Abstract

http://ssrn.com/abstract=2289173
 


 



Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures


Jonathan Kimmelman


McGill University - BioMedical Ethics Unit

Trudo Lemmens


University of Toronto - Faculty of Law

Scott Y. Kim


University of Michigan at Ann Arbor

July 3, 2013

IRB: Ethics and Human Research 34(5) Sept-Oct 2012, 1-7

Abstract:     
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.

Number of Pages in PDF File: 7

Keywords: informed consent, research involving humans, research ethics, nondiagnostic research procedures, consent validity, research risks

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Date posted: July 6, 2013 ; Last revised: July 7, 2013

Suggested Citation

Kimmelman, Jonathan and Lemmens, Trudo and Kim, Scott Y., Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures (July 3, 2013). IRB: Ethics and Human Research 34(5) Sept-Oct 2012, 1-7. Available at SSRN: http://ssrn.com/abstract=2289173

Contact Information

Jonathan Kimmelman (Contact Author)
McGill University - BioMedical Ethics Unit ( email )
3647 Peel Street
Montreal, Quebec H3A 1X1
Canada
Trudo Lemmens
University of Toronto - Faculty of Law ( email )
78 and 84 Queen's Park
Toronto, Ontario M5S 2C5
Canada
Scott Y. Kim
University of Michigan at Ann Arbor ( email )
701 Tappan St. Rm E2600
Ann Arbor, MI 48109
United States
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