CRP Ethical Considerations & Compliance 3

Question 1

A researcher wants to use existing biobank samples without re-contacting donors. Under what condition is this ethically permissible without new consent?

Accepted Answer

The samples are fully de-identified per HIPAA Safe Harbor standards

Answer

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?

Accepted Answer

An IRB may waive consent if the research poses no more than minimal risk and waiver won't adversely affect rights

Answer

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)?

Accepted Answer

To independently monitor accumulating data and protect participant safety

Answer

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?

Accepted Answer

Pregnant women, prisoners, and children

Answer

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:

Accepted Answer

Research misconduct through misrepresentation

Answer

Listing someone without their consent misrepresents authorship or personnel, constituting research misconduct.

(CRP) Certified Research Professional Practice Test

(CRP) Certified Research Professional Practice Test

CRP Ethical Considerations & Compliance 3