Question 1

According to federal regulations, an IRB must have at least two community members to fulfill membership requirements; one member whose expertise is not in a scientific area and one member who is not affiliated with the institution.

	True
	False

Question 2

Dr. Jones has submitted a study for review by the IRB. He is an active member of the organization's IRB and is listed as a Co-Investigator in the section detailing study personnel. As a member of the IRB, he must leave the room before the final discussion and voting at the IRB meeting when this study is reviewed.

	True
	False

Question 3

One of the community members on the IRB is assigned as the secondary reviewer for a new study sponsored by a company that produces standardized educational tests for school systems. During her review, she is surprised to note that the company is one in which her husband owns $20,000 worth of stock and she must tell the IRB that she has a conflict. As a member of the IRB she may answer questions from the committee, but must leave the room prior to the final deliberation and vote on the project.

	True
	False

Question 4

Which of the following IRB submissions require review and approval by the convened IRB ?

	Continuing review of activities that involve more than minimal risk
	Any research using only "coded data or specimens"
	Any research activity that involves less than minimal risk
	Any amendments in study procedures that involve less than minimal risk

Question 5

According to the federal regulations (45 CFR 46 Subpart A, also known as the "Common Rule") which of the following IRB review criteria must be met in order for an IRB to approve a study?

	Risks to subjects are minimized
	Reasonable risk/benefit ratio
	Informed consent will be appropriately documented
	Selection of subjects is equitable
	All of the above