Download this Paper Open PDF in Browser

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

Jonathan Kimmelman

McGill University - BioMedical Ethics Unit

Trudo Lemmens

University of Toronto - Faculty of Law

Scott Y. Kim

National Institutes of Health; University of Michigan at Ann Arbor

Date Written: July 3, 2013

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.

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

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: https://ssrn.com/abstract=2289173

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 )

500 S. State Street
Ann Arbor, MI 48109
United States

National Institutes of Health ( email )

Warren G. Magnuson Clinical Center
Bethesda, MD 20895-1156
United States

Paper statistics

Downloads
52
Rank
325,426
Abstract Views
454