Good Clinical Practice (GCP) Practice Exam

Disable ads (and more) with a membership for a one time $2.99 payment

Prepare effectively for the Good Clinical Practice Exam with comprehensive study materials, including flashcards and in-depth explanations. Boost your understanding and confidence for the exam!

Each practice test/flash card set has 50 randomly selected questions from a bank of over 500. You'll get a new set of questions each time!

Practice this question and more.

Which subpart of the HHS regulations is also known as the Federal Policy or "Common Rule"?

Subpart A
Subpart B
Subpart C
Subpart D

The correct answer is: Subpart A

Subpart A of the HHS regulations is commonly referred to as the "Common Rule." This subpart outlines the basic provisions for institutional review boards (IRBs), informed consent, and assurances of compliance for research involving human subjects. The term "Common Rule" applies specifically to the federal policy that governs ethical standards for research across multiple federal agencies, ensuring consistency in protections for human subjects. Subpart A establishes essential principles such as the necessity for minimizing risks to participants, ensuring that the potential benefits justify those risks, and requiring that informed consent be obtained in a way that enables participants to understand what participation entails. Its influence extends across various fields of research, underscoring the importance of ethical research practices and the protection of human subjects. The other subparts (B, C, and D) refer to specific regulations that apply to particular populations such as pregnant women, prisoners, or children. These provide additional protections tailored to the vulnerabilities of these groups but do not constitute the overall framework of the Common Rule, which is encapsulated in Subpart A.