00327-6 · Cited by 374 · see citing works
Moving to research partnerships in developing countries
Costello, A. (2000) · BMJ · doi:10.1136/bmj.321.7264.827 · Cited by 349 · see citing works
The Ethical Problems with Sham Surgery in Clinical Research
Macklin, R. (1999) · New England Journal of Medicine · doi:10.1056/nejm199909233411312 · Cited by 340 · see citing works
Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases
Ellenberg, S. S., & Temple, R. (2000) · Annals of Internal Medicine · doi:10.7326/0003-4819-133-6-200009190-00015 · Cited by 331 · see citing works
Vaccine adjuvant systems: Enhancing the efficacy of sub-unit protein antigens
Perrie, Y., Mohammed, A. R., Kirby, D. J., McNeil, S. E., & Bramwell, V. W. (2008) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2008.04.036 · Cited by 333 · see citing works
Scientific research is a moral duty
Harris, J. (2005) · Journal of Medical Ethics · doi:10.1136/jme.2005.011973 · Cited by 328 · see citing works
A new look at international research ethics
Benatar, S. R. (2000) · BMJ · doi:10.1136/bmj.321.7264.824 · Cited by 326 · see citing works
Ethical variability: Drug development and globalizing clinical trials
Petryna, A. (2005) · American Ethnologist · doi:10.1525/ae.2005.32.2.183 · Cited by 317 · see citing works
The History Of Vaccines And Immunization: Familiar Patterns, New Challenges
Stern, A. M., & Markel, H. (2005) · Health Affairs · doi:10.1377/hlthaff.24.3.611 · Cited by 301 · see citing works
Racial differences in attitudes toward professional mental health care and in the use of services.
Diala, C. C., Muntaner, C., Walrath, C., Nickerson, K. J., LaVeist, T. A., & Leaf, P. J. (2000) · American Journal of Orthopsychiatry · doi:10.1037/h0087736 · Cited by 282 · see citing works
The Need to Revise the Declaration of Helsinki
Levine, R. J. (1999) · New England Journal of Medicine · doi:10.1056/nejm199908123410713 · Cited by 265 · see citing works
Public secrets in public health: Knowing not to know while making scientific knowledge
Geissler, P. W. (2013) · American Ethnologist · doi:10.1111/amet.12002 · Cited by 260 · see citing works
Beyond informed consent.
(2004) · Europe PMC (PubMed Central) · Cited by 257 · see citing works
Clinical Trials Offshored: On Private Sector Science and Public Health
Petryna, A. (2007) · BioSocieties · doi:10.1017/s1745855207005030 · Cited by 242 · see citing works
Ethics in international health research: a perspective from the developing world.
Bhutta, Z. A. (2002) · Europe PMC (PubMed Central) · Cited by 232 · see citing works
Responsible Conduct of Research
Shamoo, A. E., & Resnik, D. B. (2022) · doi:10.1093/oso/9780197547090.001.0001 · Cited by 224 · see citing works
When are research risks reasonable in relation to anticipated benefits?
Weijer, C., & Miller, P. B. W. (2004) · Nature Medicine · doi:10.1038/nm0604-570 · Cited by 215 · see citing works
Twice weekly tuberculosis preventive therapy in HIV infection in Zambia
Mwinga, A., Hosp, M., Godfrey‐Faussett, P., QUIGLEY, M. A., Mwaba, P., Mugala, B. N., Nyirenda, O. M., Luo, N. P., Pobee, J. O. M., Elliott, A. M., et al. (1998) · AIDS · doi:10.1097/00002030-199818000-00014 · Cited by 211 · see citing works
Ethical review of health research: a perspective from developing country researchers
Hyder, A. A., Wali, S., Khan, A. N., Teoh, N., KASS, N. E., & Dawson, L. (2004) · Journal of Medical Ethics · doi:10.1136/jme.2002.001933 · Cited by 205 · see citing works
Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries
Shapiro, H. T., & Meslin, E. M. (2001) · New England Journal of Medicine · doi:10.1056/nejm200107123450212 · Cited by 204 · see citing works
Justice and the Human Development Approach to International Research
London, A. J. (2005) · The Hastings Center Report · doi:10.1353/hcr.2005.0009 · Cited by 202 · see citing works
Fair Benefits for Research in Developing Countries
(2002) · Science · doi:10.1126/science.1076899 · Cited by 200 · see citing works
North-South research partnerships: the ethics of carrying out research in developing countries
Edejer, T. T.-T. (1999) · BMJ · doi:10.1136/bmj.319.7207.438 · Cited by 199 · see citing works
Trust and informed consent: insights from community members on the Kenyan coast
Molyneux, S. C., Peshu, N. M., & Marsh, K. (2005) · Social Science & Medicine · doi:10.1016/j.socscimed.2004.11.073 · Cited by 197 · see citing works
