Ethics

Question 1

Principals of Helsinki declaration of 1964

Answer 1

Respect for the individual, right to self-determination and right to make informed decisions.

Participant’s welfare must be put before the interests of science and society.

Ethical consideration must precede laws and regulations.

Research overseen individually by convened committee

Question 2

Studies that require ethical approvals

Answer 2

Involve human/ animal participants

Gathering new data or information

Creating knowledge that can be generalised beyond the participant sample or setting.

Question 3

Considerations for ethical review

Answer 3

1. Scientific rational
2. Methodology
   - Most appropriate method for setting and sample
   - Materials/ equipment should be valid and reliable
   - Robust data management and analysis
3. Informed consent
   - Participant information sheet,
   - Method of allowing participants to ask questions.
   - Written evidence of consent, right to withdraw
4. Vulnerability of participant group
   - Groups: children, dementia, learning difficulties, mental health problems, care facilities, over-research populations.
   - Reducing risk to group
5. Data protection, confidentiality and records management.
   - Ensuring patient information is an unidentifiable as possible.
   - Consider how and how long data will be stored for.
6. Researcher safety and wellbeing

Question 4

Committees for research ethics

Answer 4

NHS patient/ staff as participants= NHS Health research authority

Participants external from NHS= BSMS RGEC (Research Governance and ethics committee)

Question 5

Projects that do NOT require ethical approvals

Answer 5

Service evaluation/ improvement/ quality improvement

Clinical audit