Ethics

Question 1

What is informed consent?

Answer 1

• Informed consent is the central legal doctrine that determines the legitimacy of interactions between two or more parties, individuals and institutions - of course assuming that the interactions are in themselves lawful

Question 2

what settings does consent apply to

Answer 2

medicine and the wider society

Question 3

what is the legal doctrine?

Answer 3

A legal doctrine is a framework, set of rules, procedural steps, or test, often established through precedent in the common law, through which judgments can be determined in a given legal case

• it constitutes the minimum our medicine regards as ethical

Question 4

When should consent be sought for and by whom and who from

Answer 4

1. all medical staff including professionals and students must seek consent from every patient with mental capacity prior to every intervention
2. if the patient has no capacity, consent must be sought from their legal representative
3. if no representative is available and/or the treatment cannot be delayed one may proceed without consent, based on the doctrine of best interests or the doctrine of necessity

Question 5

What are the implications of failure to seek consent

Answer 5

• failure to seek valid consent when require is a criminal, civil and professional offence
• might result in charges of assult and battery as well as losing one’s licence to practise

Question 6

Name the three conditions of valid consent

Answer 6

1. the patient must have mental capacity (capacity)
2. The consent must be informed (informedness)
3. the consent must be voluntary (voluntariness)

Question 7

A patient who has mental capacity…

Answer 7

has almost absolute right to refuse any intervention including life-saving ones

• in public health context the right to refuse mya be subject to restrictions

Question 8

what does the validity of consent depend on

Answer 8

• whether or not its conditions have been met

Question 9

what are the different forms of consent

Answer 9

1. consent given directly by the patient
2. consent obtained via authorising their doctor to decide on their behalf
3. consent obtained via a shared decision with their doctor, relatives, friends and/or religious leaders
4. consent by proxy
5. advance directives - living wills
6. explicit (express ) consent
7. implied consent
8. opt-out consent

Question 10

when should consent be signed/witnessed/recorded

Answer 10

• when the risks of intervention and litigation are relatively high
• these practices only severe as evidence to the effect that consent has been given
• have nothing to do with the validity

Question 11

what are each of the conditions of valid consent subject to

Answer 11

– its own test

Question 12

describe the tests of valid consent

Answer 12

1. each condition of valid cosnent is subject to its own test
2. the tests are binary - either all pass or fail
3. the pass thresholds are set low
4. Mental capacity - this must be established before seeking the patietns consent - capacity is thus the criterion of eligibility to give consent
5. informedness and voluntariness must be established after consnet has been formed but before it is given- thus properites of the consent
6. in case of dispute all three conditions or some of them may be assessed or reassessed retroactively, and the onus of proving the validity of consent rests with the person who seeks to challenge the legal status quo, be it the doctor, the patient or a relative thereof. The court’s decision will appeal to the civil standard of the balance of probabilities, as opposed to the criminal standard of beyond reasonable doubt
7. one cannot determine the substantive(real) meaning of capacity, informedness and voluntariness by their test. this is because the tests only tell us what they actually check for, which may, in principle differ form the conditions they purport to establish
8. the substantive meaning of capacity, informedness and voluntariness can only be deduced from the legal implications of valid consent which are
   A - privatisation of responsibilities (each party takes responsibility for their own choice)
   B - reciprocal exemption of liabilities ( no party can sue the other for the outcomes of their own choices)
   C - the legitimacy of the interaction

Question 13

what happens if consent is in dispute

Answer 13

in case of dispute, all three conditions or some of them may be assessed or reassessed retroactively, and the onus of proving the validity of consent rests with the person who seeks to challenge the legal status quo, be it the doctor, the patient or a relative thereof. The court’s decision will appeal to the civil standard of the balance of probabilities, as opposed to the criminal standard of beyond reasonable doubt

• the court has the final say

Question 14

what are the legal implications of valid consent

Answer 14

8. the substantive meaning of capacity, informedness and voluntariness can only be deduced from the legal implications of valid consent which are
   A - privatisation of responsibilities (each party takes responsibility for their own choice)
   B - reciprocal exemption of liabilities ( no party can sue the other for the outcomes of their own choices)
   C - the legitimacy of the interaction

Question 15

What are the tests of capacity

Answer 15

1. in the ordinary default case (the normal adult) capacity is established by the presumption called “the presumption of capacity” a normal adult is thus presumed to have capacity for any choice they might make - this is referred to as a staus test

Question 16

what happens in cases that dispute capacity

Answer 16

• capacity is established via an assessement of a set of certain cognitive faculties
• this test is referred to as ‘function test’ since faculties (potentialities) can only be determined by their corresponding functions (actualities)
• by this test - capacity is merely specific to a choice or a category of choices

Question 17

What must the patient be shown to have in the function test of capacity?

