CRA Ethical & Legal Considerations 3

Question 1

A participant in a longitudinal study becomes legally incapacitated after enrolling. What happens to their continued participation?

Accepted Answer

A legally authorized representative may provide consent to continue

Answer

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?

Accepted Answer

Having a financial interest in the sponsor company funding the study

Answer

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:

Accepted Answer

Fair distribution of research benefits and burdens across populations

Answer

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:

Accepted Answer

Data falsification, a form of research misconduct

Answer

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?

Accepted Answer

The name of the IRB chairperson

Answer

The eight basic elements of informed consent do not include identifying the IRB chairperson by name.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA Ethical & Legal Considerations 3