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Satalkar, Priya
Satalkar, Priya
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n201csr55.html.pdf
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"This particular observational study, to understand the progression of cervical dysplasia to malignancy, was expected to guide a national cervical cancer control programme in resource-constrained settings in a south Asian country in the 1970s. In the absence of conclusive scientific evidence that could adequately predict the progression of cervical lesions to cancer, such research was justified, rather commended, for it promised the rational use of available resources to detect and treat cancers in a timely fashion. Nonetheless, we can discuss a number of ethical issues in this study, ranging from informed consent and the standard of care to researchers’ responsibility towards research participants at the end of a study and the role of external study monitors. It must be noted that most of these issues have been debated extensively in the context of experimental study designs, particularly RCTs, and standards established (2). Can we apply the same standards to an observational study? I argue that irrespective of the nature of the study design, one must aim for the highest ethical standards for any research that involves human subjects and I elaborate my reasons below."(pg 53)
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2012-01
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