Answer 17

1. ability to distinguish between what one regards - within normative bounds - as good and bad for oneself
2. ability to distinguish between what is normative regarded as true and false information
3. ability to understand and process the pertinent information
4. ability to remember the information long enough to make a choice
5. ability to grasp the potential implications of ones choice
6. ability to construct the choice subjectively rationally - that is to match it to the goals one thereby hopes to achieve
7. agency - e.g. to make the choice and communicate it

the patient will pass this test if they demonstrate even the faintest sign of each of these faculties

Question 18

Describe how they demonstrate the task of informedness

Answer 18

1. the consenter must offer the consentee what the law regards as sufficient information strictly concerning the proposed intervention: nature, purpose, potential benefits and risks = the standard of disclosure
2. the consentor must encourage the consentee to ask to ask any questions and make further inquiries as they see fit

Question 19

Describe the test of voluntariness

Answer 19

• The consentor must give the consentee the options to refuse to give consent or rescind it at any point before the intervention takes place - no questions asked and no penalties incurred - if so the consent will be deemed voluntary
• the test is concerned neither with the forces that have shaped the decision, making capacity of the consentee nor with the forces that made them pick this option rather than any other, nor with the forces that had determined the scope, content and validity of the information available to them, nor with the nature of her options and of the forces that defined and confined them, it considers none of these forces even potentially coercive and considers then non-exisitent
• therefore the patient may be subject to certain forms of coercion without this affecting the voluntariness of their consent

Question 20

What is the test of voluntariness not concerned with

Answer 20

• the test is concerned neither with the forces that have shaped the decision, making capacity of the consentee nor with the forces that made them pick this option rather than any other, nor with the forces that had determined the scope, content and validity of the information available to them, nor with the nature of her options and of the forces that defined and confined them, it considers none of these forces even potentially coercive and considers then non-exisitent
• therefore the patient may be subject to certain forms of coercion without this affecting the voluntariness of their consent

Question 21

Consent is ..

Answer 21

• bilateral and reciprocal: the patient agrees to obtain the intervention, while the the doctor agrees to provide it.
• Both parties are consentors and consentees at one and the same time.
• It follows, then, that by exchanging their consents, the parties enter into some sort of a mutual agreement.

Question 22

What is privatisation of responsibilities and reciprocal exemption of liabilities

Answer 22

Thus, if something were to go wrong for one party of no fault of the other, that party could only blame itself, e.g. - legally binding the parties must in advance also accept responsibility for their choices and their outcomes

Question 23

what are legal fictions

Answer 23

factual premises that are taken to be true by the courts of law, irrespective of whether they are true or false and even though they might knowingly be false

Question 24

what are the two tests of capacity

Answer 24

• The status test

- the function test

Question 25

what are the differences between the two tests of capacity

Answer 25

• Status test/status capacity presupposes nothing about the nature of capacity
• function capacity/substantive capacity presupposes it as a private faculty
• in fact faculties associated with decision making a strictly and invariably social and not private, however were the treated as such they would be incompatible with the privatisation of responsibility

Question 26

What is fictions of capacity

Answer 26

Since to have capacity means to be regarded as capable of taking responsibility for the choice in question, capacity means the fictitious ability to take responsibility for that choice or, implicitly, perfect choice-specific decision-making competence

Question 27

What is disclosure

Answer 27

Disclosure is considered adequate if it covers what a ‘reasonable person’ in the position of the patient would want to know, assuming that the former wishes to be informed of even the rarest risks

Question 28

what is the fictions of informedness

Answer 28

• Disclosure is considered adequate if it covers what a ‘reasonable person’ in the position of the patient would want to know, assuming that the former wishes to be informed of even the rarest risks.
• Since the ‘reasonable person’ is a fictitious entity, the premise that what ‘she’ wants to know is what the concrete patient wants to know, is clearly fictitious too.
• the pertinent fiction is the the presumption that disclosure of whichever standard implies either a fully informed consent or a wilfully ignorant one, the latter affording no exemption from private responsibility either.

Question 29

what is the fiction of voluntariness

Answer 29

The premise that a choice between permission and refusal plus the unqualified right to withdraw one’s permission prior to the intervention imply total voluntariness is evidently fictitious.

Question 30

name the new medical relations

Answer 30

1. The parties are only brought together by their own, selfish interests.
2. Because of that, they all appear as if they were working together to their mutual advantage, neither incurring any loss or harm by the other.
3. Each takes responsibility for his own choice and exempts the other from liability for its outcomes. Necessarily, then, their choices appear to them as if they were absolutely autonomous.
4. However, each is only required to ensure that the other’s choice is merely ‘adequately’ autonomous.
5. The gap between the absolutely autonomous appearance and the ‘adequately’ autonomous essence of their choices effectively allows the parties, indeed invites them, to legitimately take advantage of each other according to their relative power.

