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C. Auerbach, L. Silverstein (2003)
Qualitative Data: An Introduction to Coding and Analysis
D. Guenter, J. Esparza, R. Macklin (2000)
Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS)Journal of Medical Ethics, 26
H. Richardson, L. Belsky (2004)
The ancillary-care responsibilities of medical researchers. An ethical framework for thinking about the clinical care that researchers owe their subjects.The Hastings Center report, 34 1
Kwaku Asante, C. Agyemang, Charles Zandoh, Jacob Saah, L. Febir, Casimir Donlebo, S. Owusu-Agyei (2013)
Community engagement in biomedical research in an African setting: the Kintampo Health Research Centre experienceBMC Health Services Research, 13
Edwin Liheluka, J. Lusingu, R. Manongi (2013)
Community perceptions on the secondary health benefits established by malaria vaccine trials (RTS,S phase 2 and phase 3) at the Korogwe site in North Eastern TanzaniaMalaria Journal, 12
(2015)
Clinical Trials Partnership
Daniel Tarantola, Ruth Macklin, Z. Reed, Marie-Paule Kieny, Saladin Osmanov, M. Stobie, Catherine Hankins (2007)
Ethical considerations related to the provision of care and treatment in vaccine trials.Vaccine, 25 26
J. Breault, M. Miceli (2016)
Bioethics in Practice: Therapeutic Misconception.The Ochsner journal, 16 4
C. Krubiner, Raafay Syed, M. Merritt (2015)
Health Researchers' Ancillary-Care Responsibilities in Low-Resource Settings: The Landscape of Institutional Guidance.IRB, 37 3
J. Delden, R. Graaf (2017)
Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans.JAMA, 317 2
(2012)
Ethics Working Group of the HIV Prevention Trials Network
Bridget Pratt, D. Zion, K. Lwin., P. Cheah, F. Nosten, B. Loff (2013)
Ancillary Care: From Theory to Practice in International Clinical ResearchPublic Health Ethics, 6
B. Keraita, F. Konradsen, P. Drechsel, R. Abaidoo (2007)
Reducing microbial contamination on wastewater‐irrigated lettuce by cessation of irrigation before harvestingTropical Medicine & International Health, 12
(2005)
Undue inducement: Nonsense on stilts? American Journal of Bioethics, 5(5), 9-13
(2013)
Experience and challenges
E. Emanuel (2004)
Ending Concerns about Undue InducementThe Journal of Law, Medicine & Ethics, 32
T. Lang, G. Kokwaro (2008)
Malaria drug and vaccine trials in Africa: obstacles and opportunities.Transactions of the Royal Society of Tropical Medicine and Hygiene, 102 1
B. Haire, C. Jordens (2013)
Standard of Prevention in the Real World: A Qualitative Study of Principal Investigators in HIV Biomedical Prevention TrialsAJOB Primary Research, 4
(2019)
Council for International Organizations of Medical SciencesCobert's Manual of Drug Safety and Pharmacovigilance
S. Molyneux, Dorcas Kamuya, T. Chantler (2013)
FIELD WORKERS AT THE INTERFACEDeveloping World Bioethics, 13
Vibian Angwenyi, K. Asante, A. Traore, L. Febir, C. Tawiah, Anthony Kwarteng, A. Ouédraogo, S. Sirima, S. Owusu-Agyei, E. Imoukhuede, J. Webster, D. Chandramohan, S. Molyneux, Caroline Jones (2015)
Health Providers’ Perceptions of Clinical Trials: Lessons from Ghana, Kenya and Burkina FasoPLoS ONE, 10
L. Febir, Kwaku Asante, Dan-Bright Dzorgbo, K. Senah, T. Letsa, S. Owusu-Agyei (2013)
Community perceptions of a malaria vaccine in the Kintampo districts of GhanaMalaria Journal, 12
A. Wertheimer (2012)
Exploitation in Clinical Research
H. Tinto, I. Valéa, H. Sorgho, M. Tahita, Maminata Traoré, Biébo Bihoun, I. Guiraud, H. Kpoda, J. Rouamba, S. Ouédraogo, P. Lompo, S. Yara, W. Kaboré, J. Ouédraogo, R. Guiguemdé, F. Binka, B. Ogutu (2014)
The impact of clinical research activities on communities in rural Africa: the development of the Clinical Research Unit of Nanoro (CRUN) in Burkina FasoMalaria Journal, 13
Wim Pinxten, R. Ravinetto, A. Buvé (2016)
Never Look a Gift Horse in the Mouth? Four Reasons Not to Blur the Line Between Research and Care in Low- and Middle-Income CountriesThe American Journal of Bioethics, 16
P. Kingori (2015)
The ‘empty choice’: A sociological examination of choosing medical research participation in resource-limited Sub-Saharan AfricaCurrent Sociology. La Sociologie Contemporaine, 63
D. Resnik (2003)
Exploitation in Biomedical ResearchTheoretical Medicine and Bioethics, 24
M. Angell (1997)
The ethics of clinical research in the Third World.The New England journal of medicine, 337 12
E. Emanuel, Xolani Currie, A. Herman (2005)
Undue inducement in clinical research in developing countries: is it a worry?The Lancet, 366
