Ethics Flashcards
Ethics in clinical trials
Minimize possibility of exploitation
Ensure rights and welfare of subjects
Important history in terms of ethics
The Nuremberg code (1947) The declaration of Helsinki (1964) US code of federal regulations (1974) The national research Act and the IRB system (1979) The Belmont report (1979) ICMR Guidelines (2000, 2006)
Nuremberg trials
Nazi experimentation
Jewish Children and prisoners in concentration camps were used for experimentation
Thalidomide
Used by pregnant women for morning sickness.
Caused phocomelia in newborns.
Conducted without consent
Caused uneccessary pain suffering and death
Absence of benefit for the participants
Lack of adequate scientific rationale
Nuremberg Code
A set of 10 points for research ethics principles for human experimentation as a result of Nuremberg trials in second world war
The voluntary consent of human subject is absolutely essential
Declaration of Helinski
Relaxation of consent
Obtain consent if at all possible
Oversight by an independent committe (IRB/IEC)
Belmont report
Most famous biomedical research in US history
399 black men thought of have syphilis were recruited and followed to determine the course of disease (what would happen to them)
Penicillin was known to be an effective treatment of syphilis by about 1947
The subjects were NOT INFORMED of what was being studied or of the treatment alternatives available
National research Act/Belmont report
1979
Three tenet of ethical research were established
- Respect for person
- Beneficence
- Justice
What is beneficence
Welfare of research participants as a primary goal
Remove harm from the patient to the best of one’s ability
Essential elements of ethics in research
Minimize risks to subject
Maximize benefits
Benefits should proportionally weigh out risks
Non maleficence or Beneficence
Essentiallity
Only test on human beings if Absolutely necessary
Does all current research certify the drug is safe?
Non exploitation
Provide remuneration to test subjects
Inform subjects about all potential side effects and risks
Ensure amole compensation for accidental injury
(Insurance , rehabilitation, life long support)
Privacy and confidentiality
Inform subjects about the extend ti which personal info should be disclosed
Do not divulge identity & records of test subjects as far as possible
Do not provide information which will allow identity to be guessed
Balancing principles
Balancing need for rigorous design with obligation to maximize benefits and minimize harm
Equipoise
Randomization
Choice of control
Choice of control
The benefits risks and effectiveness of a new method should be tested against those of the best current prophylactic diagnostic and therapeutic methods
Helsinki 2000