GLOBAL HEALTH ETHICS FOR STUDENTS
Pinto, A. D., & Upshur, R. E. G. (2007) · Developing World Bioethics · doi:10.1111/j.1471-8847.2007.00209.x · Cited by 189 · see citing works
The Rise of `Recruitmentology'
Epstein, S. (2008) · Social Studies of Science · doi:10.1177/0306312708091930 · Cited by 183 · see citing works
The Nuremberg Code: Hippocratic ethics and human rights
Shuster, E. (1998) · The Lancet · doi:10.1016/s0140-6736(05)60641-1 · Cited by 179 · see citing works
‘Even if they ask you to stand by a tree all day, you will have to do it (laughter)…!’: Community voices on the notion and practice of informed consent for biomedical research in developing countries
Molyneux, S. C., Wassenaar, D. R., Peshu, N. M., & Marsh, K. (2005) · Social Science & Medicine · doi:10.1016/j.socscimed.2004.12.003 · Cited by 178 · see citing works
Editorial: Popular concerns about medical research projects in sub‐Saharan Africa – a critical voice in debates about medical research ethics
Geissler, P. W., & Pool, R. (2006) · Tropical Medicine & International Health · doi:10.1111/j.1365-3156.2006.01682.x · Cited by 178 · see citing works
Investigators' Responsibilities for Human Subjects in Developing Countries
Angell, M. E. (2000) · New England Journal of Medicine · doi:10.1056/nejm200003303421309 · Cited by 175 · see citing works
Self-citation
After Helsinki: Unresolved Issues in International Research
Macklin, R. (2001) · Kennedy Institute of Ethics journal · doi:10.1353/ken.2001.0005 · Cited by 166 · see citing works
Research Misconduct in Low- and Middle-Income Countries
Ana, J., Koehlmoos, T. P., Smith, R. W., & Yan, L. L. (2013) · PLoS Medicine · doi:10.1371/journal.pmed.1001315 · Cited by 159 · see citing works
Rethinking Medical Ethics: A View From Below
Farmer, P. E. (2004) · Developing World Bioethics · doi:10.1111/j.1471-8731.2004.00065.x · Cited by 158 · see citing works
The ethics of placebo-controlled trials: Methodological justifications
Millum, J., & Grady, C. (2013) · Contemporary Clinical Trials · doi:10.1016/j.cct.2013.09.003 · Cited by 155 · see citing works
Responsibilities in international research: a new look revisited
Benatar, S. R., & SINGER, P. A. (2010) · Journal of Medical Ethics · doi:10.1136/jme.2009.032672 · Cited by 150 · see citing works
Human rights and maternal-fetal HIV transmission prevention trials in Africa.
Annas, G. J., & Grodin, M. A. (1998) · American Journal of Public Health · doi:10.2105/ajph.88.4.560 · Cited by 144 · see citing works
Preoperative Preparation Programs in Children
Kain, Z. N., Caramico, L. A., Mayes, L. C., Genevro, J., Bornstein, M. H., & Hofstadter, M. B. (1998) · Anesthesia & Analgesia · doi:10.1097/00000539-199812000-00007 · Cited by 139 · see citing works
Considerations for a phase-III trial to evaluate a group B Streptococcus polysaccharide-protein conjugate vaccine in pregnant women for the prevention of early- and late-onset invasive disease in young-infants
Madhi, S. A., Dangor, Z., Heath, P. T., Schrag, S. J., Izu, A., Meulen, A. S.-T., & Dull, P. M. (2013) · Vaccine · doi:10.1016/j.vaccine.2013.02.029 · Cited by 133 · see citing works
Imperialism, research ethics and global health.
Benatar, S. R. (1998) · Journal of Medical Ethics · doi:10.1136/jme.24.4.221 · Cited by 129 · see citing works
The medical student global health experience: professionalism and ethical implications
Shah, S., & Wu, T. C. (2008) · Journal of Medical Ethics · doi:10.1136/jme.2006.019265 · Cited by 127 · see citing works
Unraveling the Tuskegee Study of Untreated Syphilis
White, R. M. (2000) · Archives of Internal Medicine · doi:10.1001/archinte.160.5.585 · Cited by 126 · see citing works
Research at the Auction Block: Problems for the Fair Benefits Approach to International Research
London, A. J., & Zollman, K. (2010) · The Hastings Center Report · doi:10.1353/hcr.0.0281 · Cited by 124 · see citing works
Proposed Revisions to the Declaration of Helsinki — Will They Weaken the Ethical Principles Underlying Human Research?
Brennan, T. A. (1999) · New England Journal of Medicine · doi:10.1056/nejm199908123410712 · Cited by 121 · see citing works
A Theory of International Bioethics: The Negotiable and the Non-Negotiable
Baker, R. (1998) · Kennedy Institute of Ethics journal · doi:10.1353/ken.1998.0018 · Cited by 121 · see citing works
