CRP Professional Standards & Best Practices 3 — Questions and Answers
Question 1: A CRP professional notices that an IRB-approved protocol has drifted from the actual procedures being used. What is the required action?
- Continue the study and correct the protocol at annual renewal
- Submit a protocol amendment to the IRB and pause non-urgent deviations (Correct answer)
- Inform only the principal investigator and make no formal record
- Stop the study immediately and destroy all collected data
Correct answer: Submit a protocol amendment to the IRB and pause non-urgent deviations
Protocol deviations require a formal amendment submitted to the IRB, and significant deviations may necessitate pausing procedures until approval is granted.
Question 2: Which standard specifically governs the protection of personally identifiable information (PII) in federally funded research in the United States?
- HIPAA Privacy Rule and the Common Rule (45 CFR 46) (Correct answer)
- Sarbanes-Oxley Act
- Foreign Corrupt Practices Act
- Uniform Commercial Code
Correct answer: HIPAA Privacy Rule and the Common Rule (45 CFR 46)
HIPAA and the Common Rule (45 CFR 46) together establish federal standards for protecting PII and health information in research contexts.
Question 3: What is 'certificate of confidentiality' in U.S. research, and why is it used?
- A document certifying IRB approval of the consent form
- A federal protection that shields research data from compelled legal disclosure (Correct answer)
- A sponsor agreement not to publish findings without permission
- A participant agreement to keep their participation confidential
Correct answer: A federal protection that shields research data from compelled legal disclosure
A Certificate of Confidentiality is issued by NIH and protects identifiable research data from forced disclosure in legal, administrative, or legislative proceedings.
Question 4: When authorship is disputed on a multi-site research paper, what standard should be applied to determine legitimate authorship?
- Alphabetical order by last name of all team members
- ICMJE criteria: substantial contribution, drafting/revision, final approval, and accountability (Correct answer)
- Seniority-based order determined by the principal investigator
- Contribution of funding or equipment qualifies as authorship
Correct answer: ICMJE criteria: substantial contribution, drafting/revision, final approval, and accountability
The ICMJE (International Committee of Medical Journal Editors) criteria are the globally accepted standard for determining legitimate authorship.
Question 5: A researcher plans to use existing medical records for a retrospective study. Under the Common Rule, this is most likely classified as:
- Greater-than-minimal risk research requiring full IRB review
- Exempt research if data are de-identified per HIPAA Safe Harbor standards (Correct answer)
- Research not subject to any ethical oversight
- Research requiring signed consent from each patient's physician
Correct answer: Exempt research if data are de-identified per HIPAA Safe Harbor standards
Retrospective chart reviews using de-identified data typically qualify for exemption under 45 CFR 46.104(b)(4) when HIPAA de-identification standards are met.
Question 6: What does 'minimal risk' mean in the context of human subjects research regulation?
- No physical harm is possible under any circumstance
- The probability and magnitude of harm is not greater than that ordinarily encountered in daily life (Correct answer)
- The study involves fewer than 10 participants
- Risk is acceptable if participants are compensated adequately
Correct answer: The probability and magnitude of harm is not greater than that ordinarily encountered in daily life
The regulatory definition of minimal risk compares research risks to those encountered in everyday life or routine physical or psychological examinations.
Question 7: A CRP professional is designing a survey on politically sensitive topics. Which sampling approach best reduces response bias?
- Convenience sampling from social media followers
- Stratified random sampling with anonymous response collection (Correct answer)
- Voluntary online panels with incentives for agreeable responses
- Purposive sampling limited to participants with strong opinions
Correct answer: Stratified random sampling with anonymous response collection
Stratified random sampling combined with anonymity reduces self-selection bias and social desirability effects on sensitive topics.
CRP Professional Standards & Best Practices 3
A CRP professional notices that an IRB-approved protocol has drifted from the actual procedures being used.
What is the required action?