Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation

IRB: Ethics & Human Research 2014;36(3):9-15

7 Pages Posted: 13 May 2014

See all articles by Roberto Abadie

Roberto Abadie

CUNY, John Jay College of Criminal Justice

Jonathan Kimmelman

McGill University - BioMedical Ethics Unit

Josiane Lafleur

McGill University

Trudo Lemmens

University of Toronto - Faculty of Law

Date Written: May 11, 2014

Abstract

Research biopsies involve nontrivial burdens, complication risk, and often have no clinical value for subjects. However, little is known about the motivations and consent quality for patients enrolling in such studies- especially outside the context of drug trials. This paper discusses the findings of 10 semi-structured interviews of patients, conducted months after they participated in biomarker studies involving nondiagnostic breast tumor biopsies. Subjects recalled being primarily motivated by altruism, and adequately understood the nontherapeutic nature of research biopsies. Many recalled burdens as modest to minimal. Nevertheless, subjects were generally disengaged from study objectives, and recounted being distracted by recent medical events during the consent process. In addition, two subjects described biopsies as very burdensome. The findings of this study suggest that, at least in recall, subjects are capable of distinguishing care and research procedures, and comprehending research burdens. However, subjects’ detachment from study objectives, and their emotional turmoil during consent, point to limitations in the consent process.

Keywords: Informed consent, clinical research, biopsy, oncology, therapeutic misconception, voluntariness, comprehension, motivation, research procedures

Suggested Citation

Abadie, Roberto and Kimmelman, Jonathan and Lafleur, Josiane and Lemmens, Trudo, Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation (May 11, 2014). IRB: Ethics & Human Research 2014;36(3):9-15. Available at SSRN: https://ssrn.com/abstract=2435728

Roberto Abadie

CUNY, John Jay College of Criminal Justice

695 Park Avenue
New York, NY 10021
United States

Jonathan Kimmelman

McGill University - BioMedical Ethics Unit ( email )

3647 Peel Street
Montreal, Quebec H3A 1X1
Canada

Josiane Lafleur

McGill University ( email )

1001 Sherbrooke St. W
Montreal, Quebec H3A 1G5
Canada

Trudo Lemmens (Contact Author)

University of Toronto - Faculty of Law ( email )

78 and 84 Queen's Park
Toronto, Ontario M5S 2C5
Canada

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