The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia
Carpenter, W. T., Appelbaum, P. S., & Levine, R. J. (2003) · American Journal of Psychiatry · doi:10.1176/appi.ajp.160.2.356 · Cited by 117 · see citing works
Treating AIDS: Dilemmas of unequal access in Uganda
Whyte, S. R., Whyte, M. A., Meinert, L., & Kyaddondo, B. (2004) · SAHARA-J Journal of Social Aspects of HIV/AIDS · doi:10.1080/17290376.2004.9724823 · Cited by 112 · see citing works
Research Ethics Capacity Building in Sub-Saharan Africa: A Review of NIH Fogarty-Funded Programs 2000–2012
Ndebele, P., Wassenaar, D. R., Benatar, S. R., Fleischer, T. E., Kruger, M., Adebamowo, C., KASS, N. E., Hyder, A. A., & Meslin, E. M. (2014) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2014.9.2.24 · Cited by 112 · see citing works
The Pharmaceutical Nexus
Petryna, A., & Klienman, A. (2006) · Duke University Press eBooks · doi:10.1215/9780822387916-001 · Cited by 112 · see citing works
Research in children: ethical and scientific aspects
Smyth, R. L., & Weindling, A. M. (1999) · The Lancet · doi:10.1016/s0140-6736(99)90253-2 · Cited by 111 · see citing works
Informed Consent in International Health Research
Marshall, P. A. (2006) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2006.1.1.25 · Cited by 110 · see citing works
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 109 · see citing works
Health Research Ethics Committees in South Africa 12 years into democracy
Moodley, K., & Myer, L. (2007) · BMC Medical Ethics · doi:10.1186/1472-6939-8-1 · Cited by 105 · see citing works
The ethics of research related to health care in developing countries
McMillan, J. R., & Conlon, C. P. (2004) · Journal of Medical Ethics · doi:10.1136/jme.2002.001263 · Cited by 105 · see citing works
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 · see citing works
The Body Hunters: Testing New Drugs on the World`s Poorest Patients
Shah, S., & Carré, J. L. (2007) · Cited by 102 · see citing works
The standard of care debate: the Declaration of Helsinki versus the international consensus opinion: Table 1
Lie, R. K., Emanuel, E. J., Grady, C., & Wendler, D. S. (2004) · Journal of Medical Ethics · doi:10.1136/jme.2003.006031 · Cited by 102 · see citing works
The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?
Forster, H. P., Emanuel, E. J., & Grady, C. (2001) · The Lancet · doi:10.1016/s0140-6736(01)06534-5 · Cited by 99 · see citing works
The Ambiguity and the Exigency: Clarifying 'Standard of Care' Arguments in International Research
London, A. J. (2000) · The Journal of Medicine and Philosophy A Forum for Bioethics and Philosophy of Medicine · doi:10.1076/0360-5310(200008)25:4;1-a;ft379 · Cited by 97 · see citing works
A Model Agreement for Genetic Research in Socially Identifiable Populations
Foster, M. W., Bernsten, D., & Carter, T. H. (1998) · The American Journal of Human Genetics · doi:10.1086/302013 · Cited by 96 · see citing works
Ethical Review of Global Short-Term Medical Volunteerism
DeCamp, M. W. (2011) · HEC Forum · doi:10.1007/s10730-011-9152-y · Cited by 94 · see citing works
Exporting ethics: a narrative about narrative research in South India
Riessman, C. K. (2005) · Health An Interdisciplinary Journal for the Social Study of Health Illness and Medicine · doi:10.1177/1363459305056414 · Cited by 93 · see citing works
The debate over maternal-fetal HIV transmission prevention trials in Africa, Asia, and the Caribbean: racist exploitation or exploitation of racism?
Bayer, R. (1998) · American Journal of Public Health · doi:10.2105/ajph.88.4.567 · Cited by 90 · see citing works
Principlism, medical individualism, and health promotion in resource-poor countries: can autonomy-based bioethics promote social justice and population health?
Azétsop, J., & Rennie, S. (2010) · Philosophy Ethics and Humanities in Medicine · doi:10.1186/1747-5341-5-1 · Cited by 90 · see citing works
Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia
Osrin, D., Azad, K., Fernandez, A., Manandhar, D. S., Mwansambo, C. W., Tripathy, P., & Costello, A. M. D. L. (2009) · Bulletin of the World Health Organization · doi:10.2471/blt.08.051060 · Cited by 86 · see citing works
Evidence based medicine: concerns of a clinical neurologist
Caplan, L. R. (2001) · Journal of Neurology Neurosurgery & Psychiatry · doi:10.1136/jnnp.71.5.569 · Cited by 88 · see citing works
