CIP CIP Informed Consent Process & Documentation 1

Question 1

Which federal regulation establishes the basic requirements for informed consent in human subjects research in the US?

Accepted Answer

45 CFR 46

Answer

45 CFR 46 (the Common Rule) establishes the foundational informed consent requirements for federally funded human subjects research.

Question 2

What is the minimum required element of informed consent regarding duration?

Accepted Answer

A statement of the expected duration of the subject's participation

Answer

The regulations require disclosure of the expected duration of the individual subject's participation, not just the overall study timeline.

Question 3

Under 21 CFR 50, which of the following is a basic element of informed consent?

Accepted Answer

A description of reasonably foreseeable risks or discomforts

Answer

Reasonably foreseeable risks and discomforts must be disclosed as a basic element under both 21 CFR 50 and 45 CFR 46.

Question 4

When may an IRB waive the requirement to obtain a signed informed consent document?

Accepted Answer

When the research presents no more than minimal risk and involves no procedures for which consent is normally required

Answer

An IRB may waive signed consent when the research is minimal risk and involves no procedures ordinarily requiring written consent, per 45 CFR 46.117(c).

Question 5

Which of the following best describes 'legally authorized representative' (LAR) in the context of informed consent?

Accepted Answer

An individual or judicial body authorized under applicable law to consent on behalf of a prospective subject

Answer

An LAR is defined by applicable law and may provide consent on behalf of subjects who lack decision-making capacity.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP CIP Informed Consent Process & Documentation 1