CCRC CCRC - Certified Clinical Research Coordinator Ethics and Compliance in Clinical Research Questions and Answers 2

Question 1

A study participant who is enrolled in a clinical trial later loses decision-making capacity. What is the ethical obligation of the research team?

Accepted Answer

Obtain consent from a legally authorized representative (LAR) to continue participation

Answer

Continue the study as originally consented without modification

Answer

Automatically withdraw the participant from all study procedures

Answer

Consult the sponsor for permission to continue

Question 2

Which principle from the Belmont Report most directly supports the requirement for informed consent?

Accepted Answer

Respect for Persons

Answer

Beneficence

Answer

Justice

Answer

Non-maleficence

Question 3

When is a waiver of informed consent permissible for non-exempt research under the US Common Rule (45 CFR 46)?

Accepted Answer

When the research involves no more than minimal risk, cannot practicably be carried out without the waiver, and rights are not adversely affected

Answer

Whenever the sponsor requests it for operational convenience

Answer

When participants are unable to read the consent form

Answer

When the study involves only retrospective chart review regardless of risk

Question 4

What is the ethical rationale for including women and minorities as required participants in federally funded clinical research in the US?

Accepted Answer

To satisfy NIH Revitalization Act requirements ensuring results are generalizable across populations

Answer

To increase enrollment speed

Answer

To reduce the cost of the study

Answer

To comply with HIPAA data diversity requirements

Question 5

A coordinator discovers that a colleague has been entering fabricated lab values into the study database. What is the appropriate response?

Accepted Answer

Report the concern to the PI, IRB, and institutional research integrity office

Answer

Ignore it to avoid workplace conflict

Answer

Confront the colleague privately and ask them to stop

Answer

Correct the entries silently without reporting

Question 6

Under the Common Rule, which of the following studies qualifies for exemption from full IRB review?

Accepted Answer

A survey study of adults involving no sensitive topics and no identifiable information

Answer

A phase II drug trial in cancer patients

Answer

An observational study of pregnant women with blood draws

Answer

A gene therapy study in healthy volunteers