Professional Standards & Best Practices Flashcards

A research participant asks to see their individual data after study completion. What is the best practice response?

Answer: Provide access to their own data unless specific scientific or ethical justifications prevent it

Participants generally have the right to access their own data; researchers should accommodate such requests unless doing so would harm other participants or compromise blinding.

What is the purpose of a Data Safety Monitoring Board (DSMB) in clinical research?

Answer: To provide independent interim review of accumulating data for safety and efficacy

A DSMB independently reviews interim data to protect participant safety and can recommend stopping or modifying a trial if harm or clear benefit is detected.

Under the revised Common Rule (2018), what is the key feature of 'broad consent'?

Answer: Consent for future unspecified research use of stored biospecimens or data within defined limits

Broad consent allows stored specimens or data to be used in future studies without re-consent, provided participants are informed of the scope and limitations.

A junior researcher discovers that a senior colleague plagiarized sections of a grant application. The junior researcher is not named on the grant. What should they do?

Answer: Report the suspected misconduct through the institution's research integrity channels

Research misconduct should be reported through institutional channels regardless of the reporter's status on the grant, as integrity obligations extend to all research community members.

Which best describes the ethical obligation when unexpected incidental findings are discovered during research, such as detecting a health condition in a participant?

Answer: Follow a pre-specified plan for disclosing clinically actionable findings to participants

Best practice requires a prospective plan for managing incidental findings, with disclosure of clinically significant and actionable findings to protect participant welfare.

A pharmaceutical company funds an independent academic researcher to conduct a drug trial. To maintain independence, which safeguard is most important?

Answer: The researcher controls data access, analysis, and publication decisions independently of the sponsor

Researcher independence requires control over data, analysis, and the right to publish regardless of outcome, which must be contractually established before the study begins.

A CRP professional is closing out a completed study. Which of the following is a required best practice for data management at study close?

Answer: Archive data securely per retention policy, de-identify where required, and document the disposition of all study materials

Proper study closeout requires secure archiving, appropriate de-identification, and documentation of all data and material dispositions per regulatory and institutional standards.