CRP CRP Informed Consent & Participant Rights 1 — Questions and Answers
Question 1: Which federal regulation establishes the basic requirements for informed consent in research involving human subjects in the US?
- 45 CFR Part 46 (The Common Rule) (Correct answer)
- 21 CFR Part 11
- 40 CFR Part 26
- 29 CFR Part 19
Correct answer: 45 CFR Part 46 (The Common Rule)
45 CFR Part 46, known as the Common Rule, establishes the foundational requirements for informed consent in federally funded human subjects research.
Question 2: What is the primary purpose of the informed consent process in research?
- To protect the institution from liability
- To ensure participants voluntarily agree after understanding the study (Correct answer)
- To satisfy publication journal requirements
- To speed up IRB approval
Correct answer: To ensure participants voluntarily agree after understanding the study
Informed consent ensures participants voluntarily choose to join a study with a full understanding of its risks, benefits, and procedures.
Question 3: Which of the following is a required element of informed consent under the revised Common Rule?
- Participant's Social Security Number
- A statement describing the extent to which confidentiality will be maintained (Correct answer)
- The IRB chairperson's signature
- Sponsor's financial projections
Correct answer: A statement describing the extent to which confidentiality will be maintained
Confidentiality protections are a required element of informed consent so participants understand how their data will be safeguarded.
Question 4: When may a researcher waive the requirement for written informed consent?
- Whenever the study is observational
- When the IRB determines the research presents no greater than minimal risk and a waiver won't adversely affect participants' rights (Correct answer)
- When the study is industry-sponsored
- When fewer than 50 participants are enrolled
Correct answer: When the IRB determines the research presents no greater than minimal risk and a waiver won't adversely affect participants' rights
An IRB may waive written informed consent for minimal-risk studies where the waiver does not adversely affect participants' rights and welfare.
Question 5: Which principle from the Belmont Report directly underpins the informed consent requirement?
- Justice
- Beneficence
- Respect for Persons (Correct answer)
- Non-maleficence
Correct answer: Respect for Persons
Respect for Persons recognizes individuals' autonomy and requires that those capable of self-determination be given the opportunity to choose whether to participate.
Question 6: What must a researcher do if significant new information arises during a study that could affect a participant's willingness to continue?
- Wait until the study ends to disclose it
- Re-consent participants by providing updated information (Correct answer)
- Only notify the IRB without telling participants
- Terminate only participants at elevated risk
Correct answer: Re-consent participants by providing updated information
Researchers must re-consent participants when new information emerges that could materially affect their decision to remain in the study.
CRP CRP Informed Consent & Participant Rights 1
Which federal regulation establishes the basic requirements for informed consent in research involving human subjects in the US?