The History and Justification of Medical Consent: A Critical Examination, Schemes and Mind Maps of Medicine

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Extended Project Dissertation

Can the lack of medical

consent ever be justified?

Words count: 8658

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Contents

Abstract 3

Introduction 4

Literature Review 6

Discussion 18

Conclusion 30

Bibliography 32

Project Proposal Form

Activity Log

Presentation Slides 42

Introduction

Consent is the formal permission given for something to happen. The past sixty years has seen significant progress in establishing medical consent as a patient’s right. The discovery of Nazi atrocities during their experimentation on unwilling concentration camp prisoners during World War Two shocked the world into action, and has subsequently led to the development of a legal framework to cater for issues of medical consent.

With the recognition of autonomy, the right for a person to make choices for themselves, came many legal battles between patients and doctors over the ethics of actions taken by doctors, where a lack of informed consent led to consequences previous unknown to the patient. Medicine today is becoming increasingly patient orientated; however are still instances when patient wishes are ignored or overruled by courts and doctors. In most cases this occurs when a patient refuses life prolonging, vital treatment. The concern for beneficence, to do what is best for the patient, is upheld by healthcare professionals as their reasoning behind overriding autonomy.

Often the demands of patients regarding their treatment, when contrary to that recommended, put great strain on the healthcare system both economically and in terms of resources and time. Should doctors go to great lengths to provide for medical patients who for certain reasons cannot consent to regular medical treatment? The right for autonomy would argue that yes; only the patient themselves should have the right to decide what happens to their own body, as it is them alone who will have to deal with the consequences.

Consent first interested me after first hand viewing of a controversial situation in clinical practice. On a work experience placement in a large teaching hospital , whilst shadowing an anaesthetist on ward rounds we came across a patient who was going in for surgery, however due to her religious beliefs- she was a Jehovah Witness, she would not accept blood transfusions if needed during her surgery. I found this fascinating, firstly due to my unfamiliarity with such a situation where somebody would refuse life saving treatment and,

perhaps more worryingly due to the patient apparent particular lack of knowledge regarding the various consequences of such a decision. This is something the doctor did not seek to fully amend. My realisation of this however has only come since looking closely at the process and requirements of informed consent. Patient central care is now a main focus within medical education and practice, and wanting to pursue a medical career myself the topic is one that will no doubt become prominent in my working life. Consent itself does not concern science; but has a great importance within scientific practice as it is fundamental within medicine and scientific experimentation. Greater are the philosophical and ethical issues that support consent and lie at the very heart of its creation, such as autonomy and beneficence. Examining consent brings into play many philosophical frameworks. Relativism, the idea that every situation needs to be assessed separately and thoughts surrounding this tailored accordingly. Absolutism the opposite of relativism – that one overall rule should govern. And utilitarianism, the belief that ethically superior actions are those that result in overall benefit or happiness for a greater number of peoples. Thoughts such as those of John Stuart Mill’s on when one should be able to overrule another individual’s wishes can also be applied to consent as can the ideas of Kant and Nietzsche are relevant when discussing the pros and cons of human research. Nietzsche argues that we too easily ‘give up’ when blocked by long established morals and ethics, and instead we should strive to reassess and revalue these, not allowing our morals to get in the way of our progression as a race. Such thoughts would therefore support human experimentation when consent has not be gained, in favour of the eventual results gained rather than concern for inhumane actions taken.

treatment; this therefore excludes children and the mentally ill, and they must also have been presented with a satisfactory amount of information about the proposed treatment.

