How ethical is your clinical trial?

Is Institutional Review Board (IRB) approval and a rigorous informed consent process enough? It is our view that this is no longer the case. Conventional research ethics emphasise the importance of weighing the risks and benefits for prospective participants as one of the key determinants of deeming...

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Published inInternational journal of clinical practice (Esher) Vol. 64; no. 9; pp. 1179 - 1182
Main Authors Miller, L., Folayan, M., Allman, D., Nkala, B., Kasirye, L. M., Mingote, L. R., Calazans, G., Mburu, R., Ntombela, F., Ditmore, M.
Format Journal Article
LanguageEnglish
Published Oxford, UK Blackwell Publishing Ltd 01.08.2010
Wiley-Blackwell
Hindawi Limited
Subjects
Biological and medical sciences
Clinical Trials as Topic - ethics
Ethics
Ethics, Research
General aspects
Informed Consent - ethics
Medical sciences
Public health. Hygiene
Public health. Hygiene-occupational medicine
Teaching. Deontology. Ethics. Legislation
Medicine
Ethics
Clinical trial
Public health
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Summary:Is Institutional Review Board (IRB) approval and a rigorous informed consent process enough? It is our view that this is no longer the case. Conventional research ethics emphasise the importance of weighing the risks and benefits for prospective participants as one of the key determinants of deeming a clinical trial ethical. We support the notion that ethical obligations of research should include considerations not only at the individual level, but also at the community level ( 1 , 2 ).
Bibliography:ArticleID:IJCP2421
istex:98C3D5FCE5F36CA5AFACFBF0D250B7DB3CEC06EC
ark:/67375/WNG-GSK84VWX-G
http://www3.interscience.wiley.com/authorresources/onlineopen.html
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Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://www3.interscience.wiley.com/authorresources/onlineopen.html
ISSN:1368-5031
1742-1241
DOI:10.1111/j.1742-1241.2010.02421.x