Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures
IRB: Ethics and Human Research 34(5) Sept-Oct 2012, 1-7
7 Pages Posted: 6 Jul 2013 Last revised: 17 Nov 2015
Date Written: July 3, 2013
A growing number of clinical trials use invasive research procedures for screening patients, monitoring the effects of drugs, biomarker analysis, or sham comparators. These procedures can be ethically contentious, in part because of concerns about the quality of informed consent provided by patient-volunteers. In the first section of this paper, we describe burdens, risks, and benefits associated with certain common invasive, research procedures. We next offer a series of arguments about the general properties of a valid consent for such procedures. We close by examining what is currently known about consent quality for invasive research procedures against the standards laid out in the second section. We conclude that there is little evidence to either confirm or dispel concerns about consent quality for invasive, nondiagnostic research procedures applied in patient-volunteers.
Keywords: informed consent, research involving humans, research ethics, nondiagnostic research procedures, consent validity, research risks
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