OH YOU WANT TO TALK ABOUT ETHICS HUH?!

During which year was the Declaration of Helsinki published? 1970 1920 1964 1997

1964

Preventative measures for fraud or misconduct are: (Select all that apply) 1) Adopting zero tolerance 2) Protecting whistle blowers 3) Calling your mother 4) Being friends with your peers in the clinical research team 5) Modeling ethical behavior 6) Trusting the researchers will do a good job

Adopting zero tolerance, Protecting whistle blowers, modeling ethical behavior

Adhering to ethical practices: (Select all that apply) 1) Establishes sound principles for evaluating clinical studies on a global scale 2) Reduces the risks for the sponsor 3)Protects the reputation of the clinical researcher 4) Protects the subject and thereby human life

All of the Above

Which is true regarding the Declaration of Helsinki? (Select all that apply) 1) Developed by the World Medical Association 2) Purpose was to develop and regulate ethical principles on a global scale 3) The first significant effort by the medical community to regulate itself. 4) Translated the Nuremburg Code and provided the ethical principles for ICH GCP (International Conference on Harmonization, Good Clinical Practice).

All of the Above

No conflict between the ethics of clinical care (treating the patient) and those of research (collecting data)

Clinical equipoise

The characteristics of the 'Informed Consent' as per the Belmont Report are:(Select all that apply) 1) Comprehension 2) Voluntary 3) Deliberate 4)Specific 5) Information

Comprehension, Voluntary, Information

The introduction of which ethical guideline states: It is the mission of the doctor to safeguard the health of the people. His knowledge and conscience are dedicated to the fulfilment of this mission. The Belmont Report Declaration of Helsinki The Nuremberg Code None of the above

Declaration of Helsinki

Why are ethics importas in clinical research?

Ensures respectful treatment of all trials

The rules that govern how ethics are to be handled

Ethical codes

Involves moral decision making processes and distinguishes right from wrong, good from bad and acceptable from unacceptable behaviors.

Ethics

The governing bodies established to oversee research conducted in human subjects

Ethics committees

Actions or conduct that protect a subjects rights, safety and well being at all times

Ethics in clinical research

A trial coordinator told an investigator that unethical conduct almost never occurs anymore since there are accepted guidelines for ethical conduct in clinical trials, so she/he doesn't need to review and cross-check the data for its accuracy for each enrolled subject. Is this statement true or false in view of what you learned in this course?

False

A trial site is behind on its enrollment of trial subjects - only two subjects enrolled and two enrollment failures while the average enrollment on a global scale is 15 subjects per trial site. The site has limited resources (no study coordinator) to conduct the trial and it is the first Phase II trial the investigator undertakes. It takes an average of five (5) days to screen a patient for enrollment. The investigator is promised by a monitor (CRA) a city trip to New York if he/she enrolls another ten (10) patients in the trial in the next couple of weeks. The investigator really appreciates the offer and promised to have at least five (5) more subjects enrolled this week and ten (10) more next week. The CRA claims this is ethical behavior and the enrollment expectations are feasible, because the enrollments will occur according the protocol and the investigator knows what he/she is doing as the investigator did a Phase III trial before. They just now need to prioritize the trial over their other duties. Is this a true or false statement, in view of what you have learned in this course?

False

The Belmont Report has four (4) ethical principles, meaning respect for persons, beneficence, justice and respect for society. Is this statement true or false?

False

The Nuremberg code is considered the first actual law on ethical conduct in clinical trials. True/False

False

When you suspect fraud it is ok to speak of 'fraud' in any communication related to the issue. Is this statement true or false?

False

A deception deliberately practiced in order to secure unfair or unlawful gain.

Fraud

What do you do when you detect potential fraud or misconduct? (Select all that apply) 1) Call the police or fire brigade 2) Investigate 3) Leave as it is, it will be resolved by itself 4) Gather evidence in any matter (legal or illegal) 5) Discuss with the person you suspect 6) Believe hearsay 7) Follow applicable regulations

Investigate, Follow applicable regulations

Possible reasons for fraud or misconduct are (Select all that apply): 1) Lack of resources 2) Lack of knowledge and training 3) Conducting clinical trials mainly for financial reasons 4) Human nature, which is by default 'bad' 5) The will to challenge inspectors to see if they can get 'caught' 6) Time constraints

Lack of Resources, Lack of knowledge and training, conducting clinical trials mainly for financial reasons, time constraints

A deviation from duty by one employed in a professional capacity;a transgression of an established rule

Misconduct

A data manager detects an inconsistency in trial data. He/she immediately calls the investigator of the trial at the trial site and asks for clarifications and starts the conversation by saying fraud has been committed. The data manager then sets up an appointment to visit the site and to check all data. Based upon what you learned in this course, did the data manager act as he/she should?

No

In the case of a randomized study - two or more investigational products (medicines) are being used - an investigator keeps on randomizing the same patient until this patient gets the investigational product or medication he/she wants the patient to get to ensure the patient's health. Is this ethical conduct in view of what you learned in this course?

No

The three key principals of the Belmont Report are (select all that apply): 1) Respect for Persons, Justice, Beneficence 2) Competence, Respect, Beneficence 3) Benevolence, Justice, Respect 4) Competence, Trust, Benevolence

Respect for Persons, Justice, Beneficence

According to the Nuremberg code, experiments can be conducted by A. Nurses and doctors only B. Scientifically qualified persons C. Any persons who was trained on the protocol D. Doctors only

Scientifically qualified persons

TEST

TEST

When selecting a trial site for a clinical trial, which does the selector need to be vigilant about with regards to 'ethics'? 1) The investigator and the site staff have the potential subjects and the resources to be able to conduct the trial according the protocol 2) The Investigator is close friends with several sponsor employees. 3) The Investigator and Site Staff are approachable and hard working. 4) The Investigator commits to meeting enrollment targets within the designated timeframe.

The investigator and the site staff have the potential subjects and the resources to be able to conduct the trial according the protocol

Tensions between the ethical obligations of the physician patient relationship and those of the research subject relationship

Therapeutic misconception

'IRB' is the term used for ethics committees in the US. True/False

True

Anyone working with trial data can detect fraud or misconduct.

True

Fraud or misconduct can be detected by anyone working with the trial data. Is this statement true or false?

True

The Nuremberg Code (1949) states that during the course of an experiment, the human subjects should be at liberty to bring the experiment to an end if they have reached the physical or mental state where continuation seems to be impossible to them. True or False?

True

Unethical conduct in clinical trials can result in subject safety issues. Is this statement true or false?

True

An investigator conducting a trial in your institute or for your organization keeps on postponing the dates for organizing a quality control (QC) monitoring visit by the monitor (CRA) because he/she is too busy. Can you consider this 'unethical' behavior based on what you learned in this course?

Yes