Author: Jeffrey C. McILwain

Consent: Practical Principles for Clinicians

Volume 1

eBook: US $21 Special Offer (PDF + Printed Copy): US $81
Printed Copy: US $71
Library License: US $84
ISBN: 978-1-60805-357-5 (Print)
ISBN: 978-1-60805-093-2 (Online)
Year of Publication: 2011
DOI: 10.2174/97816080509321110101


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 The approach of 'doctor knows best' is now superseded by patient rights to make decisions.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 588/2102314 .htm

[2] Public and Commercial Services Union Knowledge Centres / Health and Safety / Legal Summaries / Crown Immunity

[3] Archive/Archive - Medical careers and education Guide for doctors new to the UK October 2004

[4] NHS Litigation Authority Clinical Negligence Scheme for Trusts (CNST)

[5] Department of Health Policy and Guidance about the consent form

[6] Department of Health Policy and Guidance consent key documents

[7] Human Tissue Authority about the HTA

[8] Medical Research Council Policy and Guidance Consent to take placed in research

[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.


Correct and up to date knowledge of consent for clinical care is fundamental to good clinical practice and patient communication. Most clinicians in busy wards and clinics will recognize that there is considerable room for improvement in seeking and recording consent at present from most patients in such locations. Furthermore, as case law on consent has evolved significantly over recent years as has guidance from the Department of Health and General Medical Council, the need for concise practical up to date guidance for front line staff is palpable. It thus gives me great pleasure to introduce this topical guide Consent, Practical Principles for Clinicians by Mr. Jeffrey McIlwain. It will be of use to clinicians, risk managers and lawyers. The clarity of presentation, in what is often a difficult subject for many of us, is especially appealing. While this short book is modestly presented as a broad overview to consent in clinical practice, it covers the subject matter comprehensively. For those who like to know that little bit more, the text is thoroughly referenced. While the context principally relates to English law and current clinical practice in the UK it will also be of interest to international readers in jurisdictions that often draws upon such principles.

Jeff McIlwain is ideally placed to present such a guide to healthcare professionals given his dual surgical and clinical risk expertise and experience. The author’s approach to this subject is both conceptual and practical and is aptly illustrated with clinical and legal cases examples. A final ‘stretch yourself’ self test section provides numerous scenarios that will exercise healthcare practitioners’ key knowledge and skills in consent. Consideration of these scenarios will also be a bonus to medical practitioners presenting for Appraisal and for those seeking Revalidation as well as being an educational bonus for clinical training.

If I may speak directly to those undertaking consent for treatment; you can be grateful that there is a handy book such as this as an aid to navigation in this field. This is a key item to buy and read now and to then return when uncertain waters reappear, as they will do. The clinician aiming for best practice on consent will keep this textbook close at hand and will re-visit it as a reference when new clinical challenges in consent are encountered.

Consultant Ophthalmic Surgeon,
Bolton, England


.Disease Prediction using Machine Learning, Deep Learning and Data Analytics.
.Exploration of Artificial Intelligence and Blockchain Technology in Smart and Secure Healthcare.
.Blockchain and IoT based Smart Healthcare Systems.
.Occupational Health and Safety.