Question 31

why should you resepct confidentiality

Answer 31

Pragmatic arguments:

  1. Confidentiality is necessary for trustful communication required for good medical care. 
  2. Ditto, for medical business. 
  3. Improper breach of confidentiality might have legal and professional consequences for you.

Moral arguments:

  1. Confidentiality is a precondition of privacy, which is considered a moral value in our society. 
  2. Breach of confidentiality may harm the patient.

Question 32

What is the definition of confidentiality

Answer 32

Confidentiality is a contract that gives the confider the right to expect discretion from the confidant as well as guardianship of the information received.

Question 33

What is confidential information

Answer 33

Any information disclosed to the professional about the patient before or after death, which has a nature of confidence, or seen by the patient as having such a nature.

Question 34

Who has a duty of confidentiality

Answer 34

Anyone receiving personal information in the context of care or research: managers, clinicians, nurses, paramedics, social workers, receptionists, students.

Question 35

Who has a right to confidentiality

Answer 35

1. The competent patient (adult or minor).
2. The patient’s primary carer, if the patient has no capacity (adult or minor).
3. Deceased patients: The duty remains even after the death of the patient. It only ceases to exist when no representatives can give consent or refuse disclosure. Nonetheless, whereas a PM report is confidential, a death certificate is not

Question 36

What are exceptions to the duty of confidenetiality

Answer 36

1. The patient consents to the disclosure of information, either explicitly or implicitly (including opt-out, see for example care.data).
2. Disclosure is in the public interest:
   a. Preventing harm to others (e.g. dangerous drivers, possible harm to named individuals, TB, AIDS/HIV of professionals).
   b. Preventing or detecting crime and terrorism.
3. Child protection and prevention of harm to minors.
4. Teaching, research and audit.
5. Statutory exceptions:
   a. Courts of law can compel the disclosure of medical information.
   b. Abortions must be notified to the Chief Medical Officer (Abortion Act, 1991).
   c. Known/suspected drug addicts must be notified to the Home Office (Misuse of Drugs Act, 1971, 1985).
   d. Births and deaths must be notified (NHS Regulations 1982).
   e. Food poisoning and certain infectious diseases are notifiable (Public Health Act, 1984). HIV/AIDS are not notifiable!
6. When the professional has dual responsibility (e.g. working in prison, members of the armed forces, company staff, insurance. Legally speaking, duty to the employer comes before duty to patient.
7. Insurers may under certain circumstances require disclosure of medical information, including positive genetic findings implying the possibility of a future condition.
8. Employers may under certain circumstances require disclosure of medical information.
9. Tax inspectors can compel disclosure of financial info only.

Question 37

what is the policy of the GMC regarding doctros with HIV

Answer 37

Confidentiality of sick doctors may only be breached without their consent in the most exceptional circumstances, where the release of a doctor’s name is essential for the protection of patients.

Question 38

How should confidential data be protected

Answer 38

1. Do not discuss about, or talk to, patients in public areas.
2. Store, transfer and dispose of confidential information carefully.

3.Record-holders are only trusts for NHS, GPs, and private clinics.
Records must be retained 8y min (25y for maternity/obstetric records).

4. Never disclose more than needed. Disclose only necessary information and only to relevant and authorised bodies

Question 39

In terms of condifentiality what does each NHS trust have

Answer 39

Every NHS trust has a confidentiality officer, called Caldicott Guardian, whose role is to ensure the protection of medical information and confidentiality in the trust.

Question 40

What is the duty of confidentiality protected by

Answer 40

• A general common law (civil proceedings for breach of implied contract).
  * Statutory law - Human Rights Act 1998, Art. 8 (criminal proceedings).
  * GMC and UKCC Code of professional Conduct for nurses, and the Ambulance
  Service Code of Ethics and Professional Conduct of paramedics.
  * Patient’s Charter

Question 41

what happens when you breach confidentiality

Answer 41

1. Disciplinary proceedings – up to and including being struck off.
2. Civil proceedings – having to pay compensation. The patient may claim damages for improper disclosure even without financial or other harm.
3. Criminal proceedings.

Question 42

What are the general rules of confidentiality

Answer 42

1. Since the duty of confidentiality is not absolute and the subject contains grey areas, you might have to use your judgment and make some difficult decisions. Be always prepared to justify your decision to breach confidentiality.
2. Anonymised data may be used without consent, including in publications.
3. If you consider disclosing confidential information, always try to obtain the patient’s explicit consent first. Explain, document and reveal your intentions and actions to the patient.
4. If in doubt, consult your supervisors.