CIP Ethical & Regulatory Compliance

Question 1

What is the primary role of an Institutional Review Board (IRB)?

Accepted Answer

Protect research participants’ rights

Answer

The primary role of an Institutional Review Board (IRB) is to protect the rights, welfare, and safety of human participants involved in research. IRBs review and approve research protocols to ensure they meet ethical standards and regulatory requirements, safeguarding vulnerable populations and promoting responsible scientific inquiry.

Question 2

Which regulation governs ethical standards for human subjects research in the US?

Accepted Answer

The Common Rule

Answer

The Common Rule (45 CFR Part 46) is the foundational federal regulation in the United States that governs ethical standards for human subjects research. It outlines the requirements for Institutional Review Boards (IRBs), informed consent, and other protections to ensure the safety and rights of research participants.

Question 3

What is informed consent?

Accepted Answer

Providing information for informed decision

Answer

Informed consent is the ethical and legal process of providing potential research participants with comprehensive information about a study, including its purpose, procedures, risks, and benefits. This enables them to make a voluntary, educated, and autonomous decision about whether or not to participate, ensuring respect for their rights.

Question 4

What is a conflict of interest in IRB review?

Accepted Answer

Personal bias affecting decisions

Answer

A conflict of interest in IRB review arises when a board member's personal, financial, or professional relationships could improperly influence their judgment or objectivity regarding a research protocol. Such conflicts can compromise the IRB's impartiality and its primary mission to protect research participants.

Question 5

How often must IRB review research protocols?

Accepted Answer

At least annually

Answer

IRBs are mandated to review approved research protocols at least annually through a process called continuing review. This regular oversight ensures that the study continues to meet ethical standards, protect participant rights, and adhere to the approved protocol throughout its duration, adapting to any changes or new information.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Ethical & Regulatory Compliance