Ethical challenges in designing and conducting medicine quality surveys.
In this paper we discuss the main ethical challenges related to the conduct of medicine quality surveys and make suggestions on how to address them.



Most evidence-based information regarding medicine quality derives from surveys. However, existing research ethical guidelines do not provide specific guidance for medicine quality surveys. Hence, those conducting surveys are often left wondering how to judge what counts as best practice. A list of the main ethical challenges in the design and conduct of surveys is presented.



It is vital that the design and conduct of medicine quality surveys uphold moral and ethical obligations and analyse the ethical implications and consequences of such work. These aspects include the impact on the local availability of and access to medicines; the confidentiality and privacy of the surveyors and the surveyed; questions as to whether outlet staff personnel should be told they are part of a survey; the need of ethical and regulatory approvals; and how the findings should be disseminated. Medicine quality surveys should ideally be conducted in partnership with the relevant national Medicine Regulatory Authorities. An international, but contextually sensitive, model of good ethical practice for such surveys is needed.
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Mahosot Hospital, Vientiane, Lao PDR.|WorldWide Antimalarial Resistance Network, Oxford, UK.|Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, UK.
Patricia
P
Tabernero
The Ethox Centre, University of Oxford, Oxford, UK.
Michael
M
Parker
Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.|Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.
Raffaella
R
Ravinetto
United States Pharmacopeia, Promoting the Quality of Medicines Program, United States Pharmacopeial Convention, Rockville, MD, USA.
Souly
S
Phanouvong
Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.
Shunmay
S
Yeung
Pharmacy Department and School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda.|International Maternal and Child Health Unit, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Freddy E
FE
Kitutu
Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, UK.|The Ethox Centre, University of Oxford, Oxford, UK.|Mahidol Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.
Phaik Yeong
PY
Cheah
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Mahosot Hospital, Vientiane, Lao PDR.|Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, UK.|Faculty of Postgraduate Studies, University of Health Sciences, Vientiane, Lao PDR.
Mayfong
M
Mayxay
WorldWide Antimalarial Resistance Network, Oxford, UK.|Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, UK.
Philippe J
PJ
Guerin
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Mahosot Hospital, Vientiane, Lao PDR.|WorldWide Antimalarial Resistance Network, Oxford, UK.|Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, UK.|Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
Paul N
PN
Newton
D032984:Ethics, Research; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D011795:Surveys and Questionnaires; D014612:Vaccines / Q000592:standards*
D004364:Pharmaceutical Preparations; D014612:Vaccines
contrefaçon; counterfeit; encuestas; ethics; falsificación; falsified and substandard medicines; mala calidad; mauvaise qualité; medicamentos; medicamentos falsificados y subestándar; medicines; médicaments; médicaments falsifiés et de qualité inférieure; poor quality; surveillances; surveys; éthique; ética