1. Research Ethics
George Masterton

2. Research ethics committees
Protect participants from poor quality, dangerous or inappropriate medical research
Ensure ethical principles and relevant legislation are complied with
Facilitate, and sometimes improve, worthwhile research

3. Learn about research ethics!
Declaration of Helsinki (WMA)
NRES (National Research Ethics Service)
RCP London (other Colleges too)
MRC
Seek advice from experienced researchers or members of RECs before submitting

4. What is research? NRES guidance Research = acquiring new knowledge
Audit/service evaluation = assessing implementation of known knowledge

5. Design issues What do you hope to learn? (aims)
How do you intend to do it? (methods)
Will you get an answer? (statistics)
Is it feasible? (funding, time, personnel)

6. Participant issues How are participants going to be –
a) identified b) approached
c) informed d) recruited
What are you expecting them to submit to: is this feasible and reasonable?
Risks, side effects, distress, inconvenience
Coercion, role conflicts, over-studying

7. Information sheets Crucial! NRES guidance
Lay language, short and readable
Provide a summary if long or complex
Separate ISs for controls, relatives etc.
Letters for GPs, clinicians etc.
Posters and adverts

8. Consent forms Equally crucial: NRES guidance Separate from IS
Don’t put material in that isn’t covered in the IS, but OK to repeat key issues
Specific requirements for AWI research

9. Incapacitated adults Research covered by AWI(S) Act 2000
Four key requirements:
1) Research into the condition for the benefit of the patient, their family or others with the disorder
2) Unable to get a valid and reliable answer using patients who can consent
3) Minimal or no foreseeable risk
4) Minimal or no foreseeable discomfort

10. Other vulnerable groups
Children
Mentally ill
Prisoners
Students
Emergency situations
End of life patients

11. Relevant legislation Adults with Incapacity (Scotland) Act
Human Tissue Act
Data Protection Act
Medicines for Human Use (Clinical Trials) Regulations