Professional Standards and Ethics Flashcards
7 cards from real RA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Professional Standards and Ethics flashcards as text
Under FDA regulations (21 CFR 312.62), how long must an investigator generally retain records for a drug study?
Answer: 2 years after marketing approval, or 2 years after the investigation is discontinued and FDA is notified
FDA requires retention for 2 years following approval of the application, or 2 years after the investigation is discontinued and FDA notified, though sponsors may require longer.
A research assistant suspects a colleague of fabricating interview data. What is the most appropriate action?
Answer: Report concerns in good faith through institutional channels, such as the PI or research integrity officer
Good-faith reporting through official channels is expected, and whistleblowers are protected from retaliation under federal policy.
Which of the following is an example of coercion in research recruitment?
Answer: A professor telling students their grade may suffer if they do not participate
Coercion involves an overt or implied threat of harm to obtain compliance.
Why must study staff complete human subjects protection training (such as CITI) before working with participants?
Answer: It ensures staff understand ethical and regulatory requirements for protecting participants
Institutions and sponsors require such training so all personnel understand participant protections and regulations.
A participant tells a research assistant about a new serious hospitalization. What is the assistant's responsibility?
Answer: Promptly inform the PI so it can be assessed and reported as a possible serious adverse event per the protocol
Serious adverse events have strict reporting timelines, so the PI must be notified promptly for assessment and reporting.
Which statement about using a Certificate of Confidentiality is accurate?
Answer: It protects identifiable sensitive research information from compelled disclosure, such as subpoenas
Certificates of Confidentiality protect identifiable, sensitive research data from forced disclosure in legal proceedings.
A research assistant is also a friend of a potential participant. What is the best way to manage this during recruitment?
Answer: Have another qualified team member conduct the consent discussion to minimize undue influence
Having a neutral team member obtain consent reduces the risk of perceived pressure from a personal relationship.