Ethics
Action and conduct when rights, safety, and safety are safeguarded at all times
What does a successful clinical trial look like?
- High quality data collected within time frame
- conducted according to the applicable regulatory requirements + guidelines at every stage
Who participates in clinical research trials?
Protocol writers, scientists, IRB + IEC ( ethics boards), investigators, CRC, CRN, Montors, Associates, Auditors, Inspectors, Trial Report Writers, trial administrators
What are the fundamental principles?
Informed Consent, Beneficence, and Justice
What are the components of informed consent?
- treating patients as autonomous agents and extra protections for vulnerable populations, not a means to a end
What is components of Beneficence?
Minimize Harm, Maximize benefits
What are components of justice?
Equitable distribution of benefits and burdens
What is unethical behavior?
- actions or conducts that violates rights, safety, and well being
- not always deemed illegal
- when someone has to distinguish between right and wrong
What is Bioethics?
- study of ethical issues resulting from advances in biology and medicine
- concerns law, politics, science, and religion
What are the two famous older ethical codes?
- 1900 Prussian Directive
- 1931 Reich Council Regulations
What are ethics committees?
- governing bodies established to oversee research conduct in human subjects
What is IRB?
Institutional Review Boards, Ethics Comittee in US
What is the IEC?
Independent Ethics Committee- ethics committee outside of the US
What is the ICH?
- International Council of Harminisation
- international quality standard for research implementation
What is GCP?
Good Clinical Practice
How does GCP define ethics committees?
Independent or governing bodies constituted of medical, scientific, and non-scientific, members whose responsibility is to ensure the protection of the rights safety and well being of human subjects in involved in a trial
What is the goal of a ethics committee?
- to ensure clinical trials are carried out ethically
What is fraud?
Deception practiced deliberately in order to secure unfair or unlawful gain
Intentional perversion of the truth
What are examples of fraud?
- deliberately reporting false, fabricated, or misleading data
- withholding of reporting data, omission or commission of data
- fabricating (making up)
- plagarizm
What term should you use for fraud not verified?
- must refer to it as suspected fraud
What Is misconduct?
- deviation from duty by a professional or transgression of a established agreed upon role
What is a example of misconduct?
- when a investigator is never available for monitor visits even though agreed upon visit
Therapeutic misconception
- false and often implicit thought that the primary silent of research is to benefit the patient
- there is a tension between the ethical obligations of the patient-physician relationship and the research-subject relationship
Implicit
Implied thought not plainly expressed
