Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures

Jonathan Kimmelman; Trudo Lemmens and Scott Y.H. Kim

Disclosures

IRB. 2012;34(5):1-7. 

In This Article

Abstract and Introduction

Introduction

A growing number of clinical trials use invasive, nondiagnostic research procedures to obtain tissue for disease screening or to monitor the effects of drugs. This is best documented in cancer studies, where a larger proportion of early-phase trials collect tumor tissue through research biopsies.[1] Between 1991 and 1992, a quarter of phase I cancer trials involved analysis of tumor tissue.[2] Because these procedures often have neither therapeutic nor diagnostic value for research participants, using them in the research context is ethically contentious.

Some commentators worry that invasive, nondiagnostic research procedures are of insufficient scientific value to justify the burden and risk to research participants.[3] Others have concerns about the validity of informed consent if patients participating in research erroneously believe that invasive research procedures have therapeutic value.[4]

In this article we analyze concerns about informed consent for clinical trials that include invasive, nondiagnostic research procedures. In the first section, we situate our analysis by describing the burdens, risks, and benefits of invasive, nondiagnostic research procedures. In section two, we offer arguments about the properties of a valid consent to these procedures. We close by examining what is currently known about consent to these procedures and compare it to the standards we describe in the second section. Our analysis provides a set of points to consider for institutional review boards (IRBs), investigators, and others who have responsibilities related to the consent process for studies that include invasive, nondiagnostic research procedures. It is also meant to inform the design of studies that assess informed consent to these procedures.

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