CCRC CCRC - Certified Clinical Research Coordinator Ethics and Compliance in Clinical Research Questions and Answers 1 — Questions and Answers
Question 1: Which historical document established the foundational ethical principles for conducting research involving human subjects?
- Declaration of Helsinki
- Belmont Report
- Nuremberg Code (Correct answer)
- Common Rule (45 CFR 46)
Correct answer: Nuremberg Code
The Nuremberg Code (1947) was the first international standard for ethical human subjects research, developed in response to Nazi experimentation atrocities.
Question 2: The Belmont Report's principle of 'justice' in clinical research primarily means:
- Maximizing benefits while minimizing risks
- Ensuring fair selection of research participants and equitable distribution of burdens and benefits (Correct answer)
- Respecting participants' right to make autonomous decisions
- Providing truthful information to participants
Correct 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.
Question 3: Under HIPAA, what is the minimum necessary standard as applied to clinical research?
- Researchers may access all medical records for any participant
- Protected health information should be limited to the minimum needed to accomplish the research purpose (Correct answer)
- All PHI must be de-identified before any research use
- Participants must re-consent for every data access
Correct 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.
Question 4: What constitutes a conflict of interest (COI) for a clinical investigator in the US?
- Holding a medical license while conducting research
- Having a significant financial interest in the sponsor or study outcome (Correct answer)
- Enrolling participants from their own patient population
- Receiving salary support from a federal grant
Correct 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.
Question 5: Which federal regulation requires financial conflict of interest disclosure for PHS-funded research at US institutions?
- 21 CFR Part 312
- 45 CFR Part 46
- 42 CFR Part 50 / 45 CFR Part 94 (Correct answer)
- 21 CFR Part 50
Correct 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.
Question 6: Research misconduct in the US is formally defined under federal policy to include which of the following?
- Honest errors in data interpretation
- Fabrication, falsification, and plagiarism in proposing, performing, or reviewing research (Correct answer)
- Publishing negative study results
- Disagreements among co-investigators about study design
Correct 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.
CCRC CCRC - Certified Clinical Research Coordinator Ethics and Compliance in Clinical Research Questions and Answers 1
Which historical document established the foundational ethical principles for conducting research involving human subjects?