Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures

A growing number of clinical trials use invasive research procedures to obtain tissue for disease screening and to monitor the effects of drugs. These procedures can be ethically contentious because they often have neither therapeutic nor diagnostic value, and because research participants may not realize this, which could compromise the validity of their consent to the procedure. In the first section of this paper, we describe the burdens, risks, and benefits associated with certain common invasive, nondiagnostic research procedures. We next offer a series of arguments about the general properties of a valid consent for such procedures, and we close by examining what is currently known about consent quality for invasive research procedures when measured against the standards laid out in the second section. We conclude that there is little evidence to either confirm or dispel concerns about participants’ consent quality for protocols involving invasive, nondiagnostic research procedures.

Key words/concepts: human subjects research; research ethics; informed consent; risk/benefit assessment; invasive, nondiagnostic research procedures; comprehension; voluntariness; authenticity

Jonathan Kimmelman, Trudo Lemmens, and Scott Y.H. Kim, “Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures,” IRB: Ethics & Human Research 34, no. 5 (2012): 1-7.