Taking Respect Seriously: Clinical Research and the Demands of Informed Consent

Research output: Contribution to journalReview article

Abstract

There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to obtain this informed consent follows from the need to respect persons and their autonomous decisions. However, the nature of informed consent and the demands it places on investigators are open to dispute and recently have been challenged. Respect for persons, it has been claimed, does not require investigators to guarantee that the subjects enrolled in their trials comprehend the risk/benefit information disclosed to them or even that they appreciate the difference between research and therapy. According to this critique, the significance of defects in informed consent, like therapeutic misconception or unrealistic optimism, has been greatly exaggerated. This article reevaluates informed consent in clinical research in light of this critique. It not only rebuts the main points the critics raise, but also shows that other points they raise can be accepted by a doctrine of informed consent that resembles the common view in maintaining that autonomous authorization is central to informed consent.

Original languageEnglish (US)
Pages (from-to)342-360
Number of pages19
JournalJournal of Medicine and Philosophy (United Kingdom)
Volume43
Issue number3
DOIs
StatePublished - May 9 2018

Fingerprint

Informed Consent
Research
Research Personnel
Therapeutic Misconception
Ethicists
Dissent and Disputes
Clinical Research

Keywords

  • clinical
  • consent
  • informed
  • respect

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Philosophy

Cite this

Taking Respect Seriously : Clinical Research and the Demands of Informed Consent. / Jansen, Lynn.

In: Journal of Medicine and Philosophy (United Kingdom), Vol. 43, No. 3, 09.05.2018, p. 342-360.

Research output: Contribution to journalReview article

@article{df810d512678402c8afb1f1e153f5eed,
title = "Taking Respect Seriously: Clinical Research and the Demands of Informed Consent",
abstract = "There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to obtain this informed consent follows from the need to respect persons and their autonomous decisions. However, the nature of informed consent and the demands it places on investigators are open to dispute and recently have been challenged. Respect for persons, it has been claimed, does not require investigators to guarantee that the subjects enrolled in their trials comprehend the risk/benefit information disclosed to them or even that they appreciate the difference between research and therapy. According to this critique, the significance of defects in informed consent, like therapeutic misconception or unrealistic optimism, has been greatly exaggerated. This article reevaluates informed consent in clinical research in light of this critique. It not only rebuts the main points the critics raise, but also shows that other points they raise can be accepted by a doctrine of informed consent that resembles the common view in maintaining that autonomous authorization is central to informed consent.",
keywords = "clinical, consent, informed, respect",
author = "Lynn Jansen",
year = "2018",
month = "5",
day = "9",
doi = "10.1093/jmp/jhy006",
language = "English (US)",
volume = "43",
pages = "342--360",
journal = "The Journal of medicine and philosophy",
issn = "0360-5310",
publisher = "Oxford University Press",
number = "3",

}

TY - JOUR

T1 - Taking Respect Seriously

T2 - Clinical Research and the Demands of Informed Consent

AU - Jansen, Lynn

PY - 2018/5/9

Y1 - 2018/5/9

N2 - There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to obtain this informed consent follows from the need to respect persons and their autonomous decisions. However, the nature of informed consent and the demands it places on investigators are open to dispute and recently have been challenged. Respect for persons, it has been claimed, does not require investigators to guarantee that the subjects enrolled in their trials comprehend the risk/benefit information disclosed to them or even that they appreciate the difference between research and therapy. According to this critique, the significance of defects in informed consent, like therapeutic misconception or unrealistic optimism, has been greatly exaggerated. This article reevaluates informed consent in clinical research in light of this critique. It not only rebuts the main points the critics raise, but also shows that other points they raise can be accepted by a doctrine of informed consent that resembles the common view in maintaining that autonomous authorization is central to informed consent.

AB - There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to obtain this informed consent follows from the need to respect persons and their autonomous decisions. However, the nature of informed consent and the demands it places on investigators are open to dispute and recently have been challenged. Respect for persons, it has been claimed, does not require investigators to guarantee that the subjects enrolled in their trials comprehend the risk/benefit information disclosed to them or even that they appreciate the difference between research and therapy. According to this critique, the significance of defects in informed consent, like therapeutic misconception or unrealistic optimism, has been greatly exaggerated. This article reevaluates informed consent in clinical research in light of this critique. It not only rebuts the main points the critics raise, but also shows that other points they raise can be accepted by a doctrine of informed consent that resembles the common view in maintaining that autonomous authorization is central to informed consent.

KW - clinical

KW - consent

KW - informed

KW - respect

UR - http://www.scopus.com/inward/record.url?scp=85048681867&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85048681867&partnerID=8YFLogxK

U2 - 10.1093/jmp/jhy006

DO - 10.1093/jmp/jhy006

M3 - Review article

C2 - 29746686

AN - SCOPUS:85048681867

VL - 43

SP - 342

EP - 360

JO - The Journal of medicine and philosophy

JF - The Journal of medicine and philosophy

SN - 0360-5310

IS - 3

ER -