CRP Ethical Considerations & Compliance 3 — Questions and Answers
Question 1: A researcher wants to use existing biobank samples without re-contacting donors. Under what condition is this ethically permissible without new consent?
- The research is federally funded
- The samples are fully de-identified per HIPAA Safe Harbor standards (Correct answer)
- The original consent was obtained more than 10 years ago
- The IRB chair verbally approves the use
Correct 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.
Question 2: Which of the following BEST describes a 'waiver of informed consent' as permitted by the Common Rule?
- Consent is waived whenever participants are deemed incompetent
- An IRB may waive consent if the research poses no more than minimal risk and waiver won't adversely affect rights (Correct answer)
- Consent can be waived for all federally funded studies upon sponsor request
- Waivers are only permitted for retrospective chart reviews
Correct 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.
Question 3: In the context of research compliance, what is the primary purpose of a Data Safety Monitoring Board (DSMB)?
- To ensure data is stored securely on encrypted servers
- To independently monitor accumulating data and protect participant safety (Correct answer)
- To audit financial records of the study sponsor
- To review and approve informed consent documents
Correct 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.
Question 4: Research involving which of the following groups triggers additional federal protections under Subparts B-D of 45 CFR 46?
- Graduate students and academic staff
- Pregnant women, prisoners, and children (Correct answer)
- International participants and non-English speakers
- Participants in Phase IV post-marketing studies
Correct 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.
Question 5: A PI lists a colleague as a co-investigator without their knowledge to meet funding requirements. This is an example of:
- Protocol deviation
- Research misconduct through misrepresentation (Correct answer)
- A minor administrative error
- Conflict of interest disclosure failure
Correct answer: Research misconduct through misrepresentation
Listing someone without their consent misrepresents authorship or personnel, constituting research misconduct.
Question 6: Which ethical framework requires that research minimize risks to participants and maximize potential benefits, even when participants cannot fully protect their own interests?
- Autonomy-based ethics
- Beneficence as defined in the Belmont Report (Correct answer)
- Virtue ethics in research
- Contractarian research ethics
Correct 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.
Question 7: A researcher collects data on substance use but fails to obtain a Certificate of Confidentiality. What is the primary risk?
- Data may not be used in peer-reviewed publications
- Participant data could be compelled by legal subpoena (Correct answer)
- The study will be automatically terminated by the IRB
- Federal funding will be immediately withdrawn
Correct 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.
CRP Ethical Considerations & Compliance 3
A researcher wants to use existing biobank samples without re-contacting donors.
Under what condition is this ethically permissible without new consent?