7. Ethics and Clinical Research Flashcards
Ethics definition
A branch of philosophy dealing with values pertaining to human conduct, considering the rightness and wrongness of actions
Justice
fairness and equality
Nonmaleficence
means to “do no harm” (The pertinent ethical issue is whether the benefits outweigh the burdens)
Beneficence
action that is done for the benefit of others
Non exploitation
we should not exploit one group for the benefit of others
Autonomy
“self rule” - Physicians must respect a patient’s right to make decisions regarding his medical care.
A Historical Events of Ethical Misconduct
Nazi physicians conducted experiments that resulted in about 200,00 deaths
The Nuremberg Code
The voluntary consent of the human subject is absolutely essential
The Nuremberg Code
The voluntary consent of the human subject is absolutely essential
7 GUIDELINES IN A UNIFIED FRAMEWORK
- Value
- Scientific Validity
- Fair subject selection
- Favourable risk-benefit ratio
- Independent Review
- Informed consent
- Respect
Why must clinical research have VALUE?
- Fundamental reason #1:
– Responsible use of finite resources
– Doing all possible research diverts resources
from other worthy pursuits - Fundamental reason #2
– Avoidance of exploitation
Examples of research with no value
- research that will lead to ungeneralizable results
- Research with an already proven, trifling or trivial hypothesis
- Research in which the intervention could never be practically implemented, even if effective
What is required for research to have scientific validity
research must be conducted with rigorous methods
Clinical equipoise
the assumption that there is not one ‘better’ intervention present (for either the control or experimental group) during the design of a randomized controlled trial (RCT)
Requirements for fair subject selection
- unbiased subject selection
- fair distribution of risk and benefits
- inclusion and exclusion criteria
inclusion criteria
the factors that allow a person to participate in a study,
exclusion criteria
are the factors that disqualify a person from participating
Requirements for a study to have a favourable risk-benefit ratio (3 conditions)
A) the potential risks to individual subjects are minimized
B) the potential benefits to individual subjects are enhanced
C) the potential benefits to individual subjects and society are proportionate to the risks
How to have a favourable risk-benefit ratio
- Avoid extraneous benefits
- Specify potential benefits
Requirements for a study to be independently reviewed
Before a clinical trial can start (e.g. at a hospital or clinic), the principal investigator must submit a detailed application to the local REB for approval (to make sure that a researcher’s legitimate multiple interests do not affect the study design)
Key Components to an REB application
Recruitment, consent, balancing risk vs. benefit, fairness/equity, conflicts of interest, and confidentiality
REB
research ethics board
IRB
Institutional review board
What is required for a study to have informed consent
autonomy
What does REB need to see to confirm that a study has a valid form of informed consent
- Consent is voluntary
- Consent is informed
- Consent is ongoing
Consent form must haves
1) Contact info
2) Risks & benefits
3) Clearly defined purpose
4) Statement of confidentiality
5) Statement or voluntary consent
6) Summary and signatures
7) Updated version
5 forms of respect in a study
1) Information privacy
2) Subjects can change their mind
3) New information during course of research
4) Welfare of subjects is monitored throughout
5) Subjects contributions should be recognized
3 Requirements that are especially relevant to evaluate the ethics of this clinical trial:
1) Value
2) Scientific validity
3) Risk-benefit ratio
Example of a study that had no value
- Existing anti-emetic (anti-vomiting) medications of the time: effective, but not completely effective