These three parts can be further explained through the following necessary components:

1. Competence –The doctor must decide whether the patient is competent both to understand and decide upon their medical treatment
2. Disclosure – The doctor must ensure the patient has an adequate knowledge by disclosing a set of ‘core disclosures’^4
3. Understanding – The patient must understand the information given to them
4. Voluntariness
5. Consent (Beckerman, www.deathreference.com)

The driving force behind informed consent is that the patient is given adequate knowledge of their proposed treatment and thus ‘substantially understands the nature of the procedure he is authorizing.’(Donnelly, 2000, Ch 2, p.21) However, it is impractical to give the patient absolutely all the information available surrounding the procedure they hopefully will consent to, therefore a set of ‘core disclosures’ are given to the patient. ‘This is the information which patients…usually consider material in deciding whether to consent and also the information that the medical professional believes to be material about the proposed intervention or research.’(Donnelly, 2000, Ch 2, p.23)

Core disclosures include:

• Risks
• Success rates
• Uncertainties
• Benefits and side effects
• Doctor’s recommendation

(^4) Donnelly, M (2002) Consent: Bridging the Gap between Doctor and Patient , Cork University Press, Cork , Ch 3, p. This is a book written about consent within Irish healthcare, it is one which argues for patient rights to information and understanding, however the information that I have sourced are purely factual, although due to the location of the author the information may be more tailored to Irish healthcare. The author is a solicitor and lecturer in medical law at University College, Cork and therefore the information within the book comes from an expert in the field of medical consent.

• Alternative recommendation
• The experience of the doctor in dealing with this specific procedure
• The role of the rest of those included in the medical team
• The costs of the treatment
• The presence of medical students is also something which the patient must consent to (Donnelly, 2000, Ch 2, p.23) The points listed above are those which surveys have identified as factors patients consider most important regarding informed consent. 5 With medical research the additional core disclosures include:
• The purpose of the research
• How it will be funded
• How the research will be carried out
• If placebos will be used (Donnelly, 2000, Ch 2, pp.23-24)

However these are merely guidelines, ‘Unlike in legal discourse relating to information disclosure, there is no reference to the …patient or professional.’ (Donnelly, 2000, Ch 2, p.23)Therefore it is up to the doctor to listen to the patient and decide what information is relevant. ‘This focus on the individual patient regards communication of information as a two-way process.’ (Donnelly, 2000, Ch 2, p.24)

It is evident that today the interests and decisions of the patient lie at the heart of medical treatment, but this has not always been the case, indeed only in the past hundred years has this become the norm. Informed consent as we understand it has developed and evolved throughout the history of medicine. In particular, the notion of consent is historically linked to, and revolves around two ethical concepts.

The ethical concepts behind medical consent

Autonomy

(^5) O’Flynn, Norma et al, (1997) ‘Consent and Confidentiality in Teaching in General Practice: Survey of Patients’ Views on Presence of Students’ BMJ 315 (1142) This was a survey which was published in the medical journal the BMJ. Publication of work within reputable journals such as the BMJ requires an extensive process of peer review and therefore I feel the data is reliable.

atonement for sins, which led up to Jesus' shed blood.’ 9 The doctrine also states, ‘Even in the case of an emergency, it is not permissible to sustain life with transfused blood.’^10 The followers of the religion believe that blood cannot be removed from the body, therefore blood/organ transfusion/transplant and storage is not an option for them. This of course brings up many ethical issues and controversial cases have arisen revolving around this. In 2007, the story of a woman’s death, due to refusal of blood transfusions during labour made headlines nationally.^11 The patient in question, Emma Gough, having signed an advance directive, legally prevented doctors from providing her with blood which would have saved her life. Advanced directives ‘allow a competent person to express who should be a decision maker and what preferences the patient may have.’(Beckerman, www.deathreference.com) In some cases, such as with terminally ill patients, there can be seen to be many advantages to this decision. However in the Gough case her newlywed husband was left to deal with both the death of a wife and the upbringing of baby twins. As mentioned earlier, patients can reject treatment ‘which could prolong their lives, but has no direct impact on the lives of others’(Mayberry and Mayberry, 2003, Ch 1, p,12) but clearly in this instance the patient’s death has direct impact on many, namely her husband and children. This is an example of where lack of autonomy can be seen as the greater of two evils. This is recognised by the law and sometimes patient’s wishes are often overruled by a court. An example of this is ‘M …a gravely ill 15-year-old…the courts decided that her refusal to undergo a heart transplant could be overridden.’(Mayberry and Mayberry, 2003, Ch 1, p,12) In direct contrast to this Hannah Jones, a terminally ill 13 year old has been granted permission to refuse a heart transplant. Hannah has decided that, rather than prolong a miserable life in and out of hospital, she will ‘let nature take its course’ at home, surrounded by her friends and family.^12