Placebo-Associated Blood Pressure Response and Adverse Effects in the Treatment of Hypertension
Preston, R. A., Materson, B. J., Reda, D. J., & Williams, D. W. (2000) · Archives of Internal Medicine · doi:10.1001/archinte.160.10.1449 · Cited by 2 · see citing works
INFORMED CONSENT AND COLLABORATIVE RESEARCH: PERSPECTIVES FROM THE DEVELOPING WORLD
Hyder, A. A., & Wali, S. (2006) · Developing World Bioethics · doi:10.1111/j.1471-8847.2006.00134.x · Cited by 87 · see citing works
Pharmaceutical Governance
Biehl, J. G. (2006) · Duke University Press eBooks · doi:10.1215/9780822387916-008 · Cited by 94 · see citing works
A Summary of Important Documents in the Field of Research Ethics
Fischer, B. A. (2005) · Schizophrenia Bulletin · doi:10.1093/schbul/sbj005 · Cited by 86 · see citing works
Declaration of Helsinki should be strengthened
Lilford, R. J., & Djulbegović, B. (2001) · BMJ · doi:10.1136/bmj.322.7281.299/a · Cited by 86 · see citing works
Masks and respirators for prevention of respiratory infections: a state of the science review
Greenhalgh, T., MacIntyre, C. R., Baker, M. G., Bhattacharjee, S., Chughtai, A. A., Fisman, D. N., Kunasekaran, M. P., Kvalsvig, A., Lupton, D. A., Oliver, M., et al. (2024) · Clinical Microbiology Reviews · doi:10.1128/cmr.00124-23 · Cited by 103 · see citing works
Can rigorous impact evaluations improve humanitarian assistance?
Puri, J., Aladysheva, A., Iversen, V., Ghorpade, Y., & Brück, T. (2017) · Journal of Development Effectiveness · doi:10.1080/19439342.2017.1388267 · Cited by 84 · see citing works
Toward a New Common Sense
Bakker, I., Gill, S. R., & Wamsley, D. (2021) · Cambridge University Press eBooks · doi:10.1017/9781108692137.040 · Cited by 83 · see citing works
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 · see citing works
PROTECTING COMMUNITIES IN HEALTH RESEARCH FROM EXPLOITATION
Gbadegesin, S., & Wendler, D. S. (2006) · Bioethics · doi:10.1111/j.1467-8519.2006.00501.x · Cited by 80 · see citing works
Globalizing Human Subjects Research
Petryna, A. (2006) · Duke University Press eBooks · doi:10.1215/9780822387916-002 · Cited by 78 · see citing works
Adverse events and placebo effects: African scientists, HIV, and ethics in the ‘global health sciences’
Crane, J. T. (2010) · Social Studies of Science · doi:10.1177/0306312710371145 · Cited by 77 · see citing works
Informed consent comprehension in A frican research settings
Afolabi, M. O., Okebe, J., McGrath, N. M., Larson, H. J., Bojang, K., & Chandramohan, D. (2014) · Tropical Medicine & International Health · doi:10.1111/tmi.12288 · Cited by 77 · see citing works
The Ethics of International Research with Abandoned Children
Millum, J., & Emanuel, E. J. (2007) · Science · doi:10.1126/science.1153822 · Cited by 75 · see citing works
The Human Right to Health
Wolff, J. (2011) · Cambridge University Press eBooks · doi:10.1017/9781108692137.008 · Cited by 75 · see citing works
Developing World Bioethics
Resnik, D. B. (2012) · Elsevier eBooks · doi:10.1016/b978-0-12-373932-2.00029-6 · Cited by 74 · see citing works
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 · see citing works
Ethical Oversight of Public Health Research: Can Rules and IRBs Make a Difference in Developing Countries?
London, L., & Health), (. (2002) · American Journal of Public Health · doi:10.2105/ajph.92.7.1079 · Cited by 70 · see citing works
Globalized Clinical Trials and Informed Consent
Annas, G. J. (2009) · New England Journal of Medicine · doi:10.1056/nejmp0901474 · Cited by 69 · see citing works
The ethics of New Development Economics: is the Experimental Approach to Development Economics morally wrong?
Baele, S. J. (2013) · The Journal of Philosophical Economics · doi:10.46298/jpe.10653 · Cited by 68 · see citing works
The declaration of Helsinki: The cornerstone of research ethics
Bosnjak, S. M. (2001) · Archive of oncology · Cited by 68 · see citing works
Pharmaceuticals in Urban Ecologies
Das, V., & Das, R. (2006) · Duke University Press eBooks · doi:10.1215/9780822387916-007 · Cited by 68 · see citing works
Should structural interventions be evaluated using RCTs? The case of HIV prevention
Bonell, C. P., Hargreaves, J., Strange, V., Pronyk, P., & Porter, J. (2006) · Social Science & Medicine · doi:10.1016/j.socscimed.2006.03.026 · Cited by 68 · see citing works

