CCRC CCRC - Certified Clinical Research Coordinator Ethics and Compliance in Clinical Research Questions and Answers 2 — Questions and Answers
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?
- Continue the study as originally consented without modification
- Obtain consent from a legally authorized representative (LAR) to continue participation (Correct answer)
- Automatically withdraw the participant from all study procedures
- Consult the sponsor for permission to continue
Correct answer: Obtain consent from a legally authorized representative (LAR) to continue participation
When a participant loses capacity, ongoing research participation requires consent from a legally authorized representative unless the IRB has approved a waiver.
Question 2: Which principle from the Belmont Report most directly supports the requirement for informed consent?
- Beneficence
- Justice
- Respect for Persons (Correct answer)
- Non-maleficence
Correct answer: Respect for Persons
Respect for Persons requires acknowledging individuals as autonomous agents capable of making their own decisions, which is operationalized through the informed consent process.
Question 3: When is a waiver of informed consent permissible for non-exempt research under the US Common Rule (45 CFR 46)?
- Whenever the sponsor requests it for operational convenience
- When the research involves no more than minimal risk, cannot practicably be carried out without the waiver, and rights are not adversely affected (Correct answer)
- When participants are unable to read the consent form
- When the study involves only retrospective chart review regardless of risk
Correct answer: When the research involves no more than minimal risk, cannot practicably be carried out without the waiver, and rights are not adversely affected
Under 45 CFR 46.116(f), a waiver of consent may be granted if the research poses no more than minimal risk, cannot practicably be conducted otherwise, and does not adversely affect participant rights.
Question 4: What is the ethical rationale for including women and minorities as required participants in federally funded clinical research in the US?
- To increase enrollment speed
- To satisfy NIH Revitalization Act requirements ensuring results are generalizable across populations (Correct answer)
- To reduce the cost of the study
- To comply with HIPAA data diversity requirements
Correct answer: To satisfy NIH Revitalization Act requirements ensuring results are generalizable across populations
The NIH Revitalization Act of 1993 mandates inclusion of women and minorities in federally funded research so that findings are applicable to all segments of the US population.
Question 5: A coordinator discovers that a colleague has been entering fabricated lab values into the study database. What is the appropriate response?
- Ignore it to avoid workplace conflict
- Confront the colleague privately and ask them to stop
- Report the concern to the PI, IRB, and institutional research integrity office (Correct answer)
- Correct the entries silently without reporting
Correct answer: Report the concern to the PI, IRB, and institutional research integrity office
Data fabrication is research misconduct; the coordinator has an ethical and regulatory obligation to report it to the PI, IRB, and the institution's research integrity office.
Question 6: Under the Common Rule, which of the following studies qualifies for exemption from full IRB review?
- A phase II drug trial in cancer patients
- A survey study of adults involving no sensitive topics and no identifiable information (Correct answer)
- An observational study of pregnant women with blood draws
- A gene therapy study in healthy volunteers
Correct answer: A survey study of adults involving no sensitive topics and no identifiable information
Under 45 CFR 46.104(d)(2), surveys/interviews of adults that do not involve sensitive topics or identifiable information may qualify for exemption from full IRB review.
CCRC CCRC - Certified Clinical Research Coordinator Ethics and Compliance in Clinical Research Questions and Answers 2
A study participant who is enrolled in a clinical trial later loses decision-making capacity.
What is the ethical obligation of the research team?