Part 50: Protection Of Human Subjects

Question 1

An individual who actually conducts a clinical investigation

Answer 1

Investigator

Question 2

A person who initiates a clinical investigation, but who does not actually conduct the investigation

Answer 2

Sponsor

Question 3

An individual who both initiates and actually conducts, alone or with others, a clinical investigation

Answer 3

Sponsor-investigator

Question 4

A child’s affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as ___________

Answer 4

Assent

Question 5

Exception from general requirements of informed consent (IC) must certify in writing all of the following:

Answer 5

must be certified by an investigator and a physician who is not otherwise participating in the clinical investigation
1) human subject is confronted by life-threatening situation
2) IC cannot be obtained because of an inability to communicate with or obtain legally effective consent from the subject
3) time is not sufficient to obtain IC from subject’s legal representative
4) if time is of the essence and cannot receive determination from a non-involved physician, within 5 working days of using the test article, must be reviewed and evaluated in writing by the non-involved physician
5) written documentation must be submitted to IRB within 5 working days