Ethical Standards & Compliance Flashcards

Under the PHS policy (42 CFR Part 93), research misconduct includes:

Answer: Fabrication, falsification, or plagiarism

Research misconduct is defined as fabrication, falsification, or plagiarism and explicitly excludes honest error or differences of opinion.

For an FDA-regulated drug study, an investigator must retain records for at least:

Answer: 2 years after marketing approval, or 2 years after the investigation is discontinued and FDA is notified

21 CFR 312.62(c) sets retention at 2 years after approval or after discontinuation and FDA notification; sponsors or institutions may require longer.

In the ALCOA principles of data integrity, the 'C' stands for:

Answer: Contemporaneous

ALCOA means Attributable, Legible, Contemporaneous, Original, and Accurate; data should be recorded at the time of observation.

What is the correct way to correct an error on a paper source document?

Answer: Draw a single line through the error, write the correction, and initial and date it

GCP requires corrections that keep the original entry legible, with initials, date, and reason when needed.

An investigator changes a procedure without prior IRB approval to eliminate an immediate hazard to a participant. This is:

Answer: Permitted, but must be promptly reported to the IRB

21 CFR 56.108(a)(4) and 45 CFR 46 allow changes to eliminate apparent immediate hazards, which must then be promptly reported.

Under PHS financial conflict of interest regulations (42 CFR Part 50 Subpart F), the general threshold for a significant financial interest is:

Answer: $5,000

The 2011 PHS rule set $5,000 as the threshold for remuneration or equity in a publicly traded entity.

How should IRBs and study staff treat payment to research participants?

Answer: As compensation that should not be so large as to be unduly influential, and not as a benefit of research

FDA and OHRP guidance say payment is not a benefit, should be prorated, and must not unduly influence participation.