Author: "Jeffrey C. McILwain"

Consent: Practical Principles for Clinicians

Volume 1

Personal Book: US $21 Special Offer (PDF + Printed Copy): US $81
Printed Copy: US $71
Library Book: US $84
ISBN: 978-1-60805-357-5
eISBN: 978-1-60805-093-2 (Online)
DOI: 10.2174/97816080509321110101

Introduction

Obtaining proper patient consent in clinical care is vital in current times. The approach of 'doctor knows best' is now superseded by patient rights to make decisions. The approach of this book from the author's experience of 13 years in Clinical Risk Management with a special interest in generic consent is to combine different disciplines into a more unified approach that reflects every day practice, rather than citing individual examples of law case studies. By analyzing the elements of these different disciplines a more logical, practical and synergistic approach to consent is achieved. This book differs from others in that the principle elements are combined into one text. The book should help professional and trainee clinicians to acquire a wider understanding of the fundamental principles of medical law, ethics and risk management and their combined role in many situations, particularly in the NHS.

Consent is a fundamental principle that shapes the relationship between a patient and a clinician. A clinician cannot proceed to deliver, in physical terms, the proposed system of healthcare management for a disease or a disorder without the patient giving their permission to do so. Over the past century there has been a shift from medical paternalism of “I know what is best for you and you shall have it” towards a more autonomous approach of “Please make up your mind of what is best for you”. This process has accelerated over the past 15 years largely due to the effects of the litigation process. Prior to 1991 in the UK doctors subscribed to Medical Defence Organisations (MDO’s) to protect themselves from allegations of clinical negligence. The NHS effectively devolved such negligence issues to be part of the professional’s life. Crown Immunity [1, 2] protected NHS employees from prosecution of a criminal matter. When this was lifted within the NHS in 1990 it was replaced by Crown Indemnity [3] whereby each NHS organisation became directly responsible for the acts of its employees, including allegations of negligence. Thereafter the establishment of the NHS Litigation Authority (NHSLA) to manage and monitor allegations of negligence resulted in recognition of the need for stronger risk management controls within NHS organisations and so the concept of the Clinical Negligence Scheme for Trusts (CNST) was born whereby there would be standardised risk imperatives to be achieved [4].

Part of these standards includes consent and this stimulated the UK Department of Health to produce standardised consent forms and guidance [5, 6] in 2003 throughout the NHS. Organisations within the NHS who wish to achieve a reduction in their contribution to the mutuality of the crown indemnity provided through NHSLA must subscribe to these standardised forms.

Part of the acceleration of consent taking and giving has been realised through events in Alder Hey Hospital vis a vis organ retention with the establishment of the Human Tissue Authority in 2004 [7] to cover the donation, storage and display of human tissue for various purposes. The fields of medical research which already had a strong consent position have also been strengthened [8] within the UK Medical Research Council (MRC).

It is apparent that faced with a change from immunity to indemnity and a rising ability of the legal profession within the area of negligence that consent has risen from “sign this piece of paper” to a complicated system with internal auditing through risk management processes and evidence trails.

That there is a less than 100% ability or compliance in consent has been shown in a survey published by Hamilton [9] whereby the range of ability to obtain complete “informed consent” between FY 1&2, SpR and Consultant surgeons varied between 69% and 80%. In obtaining consent from children varied between 50% and 64%, from psychiatric patients between 70% and 90% and for research and screening between 80% and 100%. Although this was a small sample and a survey it rather defies the belief that consent taking has actually vii penetrated the professional surgeon’s training and ability even in 2007. Interestingly the SpR group (registrars) fared best overall suggesting that senior trainees better more junior trainees and even their peers and trainers!

