L9 28/02 Flashcards
Declaration of Helsinki
This statement of ethical principles concerning human experimentation was written by the World Medical Association (WMA) and forms the basis for human research ethics.
5 domains of NHS Research Governance Framework
- Ethics
- Science
- Information
- Health, safety & employment
- Finance and intellectual property
4 key ethical principles
- Benefice
- Respect for human dignity
- Justice
- Care of vulnerable groups
Benefice definition
Beneficence refers to doing good things only. Accordingly ethical research should.
• Ensure freedom from physical or psychological harm
• Avoid exploitation, either overt or subtle
• Have more benefits than risks for individuals, researchers and society
Respect for human dignity definition
Ethical research should ensure that participants engage with research of their own will, and know what will happen to them…
• Self-determination (Voluntary participation with no coercion)
• Full disclosure (Avoiding covert data collection or deception)
• Informed consent (Providing accurate and accessible participant information)
Justice definition
Everyone has the right to fair and equitable treatment. There should be non-discriminatory allocation to treatment and control groups, equal access to research personnel and relevant support. It is important to respect the individual’s right to privacy
• Minimise intrusion
• Assure anonymity
• Ensure confidentiality
Care of vulnerable groups definition
Vulnerable groups are those who will struggle to provide informed consent or are susceptible to coercion:
• Children <16 years
• People with mental illness, dementia, learning disabilities
• Unconscious, severely ill, terminally ill people and their families
• People in emergency situations
• Prisoners, young offenders
• Those in dependent relationships e.g. care homes, students
• Non-English speakers
Participant information sheet (PIS)
- The purpose of the study
- Why the research is needed
- Why you have been invited to participate
- Voluntary participation (and the right to withdraw)
- What will happen if you take part
- Risks of participation
- Benefits of participation
- Compensation (if any)
- Data processing and storage (confidentiality, anonymity and data security)
- Results of the study
- Governance and complaints
- Further information
What does health research involve?
Addresses well defined research questions, has aims and objectives
Data collection outside of routine collection
New intervention
Possible randomisation
Requires REC review
What does service evaluation involve?
Measures current service Analysis of existing or routinely collected data No new interventions No randomisation R&D review only
What does clinical audit involve?
Compares services with a specified standard
Analysis of existing or routinely collected data against a standard
No new interventions
No randomisation
R&D review only
What does surveillance involve?
Identifies trends and risk in the general population
Uses existing data or may involve collection of new data or samples
No new interventions
No randomisation
May need R&D review
NHS REC approval is required for all research in areas covered by legislation
- Clinical trials
- Human tissue
- Adults lacking capacity
- Radiation
- NHS patients, carers or service users
- Adult social care
- Prisoners
- Offenders in the community
5 requirements of good research
- Scientific rigour
- Public involvement
- Data management
- Data confidentiality
- Information dissemination
Is the Declaration of Helsinki is solely concerned with ethical principles of human research?
Yes
