Ethical & Legal Considerations 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 Ethical & Legal Considerations flashcards as text
A sponsor proposes paying investigators based on the number of participants enrolled. Under GCP, this arrangement:
Answer: Creates a financial incentive that could bias enrollment and must be disclosed
Per-participant payments tied to enrollment create financial incentives that may bias judgment and must be disclosed to the IRB as a potential conflict.
The 'minimal risk' standard in research ethics means that:
Answer: The probability and magnitude of harm are not greater than those ordinarily encountered in daily life
Minimal risk compares the anticipated risks of research to the everyday risks healthy individuals normally experience.
A clinical trial site is audited by the FDA and found to have inadequate consent documentation. The primary regulatory consequence may include:
Answer: Warning letters, disqualification of data, or investigator debarment
FDA audits for consent deficiencies can result in warning letters, rejection of study data, or investigator disqualification proceedings.
Which of the following is an example of the 'respect for persons' principle from the Belmont Report?
Answer: Allowing competent adults to make autonomous decisions about participation
Respect for Persons requires treating individuals as autonomous agents capable of making their own informed decisions.
A researcher publishes study results that omit negative findings about the primary endpoint. This practice is known as:
Answer: Selective reporting, a form of research misconduct
Selectively reporting only favorable findings distorts the scientific record and is considered a form of research misconduct or bias.
Under the HIPAA Privacy Rule, a 'limited data set' may be used for research without individual authorization provided:
Answer: A data use agreement is in place and direct identifiers are removed
A limited data set retains some indirect identifiers but may be used for research under a data use agreement without individual authorization.
When an IRB reviews a consent form and finds it uses highly technical language at a graduate reading level, the primary ethical concern is:
Answer: Participants may not truly understand what they are consenting to, undermining autonomy
Informed consent requires that information be presented in language understandable to the participant, typically at an 8th-grade reading level.