KEY NOTES CHAPTER 10: ETHICS, THE LAW AND STATISTICS - Ethics and the Law.

Question 0

What are the 4 pillars of medical ethics?

Answer 0

Beauchamp and Childress
Should apply all 4 principles to an ethical problem.

1. Autonomy
2. Nonmaleficence
3. Beneficence
4. Justice

Question 1

What are the ethical codes we abide by in medicine?

Answer 1

Hippocratic oath (5th Century BC)
Geneva declaration (1948; last amendment 2006) after Nazi medical crimes in WWII
Helsinki declaration (1964; last amendment 2013) governs human experimentation & incorporates Nuremburg code.
GMC (UK)

Question 2

Please elaborate on the 4 pillars of medical ethics.

Answer 2

1. Autonomy
   • It is not right to impose treatment on a patient without valid consent.
   • e.g. Jehovah’s Witness to refuse blood transfusion (even if it leads to death)
   • Paternalistic approach - goes against autonomy.
2. Nonmaleficence
   • Obligation not to harm others - primum non nocere (Latin ‘first, do no harm’).
3. Beneficence
   • Must do good for patients. (doing what patient considers best for himself).
   • Blood transfusion for Jehovah’s Witness is doing good to save his life. (However, from patient’s perspective, withholding blood is best way to do good).
4. Justice
   • Doing what is fair, equitable or reasonable.
   • Usually, applicable to issues of access to health care and resource allocation.

Question 3

What are the other concepts of medical ethics?

Answer 3

Utilitarianism
• Theory: our acts should be for the greater good.
• E.g. justifies not treating 90-year-old with dementia who has suffered 70% TBSA burns.
• However, could also be used to justify killing a patient because his transplanted
organs could save five others.

Deontology
• Counter-argument to utilitarianism.
• States that certain actions are good because they are good and right in themselves.
• E.g. overweight friend asks, ‘Does my bum look big in this?’
- Utilitarian approach = saying “no” to satisfy the greater good, not hurt their feelings or risk backlash.
- Deontological approach = saying “yes” - telling truth is right thing to do.
• E.g. killing patient so their organs can save five others is not justified in deontology because killing is an absolute wrong, even if good will come of it.

Question 4

What is consent?

Answer 4

Mental Health Act Code of Practice (2008) definition:
“…the voluntary and continuing permission of a patient to be given a particular treatment, based on a sufficient knowledge of the purpose, nature, likely effects and risks of that treatment, including the likelihood of its success and any alternatives to it. Permission given under any unfair or undue pressure is not consent.”

Question 5

What is the purpose of consent?

Answer 5

1 Ethical

• Recognises patient’s right of autonomy and self determination.
  2. Clinical
• Gaining patient’s confidence can affect success of treatment.
  3. Legal
• Provides medical practitioners with a defence.

Question 6

What makes the consent valid?

Answer 6

1. Voluntary
2. Informed
3. Given by a competent individual who has capacity to give consent; may be oral, written or non-verbal (implied).

Question 7

What constitutes voluntary consent?

Answer 7

• Means that consent is given without coercion, deceit or duress.
• The right to consent to treatment is part of the right of self-determination.
• Case: Re T (1992)

Question 8

What constitutes informed consent?

Answer 8

‘Standard of disclosure’ includes:
∘ Risks that a responsible doctor would disclose (Sidaway v Bethlem Royal Hospital Governors 1985).
∘ Risks that a prudent patient would want to know about (‘Prudent patient test’ applies in United States, Canada and Australia).

Question 9

Who has capacity to give consent?

Answer 9

Capacity: Mental Capacity Act (MCA) 2005:

1. Capacity is presumed unless incapacity from mental disability is established by those alleging it:
   • UNDERSTAND and RETAIN information relevant to the decision.
   • Use or WEIGH the INFORMATION as part of the process of arriving at a decision (including inability to believe the information).
   • COMMUNICATE his or her decision by any means.
2. All REASONABLE STEPS must be taken to help a person to make the relevant decision.
3. A person is not to be treated as unable to make a decision merely because the decision
   is UNWISE.
4. Acts done for people who lack capacity must be in their BEST INTERESTS.

