Ch. 10 Flashcards
(18 cards)
Define research
A systematic investigation designed to develop or contribute to generalizable knowledge
Define human subject
A living individual about whom an investigator conducting research obtains data through intervention or interaction w/the individual, or identifiable private info
Why is ethics so important in research and clinical practice?
B/c people are capable of horrible acts w/o some method to insure ethical practice
What three important finding of the Belmont Report?
- Respect for the person’s individual autonomy and protection of individuals w/reduced autonomy
- Beneficence by insuring maximizing benefit and minimizing harm
- Guiding principles cannot be inferred from efficacy alone, such as benefits to some at the expense of others, or a prevailing ideology, or culture
What are four threats to ethical behavior?
- Utilitarianism applied to people: treating people as objects or things; viewing people worth as what they can contribute
- Scientism: places science as the highest value; at the extreme end it puts answering scientific questions above other considerations
- Rationalization: biased justification of our bx, which we’re prone to
- Greater good: making a perfect world; the ends justify the means
Can we have a Science of Ethics?
Determining what bx to value are not likely within the realm of science
Name 4 benefits of the HSIRB process
- It affirms respect for the dignity of each person
- It contributes to public trust of research
- It protects researchers
- Reduces the probability of incidents
What are the 4 principles of the Canadian ethical code arranged from most to least importance?
- Respect for the dignity of the person
- Responsible caring
- Integrity in relationships
- Responsibility to society
What is the relationship b/t benefits and risk in research and in clinical practice?
Benefits should always outweigh risks in research and clinical practice. Although research can have risks, they should be understood by the participant and should be outweighed by the potential benefits
Lists several types of risk
Risks to safety, psych risks, social risks, econ risks, criminal or civil liability, biomed risks
List several potential benefits of research
Health, psychosocial, econ (can be seen as coercive if they are large)
List 4 practices for handling risks
- Providing anonymity or protecting confidentiality
- Avoiding coercion
- Monitoring risk
- Balancing risks against benefits
Why is the consent process so important?
B/c the participants need to be able to decide whether the benefits outweigh the risks to make an informed decision
What are four ways to ensure potential participants understand the benefits and risks involved in participation?
- Ensure they have the legal and mental capacity to make a decision
- Determine whether they can describe the benefits and risk in their own words
- The language used should be age and educationally appropriate
- Ensure here is no coercion or undue influence
What is a consent waiver?
A waiver that allows one to not obtain consent. Typically used for benign surveys where requiring consent may deter participation
List and describe the 3 review categories
- Exempt: includes obs of public bx and standard practices in edu
- Expedited: research that involves little or no risk over normal activity
- Full: involves risks greater than usual or work w/a vulnerable pop
What is a Conflict of Interest?
A special set of competing contingencies. On one hand, I want to conduct high quality work that can be replicated by others and, on the other hand, I may receive reinforcement only if I obtain positive results
What are 3 ways to mitigate a COI?
- Could disqualify conflicted staff from any role in the research
- Have an independent person collect and evaluate data
- Have an independent party spot check data collection and analysis
