Confidentiality, Consent and Data Protection

Elizabeth M RobertsonDeputy Medical Director

Grampian University Hospitals Trust

Confidentiality, Consent and Data Protection

• Who can give consent

• On whose behalf

• In what circumstances

Patients have a fundamental right to:

• Receive sufficient verbal and written information to enable an informed decision to be made.

• Grant or withhold consent prior to any examination or treatment. - unless the patient is an adult with incapacity or a child

Consent is only legally valid if certain conditions are satisfied. This means that in any particular case a clinician must satisfy him/herself that any consent obtained from a patient meets these conditions.

Conditions

• The patient is legally competent (i.e capable of consenting)

• The consent is given freely• The patient has been adequately informed

and has understood the information given

Conditions

• The patient has been given sufficient time to reflect on the information provided before giving consent

• If a significant period of time has elapsed between consent and procedure, new consent will be obtained

• If the treatment or procedure has changed significantly, new consent will be obtained

Rationale

• Successful patient/clinician relationships depend on trust

• Consent is a process rather than a one off decision

• All steps should be documented• Consent forms are evidence of a process

and not the process itself

Definition

Consent is the voluntary and continuingpermission of the patient to receive a particular treatment or procedure based upon adequate knowledge and understanding of ………….

• Purpose• Nature• Likely effects• Significant risks (including likelihood of

success and outcomes)• Consequences of no treatment or

alternative treatment

Permission given under unfair or undue

pressure is not consent

Capacity and Incapacity

• The Adults with Incapacity (Scotland) Act 2000

• Relates to property, financial and personal welfare

• Section 5 - medical treatment

The clinician primarily responsible for the care of an adult is required to assess and document the adults’ capacity to consent

to any proposed medical treatment.

Core principles

• Benefit to the adult• Minimum restriction to adults’ freedom to

achieve the desired benefit• Account of adults’ wishes if these can be

ascertained• Consultation with relevant others (carers)• Encouragement to exercise residual capacity

Adults deemed incapable ?

• Clinician with primary responsibility• Certificate of incapacity• As only adult or legally appointed proxy with

welfare powers can consent• Certificate will stand in place of an incapable

patient’s consent• ? More formal intervention or guardianship

order may be more appropriate

“Incapable”

Incapable of• Acting; or• Making decision; or• Communicating decisions; or• Understanding decisions; or• Retaining memory of decisions

In practical terms

An adult should be able to demonstrate capacity to………..

• Understand in simple language what the treatment is, its purpose and nature and why it is being proposed

• Understand its principle risks, benefits and alternatives

In practical terms

• Understand in broad terms, the consequences of not receiving the proposed treatment

• Retain the information• Make the choice freely

The Act accepts that no single measure of capacity exists at present.

• Relatives - Carers and Professionals will all be involved in decisions about incapacity

In an emergency ?

• The situation in an emergency is unchanged by the act.

• Treatment to save life or serious harm should be given

• Consideration of matters of incapacity and consent occur later

Children

• Before examining, treating or caring for a child, the clinician must also seek consent.

• 16 years and over are presumed to have competence to give consent for themselves

Children

• Younger children who understand fully what is involved can also give consent (although ideally parents would be involved)

• In other cases - someone with parental responsibility must give consent on the child’s behalf

Children

• If a competent child consents to treatment, a parent cannot over-ride that consent.

Who obtains consent ?

• This is the responsibility of the clinician providing the treatment, carrying out the investigation or performing the surgical operation or procedure.

• Discuss• Provide information for patient’s

understanding• Obtain consent

Provision of Information

The amount of information will vary dependant upon

• The nature of the condition• Complexity of treatment• Risks associated• Patient wishes

The balance

• Listening to what the patients wants• Providing enough to ensure that the

patient’s decisions are informed

What information ?

• Purpose of investigation or treatment• Details and uncertainties of diagnosis• Options for treatment (inc. none )• Benefits and probabilities of success• Side effects and risks• Name of clinician with overall responsibility• Reminder about change of mind - even after

consent form signed

Specific consent forms

• Female and Male sterilisation• Patients unable to consent• Post mortem examination• Photography and video recording• Objection to transfusion of blood and blood products• Research• Genetic medicine

• Radio-iodine treatment (and similar)