CRP Professional Standards & Best Practices 3

Question 1

A CRP professional notices that an IRB-approved protocol has drifted from the actual procedures being used. What is the required action?

Accepted Answer

Submit a protocol amendment to the IRB and pause non-urgent deviations

Answer

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?

Accepted Answer

HIPAA Privacy Rule and the Common Rule (45 CFR 46)

Answer

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?

Accepted Answer

A federal protection that shields research data from compelled legal disclosure

Answer

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?

Accepted Answer

ICMJE criteria: substantial contribution, drafting/revision, final approval, and accountability

Answer

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:

Accepted Answer

Exempt research if data are de-identified per HIPAA Safe Harbor standards

Answer

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.

(CRP) Certified Research Professional Practice Test

(CRP) Certified Research Professional Practice Test

CRP Professional Standards & Best Practices 3