Question 10

How is a patient’s best interest assessed?

Answer 10

• Patient’s past and present wishes and feelings, beliefs and values that might influence decision.
• Views of anyone named by patient to be consulted.
• Any carer or person interested in their welfare.
• Any donee of a Lasting Power of Attorney granted by patient.
• Any deputy appointed by Court of Protection.
• Wishes and feelings of patient expressed when capable.

Nobody can give consent on behalf of an incompetent adult unless:- The power to consent has been conferred under the MCA 2005 on a donee under a
Lasting Power of Attorney.

The Court of Protection or a Deputy appointed by the Court of Protection can also consent.

Question 11

What is the legal age of consent?

What was the Fraser ruling of Gillick competence?

Answer 11

• Minor = younger than 18 years.
• Minors aged between 16 and 18 years can consent (Family Law Reform Act 1969).

Gillick competence:
• Consent of a Gillick competent child younger than 16 years is valid (even if parents refuse).
• Is situation-specific: e.g. may understand process of nail bed repair but not heart transplant.
• Good medical practice to involve parents in decision making.

(Case: Mother of 5 girls did not want contraceptive advice or prescription by GP without her knowledge or consent. Lord Fraser “provided (the minor) is capable of understanding what is proposed, and of expressing his or her own wishes… (the doctor) is authorised to make examination and give treatment he advises.”)

Question 12

Can Gillick competent minors refuse treatment?

Answer 12

Parents (or court) can overrule refusal of treatment in a child under 18 it is in the child’s best interest.

Question 13

What is a doctor liable to

a) trespass (battery
(b) negligence?

Answer 13

Liable to:
(a) Battery (‘intentionally bringing about a harmful or offensive contact with the person of another’): if no valid consent obtained.
(b) Negligence: if consent was obtained but inadequate information was
given about risks.

Question 14

What is the difference between advance decisions (directives) and advance statements?

Answer 14

• Advance decisions refusing medical treatment were introduced in the MCA 2005. (Advance directives prior to 2005) - legally binding on drs.

• Advance statement = statement made by a capable person asking for specific treatment to be given in specified circumstances if the person loses mental capacity.
- are not legally binding on drs.

Question 15

What needs to be followed in order for an advance decision to be valid?

Answer 15

Advance decision is made by an adult:
• While they have capacity.
• Informed decision (sufficient, accurate and relevant information).
• Not unduly influenced by anyone else.

An advance decision to refuse treatment:
∘ Specify treatment to be refused.
∘ Circumstances when refusal will apply.
∘ Confirm refusal will apply when the person no longer has capacity to consent to specified treatment.
∘ Refusal of life-sustaining treatment must be explicitly stated.
∘ A minimum amount of other essential information must also be included on a valid
advance decision.

Question 16

What if a person comes into A&E but you cannot confirm an advance decision exists?

Answer 16

The MCA (2005) states:

1. A person does not incur liability for carrying out or continuing the treatment unless, at the time, he is satisfied that an advance decision exists, which is valid and applicable to the treatment.
2. A person does not incur liability for the consequences of withholding or withdrawing a treatment from a patient if, at the time, he reasonably believes that an advance decision exists, which is valid and applicable to the treatment.

Question 17

What is negligence?

Answer 17

A breach of a duty of care, which results in damage.

Question 18

What needs to be proved in order for a negligence case to be successful?

Answer 18

1 A duty of care was owed to the claimant by the defendant doctor.
2 There was a breach of duty.
3 The injury suffered was caused by that breach of duty (causation).

Question 19

What is the Bolam test?

Answer 19

It is usually applied to establish breach of duty.

