Research Ethics George Masterton

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

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

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

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)

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

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

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

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

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

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