Module 1- Introduction

Question 1

Ethics

Answer 1

Action and conduct when rights, safety, and safety are safeguarded at all times

Question 2

What does a successful clinical trial look like?

Answer 2

• High quality data collected within time frame

- conducted according to the applicable regulatory requirements + guidelines at every stage

Question 3

Who participates in clinical research trials?

Answer 3

Protocol writers, scientists, IRB + IEC ( ethics boards), investigators, CRC, CRN, Montors, Associates, Auditors, Inspectors, Trial Report Writers, trial administrators

Question 4

What are the fundamental principles?

Answer 4

Informed Consent, Beneficence, and Justice

Question 5

What are the components of informed consent?

Answer 5

• treating patients as autonomous agents and extra protections for vulnerable populations, not a means to a end

Question 6

What is components of Beneficence?

Answer 6

Minimize Harm, Maximize benefits

Question 7

What are components of justice?

Answer 7

Equitable distribution of benefits and burdens

Question 8

What is unethical behavior?

Answer 8

• actions or conducts that violates rights, safety, and well being
• not always deemed illegal
• when someone has to distinguish between right and wrong

Question 9

What is Bioethics?

Answer 9

• study of ethical issues resulting from advances in biology and medicine
• concerns law, politics, science, and religion

Question 10

What are the two famous older ethical codes?

Answer 10

• 1900 Prussian Directive

- 1931 Reich Council Regulations

Question 11

What are ethics committees?

Answer 11

• governing bodies established to oversee research conduct in human subjects

Question 12

What is IRB?

Answer 12

Institutional Review Boards, Ethics Comittee in US

Question 13

What is the IEC?

Answer 13

Independent Ethics Committee- ethics committee outside of the US

Question 14

What is the ICH?

Answer 14

• International Council of Harminisation

- international quality standard for research implementation

Question 15

What is GCP?

Answer 15

Good Clinical Practice

Question 16

How does GCP define ethics committees?

Answer 16

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

Question 17

What is the goal of a ethics committee?

Answer 17

• to ensure clinical trials are carried out ethically

Question 18

What is fraud?

Answer 18

Deception practiced deliberately in order to secure unfair or unlawful gain

Intentional perversion of the truth

Question 19

What are examples of fraud?

Answer 19

• deliberately reporting false, fabricated, or misleading data
• withholding of reporting data, omission or commission of data
• fabricating (making up)
• plagarizm

Question 20

What term should you use for fraud not verified?

Answer 20

• must refer to it as suspected fraud

Question 21

What Is misconduct?

Answer 21

• deviation from duty by a professional or transgression of a established agreed upon role

Question 22

What is a example of misconduct?

Answer 22

• when a investigator is never available for monitor visits even though agreed upon visit

Question 23

Therapeutic misconception

Answer 23

• 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

Question 24

Implicit

Answer 24

Implied thought not plainly expressed

Question 25

Sinecure

Answer 25

A position requiring little or no work but giving the holder status or financial benefit