CRA Regulatory Compliance and Ethics

Question 1

Why is IRB approval important in research involving humans?

Accepted Answer

To protect the rights and safety of participants

Answer

Institutional Review Board (IRB) approval is paramount in research involving human subjects because its primary purpose is to safeguard the rights, welfare, and safety of participants. The IRB reviews research protocols to ensure ethical conduct, minimize risks, and confirm that informed consent procedures are adequate, thereby upholding ethical standards in research.

Question 2

What does informed consent mean?

Accepted Answer

Participants understand and voluntarily agree

Answer

Informed consent is a fundamental ethical principle in research, meaning that potential participants must be fully informed about the study's purpose, procedures, risks, and benefits before they agree to participate. Their agreement must be voluntary, free from coercion, and based on a clear understanding of what their involvement entails, ensuring respect for autonomy.

Question 3

What is a conflict of interest in research?

Accepted Answer

Personal interests could bias research decisions

Answer

A conflict of interest in research arises when a researcher's personal financial, professional, or other private interests could potentially influence or appear to influence the design, conduct, or reporting of research. Such conflicts can undermine objectivity, compromise the integrity of the research, and erode public trust, necessitating disclosure and management.

Question 4

Why is data confidentiality important?

Accepted Answer

To protect participant privacy

Answer

Data confidentiality is crucial in research, especially when dealing with sensitive information from human subjects. It ensures that identifiable information collected from participants is protected from unauthorized access, disclosure, or misuse. Maintaining confidentiality is an ethical obligation and a legal requirement to safeguard participant privacy and trust.

Question 5

Which regulation protects human subjects in U.S. research?

Accepted Answer

Common Rule

Answer

The Common Rule (45 CFR Part 46, Subpart A) is the foundational federal policy in the United States that outlines the ethical principles and regulatory requirements for protecting human subjects in research. It mandates institutional review board (IRB) review, informed consent, and other safeguards for federally funded research involving humans.

(CRA) Certified Research Administrator Practice Test

(CRA) Certified Research Administrator Practice Test

CRA Regulatory Compliance and Ethics