Introducing Research Ethics Flashcards
Define “Research”
“A structured activity which is intended to provide new knowledge which is generalisable and intended for wider dissemination.”
Give examples of Historical Atrocities which have motivated the development of research ethics
- Nazi medical experiments
- Willowbrook study
- Tuskegee syphillis study
- Alderhey
- Andrew Wakefield MMR scandal
Give examples of Social, Moral, Political tends which have motivated the development of research ethics
- Patient autonomy
- Related legislation
- Nuremberg code
- Helsinki declaration
Give examples of 6 principles which should be questioned when carrying out research?
Usefullness Necessity Risks Consent Confidentiality Ethics approval
What is consent defined as?
Permission from a person before involving them in research projects
What two things must consent be?
Informed
Voluntary
What things should be included in Participant Information Sheets when conducting a study?
- Purpose of study
- What happens if I take part
- Risks / benefit of taking part
- What happens if study stops / goes wrong
- How will privacy / confidentiality be respected
- Is there an ethics review?
What does the phrase “voluntary” mean? 3 points
- Not putting pressure on person
- Not offering incentives i.e. money
- Not threatening
What 4 things can be offered to help facilitate consent?
- Presentation of info
- Summary of key points
- Opportunity to ask questions
- Time to decide, at least 24 hours
How is research in a clinical context kept confidential?
- If identifiable information / anonymised from NHS -> must be granted REC approval
- Must be coded, anonymised
- Must be stored securely
When is REC approval required?
For human tissue, information, or personal data
Why is REC approval required for handling of sensitive data? 4 points
- Protects participants & researchers from harm
- Minimises claims of negligence
- Protects integrity and NHS reputation
- Condition of grant funding
