Professional Standards and Ethics Flashcards
7 cards from real RA practice questions. Tap to flip, then mark Knew It or Still Learning โ missed cards come back until you master them.
Read the first 7 Professional Standards and Ethics flashcards as text
A participant who is midway through a study states they want to stop. What is the research assistant's correct response?
Answer: Respect the withdrawal without penalty and follow the protocol's withdrawal procedures
Participants may withdraw at any time without penalty or loss of benefits to which they are otherwise entitled.
Which group is given additional protections under Subpart B of 45 CFR 46?
Answer: Pregnant women, human fetuses, and neonates
Subpart B covers pregnant women, human fetuses, and neonates; Subpart C covers prisoners and Subpart D covers children.
For research with children, what is the term for a child's affirmative agreement to participate?
Answer: Assent
Children give assent, while parents or guardians provide permission.
A research assistant accidentally emails a spreadsheet containing participant names and diagnoses to the wrong outside recipient. What should they do first?
Answer: Promptly report the incident to the PI and follow institutional breach reporting procedures
Potential privacy breaches must be reported promptly so the institution can assess and meet HIPAA and IRB reporting obligations.
Which of the following is NOT one of the HIPAA Safe Harbor identifiers that must be removed to de-identify data?
Answer: A participant's year of birth
Under Safe Harbor, all elements of dates except year must be removed, so year of birth may remain (except for ages over 89).
A sponsor offers a research assistant a gift card for enrolling more participants than other sites. What is the main ethical concern?
Answer: The incentive may pressure staff to enroll ineligible participants or apply undue influence
Enrollment-based bonuses (finder's fees) create conflicts that may compromise eligibility decisions and voluntary consent, and many institutions prohibit them.
Which practice best reflects the ALCOA principle of 'Contemporaneous' documentation?
Answer: Recording data at the time the activity occurs
Contemporaneous means data are recorded at the time the observation or activity is performed.