(^9) Woods, A. (2007) Why do Jehovah’s Witnesses refuse blood transfusions? [online]. Available from: http://www.digitaljournal.com/article/246961 [26/11/08] This is an online article; however the information provided matches up with that which is included in the Witness’s doctrine. 10 Wikipedia, Jehovah’s Witnesses and Blood Transfusions [online]. Available from: http://en.wikipedia.org/wiki/Jehovah%27s_Witnesses_and_blood#cite_note-8 [27/11/08] Although the information is from Wikipedia that which has been referenced this can be backed by reading the Witness’s doctrine. 11 Pavia, W. (2007) Jehovah’s Witness mother dies after refusing blood [online]. Available from: http://www.timesonline.co.uk/tol/news/uk/article2809423.ece A news article from The Times, as it is a broadsheet newspaper it has a reputation to uphold and therefore it would be in the paper’s interest to reproduce accurate information. 12 De Bruxelles, S. (2008) I’ll take my chances, says Hannah Jones after refusing heart swap. The Times, London. Available from: http://www.timesonline.co.uk/tol/life_and_style/health/article5134048.ece [27/11/08] A news article from The Times, the information from this source used in this document is factual and not opinion based, and as it is from the Times it is likely to be very reliable.

This case brings in many other ethical topics, not only those surrounding autonomy and consent, the complexity of which will be explored more fully in the discussion.

Beneficence

‘[T]he term ‘beneficence’ includes acts of mercy, kindness and charity…it concerns the motivation to act in the best interests of others.’ (Mayberry and Mayberry, 2003, Ch 1, p.16)

Despite being mentioned earlier, that patients in sixth century Italy were encouraged to question their doctor, this was very uncommon and ‘throughout most of antiquity and the Middle Ages the physician was expected to provide the patient with the best treatment available and this was to be accepted by the patient without question.’(Mayberry and Mayberry, 2003, Ch 1, p.17) This sets beneficence as the primary goal of medicine and healthcare, however completely disregards the morals and ethics which autonomy serves. Beneficence and autonomy do not blend well,

‘Whether respect for the autonomy of patients should have priority over professional beneficence directed at those patients is a central problem in biomedical ethics’^13

‘Since the time of Hippocrates the moral basis for the practice of medicine has been to help at least to do no harm’(Mayberry and Mayberry, 2003, Ch 1, p.16) Doctors obviously try to provide treatment that has a positive benefit to the patient as per the Oath which encourages doctors, ‘To practice and prescribe to the best of [their] ability for the good of [their] patients ’^14 Nowadays, however, many treatments that help ‘alleviate disease and injury’ (Mayberry and Mayberry, Ch 1, p.16) may also cause harm, the harm being pain and suffering.

(^13) Beauchamp, TL. and Childress, JF. (2001 ) Principles of Biomedical Ethics (5e). Oxford University Press, Oxford This guide to biomedical ethics has been published by Oxford University Press and has gone through review by experts in the field, therefore a reliable source. 14 Hippocratic Oath. Available from: http://en.wikipedia.org/wiki/Hippocratic_Oath [27/11/08] This online Wikipedia article summarises accurately the elements of the Hippocratic Oath

Origins of Informed Consent

The nature of consent within medicine has changed enormously from its outset. In the past a ‘doctor knows best’ attitude was adopted, however today’s society is very much human- rights centred. (Beckerman, www.deathreference.com)

‘Hippocrates’s oath which granted physicians the right to practice in the patient’s best interest, has conflicted with the twentieth- century trend towards patient rights’- British Museum (Beckerman, www.deathreference.com)

In the past there was a ‘preferred conception that physicians should protect their patients from information about their diseases or treatment options’ (Beckerman, www.deathreference.com) that is, the doctor knows best attitude. But ‘since the mid- twentieth century there has been a trend toward patient’s rights’ (Beckerman, www.deathreference.com) Medical advances within the last few centuries also put pressure on doctors, unsure what information to pass on to their patients ‘physicians began to disclose basic information without necessarily outlining all potential risks.’ (Beckerman, www.deathreference.com)

