CCRC - Certified Clinical Research Coordinator Ethics and Compliance in Clinical Research Questions and Answers Flashcards

Which historical document established the foundational ethical principles for conducting research involving human subjects?

Answer: Nuremberg Code

The Nuremberg Code (1947) was the first international standard for ethical human subjects research, developed in response to Nazi experimentation atrocities.

The Belmont Report's principle of 'justice' in clinical research primarily means:

Answer: Ensuring fair selection of research participants and equitable distribution of burdens and benefits

The principle of justice requires that the selection of research participants be fair and that no group bears a disproportionate burden or is excluded from potential benefits.

Under HIPAA, what is the minimum necessary standard as applied to clinical research?

Answer: Protected health information should be limited to the minimum needed to accomplish the research purpose

The HIPAA minimum necessary standard requires that access to PHI in research be limited to only what is required to accomplish the specific research purpose.

What constitutes a conflict of interest (COI) for a clinical investigator in the US?

Answer: Having a significant financial interest in the sponsor or study outcome

A COI arises when an investigator's significant financial interest — such as equity, royalties, or consulting fees — could bias study conduct or reporting.

Which federal regulation requires financial conflict of interest disclosure for PHS-funded research at US institutions?

Answer: 42 CFR Part 50 / 45 CFR Part 94

42 CFR Part 50 and 45 CFR Part 94 govern financial conflict of interest reporting requirements for investigators on PHS (NIH) funded research.

Research misconduct in the US is formally defined under federal policy to include which of the following?

Answer: Fabrication, falsification, and plagiarism in proposing, performing, or reviewing research

The US federal definition of research misconduct (42 CFR Part 93) covers fabrication, falsification, and plagiarism; it excludes honest error and differences of opinion.