CIP CIP Informed Consent Process & Documentation

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

21 CFR 11

Answer

45 CFR 164

Answer

21 CFR 50

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

A statement of the total study duration

Answer

A statement of each visit's length

Answer

A statement of the follow-up period only

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

A guarantee of confidentiality

Answer

An explanation of the sponsor's funding source

Answer

A list of all investigators on the study

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

When the PI determines it is impractical

Answer

When the study is federally funded

Answer

When the sample size exceeds 500 participants

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

Any adult family member of the subject

Answer

The subject's primary care physician

Answer

The IRB chair acting on behalf of vulnerable subjects

Question 6

What must be included in a consent form when a study involves the collection of identifiable private information?

Accepted Answer

A statement describing the extent to which confidentiality of records will be maintained

Answer

The names of all IRB members who reviewed the protocol

Answer

The complete protocol synopsis

Answer

A copy of the IRB approval letter