L2 Informed consent, confidentiality, disclosure of information, use of human tissues and organs in biomedical science

consent

giving of permission

types of consent

• implied consent

• express consent

• specific consent

• general consent

why is consent important

respect for autonomy

researchers may be liable to assault/battery in criminal law

battery

• an act that directly and either intentionally or negligently causes physical contact with the person of another without that person’s consent

Researchers may be liable to criminal negligence in

criminal law

research may be liable to trespass to the person (infringing the body integrity or liberty of another)

and negligence in civil law

describe the tort (legal wrong) of negligence

must satisfy

• the defendant owed him or her a duty of care

• this duty was breached

• the claimant was harmed by this breach and this harm was not too remote

3 requirements in relation to consent in research

the subject

• has capacity

• is informed adequately

• gives consent without being coerced, or without duress (voluntariness)

what is capacity

• necessary condition for valid consent - the person has capacity (is competent)

• legal presumption: every person has capacity from the age of 16

what should the participant do

• speak to a member of the research team bout the risks and objectives

• be provided with a contact point

• be told the subject can be withdrawn at any time

what about children

children are presumed to have capacity to consent from the age of 16

• children under 16 can have Gillick compentence

law related to clinical trials with children

• a person with parental responsibility should be asked to give consent

• legal representatives should only be used in emergencies

• consent from a person with parental responsiblility is required even if children are deemed to be Gillick competent

what does it mean to be informed adequately

• professional practice standard Bolam test

• reasonal person standard

• individual person standard

confidentiality, data sharing and data protection

• researchers may have an interest to share data with other researchers but they have a duty to safeguard patient confidentiality

• data provided by research subjects today may turn out to be useful for research long term

GDPR

everyone who uses personal data that is not anonymised and that is contained in a filing system must abide by 6’ data protection principles

• use information in a lawful way

• use information for specified purposes

• ensure information is accurate

• keep it for no longer than is necessary

• hold information securely