Common Rule Flashcards
What does IRB stand for?
Institutional Review Board
True or False: The Common Rule applies only to research funded by the federal government.
False
What is the primary purpose of the IRB Common Rule?
To protect the rights and welfare of human subjects involved in research.
Fill in the blank: The Common Rule was first adopted in _____.
1991
How many federal agencies have adopted the Common Rule?
15
Which section of the Common Rule outlines the criteria for IRB approval?
45 CFR 46.111
What are the three ethical principles outlined in the Belmont Report that inform the Common Rule?
Respect for persons, beneficence, and justice.
True or False: Informed consent is a requirement under the Common Rule.
True
What is the definition of ‘minimal risk’ as per the Common Rule?
The probability and magnitude of harm or discomfort anticipated in the research are not greater than those encountered in daily life.
Which populations are considered vulnerable according to the Common Rule?
Children, prisoners, pregnant women, and cognitively impaired persons.
What is the role of the IRB?
To review research proposals to ensure the protection of human subjects.
True or False: IRB approval is not required for research using existing data that does not involve human subjects.
True
What is one of the key changes made to the Common Rule in 2018?
The introduction of new requirements for informed consent.
What is the purpose of ‘waivers’ in the context of the Common Rule?
To allow research to proceed without full informed consent under certain conditions.
Fill in the blank: The Common Rule applies to _____.
research involving human subjects.
Which document must be provided to subjects to ensure informed consent?
Informed consent form
What does the term ‘expedited review’ refer to in the IRB process?
A faster review process for research involving minimal risk.
True or False: The IRB must consist of at least five members.
True
What is the significance of the ‘continuing review’ requirement?
To ensure ongoing protection of subjects after initial IRB approval.
What is a ‘serious adverse event’ in research?
An event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
What is the function of the ‘Federalwide Assurance’ (FWA) in relation to the Common Rule?
To provide assurance that an institution will comply with the Common Rule.
Fill in the blank: The Common Rule applies to research conducted in _____.
the United States.
What does the term ‘deception’ mean in research ethics under the Common Rule?
Withholding information or providing false information to subjects.
True or False: Researchers can begin their study as soon as they submit their proposal to the IRB.
False
What is the required action for researchers if a study changes significantly after IRB approval?
Submit an amendment to the IRB for review.
