Ethics Flashcards
What is ethics?
A branch of philosophy concerned with human character and conduct, morals and rules of behaviour.
What is the Nuremberg COde?
- Need for scientific merit
- Benefit/ risk balance
- Informed consent
- Right to withdraw
The experiment should be designed and based on the results of minimal experimentation that the anticipated results will justify the performance of the experiment.
The experiment should be conducted as to avoid all unnecessary physical and mental suffering and injury.
What is the declaration of Helsinki?
What are the basic prinicples?
A set of ethical principles regarding human experimentation
Developed from the medical community and world medical association
It is widely regarded as the cornerstone document of human research
- Safety to human subjects takes precedence over all other considerations
- Confirm to general accepted scientific principles based on laboratory and animal experiments
- Protocol
- Independent (ethics committee)
- Clinically competent medical supervisor
- Benefit/ risk analysis
- Respect of privacy
- Accuracy of results
- Informed consent
- Hazards believed to be predicted
- Independent relationship of physician to subject
- Consent from a legal guardian
How was the Declaration of Helsinki revised in 2000?
Use of placebos revised
- Placebos not ethical in virtually all studies that involve diseases with proven treatment
- Revisions were made due to controversy over use of placebos in attempting to find easy/ cheap way to reduce HIV perinatal transmission
What are the key ethical principles in research?
Based on Belmont report (1974)
Respect for persons
- The recognition of the personal dignity and autonomy of individuals
- Can say yes or no to being included in the research
Non-maleficence
- To do no harm
- No intentional harm
Beneficence
- Intend to benefit
Justice
- Distribution of the burdens of research and who actually receives the benefits
- Everyone should have equal access to being part of the research
What is Respect for Persons in terms of informed consent/ voluntary participation?
- Must be obtained before recruits subjects into a research project
- Consent should be given voluntarily
- Participants should not be coerced or bribed to enter, or remain in the study
- A consent form should be signed and witnessed
Assessed by ethics committee through scrutiny of:
- Consent forms
- Advertisements for recruitment
- Participant information sheets
- Letters of invitation to participants (often via gatekeeper - someone who is able to send the invitation instead of the students themselves to prevent coerce)
What is respect for persons in terms of openness and honest?
- Subjects be fully informed of the research aims and potential benefits and harm
- They should be informed about what they will have to if they participant
- How is emerging information fed back to participants? Participants should be debriefed about the study results?
- What is the study about? What will taking part involve?
- What are the possible benefits to taking part? Are there any risks?
- What will happen to the results of the research study?
What is respect for persons in terms of right to withdraw?
Research participants may withdraw at any time without prejudice and without impact on their care.
Explain justice in terms of ethics
Distribution of the burden of research and who actually receives the benefits
- Adequate ethical review
- Fair subject selection –> how are participants identified, approached and recruited? What are the inclusion/ exclusion criteria
- If allocated to an intervention is there a fair chance of allocation to research aims
- Compensation for injury/ harm
- Complaints dealt with fairly
- Publication/ confidentiality of results
- Non participation/ withdrawal will not affect treatment/ education
Discuss the ethical principle of beneficence
There should be:
- Favourable benefit/ risk ratio
- Good research design
You need to illustrate this by your scientific justification for the study
- Primary purpose of the study?
- Principal research questions?
- Will the study achieve its aim?
- Will the benefits outweigh the costs?
Assessed by ethics committee through scrutiny of:
- Research design, methods and analysis
- PIS in sections related to benefits and harms
- Risk assessment form
What is meant by non-malifecence?
There should be no intentional injury or harm to participants as a result of participation.
- Psychological harm/ distress experience
- Physical
- Confidentiality
Potential for harm/ discomfort to participants should be transparent and where this might occur, risks to subject are minimised and reported
Participant burden
- Are the any extra procedures or interventions?
- Are participants involved in existing research?
Are any procedures withheld from participants?
Signpost to resources on participant information sheet
- What are the possible disadvantages of taking part in this study?
- What are the possible advantages and disadvantages of taking part?
What is GDPR
Discuss confidentiality and data protection
General Data Protection Regulations (2018)
- applies to all information collected related to research data, online and paper forms
Key issues to consider:
- Confidentiality of research participants must be preserved
- Identities should not be identifiable in research projects
- Data should be coded and unique ID assigned
- All data to be stored and in locked cabinets with authorised access
Assessed by ethics committee through scrutiny of:
- PEOS application - detail provided as to how you comply with GDPR including how data will be stored, who will have access to your data and how anonymity and confidentiality will be safeguarded
- Consent forms
- Participant information sheets
What are the main principles of GDPR?
- Worldwide
- Gives rights to data subjects - there are already in place for research subjects
- Data protection comes first
- Collect only what you need and be able to justify why you need it
- Anonymise and encrypt wherever possible
- Design secure processes from the start
- Responsibilities and accountabilities
- Be clear in protocol about what data you process
- How you will ensure it is protected
- Be mindful of the law and be clear and fair with the data
- Have legal basis for the data you collect
What are the subject’s rights?
- Subject should have access to any data collected about them
- They can stop data processing –> right to withdraw
- Objecting to processing
- Correct inaccurate information
- Erasure - the right to be forgotten
What are the 5 R’s of the GDPR
Respect personal data
Reduce the data you collect
Remove identities from data if possible (but think carefully about whether you can anonymise, simply removing names in not anonymisation)
Restrict access to data
Review and delete if no longer required - rule for data destruction in research, at least 10 year
