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

Question 1

Which historical document established the foundational ethical principles for conducting research involving human subjects?

Accepted Answer

Nuremberg Code

Answer

Declaration of Helsinki

Answer

Belmont Report

Answer

Common Rule (45 CFR 46)

Question 2

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

Accepted Answer

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

Answer

Maximizing benefits while minimizing risks

Answer

Respecting participants' right to make autonomous decisions

Answer

Providing truthful information to participants

Question 3

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

Accepted Answer

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

Answer

Researchers may access all medical records for any participant

Answer

All PHI must be de-identified before any research use

Answer

Participants must re-consent for every data access

Question 4

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

Accepted Answer

Having a significant financial interest in the sponsor or study outcome

Answer

Holding a medical license while conducting research

Answer

Enrolling participants from their own patient population

Answer

Receiving salary support from a federal grant

Question 5

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

Accepted Answer

42 CFR Part 50 / 45 CFR Part 94

Answer

21 CFR Part 312

Answer

45 CFR Part 46

Answer

21 CFR Part 50

Question 6

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

Accepted Answer

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

Answer

Honest errors in data interpretation

Answer

Publishing negative study results

Answer

Disagreements among co-investigators about study design