How much do you know about HCSs?

Q1. What are the basic principles for the protection of participants in clinical research?

(choose the BEST answer)

• A. Justice, Beneficience, Volunteering

• B. Justice, Beneficence, Respect for autonomy

• C. Non-maleficience, Compensation, Respect for autonomy

• D. All of the above

Q2. Important factors to ensure participant protection in a clinical research study include:

(choose the BEST answer)

• A. Writing a detailed study protocol and standard operating procedures

• B. Review of all study documents by an independent IRB / ethics committee

• C. Informed consent from all participants

• D. All of the above

Q3. The main principle of a Human challenge study is to:

(choose the BEST answer)

• A. Give a vaccine candidate to a group of research volunteers

• B. Monitor the research volunteers for 1 to 5 years

• C. Deliberately expose the research volunteers to an infectious pathogen

• D. None of the above

Q4. The human challenge studies should only be conducted in high-income countries.

• A. Correct

• B. Incorrect

Q5. In the Human challenge studies, which of the following statements is CORRECT?

• A. Participants must fully understand the study protocol, procedures, and potential risks before they sign the consent form

• B. The investigators are only responsible for protecting study participants from risk

• C. All study procedures must be stopped if a participant withdraws from the study

• D. Human challenge studies should only be performed using pathogens for which a specific therapy is available