N. Padian, A. Buvé, J. Balkus, D. Serwadda, W. Cates (2008)
HIV Prevention 2 Biomedical interventions to prevent HIV infection: evidence, challenges, and way forward
K. Weigmann (2015)
The ethics of global clinical trialsEMBO reports, 16
Dorcas Kamuya, V. Marsh, P. Njuguna, Patrick Munywoki, M. Parker, S. Molyneux (2014)
“When they see us, it’s like they have seen the benefits!”: experiences of study benefits negotiations in community-based studies on the Kenyan CoastBMC Medical Ethics, 15
G. Aellah, T. Chantler, P. Geissler (2016)
Global Health Research in an Unequal World: Ethics Case Studies from Africa
J. Mfutso-Bengo, P. Ndebele, Vincent Jumbe, Matilda Mkunthi, F. Masiye, S. Molyneux, M. Molyneux (2008)
Why do individuals agree to enrol in clinical trials? A qualitative study of health research participation in Blantyre, Malawi.Malawi medical journal : the journal of Medical Association of Malawi, 20 2
M. Njue, Francis Kombe, Salim Mwalukore, S. Molyneux, V. Marsh (2014)
What Are Fair Study Benefits in International Health Research? Consulting Community Members in KenyaPLoS ONE, 9
Isolide Massawe, J. Lusingu, R. Manongi (2014)
Community perception on biomedical research: A case study of malariometric survey in Korogwe District, Tanga Region, TanzaniaBMC Public Health, 14
Sam Horng, C. Grady (2003)
Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism.IRB, 25 1
P. Lurie, S. Wolfe (1997)
Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries.The New England journal of medicine, 337 12
Nate Olson (2014)
Conceptualizing Ancillary Care Obligations in Health Systems ResearchThe American Journal of Bioethics, 14
F. Miller, H. Brody (2003)
A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials.The Hastings Center report, 33 3
K. Shapiro, S. Benatar (2005)
HIV prevention research and global inequality: steps towards improved standards of care*Journal of Medical Ethics, 31
G. Mwangoka, B. Ogutu, B. Msambichaka, Tutu Mzee, N. Salim, Shubi Kafuruki, Maxmillian Mpina, S. Shekalaghe, M. Tanner, S. Abdulla (2013)
Experience and challenges from clinical trials with malaria vaccines in AfricaMalaria Journal, 12
R. Ravinetto, A. Talisuna, M. Crop, H. Loen, J. Menten, C. Overmeir, H. Tinto, R. González, M. Meremikwu, Carolyn Nabasuma, G. Ngoma, C. Karema, Yeka Adoke, M. Chaponda, J. Geertruyden, U. d’Alessandro (2013)
Challenges of non‐commercial multicentre North‐South collaborative clinical trialsTropical Medicine & International Health, 18
J. Vekemans, K. Marsh, B. Greenwood, Amanda Leach, W. Kaboré, S. Soulanoudjingar, Kwaku Asante, D. Ansong, Jennifer Evans, J. Sacarlal, P. Bejon, P. Kamthunzi, N. Salim, P. Njuguna, M. Hamel, W. Otieno, S. Gesase, D. Schellenberg (2011)
Assessment of severe malaria in a multicenter, phase III, RTS, S/AS01 malaria candidate vaccine trial: case definition, standardization of data collection and patient careMalaria Journal, 10
M. Merritt, H. Taylor, L. Mullany (2010)
Ancillary care in community-based public health intervention research.American journal of public health, 100 2
S. Jaffar, B. Amuron, J. Birungi, Geoffrey Namara, C. Nabiryo, A. Coutinho, H. Grosskurth (2008)
Integrating research into routine service delivery in an antiretroviral treatment programme: lessons learnt from a cluster randomized trial comparing strategies of HIV care in Jinja, UgandaTropical Medicine & International Health, 13
L. Belsky, H. Richardson (2004)
Medical researchers' ancillary clinical care responsibilitiesBMJ : British Medical Journal, 328
E. Emanuel (2005)
Undue Inducement: Nonsense on Stilts?The American Journal of Bioethics, 5
T. Lang, Jayne Gould, L. Seidlein, J. Lusingu, S. Mshamu, S. Ismael, Edwin Liheluka, Dorcas Kamuya, D. Mwachiro, A. Olotu, P. Njuguna, P. Bejon, V. Marsh, C. Molyneux (2012)
Approaching the community about screening children for a multicentre malaria vaccine trial.International health, 4 1
(2015)
Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: Final results of a phase 3, individually randomised, controlled trial. The Lancet
N. Padian, A. Buvé, J. Balkus, D. Serwadda, W. Cates (2008)
Biomedical interventions to prevent HIV infection: evidence, challenges, and way forwardThe Lancet, 372
J. Mfutso-Bengo, L. Manda-Taylor, F. Masiye (2015)
Motivational Factors for Participation in Biomedical ResearchJournal of Empirical Research on Human Research Ethics, 10
D. Wendler, E. Emanuel, R. Lie (2004)
The standard of care debate: can research in developing countries be both ethical and responsive to those countries' health needs?American journal of public health, 94 6
