CRP CRP Informed Consent & Participant Rights

Question 1

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

Accepted Answer

45 CFR Part 46 (The Common Rule)

Answer

21 CFR Part 11

Answer

40 CFR Part 26

Answer

29 CFR Part 19

Question 2

What is the primary purpose of the informed consent process in research?

Accepted Answer

To ensure participants voluntarily agree after understanding the study

Answer

To protect the institution from liability

Answer

To satisfy publication journal requirements

Answer

To speed up IRB approval

Question 3

Which of the following is a required element of informed consent under the revised Common Rule?

Accepted Answer

A statement describing the extent to which confidentiality will be maintained

Answer

Participant's Social Security Number

Answer

The IRB chairperson's signature

Answer

Sponsor's financial projections

Question 4

When may a researcher waive the requirement for written informed consent?

Accepted Answer

When the IRB determines the research presents no greater than minimal risk and a waiver won't adversely affect participants' rights

Answer

Whenever the study is observational

Answer

When the study is industry-sponsored

Answer

When fewer than 50 participants are enrolled

Question 5

Which principle from the Belmont Report directly underpins the informed consent requirement?

Accepted Answer

Respect for Persons

Answer

Justice

Answer

Beneficence

Answer

Non-maleficence

Question 6

What must a researcher do if significant new information arises during a study that could affect a participant's willingness to continue?

Accepted Answer

Re-consent participants by providing updated information

Answer

Wait until the study ends to disclose it

Answer

Only notify the IRB without telling participants

Answer

Terminate only participants at elevated risk