Authors: Angell, M.
Corresponding author: Angell, Marcia
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 1997-09-18
Volume: 337
Issue: 12
Pages: 847-849
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm199709183371209
OpenAlex: W2062146075
Cited by: 863
References: 31
Citations by year: 2026: 6 · 2025: 8 · 2024: 28 · 2023: 18 · 2022: 32 · 2021: 63 · 2020: 19 · 2019: 13 · 2018: 12 · 2017: 20 · 2016: 25 · 2015: 26 · 2014: 45 · 2013: 32 · 2012: 27
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 › Medicine › Physiology › Biomedical Ethics and Regulation
Keywords: clinical research ethics, randomized controlled trials, equipoise, developing countries, research participant protection
MeSH terms: Clinical Trials as Topic, Developing Countries, Ethics, Medical, Humans, Informed Consent, Placebos, Tuberculosis, Pulmonary, United States, United States Public Health Service, HIV Infections, AIDS-Related Opportunistic Infections, Ethical Review, Moral Obligations, Withholding Treatment, Ethical Relativism, Codes of Ethics, Control Groups, Editorial Policies, Research Subjects, Therapeutic Human Experimentation, Pregnant Women, Pregnant People, 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

The Ethics of Clinical Research in the Third World

Abstract

Integrity signals

Claims the paper makes

Claims other papers make about this one

Cites

Cited by

Related

Record

About these checks