CPI CPI Informed Consent & Subject Rights 2

Question 1

What is the role of a Legally Authorized Representative (LAR) in the informed consent process?

Accepted Answer

To sign consent on behalf of a subject who lacks decision-making capacity

Answer

A LAR is an individual authorized under applicable law to consent to research on behalf of a prospective subject who lacks the capacity to provide their own consent.

Question 2

Which core element must be included in ALL informed consent documents under 21 CFR 50.25?

Accepted Answer

A statement that participation is voluntary and refusal involves no penalty

Answer

A statement confirming that participation is voluntary and that refusal or withdrawal carries no penalty or loss of benefits is a basic required element under 21 CFR 50.25.

Question 3

What is a 'short form' written consent document?

Accepted Answer

A document stating that required elements were presented orally and the subject agrees

Answer

A short form consent document states that the elements of informed consent were orally presented to the subject or LAR, and requires a witness signature and written summary of what was presented.

Question 4

Under which condition is an IRB permitted to waive the requirement for signed informed consent?

Accepted Answer

When the principal risk is a breach of confidentiality and the only link to the subject is the consent form

Answer

An IRB may waive the signature requirement when the primary risk is a confidentiality breach and the signed consent form itself would be the only record linking the subject to the research.

Question 5

What is 'assent' in the context of pediatric clinical research?

Accepted Answer

A minor's affirmative agreement to participate in research, supplementing parental permission

Answer

Assent is the child's affirmative agreement to participate, required in addition to parental or guardian permission for research involving minors capable of providing meaningful agreement.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI CPI Informed Consent & Subject Rights 2