Ethics Flashcards
What are the principles of ethics?
Autonomy
Beneficence - non-maleficence
Justice
Inform consent
Confidentiality
Integrity
What is autonomy?
All participants must take part voluntarily (i.e. free from coercion or undue influence)
Their rights, dignitity and autonomy should be respected & protected
What can affect autonomy?
A power difference between the recruiter and the person being recruited
Whether the risks and rewards for participation are appropriate
How do we enable autonomy?
Autonomy is about the deliberation of personal goals and acting on them so participants need to understand and retain all study information sufficiently to make a decision
What does it mean to respect autonomy?
Respect opinions and choices
Refrain from obstructing a person’s actions unless they are detrimental to others
How does lacking mental capacity affect autonomy?
The capacity for self-determination may change during an individual’s life e.g. from illness, mental disability or circumstances
But we must always protect participants from harm if they cannot make autonomous decisions
e.g. using a legal representative or family member
How do we weigh up beneficence- non-maleficence?
New discoveries that provide a benefit may require exposing persons to some risk
Where the participant may benefit directly through the research, such risks are more justifiable.
However, many research projects will not benefit the participants directly, but the wider benefits to others (e.g. to treat disease) may justify the research with some risk.
Need a risk assessment- probability of harm and of benefit
How do we ensure beneficence-non maleficence?
Research should be worthwhile (not frivolous) and provide value that outweighs any risk or harm
Researchers should aim to maximise 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 are some types of harm?
Psychological
Physical
Legal
Social
Economic
What does justice mean?
Research should be just between different members or groups in society
Research should give equal treatment
Injustice can be either being denied a benefit or having to bear undue burden
Consideration of societal impact of research needed and should be reflected in the selection of participants and any benefits/burdens arising
What are some examples of injustice?
Selection bias -> racial minorities, gender, or availability
Publically funded research should not provide advantages just to groups who can afford them
Research shouldn’t include people from groups unlikely to be the beneficiaries of the applications of this research
What is informed consent?
Informed consent= research staff and participants be given appropriate information
(a) If you’ve read it, there should be no surprises!
(b) In a comprehensible manner PLAIN ENGLISH +/- TRANSLATIONS
(c) Without duress or inappropriate inducement.
What information should be included in the participant information sheet?
Research procedures
Purpose of research
Risks and anticipated benefits
Alternative therapy if it exists
Opportunity to ask questions and to withdraw from the research at any time without giving reason(s)
What is comprehension?
Comprehensionmeans that the manner and context in which information is conveyed is as important as the information itself
What law makes intrusive research without informed consent unlawful?
Section 30 of the Mental Capacity Act 2005
(unlawful unless special provisions are made)
What are important aspects of informed consent?
Must be VOLUNTARY
No COERCION- careful use of language
No exploiting POWER DIFFERENCES between recruits and recruiters
What is confidentiality?
Information gained through participation in the study should be held confidentially
Personal data should be respected- data protection measures have to be in place- this is a matter of the law.
Anonymity should be respected unless there is agreement not to
No disclosure of potentially identifiable data
What is integrity in research?
Research should be designed, reviewed and undertaken with high standards, quality and transparency
Conflicts of interest need to be presented openly. Include anything that could be construed as a conflict of interest.
What are examples of unaceptable practice that violates integrity?
Fabrication
Plagiarism
Misrepresentation of findings
What are regional ethics committees?
If research involves NHS patients or NHS data we need to use these committees
Needs to go through the research and development department of the NHS institution in which you plan to work
Takes months to acquire along with the HRA registration
Accessed via IRAS system
How are University ethics procedures different to regional ethics committees?
Faster and more responsive than REC- weeks not months
What do participant information sheets requires
Head paper- so participants understand the institutions involved
Title of the study
Say who you and the researchers are
Needs a series of sub sections usually written as a series of questions…..order can be flexible
What are the subsections of information sheets?
What is the purpose of the study?
Why have I been invited?
Do I have to take part?
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?
-What does the law demand?
-What is your institutional guidance?
-This is also where you explain your data storage strategy
What will happen to results of the research study?
-Need to confirm confidentiality of anything published
-Need to explain the dissemination strategy
What will happen if I do not want to carry on with the study?
Further information and contact details
Who has reviewed the study?
What if there is a problem?
What is the consent form?
Headed paper
Simple language
State the different things you are expecting from the participant
Participant fills the form in
Needs to be signed and dated by both the participant and recruiter
Participant also needs a copy
What is the protocol?
Should include a plain English summary/abstract for ethics reviewers who will need to see a copy
This document needs to be mirrored by the participant information sheet which should then be reflected in the consent form
What is included in the protocol?
Title Page
Objectives
Background Information
Study Design
Study enrollment procedures
Study interventions
Study procedures
Safety assessment
Statistical and analytical considerations
Data collection
Quality assurance
Participant rights
Publication
Refs
Appendices