[1] Select Committee on Public Accounts Minutes of Evidence APPENDIX 2 Supplementary memorandum submitted by HM Treasury http://www.publications.parliament.uk/pa/cm200203/cmselect/cmpubacc/ 588/2102314 .htm

[2] Public and Commercial Services Union Knowledge Centres / Health and Safety / Legal Summaries / Crown Immunity http://www.pcs.org.uk/Templates/Internal.asp?NodeID=884239

[3] bma.org.uk Archive/Archive - Medical careers and education Guide for doctors new to the UK October 2004 http://www.bma.org.uk/ap.nsf/Content/GuidefordoctorsnewtoUK~indemnity

[4] NHS Litigation Authority Clinical Negligence Scheme for Trusts (CNST) http://www.nhsla.com/Claims/Schemes/CNST/

[5] Department of Health Policy and Guidance about the consent form http://www.dh.gov.uk/en/Policyandguidance/Healthandsocialcaretopics/Consent/Consentgeneralinformation/DH_4015937

[6] Department of Health Policy and Guidance consent key documents http://www.dh.gov.uk/en/Policyandguidance/Healthandsocialcaretopics/Consent/Consentgeneralinformation/index.htm

[7] Human Tissue Authority about the HTA http://www.hta.gov.uk/about_hta.cfm

[8] Medical Research Council Policy and Guidance Consent to take placed in research http://www.mrc.ac.uk/PolicyGuidance/EthicsAndGovernance/InformedConsent/index.htm

[9] Knowledge of the laws in consent in surgical trainees. Hamilton P Bismil Q. Ricketts DM. Annals of the Royal College of Surgeons England. 2007;89:86.

Contributors

Author(s):
Jeffrey C. McILwain
St. Helens & Knowsley Teaching Hospitals, NHS Trust
UK




Contributor(s):
D.M. Bonifati
Department of Neurological disorders
Santa Chiara Hospital
Largo Medaglie d’Oro 1
Trento
Italy


T. Farooqui
Department Entomology/Center for Molecular Neurobiology
The Ohio State University, Columbus
Ohio
USA


S. Cardoso
Department of Zoology
Faculty of Sciences and Technology, University of Coimbra
Coimbra
Portugal


Y. Hirashima
Physiological Chemistry, Faculty of Pharmaceutical Sciences
Teikyo University, Sagamiko, Sagamihara
Kanagawa
Japan


S.C. Correia
Department of Zoology, Faculty of Sciences and Technology
University of Coimbra
Coimbra
Portugal


S.R. Joshi
Interactive Research School for Health Affairs
Bharati Vidyapeeth
Pune
India


C. Carvalho
Department of Zoology, Faculty of Sciences and Technology
University of Coimbra
Coimbra
Portugal


A. Kale
Interactive Research School for Health Affairs
Bharati Vidyapeeth
Pune
India


F. Coppedè
Department of Neuroscience
University of Pisa, Via Roma
Pisa
Italy


U. Kishore
Laboratory of Human Immunology and Infection Biology
Biosciences Division Brunel University
Uxbridge West London UB8 3PH
UK


U.N. Das
Jawaharlal Nehru Technological University
Kakinada, India and UND Life Sci, Shaker Heights
Ohio
USA


S.P. Mahadik
Department of Psychiatry and Health Behavior
Medical College of Georgia
Augusta
GA
USA


A.A. Farooqui
Department of Molecular and Cellular Biochemistry
The Ohio State University
Columbus
Ohio
USA


Migliore L.
Department of Human and Environmental Sciences
University of Pisa
Via S. Giuseppe 22
Pisa
Italy


Moreira P.I.
Institute of Physiology, Faculty of Medicine
University of Coimbra
Coimbra
Portugal


Santos R.X.
Department of Zoology, Faculty of Sciences and Technology
University of Coimbra
Coimbra
Portugal


A. Nayak
Laboratory of Human Immunology and Infection Biology
Biosciences Division, Brunel University
Uxbridge West London UB8 3PH
UK


M.A. Smith
Department of Pathology
Case Western Reserve University
Cleveland
Ohio
USA


W.Y. Ong
Department of Anatomy
National University of Singapore
Singapore


L.J. Wallace
Division of Pharmacology
College of Pharmacy, The Ohio State University, Columbus
Ohio
USA


G. Perry
Department of Biology
UTSA Institute for Neuroscience, College of Sciences, University of Texas, San Antonio
Texas
USA


X. Zhu
Department of Pathology
Case Western Reserve University, Cleveland
Ohio
USA




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