S. Benatar, P. Singer (2010)
Responsibilities in international research: a new look revisitedJournal of Medical Ethics, 36
Vibian Angwenyi, Dorcas Kamuya, D. Mwachiro, Betty Kalama, V. Marsh, P. Njuguna, S. Molyneux (2014)
Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, KenyaTrials, 15
Organização Saúde (2011)
World malaria report 2011
M. Merritt, J. Katz, R. Mojtabai, K. West (2016)
Referral of Research Participants for Ancillary Care in Community-Based Public Health Intervention Research: A Guiding FrameworkPublic Health Ethics, 9
V. Lema (2010)
Therapeutic misconception and clinical trials in sub-Saharan Africa: a review.East African medical journal, 86 6
G. Henderson, L. Churchill, Arlene Davis, M. Easter, C. Grady, S. Joffe, N. Kass, N. King, C. Lidz, F. Miller, Daniel Nelson, J. Peppercorn, B. Rothschild, P. Sankar, B. Wilfond, C. Zimmer (2007)
Clinical Trials and Medical Care: Defining the Therapeutic MisconceptionPLoS Medicine, 4
Christiane, Druml, Wolzt, Pleiner (2000)
World Medical Association Declaration of HelsinkiInternational Journal of Pharmaceutical Medicine, 14
(2007)
Obligations to research participants and to communities in developing countries
J. Katz (1993)
Human experimentation and human rights.Saint Louis University law journal, 38 1
J. Lusingu, A. Olotu, A. Leach, M. Lievens, J. Vekemans, A. Olivier, Sarah, Benns, R. Olomi, Salum Msham, T. Lang, Jayne Gould, Karin Hallez, Yolanda Guerra, P. Njuguna, Ken Awuondo, Anangisye Malabeja, O. Abdul, S. Gesase, Denise, Dekker, Lincoln Malle, S. Ismael, N. Mturi, C. Drakeley, B. Savarese, Tonya, Villafana, W. Ballou, Joe Cohen, E. Riley, M. Lemnge, K. Marsh, Philip, Bejon, L. Seidlein (2010)
Safety of the Malaria Vaccine Candidate, RTS,S/AS01E in 5 to 17 Month Old Kenyan and Tanzanian ChildrenPLoS ONE, 5
A. London (2000)
The ambiguity and the exigency: clarifying 'standard of care' arguments in international research.The Journal of medicine and philosophy, 25 4
N. Homedes, A. Ugalde (2015)
Availability and affordability of new medicines in Latin American countries where pivotal clinical trials were conductedBulletin of the World Health Organization, 93
A. Hyder, M. Merritt (2009)
Ancillary care for public health research in developing countries.JAMA, 302 4
A. Denburg, C. Rodríguez-Galindo, S. Joffe (2016)
Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income CountriesThe American Journal of Bioethics, 16
A. Vallely, C. Shagi, S. Lees, K. Shapiro, J. Masanja, L. Nikolau, J. Kazimoto, S. Soteli, Claire Moffat, J. Changalucha, S. McCormack, R. Hayes (2009)
Microbicides Development Programme: Engaging the community in the standard of care debate in a vaginal microbicide trial in Mwanza, TanzaniaBMC Medical Ethics, 10
Marion Kalabuanga, R. Ravinetto, V. Maketa, Hypolite Mavoko, Blaise Fungula, R. Luz, J. Geertruyden, P. Lutumba (2016)
The Challenges of Research Informed Consent in Socio-Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo.Developing world bioethics, 16 2
A. London, David Borasky, A. Bhan (2012)
Improving Ethical Review of Research Involving Incentives for Health PromotionPLoS Medicine, 9
Article 113
R. Ravinetto, M. Afolabi, J. Okebe, J. Nuil, P. Lutumba, H. Mavoko, A. Nahum, H. Tinto, A. Addissie, U. d’Alessandro, K. Grietens (2015)
Participation in medical research as a resource‐seeking strategy in socio‐economically vulnerable communities: call for research and actionTropical Medicine & International Health, 20
Kwaku Asante, Caroline Jones, S. Sirima, S. Molyneux (2016)
Clinical Trials Cannot Substitute for Health System Strengthening Initiatives or Specifically Designed Health Policy and Systems ResearchThe American journal of bioethics : AJOB, 16
C. Ward, D. Shaw, E. Anane-Sarpong, O. Sankoh, M. Tanner, B. Elger (2017)
Defining Health Research for Development: The perspective of stakeholders from an international health research partnership in Ghana and Tanzania.Developing world bioethics, 18 4
R. Brownsword, Allegra Cermak, R. Chaisson, Michael Clayman, Peter Corr, Stephen DeCherney, Christine Grady, Elizabeth Higgs, Nandini Kumar, Reidar Lie, Maria Merritt, M. Molyneux, Beyene Petros, Henry Richardson, Jeremy Sugarman (2008)
The Ancillary-Care Obligations of Medical Researchers Working in Developing CountriesPLoS Medicine, 5
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.
Journal of Empirical Research on Human Research Ethics – SAGE
Published: Feb 1, 2018
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