∘ “A doctor is not guilty of negligence if he acted in accordance with a practice accepted as proper by a responsible body of medical opinion…A doctor is not negligent if he is acting in accordance with such a practice merely because there is a body of opinion that
takes a contrary view.”

‘Standard of care’ is that of a reasonable health care professional at the same level (not comparing FY1 vs consultants) and with the same qualifications.

Question 20

In addition to the Bolam test, what did the Bolitho case highlight?

Answer 20

1 It is not sufficient for a Bolam defence to simply establish whether the standard of care
has support from a responsible body of medical opinion.

2 The standard of care must also be deemed reasonable based on consideration of the risks and benefits of a particular action, that is ‘what ought to be done’ rather than ‘what is done’.

3 The standard of care must also withstand logical analysis.

4 Medical opinion that does not stand up to logical analysis may not be judged reasonable or responsible by the court.

Question 21

What makes establishing causation difficult in some circumstances?

Answer 21

∘ Patients are often already sick, injured or disabled.
∘ There may be several different possible causes of the illness or disability.
∘ Recollections of staff and patients seldom coincide.
∘ Staff may be in conflict.
∘ Medical records are often incomplete.
∘ Dependence on opinion from medical experts, rather than fact.

Question 22

What is the GMC’s Guidance on Confidentiality

Answer 22

“Patients have a right to expect that you will not disclose any personal information which you learn during the course of your professional duties, unless they give permission. Without assurances about confidentiality, patients may be reluctant to give doctors
the information they need in order to provide good care.”

Question 23

What is the law on confidentiality?

Answer 23

1. Common law (Hunter v Mann 1974)
   - “The doctor is under a duty not to disclose, without the consent of the patient, information which he, the doctor, has gained in his professional capacity.”
2. Data Protection Act 1998
   - The consent of the patient to keeping and disclosing information should be sought
   as a matter of course.
   - “An individual who suffers damage and distress by reason of any contravention by
   the data controller of any requirement of the Act is entitled to compensation.”
3. Human Rights Act 1998 and European Convention on Human Rights
   - “Everyone has the right to his home, privacy and family life.”

Question 24

Give some examples of disclosure with patient consent.

Answer 24

• Insurance companies
• Employers
• Lawyers
• Police

Question 25

Give some examples of disclosure when patient consent is not required.

Answer 25

1. Common law
   • Disclosure is allowable in the patient’s medical interests if he or she is incapable of consenting.
   • If a minor is not Gillick competent, the parent / guardian must consent.
   • Disclosure in the public interest or interests of others.

2. Statutory exceptions
∘ The Health and Social Care Act 2001 (for certain medical registers)
∘ Antiterrorism legislation
∘ Notifiable diseases
∘ Police and Criminal Evidence Act 1984.

3. Court orders
   • If ordered by a judge.

Question 26

Do the police have rights to patient information?

When is it appropriate to report the patient to the police?

Answer 26

No.

RTA: name and address can be disclosed in some offences.

In public interest e.g. gunshot wound (even if accidental) or stab wounds.

Question 27

What is the purpose of the Data Protection Act 1998?

Who is responsible for governing Data Protection compliance?

Answer 27

The DPA regulates disclosure of information about identifiable living individuals.

The Information Commissioner’s Office is responsible.

Question 28

What is the role of the data controller?

Answer 28

The data controller:

• deals with patients’ requests to access their health records.
• is the legal entity that determines the purposes for which and the manner in which personal data are processed.

Question 29

Who acts as data controller?

Answer 29

GP practice = GP.
Private practice = surgeon.

Therefore the surgeon must be registered as data controller with the Information Commissioner’s Office.

Question 30

If a valid request to access patient’s records is received, when must it be acted upon?

Answer 30

Within 21 days.

Question 31

When can the data controller limit or deny access to an individual’s health record?

Answer 31

According to the Data Protection (Subject Access Modification) (Health) Order 2000, if:
∘ The information released may cause serious harm to the physical or mental health or condition of the patient or any other person.
∘ Access would disclose information relating to or provided by a third party (unless 3rd party is the health professional who wrote it, or 3rd party gave consent, or it is reasonable without 3rd party’s consent to disclose).

