Ethics Flashcards
What is autonomy?
Autonomy is the capacity to make an informed, uncoerced decision
All participants in research must take part voluntarily (free from any coercion or undue influence or inducement) and their rights, dignity and the autonomy should be respected and be protected at all stages in the process
To respect autonomy is to…
Respect considered opinions and choices
Refrain from obstructing their actions unless they are clearly detrimental to others
How may individuals lose their capacity for self-determination?
Because of illness, mental disability, or circumstances that severely restrict liberty
What is beneficence and non-maleficence?
Beneficence = to do good and provide good to others
Non-maleficence = to do no harm to others
How does beneficence and non-maleficence apply to research?
New discoveries that provide a benefit may require exposing persons to some risk
Conducting research without any risk of causing harm would prevent many improvements in human welfare
Research should be worthwhile and provide value that outweighs any risk or harm
Researchers should aim to maximise the benefit of the research and minimise potential risk of harm to participants and researchers
All potential risk and harm should be explained and robust precautions put in place
What is required for all research outlining the risks and benefits?
Risk/benefit assessment - assessment of the probabilities of both the harm and of the benefit that may arise
This may be psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits
What are some examples of justice in research?
Selection bias of research pps such as particular racial minorities, one gender are often obvious but what about bias from easy availability
Research supported by public funds should provide advantages not just to those who can afford them
Research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research
What information needs to be included in the participant information sheet?
The research procedures
The purpose of the research
Risks and anticipated benefits
Alternative therapy if it exists
An opportunity to ask questions and to withdraw at any time from the research, WITHOUT giving their reason
What are some examples of unacceptable practice which lack integrity?
Fabrication of false data or documentation e.g., consent forms
Plagiarism
Misrepresentation of findings
What common practicalities are needed in research?
University ethics or regional ethics committee application
Documentation
The participant information sheet
The consent form
The protocol
When are regional ethics committees used?
If research involves NHS patients or access to their NHS data
This process is more onerous than university ethics and will necessarily involve NHS clinicians
Need to go through the research and development department of the NHS institution in which you plan to work
What is the university ethics procedure?
Faster and more responsive than REC - weeks not months
Have to apply for ethics by filling out a form
What is the correct structure of a participant information sheet?
Include a header so pps understand the institutions involved
Need a title of the study
Say who you are, who the researchers are
Then need a series of sub sections usually written as a series of questions
What sections need to be included in the participant information sheet?
What is the purpose of the study?
Why have I been invited?
Do I have to take part? (answer is always no)
What will happen to me if I take part?
What are the possible disadvantages and risks of taking part?
What are the possible benefits of taking part?
Will my taking part in the study be kept confidential?
What will happen to the results of the research study?
What will happen if I do not want to carry on with the study?
Further information and contact details
Who has reviewed the study?
Data protection privacy notice: what are my rights under the data protection legislation?
What if there is a problem?
What needs to be included in the consent form?
Simple language
State the different things you are expecting from the participant (if you are undertaking psychological tests as well as brain imaging, these need to be stated separately)
Consent requires an initialed box - no ticks or crosses
Needs to be signed and dated by both the pp and the recruiter
Needs to be copied so the pp has a copy as well as the copy for the study records
