Cited by 20Ethics in Clinical ResearchSurvey Methodology and NonresponsePharmaceutical industry and healthcare

Ethical challenges in designing and conducting medicine quality surveys

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Tabernero, Patricia, Parker, Michael, Ravinetto, Raffaella, Phanouvong, Souly, Yeung, Shunmay, Kitutu, Freddy E., Cheah, Phaik Yeong, Mayxay, Mayfong +2 more·2016·Tropical Medicine & International Health

Abstract

Objectives: 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. Method: 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. Results and conclusions: 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.

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  1. [46]WHO. Standards and Operational Guidance for Ethics Review of Health‐Related Research with Human Participants, 2011 (Available from: http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf) [24 March 2014]. 26269877

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Authors
Tabernero, P., Parker, M., Ravinetto, R., Phanouvong, S., Yeung, S., Kitutu, F. E., Cheah, P. Y., Mayxay, M., Guerin, P. J., & Newton, P. N.
Affiliations
  • University of Oxford (GB)
  • Instituut voor Tropische Geneeskunde (BE)
  • United States Pharmacopeial Convention (US)
  • London School of Hygiene & Tropical Medicine (GB)
  • Uppsala University (SE)
  • Mahidol University (TH)
Corresponding author
  • Tabernero, Patricia
  • Newton, Paul N.
Venue
Tropical Medicine & International Health
Publisher
Wiley
Published
2016-05-20
Volume
21
Issue
6
Pages
799-806
ISSN
  • 1360-2276 (ISSN-L)
  • 1365-3156
OpenAlex
W2338288166
Cited by
20
References
40
Citations by year
2024: 1 · 2023: 2 · 2022: 3 · 2021: 7 · 2019: 2 · 2018: 3 · 2017: 2
FWCI
2.31
Type
journal article
Language
en
Open access
Locations
  • Tropical Medicine & International Health (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
  • KTH Publication Database DiVA (KTH Royal Institute of Technology) (submittedVersion, other-oa)
  • Greater South Information System
Funders
Wellcome Trust
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Social Sciences › Sociology and Political Science › Survey Methodology and Nonresponse
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords
research ethics, drug quality, access to medicines, privacy and confidentiality, informed consent, research ethics approval
MeSH terms
Pharmaceutical Preparations, Humans, Surveys and Questionnaires, Vaccines, Ethics, Research

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