Ethical Considerations & Compliance Flashcards
7 cards from real CRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Ethical Considerations & Compliance flashcards as text
A researcher wants to use existing biobank samples without re-contacting donors. Under what condition is this ethically permissible without new consent?
Answer: The samples are fully de-identified per HIPAA Safe Harbor standards
If samples are de-identified according to HIPAA Safe Harbor or Expert Determination methods, they fall outside the definition of human subjects research.
Which of the following BEST describes a 'waiver of informed consent' as permitted by the Common Rule?
Answer: An IRB may waive consent if the research poses no more than minimal risk and waiver won't adversely affect rights
The Common Rule (45 CFR 46.116(f)) allows IRBs to waive consent when research involves minimal risk and participants' rights are not compromised.
In the context of research compliance, what is the primary purpose of a Data Safety Monitoring Board (DSMB)?
Answer: To independently monitor accumulating data and protect participant safety
A DSMB provides independent oversight of clinical trial data to safeguard participants and assess whether a study should continue, modify, or stop.
Research involving which of the following groups triggers additional federal protections under Subparts B-D of 45 CFR 46?
Answer: Pregnant women, prisoners, and children
Subparts B, C, and D of 45 CFR 46 provide additional protections specifically for pregnant women, prisoners, and children, respectively.
A PI lists a colleague as a co-investigator without their knowledge to meet funding requirements. This is an example of:
Answer: Research misconduct through misrepresentation
Listing someone without their consent misrepresents authorship or personnel, constituting research misconduct.
Which ethical framework requires that research minimize risks to participants and maximize potential benefits, even when participants cannot fully protect their own interests?
Answer: Beneficence as defined in the Belmont Report
Beneficence in the Belmont Report obligates researchers to maximize possible benefits and minimize possible harms to participants.
A researcher collects data on substance use but fails to obtain a Certificate of Confidentiality. What is the primary risk?
Answer: Participant data could be compelled by legal subpoena
Without a Certificate of Confidentiality, sensitive research data such as substance use information can be subpoenaed by courts or law enforcement.