CRA Ethical & Legal Considerations 3 — Questions and Answers
Question 1: A participant in a longitudinal study becomes legally incapacitated after enrolling. What happens to their continued participation?
- They are automatically withdrawn from the study
- A legally authorized representative may provide consent to continue (Correct answer)
- The original consent form remains sufficient to continue
- The IRB must approve continuation on a case-by-case basis each visit
Correct answer: A legally authorized representative may provide consent to continue
When a participant loses decision-making capacity, a legally authorized representative (LAR) must provide surrogate consent for continued participation.
Question 2: Which scenario constitutes a conflict of interest that a researcher must disclose?
- Owning stock in a company whose competitor's drug is being studied
- Receiving honoraria for speaking at a conference unrelated to the research
- Having a financial interest in the sponsor company funding the study (Correct answer)
- Being a co-investigator on a separately funded study
Correct answer: Having a financial interest in the sponsor company funding the study
A direct financial interest in the sponsoring company creates a conflict of interest that must be disclosed to the IRB and institution.
Question 3: The principle of 'justice' in the Belmont Report primarily addresses:
- Ensuring participants are compensated fairly for their time
- Fair distribution of research benefits and burdens across populations (Correct answer)
- Legal liability of researchers for participant harm
- Equitable allocation of research funding
Correct answer: Fair distribution of research benefits and burdens across populations
Justice requires that the selection of research subjects be fair and that no group bears a disproportionate burden of research risks.
Question 4: A CRA reviewing source documents finds that a laboratory value was changed without an explanation or audit trail. This is an example of:
- A protocol deviation requiring IRB notification
- A serious adverse event
- Data falsification, a form of research misconduct (Correct answer)
- An acceptable correction if the value was transcribed incorrectly
Correct answer: Data falsification, a form of research misconduct
Altering data without documentation or justification constitutes data falsification, a serious form of research misconduct.
Question 5: Under 21 CFR Part 50, which of the following is NOT a required element of informed consent?
- A description of foreseeable risks
- The expected duration of participation
- The name of the IRB chairperson (Correct answer)
- A statement describing confidentiality protections
Correct answer: The name of the IRB chairperson
The eight basic elements of informed consent do not include identifying the IRB chairperson by name.
Question 6: A participant asks to withdraw from a study but wants to keep their data in the analysis. The researcher should:
- Remove the data because withdrawal means full removal
- Honor the request since consent allows data retention if desired (Correct answer)
- Seek IRB guidance before making any decision
- Retain all data automatically regardless of participant wishes
Correct answer: Honor the request since consent allows data retention if desired
Participants may withdraw from further participation while allowing already-collected data to remain in the analysis, and researchers should honor this preference.
Question 7: Which FDA regulation governs financial disclosure requirements for clinical investigators?
- 21 CFR Part 11
- 21 CFR Part 54 (Correct answer)
- 21 CFR Part 312
- 21 CFR Part 56
Correct answer: 21 CFR Part 54
21 CFR Part 54 requires sponsors to certify or disclose financial interests of clinical investigators to the FDA.
CRA Ethical & Legal Considerations 3
A participant in a longitudinal study becomes legally incapacitated after enrolling.
What happens to their continued participation?