Exemption from informed consent: When it is possible in investigational product and drug trials?

An ethnographic field study about the informed consent process in investigational drug trials for seriously ill persons with hepatitis C suggests that nurses and physicians referred to these trials as giving treatment, even though they involved placebos. Interview data and informed consent documents contained frequent references to the term `treatment trial' or `treatment'. Although these findings were unexpected and not the original focus of our study, we consider them in the light of an extensive literature on the `therapeutic misconception' that has been described among physicians and patients with AIDS and other serious illnesses. We also suggest that certain organizational and professional characteristics of nursing and medicine reinforce this tendency to refer to the trials as treatment. Implications for further research are provided.

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MORALITY, RISK AND INFORMED CONSENT IN CLINICAL DRUG TRIALS

Contesting Moralities ◽

10.4324/9781843147725-14 ◽

2017 ◽

pp. 71-86

Keyword(s):

Informed Consent ◽

Drug Trials ◽

Clinical Drug Trials ◽

Clinical Drug

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What Selection of Patients is Achieved by Requesting Informed Consent in Placebo Controlled Drug Trials?

Pharmacopsychiatry ◽

10.1055/s-2007-1017261 ◽

1986 ◽

Vol 19 (04) ◽

pp. 335-336 ◽

Cited By ~ 3

Author(s):

P. Netter ◽

S. Heck ◽

H. Müller

Keyword(s):

Informed Consent ◽

Drug Trials ◽

Selection Of Patients ◽

Selection Of

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Informed consent and decision-making: patients’ experiences of the process of recruitment to phases I and II anti-cancer drug trials

Patient Education and Counseling ◽

10.1016/s0738-3991(01)00147-1 ◽

2002 ◽

Vol 46 (1) ◽

pp. 31-38 ◽

Cited By ~ 73

Author(s):

Karen Cox

Keyword(s):

Decision Making ◽

Informed Consent ◽

Cancer Drug ◽

Drug Trials ◽

Anti Cancer

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IECs, Drug Trials and Regulators–the Hounds Barking up the Wrong Tree

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.971 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S612-S612

Author(s):

R. Nagpal ◽

V.G. Jhanwar ◽

A.K. Mital ◽

E.M.D. Warrier

Keyword(s):

Mental Health ◽

Health Care ◽

Informed Consent ◽

Drug Trials ◽

Patient Support ◽

Policy Makers ◽

Last Mile ◽

The Family ◽

Competing Interest ◽

Last Mile Delivery

As India hurtles on into the 21st century with dizzying speed, the constantly evolving ethics, law and its interpretations fall behind. The cut and paste policy makers constantly impose regulations out of sync with the geopolitical realities. The Mental Health Care Bill now awaiting approval arose because we signed first on a global body convention and now are forced to comply. The family, a ubiquitous feature of our patient support system is slowly being derecognized. Instead, NGOs are the new approved caregivers. Our patriarchal society, earlier a repository of warmth and security is now jeered at. The mental health professional, the last mile delivery of mental health is in a quixotic position and some of the tantalizing issues of surreptitious drug administration, informed consent, the newer laws enacted or being enacted, narcoanalysis and drug trials will be discussed with pragmatic solutions offered to a disinterested regulator.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment

Korean Journal of Medical Ethics ◽

10.35301/ksme.2016.19.2.185 ◽

2016 ◽

Vol 19 (2) ◽

pp. 185-210

Author(s):

Eunae Kim

Keyword(s):

Informed Consent ◽

Patient Treatment ◽

Investigational Product ◽

Legal Standards

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Equipoise, Informed Consent and Clinical Research

Perspectives on Swallowing and Swallowing Disorders (Dysphagia) ◽

10.1044/sasd11.2.22 ◽

2002 ◽

Vol 11 (2) ◽

pp. 22-23

Author(s):

Lynne C. Brady Wagner

Keyword(s):

Informed Consent ◽

Clinical Research

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Tools and Resources: Web Sites of Interest

Guides Newsletter ◽

10.1001/amaguidesnewsletters.2001.marapr03 ◽

2001 ◽

Vol 6 (2) ◽

pp. 6-8

Author(s):

Christopher R. Brigham

Keyword(s):

Informed Consent ◽

Physical Examination ◽

Functional Status ◽

Web Sites ◽

Satisfaction Survey ◽

High Quality ◽

Diagnostic Studies ◽

Physician Relationship ◽

Complete History

Abstract The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Fifth Edition, explains that independent medical evaluations (IMEs) are not the same as impairment evaluations, and the evaluation must be designed to provide the data to answer the questions asked by the requesting client. This article continues discussions from the September/October issue of The Guides Newsletter and examines what occurs after the examinee arrives in the physician's office. First are orientation and obtaining informed consent, and the examinee must understand that there is no patient–physician relationship and the physician will not provide treatment bur rather will send a report to the client who requested the IME. Many physicians ask the examinee to complete a questionnaire and a series of pain inventories before the interview. Typical elements of a complete history are shown in a table. An equally detailed physical examination follows a meticulous history, and standardized forms for reporting these findings are useful. Pain and functional status inventories may supplement the evaluation, and the examining physician examines radiographic and diagnostic studies. The physician informs the interviewee when the evaluation is complete and, without discussing the findings, asks the examinee to complete a satisfaction survey and reviews the latter to identify and rectify any issues before the examinee leaves. A future article will discuss high-quality IME reports.

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