In most documents on the history of informed consent, the Nuremberg Trials of 1947 are seen as the basis for the development of medical consent. However, before explaining how the Nazi experiments lead to the principle of consent being outlined in the Nuremberg code, it is important to note that the Nazi’s treatment of experimental subjects is not the only instance in which unethical and inhumane medical research has been carried out. During World War II the Office of Scientific Research and Development was created by President Roosevelt, its aim was to combat diseases which commonly affected soldiers. A potential vaccine for dysentery was developed by one of the research teams and this was tested on orphans and the mentally ill. (Kiefer, http://serendip.brynmawr.edu/exchange/) This is just one example of many similar experiments that took place in America and Britain.

The case of Mohr vs. Williams in 1905 is important in the development of the notion of informed consent; a doctor had obtained consent from a patient to operate on her right ear,

but during surgery the surgeon determined that the left needed surgery instead and proceeded to operate on it. The judge’s conclusion to the case is very similar to the way informed consent works today:

‘a physician needs to advise a patient of all the information related to a particular procedure and must review all the risks and benefits. Only after this …does the patient enter into a contract…that authorizes the physician to operate only to the extent of the consent given.’ (Kiefer, http://serendip.brynmawr.edu/exchange/)

The Nazi Experiments

Finding information on the details of the experiments is difficult; no doubt due to their taboo nature, however the book ‘Doctors from Hell’ has been useful. It outlines the various experiments that were undertaken at the concentration camps during the 1940s. The High Altitude Experiments are just one of the many. In May 1941 the Luftwaffe physician Dr. Sigmund Rascher proposed high altitude experiments to be made, a proposal that was willingly authorized by Heinrich Himmler. Four experiment types were conducted:

• Slow descent without oxygen
• Slow descent with oxygen
• Falling without oxygen
• Falling with oxygen

The first two were to simulate descent with the parachute open and the other two a free fall before the chute had opened. The experiments took place at Dachau concentration camp (a short distance from Munich) between March and August 1942 for the German Air Force. The experiments were carried out by placing the victim in an airtight pressure chamber, high altitude atmospheric conditions were then simulated in the chamber and the victim’s responses recorded.

At the Nuremburg Trials the defendants argued that although subjects had been killed, the experiments did not involve torture or pain, but this was proven very wrong by the photographs taken of prisoners during experiments. It is hard to imagine that doctors, let alone anyone could carry out these experiments on any human, consenting or not. The shock factor of the inhumanity lack of consent can bring, as shown by the Nazi experiments alerted people to the need for a system of informed consent, hence its swift development in the latter part of the twentieth century.

Development of Consent following the Nuremberg Trials

There was a ‘comprehensive movement toward informed consent …after World War II with the 1947 Nuremberg Trials.’ (Kiefer, http://serendip.brynmawr.edu/exchange/) The Nuremberg Code of 1948 which was a result of the trials,

‘abandons the earlier paternalistic perspective of medicine and research and replaces it with the centrality of patient self determination by asserting that the voluntary consent of the human subject is necessary under all circumstances of medical research.’ (Kiefer, http://serendip.brynmawr.edu/exchange/)

The Nuremberg Code laid out the principle that ‘The voluntary consent of the human subject is absolutely essential.’^17 The Nazi trials re-defined the notion of consent by alerting the world to its need within medicine. By hearing of such inhumane practices within Nazi medicine suddenly the need for consent was recognised.

In the legal sphere, informed consent eventually emerged as a right in 1972 following a series of legal cases in California during 1950s. A woman sued her physician because the effects of radiation treatment he had proposed and administered ‘far exceeded the side effects described by the physician.’ ‘The court found that unless such consent was based on full information, and …the patient fully understood all the risks of the procedure, the doctor was not protected for liability.’ (Kiefer, http://serendip.brynmawr.edu/exchange/)

(^17) U.S Government, (1949) Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. [online]. Available from: http://ohsr.od.nih.gov/guidelines/nuremberg.html [27/11/08] This is from the website for the National Institutes of Health, in the Office of Subjects of Human Research section of the website, it is a national company and therefore the information is reliable.

