CME questions and objectives
CME questions
The CME objectives for IRB Advisor will help physicians to be able to:
- establish clinical trial programs using accepted ethical principles for human subject protection;
- understand the regulatory qualifications regarding human subject research;
- comply with the necessary educational requirements regarding informed consent and human subject research;
- apply the necessary safeguards for patient recruitment, follow-up, and reporting of findings for human subject research;
- have an understanding of the potential for conflict of financial interests involving human subject research;
- understand reporting adverse events during research.
1. The Institute of Medicine’s recent report on accreditation standards for the Veterans Affairs (VA) medical centers recommend:
A. the adoption of current FDA standards for VA centers
B. the adoption of NCQA standards for all IRBs
C. the adoption of PRIM&R standards for all IRBs
D. all of the above
2. Testimony from the U.S. General Accounting Office director Janet Heinrich can be summarized as:
A. failures at the individual, institutional, and governmental levels
B. gaps in the current system have created a loss of momentum
C. the newly created OHRP office has not achieved its initial goals
D. all of the above
3. According to Stephen Hanlon, a manager at Holland & Knight’s community services team in Tallahassee, FL, which items are not available to hospitals in human research compliance efforts:
A. adequate time
B. adequate resources
C. adequate mechanisms
D. all of the above
4. The primary conclusion of the National Bioethics Advisory Commission’s report on the existing human research oversight system is:
A. eliminating the common rule among government agencies
B. establishing legislation to protect all participants, including privately funded programs
C. conducting all human research programs using private funds rather than federal funds
D. all of the above
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