Resident Rights & Advocacy Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Resident Rights & Advocacy flashcards as text
In a multi-site clinical trial, which entity holds primary responsibility for ensuring that each participating site's IRB has approved the protocol before enrollment begins?
Answer: The principal investigator at each site
Each site's PI bears primary responsibility for obtaining IRB approval at their institution before enrolling any subjects, regardless of central IRB arrangements.
A subject enrolled in a Phase II oncology trial asks the research coordinator for a copy of their signed consent form. What is the correct response?
Answer: Provide a copy immediately, as subjects have the right to receive a copy of signed consent documents
Federal regulations (45 CFR 46.117) and good clinical practice require that subjects receive a copy of the signed consent document.
What is the ethical significance of including a placebo arm in a randomized controlled trial involving seriously ill patients?
Answer: It raises the ethical concern of withholding potentially beneficial treatment from the control group
The Declaration of Helsinki requires that placebo use be justified only when no proven intervention exists, due to concerns about withholding effective treatment.
Under the revised Common Rule (2018), which change most directly expanded protections for biospecimen donors?
Answer: Requirement of broad consent for future unspecified research use of stored biospecimens
The 2018 Common Rule introduced broad consent as a mechanism allowing future secondary research use of stored identifiable biospecimens with appropriate protections.
A community advisory board (CAB) in a clinical trial primarily serves which participant-protection function?
Answer: Providing community perspective to ensure research is culturally appropriate and responsive to community needs
CABs bring community voices into research design and oversight, helping ensure studies are ethical, culturally sensitive, and beneficial to the community being studied.
Which regulatory authority must approve an Investigational New Drug (IND) application before human subjects can receive an experimental drug in the United States?
Answer: The U.S. Food and Drug Administration (FDA)
The FDA must receive and allow an IND application to proceed before any experimental drug can be administered to human research subjects in the U.S.
A participant in a federally funded study experiences a serious adverse event. Which entity has oversight authority to investigate whether human subject protections were violated?
Answer: The Office for Human Research Protections (OHRP)
OHRP has authority under 45 CFR 46 to investigate compliance with human subject protection regulations at institutions receiving HHS funding.