Random Flashcards to make it to 200
(10 cards)
What ethical principle requires that research risks be minimized and benefits maximized?
Beneficence (from the Belmont Report).
Can a legally authorized representative (LAR) provide consent in place of a subject?
Yes, when the subject lacks capacity and LAR consent is permitted by law and IRB policy.
What must the IRB do when research involves more than minimal risk to children with no prospect of direct benefit?
Ensure the research meets Subpart D, Category 3 (46.406) and is likely to yield generalizable knowledge about the child’s condition.
If an IRB member has a conflict of interest in a study, can they participate in the vote?
No — they must recuse themselves from the discussion and vote and not count toward quorum.
What is the IRB’s responsibility when a study involves deception?
The IRB must determine that the risks are justified, and that subjects are debriefed when appropriate.
How long must IRB-related research records be retained?
At least 3 years after completion of the research or termination of IRB approval.
What is the purpose of a reliance agreement in cooperative research?
To designate one IRB as the IRB of record and define roles/responsibilities between institutions.
Who is typically responsible for submitting required reports to OHRP or FDA?
The Institutional Official (IO) or a designated representative from the institution.
What is the role of an educational program in human subjects research oversight?
To ensure that IRB members, investigators, and staff are trained in ethical principles, regulations, and institutional policies.
I only had 199 flash cards so I made this one to make it to 200
Yes, I know, this is pointless