Through tracing the historical developments of the notion of consent it is clear that there has been a move from a medicine in which the doctor is seen as the decision maker and mastermind to one in which the doctor must ensure the patient’s wishes and demands are met as best possible.

By law a patient can refuse treatment if this will affect nobody but the patient themselves, John Stuart Mill supports in his famous ‘harm principle’ which states that,:- ‘the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others.’^18

However allowing full autonomy in regards to medical treatment could have serious consequences ethically. Perhaps in certain circumstances a medical professional, with best interests in the patient’s health, supreme medical knowledge and experience could and should override patient’s decisions. Only in the past century have we seen a move away from a ‘doctor knows best’ approach to medicine. It is in the doctor’s best interest to do what is right for the patient and it is also the doctor who has the knowledge of the patient’s condition, the available treatments and the consequences. He may transmit much of this information to the patient, as required to ensure the patient is fully informed. However, the patient can never be on the same level in terms of experience, so perhaps the doctor should have a greater say in their patient’s treatment, as had previously been the case throughout the history of the practice of medicine.

However regarding the founding principles of consent, autonomy and beneficence, making the doctor most important in the decision process regarding patient care causes problems. As will be explored later in this essay, medical cure, although medically may be best for the patient it may not present the best solution overall. Although a doctor has the supreme medical knowledge and experience, to put themselves in the patient’s position and understand their situation fully is impossible. Who other than the patient ultimately has a right over the treatment their body receives? Although sometimes difficult to comprehend patient’s refusal of treatment autonomy must be respected as a basic yet vital patient right.

Utilitarianism

Utilitarianism is the idea that an action can be justified if it is for the greater good. The argument that an action is for the greater good is often used when overriding autonomy. Utilitarianism encourages judgement of ethical situations in terms of what promotes the

(^18) Mill, J.S (1859) On Liberty , Penguin, London, 1984 ,p This is John Stuart Mill’s own writings and therefore the quotes regarding his thoughts I have used are accurate.

greatest good for the greatest number of people, it does not focus on individual needs and it is concern for the individual that forms the basis of autonomy. The right to choice often does not result in positive benefit for the largest number of people, as it will often have a negative impact on others connected to the person involved.

Mentioned earlier in this essay was the case of a Jehovah Witness woman who died after refusing a blood transfusion whilst in labour. Had doctors gone against her wishes and invalidated her lack of consent this would have not only saved her life but prevented a grieving husband from bringing up a daughter single handed. Although the patient’s prior wishes were ignored and therefore her autonomy not given, such an action would have benefited the lives of both husband and daughter and so could be seen as an overall benefit; the lesser of two evils. In such a situation a doctor is not only faced with a moral dilemma but an economic one too; providing alternative treatments is both costly and time consuming and creates unnecessary difficulty for those providing care for the patient. There are indeed problems with a utilitarian approach; there are many different factors that need to be considered, particularly in the realms of consent. This weakness to utilitarian thought does not make it practical to then apply it to consent, due to its reliance on the ability to weigh out different consequences with clarity and ease.

For the greater good?

The foundations of medicine are that a doctor does what is best for their patient. Some patient’s beliefs and desires are so far removed from that of the healthcare professional that actions are forced upon that patient which although they may help medically, psychologically they do not. Surely the mental wellbeing of a person is at least equal if not more important than physical, unfortunately it is very hard to accept and understand viewpoints so diverse from our own. One of the arguments for the justification of lack of consent was that a Jehovah’s Witness mother should have been legally forced a blood transfusion during her caesarean in order that she could have remained alive to bring up her daughter, instead of leaving that responsibility with her grieving, widower husband. On the surface this appears preferable. However mentally what would the impact of such actions be? If she had believed so strongly in the sin that surrounded accepting transfused blood, then to have had her body accept what in her eyes was an impure substance, and sinful in practice would have had enormous effects psychologically. She herself would have also been shunned by the rest of