CRP Informed Consent & Participant Rights Flashcards

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.