Question 32

Can anyone request disclosure using the Freedom of Information Act 2000?

Answer 32

• This Act makes provisions for the disclosure of information held by public authorities.
• It cannot be used for personal health information.

Question 33

What is the Caldicott Report and why did it come about?

Answer 33

The report identified weaknesses in the way the NHS handled confidential patient data.
One recommendation was to appoint a Caldicott Guardian; a senior person responsible for protecting confidentiality of patients and service-user information and enabling appropriate information sharing.

Question 34

What was the key recommendation of the Caldicott Committee?

Answer 34

Key recommendation: every use or flow of patient-identifiable information should be tested against six principles developed in the Caldicott Report:

1. Justify the purpose for using confidential information.
2. Only use it when absolutely necessary.
3. Use the minimum that is required.
4. Access should be on a strict need-to-know basis.
5. Everyone must understand his or her responsibilities.
6. Understand and comply with the law.

Question 35

.

Answer 35

• Photographs should be stored securely and only disclosed in accordance with the Caldicott
principles.
• The Copyright, Designs and Patents Act 1988 indicates that copyright in any artistic work
is vested in the original creator, that is the photographer.
∘ However, for those working as employees, the copyright remains with the employer.

Question 36

What is the best practice in taking clinical photographs?

Answer 36

• Avoid causing harm or distress, protect patients’ rights and dignity.
• Informed consent
• ‘Anonymising’ photographs e.g. blacking out eyes should not be done in lieu of informed consent.

Photographs should be stored securely and only disclosed in accordance with the Caldicott
principles.

Question 37

Who owns the clinical photographs when taken:

(a) in an NHS hospital;
(b) in your private practice?

Answer 37

The Copyright, Designs and Patents Act 1988: copyright in any artistic work is vested in the original creator, i.e. photographer.

However if photographer is employee of the hospital, the copyright remains with the employer.

Question 38

What is the law in child protection?

Answer 38

1. Children Act 1989
   - A child’s welfare is paramount when making decisions about a child’s upbringing.
   - Local authorities have a ‘duty to investigate…if they have reasonable cause to suspect that a child who lives, or is found, in their area is suffering, or is likely to suffer, significant harm’.
2. United Nations Convention on the Rights of the Child 1989
   - Children’s rights:
   ∘ Right to protection from abuse.
   ∘ Right to express their views and have them listened to.
   ∘ Right to care and services for disabled children or children living away from home.
3. Children’s Commissioner for Wales Act 2001
   - Safeguard and promote the rights and welfare of children.
4. Children Act 2004
   - Places a duty on local authorities and their coworkers (police, health service, etc.) to cooperate in promoting the wellbeing of children and to safeguard their welfare.

Question 39

What is the law on temporary storage of skin and amputated body parts?

Answer 39

• Human Tissue Act 2004: regulates removal, storage and use of human tissue.
• A licence is required from the Human Tissue Authority (HTA).

The Human Tissue (Quality & Safety for Human Application) Regulations 2007
∘ HTA licence for storage is not required for tissues and cells for human application stored for <48 hours.
∘ However, a HTA licence is required for procurement of human tissues and cells.
∘ Donors of tissues and cells stored >48 hours are tested for HIV, Hepatitis B, C and syphilis.

Question 40

Give some examples of parametric and non-parametric statistical tests.

Answer 40

Parametric tests
• Used to compare samples of normally distributed data, e.g.
∘ Student's t test 
∘ Analysis of variance (ANOVA)
∘ χ2 test.

Nonparametric tests
• Used to compare samples not normally distributed, e.g.
∘ Mann-Whitney U test
∘ Wilcoxon signed rank test
∘ Kruskal Wallis test
∘ Friedman test.

Question 41

When analysing screening tests, what is sensitivity, specificity and predictive value?

Answer 41

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