RM2

What should research aim to do?

Maximise benefit for individuals and society and minimise risk and harm

What should be respected in research?

Rights and dignity of individuals

What should participation be?

Voluntary and appropriately informed

How should research be conducted?

With integrity and transparency

What should be clearly defined?

Lines of responsibility and accountability

What should be maintained?

Independence of research and if any conflicts cannot be avoided they are clearly stated

What gives guidance on research ethics?

Declaration of Helsinki (1964)

What does the Declaration of Helsinki (1964) state?

• Patient has autonomy to make informed decisions regarding participation

• The investigator’s primary duty is to the patient

• While there is always a need for research, the participant's welfare must always take precedence over the interests of science and society

What does good clinical practice guidelines state?

Include protection of human rights of those in clinical trial

Provided assurance of the safety and efficacy of the newly developed compounds

Includes standards on how clinical trials should be conducted

Defines roles and responsibilities

What are the legal requirements for clinical trials?

• GDPR

• Intellectual property

• Copyright

• Human Tissue Act

• Mental Capacity Act

• Licences e.g. animal research

Describe patient and public engagement?

• Research needs to matter to patients/public effected by the question

• Highlight need/urgency

• Help design trial – to make acceptable/maximise recruitment

• Make patient information understandable and relevant

Define PPI?

Patient and public and involvement and engagement