Question 1
Question :

According to the federal regulations, research is eligible for exemption, if
Your answer : The research falls into one of six categories of research activity described in the regulations.
Correct Answer : The research falls into one of six categories of research activity described in the regulations.
Comment :

Research is only eligible for exemption if all the activity associated with the research fall into one of six categories of activities described in the federal regulations. The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the investigator are not criteria for determining eligibility for exemption.
Points Earned : 1
Question 2
Question :

In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS regulations provides additional protections for which of the following vulnerable populations?
Your answer : Prisoners.
Correct Answer : Prisoners.
Comment :

Prisoners are provided additional protections in the DHHS regulations. The DHHS regulations do not have specific additional protections for the elderly, for students, or for persons whose decision-making capabilities are impaired. Investigators may consider and the IRB may require additional safeguards for these populations.
Points Earned : 1
Question 3
Question :

According to federal regulations, the expedited review process may be used when the study procedures pose:
Your answer : No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
Correct Answer : No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
Comment :

Research is eligible for expedited review when it poses no more than minimal risk to the participants and when all the activities fall within categories identified as eligible. Studies with more than minimal risk do not qualify for expedited review even if the subjects are adults, the sponsor is in a hurry, or the study replicates previously approved research.
Points Earned : 1
Question 4
Question :

Continuing review of an approved and ongoing protocol
Your answer : Must occur within 12 months of the approval date.
Correct Answer : Must occur within 12 months of the approval date.
Comment :

Continuing review of an approved protocol must occur within 12 months of the approval date even if no additional risks have been identified. Review by a convened IRB is not always required, see expedited review category 8 as an example. Any unanticipated problems must be addressed during the continuing review process, but the review must include other information such as the number of subjects accrued, any relevant recent literature, and a copy of the current consent form.
Points Earned : 1
Question 5
Question :

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?
Your answer : Officials of the institution may overrule an IRB approval.
Correct Answer : Officials of the institution may overrule an IRB approval.
Comment :

If an IRB has disapproved a protocol, that disapproval may not be overturned by an institutional official or anyone at that institution, such as a department chair. However, an IRB-approved protocol may may be subject to other reviews at the institution and may be disapproved (overruled).
Points Earned : 1